Federal Register / Vol. 77, No. 43 / Monday, March 5, 2012 / Rules and Regulations 12997 

(4) To seek permission to transit the 

Safety Zone, the Captain of the Port or 

her representative can be contacted via 

Sector Delaware Bay Command Center 

(215) 271–4940. 

(5) This section applies to all vessels 

wishing to transit through the Safety 

Zone except vessels that are engaged in 

the following operations: (i) Enforcing 

laws; (ii) servicing aids to navigation, 

and (iii) emergency response vessels. 

(6) No person or vessel may enter or 

remain in a safety zone without the 

permission of the Captain of the Port; 

(7) Each person and vessel in a safety 

zone shall obey any direction or order 

of the Captain of the Port; 

(8) The Captain of the Port may take 

possession and control of any vessel in 

the safety zone; 

(9) The Captain of the Port may 

remove any person, vessel, article, or 

thing from a safety zone; 

(10) No person may board, or take or 

place any article or thing on board, any 

vessel in a safety zone without the 

permission of the Captain of the Port; 

and 

(11) No person may take or place any 

article or thing upon any waterfront 

facility in a safety zone without the 

permission of the Captain of the Port. 

(d) Definitions. (1) The Captain of the 

Port means the Commanding Officer of 

Sector Delaware Bay or any Coast Guard 

commissioned, warrant, or petty officer 

who has been authorized by the Captain 

of the Port to act on her behalf. 

(e) Enforcement. The U.S. Coast 

Guard may be assisted in the patrol and 

enforcement of the Safety Zone by 

Federal, State, and local agencies. 

Dated: February 3, 2012. 

Todd C. Wiemers, 

Captain, U.S. Coast Guard, Alternate Captain 

of the Port Delaware Bay. 

[FR Doc. 2012–5204 Filed 3–2–12; 8:45 am] 

BILLING CODE 9110–04–P 

DEPARTMENT OF VETERANS 

AFFAIRS 

38 CFR Part 1 

RIN 2900–AN42 

Drug and Drug-Related Supply 

Promotion by Pharmaceutical 

Company Representatives at VA 

Facilities 

AGENCY: Department of Veterans Affairs. 

ACTION: Final rule. 

SUMMARY: This final rule amends the 

Department of Veterans Affairs (VA) 

regulations regarding access to VA 

facilities by pharmaceutical company 

representatives. The purposes of the 

rule are to reduce or eliminate any 

potential for disruption in the patient 

care environment, manage activities and 

promotions at VA facilities, and provide 

pharmaceutical company 

representatives with a consistent 

standard of permissible business 

practice at VA facilities. The 

amendments will facilitate mutually 

beneficial relationships between VA and 

pharmaceutical company 

representatives. 

DATES: Effective Date: This final rule is 

effective April 4, 2012. 

FOR FURTHER INFORMATION CONTACT: 

Louis E. Cobuzzi, PBM Services (119), 

Veterans Health Administration, 

Department of Veterans Affairs, 810 

Vermont Avenue NW., Washington, DC 

20420; (202) 461–7362. (This is not a 

toll-free number). 

SUPPLEMENTARY INFORMATION: Under 38 

U.S.C. 303, the Secretary of Veterans 

Affairs is responsible for ‘‘the proper 

execution and administration of all laws 

administered by the Department and for 

the control, direction, and management 

of the Department.’’ The Secretary has 

authority to prescribe all rules necessary 

to carry out the laws administered by 

the Department, such as section 303 

regarding control and management of 

the Department. See 38 U.S.C. 501(a). 

VA has implemented this authority, as 

it pertains to management of VA 

facilities, in 38 CFR part 1. 

VA amends 38 CFR part 1 to regulate 

access to VA medical facilities by 

pharmaceutical company 

representatives promoting drugs and 

drug-related supplies. Currently, many 

policies regarding access to VA facilities 

are established and maintained at the 

local level, either by Veterans Integrated 

Service Network (VISN) leaders or by 

administrators at particular facilities. A 

VISN, which we define in § 1.220(b), is 

a network of VA medical facilities 

located in a particular region. There are 

21 such regions, and the areas that they 

service can be found at http:// 

www.vacareers.va.gov/networks.cfmm. 

On May 11, 2010, we proposed VA-wide 

rules that would be followed at the 

VISN and local levels. 

We received five comments on the 

proposed rule. Although we make a few 

modifications based on these comments 

and some organizational changes for 

improved clarity, we otherwise adopt 

the rule as proposed for the reasons 

discussed in the May 11, 2010, notice. 

A detailed consideration of the 

comments follows. 

Requests for New Definitions 

In response to the comments 

concerning the scope of § 1.220 as a 

whole, we have added a ‘‘Scope’’ 

paragraph, designated as paragraph (a), 

that states: ‘‘This rule governs on-site, 

in-person promotional activities, 

including educational activities, by 

pharmaceutical company 

representatives at VA medical facilities. 

It does not apply to the distribution of 

information and materials through other 

means.’’ This note clarifies that the rule 

governs only physical access to VA 

medical facilities and that information 

and materials can be distributed through 

other means than in-person at a VA 

medical facility. Consistent with this 

clarification of the scope of the rule, we 

have revised the heading of § 1.220 to 

‘‘On-site activities by pharmaceutical 

company representatives at VA medical 

facilities.’’ Because we inserted a new 

paragraph (a) and made other 

organizational changes to the rule, the 

paragraph designations used in the 

proposed rule have changed. 

Throughout this rulemaking we cite to 

both the proposed rule paragraph 

designation and the final rule paragraph 

designation. 

We note that we have made a 

technical revision to correctly refer to 

the ‘‘official National Formulary.’’ The 

proposed rule had referred to the 

‘‘official National Formulary of the 

United States,’’ which is not the correct 

title of the National Formulary. 

A commenter stated that the proposed 

rule does not clearly define 

‘‘educational programs and materials.’’ 

The commenter stated that proposed 

paragraph (d) ‘‘appears to apply to 

programmed events with an 

educational, rather than promotional, 

purpose * * * and the materials 

associated with such events.’’ To clarify 

the applicability of proposed paragraph 

(d), now designated as paragraph (f), we 

have added the following: ‘‘An 

educational program is a pre-scheduled 

event or meeting during which a 

pharmaceutical company representative 

provides information about a drug or 

drug-related supply.’’ We have also 

modified the word ‘‘materials’’ where it 

appears in paragraph (f) with the word 

‘‘associated’’ to make clear that the 

materials discussed in paragraph (f) are 

those materials intended for use in 

connection with an educational 

program. We note that this definition 

applies only to this section and does not 

apply to the similar terms as used by 

other U.S. Government agencies, such as 

the Food and Drug Administration 

(FDA), in their regulations or guidances. 


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The commenter also argued that 

proposed paragraph (d), now designated 

as paragraph (f), may be susceptible to 

a broad interpretation that would cover 

‘‘most promotional materials,’’ such as 

documents that instruct patients on how 

to take their medication or educate 

physicians about the side-effects 

associated with particular medications. 

This commenter, as well as others, 

appears to be concerned with the 

general breadth and scope of proposed 

paragraph (d), and we agree that these 

can be clarified. The purpose of 

proposed paragraph (d) was to monitor 

materials distributed on VA grounds in 

connection with an educational 

program. As explained in the proposed 

rule, we have concerns that a VA patient 

will obtain such materials and 

misinterpret them, which could 

interfere with that patient’s clinical 

course of treatment. As explained above, 

we revised the rule so that this 

paragraph clearly applies to educational 

programs and the materials associated 

therewith. On-site distribution of 

materials outside the context of an 

educational program is addressed in 

paragraph (h)(6) of the final rule, as 

discussed later in this rulemaking. 

One commenter suggested that VA 

delete proposed paragraph (d) entirely 

because there is insufficient clarity 

about what constitutes ‘‘programs,’’ 

noting that the rule could restrict the 

provision of educational materials 

mandated by the FDA. To address this 

comment, we have explicitly stated in 

current paragraph (f) that ‘‘[t]he 

approval authority will deem suitable 

any educational program and associated 

materials if it is part of a risk evaluation 

and mitigation strategy or other duty 

imposed by the Food and Drug 

Administration.’’ However, we note that 

even such educational programs must 

be submitted to the approval authority 

for review to ensure appropriate 

scheduling and that such educational 

program is indeed an obligation 

imposed by the FDA. We also note, as 

explained later in this preamble, that 

the required notice for an educational 

program may be given on a shortened 

basis in certain cases. 

Also related to proposed paragraph 

(d), commenters requested that VA 

define ‘‘summary of the program and all 

materials’’ and ‘‘well in advance of the 

proposed date.’’ VA’s intent is to require 

that all educational programs and 

associated materials be submitted, and 

the inclusion of the word ‘‘summary’’ 

caused confusion in this regard, so we 

removed the word ‘‘summary’’ from the 

paragraph. For ‘‘well in advance of the 

proposed date,’’ we have changed the 

phrase in current paragraph (f) to read: 

‘‘at least 60 days before the proposed 

date of the educational program or 

distribution of associated materials, 

unless VA agrees in an individual case 

to a different date.’’ We believe that this 

gives VA adequate notice, while 

allowing for flexibility in cases where 

the pharmaceutical company cannot 

provide 60 days advance notice and VA 

agrees that, in a particular case, we do 

not need the full 60 days to review the 

materials. 

A commenter requested that VA 

define ‘‘non-promotable,’’ as used in 

proposed paragraph (b)(2), because the 

word could be interpreted subjectively, 

and therefore may not be applied 

consistently in the field. Commenters 

also requested that VA publish a list of 

non-promotable drugs. We agree that it 

will be useful to pharmaceutical 

company representatives to provide 

information about where to find a list of 

such drugs. Thus, we define nonpromotable drugs as ‘‘drugs designated 

by VA as non-promotable’’ and inform 

the public that a list of such drugs will 

be available upon request or on VA’s 

Web site at http://www.pbm.va.gov. We 

have also removed the following 

sentence from proposed paragraph 

(b)(2), now designated paragraph (c)(3): 

‘‘A list of the drugs or drug-related 

supplies classified by VA as nonpromotable is available at 

www.pbm.va.gov, or may be requested 

by contacting the local office of the 

Chief of Pharmacy Services.’’ This 

sentence is no longer necessary because 

virtually identical language has been 

used in the definition for nonpromotable drugs. 

We disagree with additional 

comments suggesting that VA should 

develop a mechanism that allows 

pharmaceutical manufacturers to 

participate in the determination of 

whether a drug is non-promotable. We 

reject the commenters’ suggestions in 

order to maintain the safety of our 

patients, and so that we can continue to 

make quick, important clinical 

responses to scientific and medical 

developments related to pharmaceutical 

products. VA must independently 

determine which drugs to designate as 

non-promotable. In determining 

whether a drug is non-promotable, VA 

considers many factors, including price, 

a determination that a certain drug has 

no clinical benefit, or a finding that 

promotional materials exceed the 

clinically determined specific use of a 

drug—such as when VA makes a 

clinical decision to utilize a drug for a 

narrow purpose. For example, there may 

be a drug or new molecular entity that 

does not appear on the VA National 

Formulary (VANF), which VA uses to 

treat patients for diseases that VA would 

otherwise be unable to treat. In such 

instances, VA must continue to 

maintain strict adherence to its criteriafor-use and prevent undesired 

promotion of a drug. Therefore, VA 

must be able to designate a drug as nonpromotable in order to enforce any 

attempt by pharmaceutical company 

representatives to systematically 

promote the use of a certain drug for 

uses outside of those sanctioned by VA. 

Finally, we note that VA will rarely, if 

ever, classify a drug as non-promotable. 

In fact, we currently do not have any 

drugs classified as non-promotable, as 

reflected on our Web site at http:// 

www.pbm.va.gov. 

Commenters suggested that VA define 

‘‘facility initiative,’’ as used in proposed 

paragraph (b)(4). We understand that 

this term may create some confusion, 

and rather than define the term, we have 

revised the regulation text so that it no 

longer uses that term and instead fully 

explains the requirements. Specifically, 

in new paragraph (c)(2), we clarify the 

meaning of the requirements that we set 

forth in proposed paragraphs (b)(3) and 

(4). We require that the promotions 

must have ‘‘significant educational 

value and must not inappropriately 

divert VA staff from other activities that 

VA staff would otherwise perform 

during duty hours, including patient 

care and other educational activities.’’ 

This language accurately clarifies intent 

of the previous ‘‘facility initiatives’’ 

language. We reject an additional 

request that VA identify the decisionmaker who determines whether these 

requirements for promotion are met 

under the rule. VA respects the need for 

its various facilities to be permitted to 

initiate creative responses to the needs 

of their specific patient population, as 

well as surrounding communities. 

Moreover, different facilities will have 

different management resources 

available to make these determinations. 

We will continue to allow each facility 

to delegate to the appropriate staff 

member to make this determination. 

Commenters recommended that VA 

define ‘‘promote’’ or ‘‘promotion’’ in 

order to clarify that safety discussions 

and scientific exchanges are not 

included in the rule. Commenters also 

suggested that we clarify whether 

medical or clinical liaisons are 

specifically excluded from being 

considered promoters. We understand 

that employees of pharmaceutical 

companies attempting to visit VA 

facilities work in different capacities 

and possess varying levels of expertise. 

We also understand that this could lead 

to confusion about application of the 

rule. We clarify this issue by defining a 


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‘‘pharmaceutical company 

representative’’ as ‘‘any individual 

employed by or contracted to represent 

a pharmaceutical manufacturer or 

retailer.’’ By defining pharmaceutical 

company representative broadly, we 

remove any ambiguity as to whether an 

employee of a pharmaceutical company, 

contracted or otherwise, should follow 

the procedures set out in this rule. 

Clinical liaisons may freely discuss the 

benefits of a medication manufactured 

or sold by their employer simply by 

following the requirements set out 

under this rule. We also note again that 

pharmaceutical company 

representatives are free to provide safety 

and scientific information through 

means other than on-site, in-person, 

visits to VA facilities. 

Commenters suggested that VA define 

the terms ‘‘manufacturer sponsored 

program,’’ ‘‘promotional materials,’’ 

‘‘patient education materials,’’ and 

‘‘individual departments.’’ We disagree 

with the commenters’ suggestions 

because the meaning of each of these 

terms is clear in the context of the rule. 

They are accepted terms of art in the 

industry that are well understood by 

pharmaceutical company 

representatives and VA staff. 

Commenters also suggested that VA 

define the term ‘‘marketing activities’’ as 

used in proposed paragraph (d)(2). We 

have decided to remove this paragraph 

referencing ‘‘marketing activities’’ 

because we believe that the 

requirements for educational program 

and associated materials are adequately 

described in the rest of proposed 

paragraph (d), now designated 

paragraph (f). 

Requests for Modifications to Proposed 

Definitions 

Commenters suggested that VA 

modify the definition of ‘‘drugs’’ to 

clarify the meaning of chemicals, the 

impact on drugs used for medical 

research, the basis for decisions based 

on drugs, and who that decision-maker 

will be. To address these comments, we 

have decided to adopt the definition of 

‘‘drug’’ used in the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 301 et 

seq.). We modified the definition only to 

remove internal cross-references. By 

doing so, we hope to eliminate the 

confusion expressed by the commenters. 

As we stated in the preamble to the 

proposed rule, we intend the term 

‘‘drug’’ ‘‘to be inclusive of all items 

typically promoted by pharmaceutical 

sales representatives,’’ and thus have 

adopted the definition used by Congress 

in the Federal Food, Drug, and Cosmetic 

Act. We note that nothing in this 

regulation is intended to conflict with 

FDA’s regulation regarding the 

promotion of investigational new drugs, 

see 21 CFR 312.7. 

Several commenters recommended 

modifications to the definition of ‘‘drugrelated supplies’’ because they assert 

that it is unclear whether VA intends to 

include medical devices in this 

definition. We believe that the term as 

defined properly and clearly covers 

those devices required to use a given 

drug in accordance with the prescribed 

use, but we have added as examples of 

such supplies inhalers, spacers, insulin 

syringes, and tablet splitters. These 

devices are generally given out by VA 

pharmacies in our patient setting, as 

opposed to other offices within VA 

facilities. 

One commenter stated that including 

test strips and testing devices is not 

justified because the rule is ‘‘aimed at 

promotion of particular pharmaceuticals 

and pharmaceutical representatives.’’ 

Whether a representative is promoting a 

drug or a testing device associated with 

a drug, it is important that VA be able 

to limit the effects of such promotion on 

patient care. Again, we make no changes 

based on these comments. 

Several commenters also requested 

clarification of the definition of 

‘‘criteria-for-use.’’ One commenter 

suggested that VA adjust the definition 

to require compliance only with VA’s 

national criteria-for-use standards, and 

do away with the authorization of 

exceptions at the local level. We 

disagree with these suggestions and will 

continue to provide local VA facilities 

the ability to make necessary decisions 

that are in the best interest of their 

patients with regard to criteria-for-use, 

based on geographic or other factors 

specific to the patient population at 

each VA facility. We also clarify that 

this rulemaking does not alter the wellestablished practice for learning about 

national and local criteria-for-use and 

the VANF. At the local level, 

pharmaceutical company 

representatives will continue to request 

criteria-for-use from the appropriate VA 

employee at the appropriate VISN 

Office, or the Office of the Chief of 

Pharmacy Services. We further note, in 

response to comments regarding mature 

brands, that all national criteria-for-use 

requirements are listed on VA’s Web 

site. 

One commenter suggested that VA 

exclude medical residents from being 

considered ‘‘health professional 

students’’ under proposed paragraph 

(f)(5), now designated paragraph (h)(3), 

because residents have prescribing 

power and therefore should receive drug 

information. We reject this suggestion 

because we believe that it would be 

inappropriate to allow, as a general rule, 

drug marketing to target health 

professional students who are still in 

training. Such marketing is designed to 

promote the sale of a particular product, 

and not to educate health professionals 

about a variety of pharmaceutical 

products. In addition, under the rule, 

VA has the flexibility to allow all 

trainees including residents to receive 

marketing information at the discretion 

of the VA staff member providing 

clinical supervision. In this regard, we 

changed the language in paragraph 

(h)(3) to ‘‘the staff member providing 

clinical supervision’’ rather than simply 

‘‘clinical staff member.’’ We believe this 

revision adds clarity. 

Finally, we note that we are changing 

a reference used in the definition for 

‘‘VA National Formulary (VANF) drugs 

and/or drug-related supplies.’’ We are 

changing ‘‘local office of the Chief of 

Pharmacy Services’’ to the ‘‘VA medical 

facility’s Chief of Pharmacy Services.’’ 

This is simply a technical edit that 

makes this clause consistent with the 

language added in definitions discussed 

above, and provides more clarity to the 

public. We make a similar change to 

proposed paragraphs (e)(1), now 

designated paragraph (g)(1)) and 

proposed paragraph (f)(2), now 

designated paragraph (h)(1). 

Specifically, we change references to 

‘‘local policies’’ and ‘‘local office of the 

Chief of Pharmacy Services’’ to 

‘‘medical center policy’’ and ‘‘VA 

medical facility office of the Chief of 

Pharmacy Services.’’ 

Requests for Clarification 

For clarity, we have restructured the 

content of proposed paragraphs (b) and 

(c) regarding the basic requirements for 

promotion, into newly designated 

paragraphs (c), (d), and (e). The 

proposed rule addressed the 

requirements for promotion in terms of 

three categories of drugs and drugrelated supplies: (1) VANF drugs and 

drug-related supplies, and non-VANF 

drugs and drug related supplies with 

criteria-for-use; (2) non-VANF drugs and 

drug-related supplies without criteriafor-use; and (3) new molecular entities. 

This final rule continues to address 

drugs and drug-related supplies in terms 

of these three categories, however, to 

make the requirements associated with 

each of these three categories of drugs 

or drug-related supplies more clear, we 

have broken the rule out into separate 

paragraphs addressing each category of 

drug or drug-related supply. The 

substance of these sections remains 

virtually the same with organizational 

changes for clarity. Paragraph (c) 

provides the requirements for 


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13000 Federal Register / Vol. 77, No. 43 / Monday, March 5, 2012 / Rules and Regulations 

promotion of VANF drugs and drugrelated supplies, and non-VANF drugs 

and drug related supplies with criteriafor-use. Paragraph (d) provides the 

requirements for promotion of nonVANF drugs and drug-related supplies 

without criteria-for-use, which include 

an approval requirement on top of the 

three requirements under paragraph (c). 

Similarly, paragraph (e) provides the 

requirements for promotion of new 

molecular entities, which include an 

approval requirement on top of the 

requirements found under paragraph (c). 

One consistent concern expressed by 

the commenters was the relationship 

between this rule and laws administered 

by the FDA. As explained throughout 

this rulemaking, we have made 

clarifications where commenters have 

noted the possibility of a perceived 

conflict. Thus, we have clarified that 

promotion must be consistent with FDA 

laws and VA criteria-for-use. We note 

that nothing in this regulation should be 

construed as permitting promotional or 

educational activities that are not in 

compliance with applicable FDA 

requirements. 

The proposed rule had stated that 

educational programs and associated 

materials must conform to the 

requirements detailed in paragraphs 

(d)(1) through (9), now designated 

paragraphs (f)(1) through (6). A 

commenter recommended that we 

clarify in proposed paragraph (d) 

whether educational programs and 

associated materials will be deemed 

suitable if they satisfy those 

requirements. We accept this 

recommendation and have changed the 

language in the rule to reflect this 

clarification. Paragraph (f) now states: 

‘‘[E]ducational programs and associated 

materials will be deemed suitable if the 

approval authority determines that they 

conform to the following requirements.’’ 

We have also removed the word ‘‘new’’ 

as a modifier for ‘‘drug’’ and ‘‘drugrelated supply.’’ We believe that the use 

of the term ‘‘new drug’’ could confuse 

sales representatives because this is a 

term that is specifically defined by the 

Federal Food, Drug, and Cosmetic Act. 

21 U.S.C. 321(p). VA used the word 

‘‘new’’ in the proposed rule to limit this 

sentence only to drugs and drug-related 

supplies that are ‘‘already on the VANF 

but ha[ve] not yet been reviewed by 

VA[.]’’ Because this clause already 

exists in the regulation text, the word 

‘‘new’’ is extraneous and is removed. 

Another comment suggested that VA 

clarify the ‘‘clear identification’’ 

requirements that had appeared in 

proposed paragraphs (d)(6) and (d)(7), in 

order to give companies proper notice 

about how to comply with the rule. As 

explained below, we have replaced the 

‘‘clear identification’’ requirement with 

a specific requirement that educational 

programs and associated materials 

regarding a drug, drug-related supply, or 

therapeutic indication be submitted to a 

specific approval authority. With 

respect to educational programs and 

associated materials regarding nonVANF drugs or drug-related supplies 

without criteria-for-use, we have crossreferenced the approval and other 

requirements found in newly designated 

paragraph (d). We note that the 60-day 

submission requirement applies to all 

proposed educational programs and 

associated materials. 

One commenter requested that VA 

clarify that the provision of journal 

articles that increase the reader’s 

knowledge should be specifically 

exempted from the rule, or otherwise 

advise how journal articles may be 

provided in compliance with the rule. 

There exist multiple avenues for the 

distribution of journal articles and 

similar information and therefore we 

decline to make any change in response 

to this comment. First, we note that VA 

staff and patients are free to research 

and acquire any medical literature they 

see fit. Second, as noted above, we have 

clarified in new paragraph (a) that 

‘‘[t]his rule governs on-site, in-person 

promotional activities * * *. It does not 

apply to the distribution of information 

and materials through other means.’’ 

Therefore, journal articles may be 

distributed in connection with on-site 

activities as long as the pharmaceutical 

company representative complies with 

the requirements of this rule. Further, 

nothing in this rule can or should be 

interpreted to prevent the distribution of 

such materials through means other 

than on-site, in-person distribution (e.g., 

through the mail). For further guidance, 

we note that parties distributing journal 

articles or other reprints that contain 

off-label uses should consult the FDA’s 

‘‘Good Reprint Practices for the 

Distribution of Medical Journal Articles 

and Medical or Scientific Reference 

Publications on Unapproved New Uses 

of Approved Drugs and Approved or 

Cleared Medical Devices.’’ 

We received multiple comments 

requesting clarification of the content of 

proposed paragraph (e), now designated 

paragraph (g), as it relates to the 

provision of free drugs by 

pharmaceutical company 

representatives. We agree with the 

comments that ‘‘donations’’ is a 

misleading phrase to use because it 

might connote charitable donation 

programs in which pharmaceutical 

companies participate. Therefore, we 

have removed all references to 

‘‘donations’’ and instead use the term 

‘‘samples.’’ One commenter asked that 

VA clarify the meaning of the phrase 

‘‘trial-use’’ and clarify the relationship 

between proposed paragraph (e)(2) and 

clinical trials. The phrase ‘‘trial-use’’ 

was intended to refer to the use of the 

samples on a trial basis. However, as the 

comment demonstrates, use of the word 

‘‘trial’’ might connote formal clinical 

trials. Therefore, we have revised 

proposed paragraph (e)(2), now 

designated paragraph (g)(2), to remove 

the reference to ‘‘trial-use’’ and instead 

state that ‘‘[a]ll usage information 

pertaining to the intended use of these 

drugs or drug-related supplies must be 

forwarded to the VISN Pharmacist 

Executive or VISN Formulary 

Committee.’’ 

Further comments on proposed 

paragraph (e)(2), now designated 

paragraph (g)(2), suggest that VA should 

clarify the conduct that constitutes 

compliance with this paragraph, and 

clarify whether VA employees may 

accept samples from their own personal, 

non-VA physicians. We have made 

minor revisions to the language of this 

section to clarify the requirements for 

drug samples. First, we clarify that the 

pharmaceutical company representative 

‘‘must submit samples of drugs and 

drug-related supplies for approval to the 

person at the medical facility to whom 

such responsibility is delegated under 

local policy, usually the Director.’’ 

Second, we require that ‘‘[a]ll usage 

information pertaining to these drugs or 

drug-related supplies must be forwarded 

to the VISN Pharmacist Executive or 

VISN Formulary Committee.’’ Third, 

assuming approval of a drug or drugrelated supply has been obtained, we 

require that ‘‘[a]ll samples of drugs or 

drug-related supplies must be delivered 

to the Office of the Chief of Pharmacy 

Services for proper storage, 

documentation and dispensing.’’ Third, 

this rule does not regulate the conduct 

of VA employees when receiving 

medical care from their own physicians, 

and nothing in this rule may be 

construed as regulating the private 

relationship between a VA employee 

and his or her personal doctor. 

Therefore, we make no change to the 

statement that ‘‘[d]rug or drug-related 

supply samples may not be provided to 

VA staff for their personal use.’’ Finally, 

we removed the clause ‘‘the intended 

use of’’ in reference to information that 

‘‘must be forwarded to the VISN 

Pharmacist Executive or VISN 

Formulary Committee. We did not 

intend to limit ‘‘information’’ to the 

intended use of the drug; rather, we 

intended to require that pharmaceutical 


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companies forward appropriate 

information. 

We also revised the last sentence of 

proposed paragraph (e)(1), now 

designated paragraph (g)(1), to remove 

the words ‘‘of travel’’ that had appeared 

in the proposed rule, because the 

statutory authority applies to all gifts in 

support of VA staff official travel, not 

just ‘‘[g]ifts of travel.’’ 

Another comment requested that the 

prohibition on pharmaceutical company 

representative visits and the distribution 

of materials, in instances where VA staff 

or departments indicate that they wish 

not to be called on by pharmaceutical 

company representatives, should 

exclude visits and materials that are 

necessary for patient safety, such as 

product recalls or critical, substantive 

changes to warnings about particular 

medications. We decline to make any 

changes based on this comment. First, 

we note that most communications of 

this nature can be made more quickly 

and effectively through electronic or 

telephonic communication, and 

personal visits should not be required. 

Second, the rule does not prohibit onsite distribution of any patient safety 

materials to the VA medical facility 

office of the Chief of Pharmacy Services 

or similar other appropriate authority 

for distribution as necessary for patient 

safety. In other words, if necessary, 

important patient safety information can 

be provided in-person to the VA 

medical facility office of the Chief of 

Pharmacy Services or other appropriate 

authority for distribution by VA. 

A similar comment suggested that VA 

include a patient-safety exception to the 

educational programs and associated 

materials requirement in proposed 

paragraph (d)(4), now designated 

paragraph (f)(3). Specifically, the 

commenter requested that the rule 

permit documents and discussions 

related to an FDA-required risk 

evaluation and mitigation strategy, as 

well as product safety warning and 

other labels. We recognize the value of 

the information and did not intend the 

rule to conflict with any FDA 

requirements. Therefore, we have 

revised the rule to specify the 

permissibility of solicitation of 

protected health information or patient 

participation in pharmaceutical 

company-sponsored programs when 

‘‘required by Federal laws and 

regulations such as an educational 

program that is part of a risk evaluation 

and mitigation strategy required by the 

Food and Drug Administration.’’ 

One commenter requested that VA 

clarify in proposed paragraph (f) 

whether pharmaceutical company 

representatives will be permitted to 

leave materials for individuals or 

departments on the do-not-call list 

when they are on-site for a scheduled 

appointment with another provider. We 

have clarified in newly designated 

paragraph (h)(1) that pharmaceutical 

company representatives may not ‘‘leave 

any materials for’’ any individuals or 

departments on the do-not-call list. The 

reason for this prohibition is that 

leaving products in this manner may 

disrupt our medical professionals’ 

regular activities, particularly given that 

such professionals have put their names 

on a do-not-call list. Moreover, patients 

who see such products may be misled 

into believing that VA endorses the use 

of such product. As noted several times 

in this notice, nothing in this rule 

prohibits the transmission of materials 

by mail, and for the purposes of 

facilities management, we would prefer 

that materials be distributed in this 

manner. 

A commenter requested that VA 

define or provide examples of a 

‘‘medical center conference’’ in 

proposed paragraph (f)(6), now 

designated paragraph (h)(4), and 

provide an exception allowing 

pharmaceutical company 

representatives who sign a form or 

agreement to attend such conferences. 

We decline to define the term or provide 

examples because we believe this term 

is unambiguous. We reject the requested 

exception because patient-specific 

information may be discussed at 

medical center conferences, and an 

exception allowing pharmaceutical 

company representatives to attend these 

conferences would be inconsistent with 

VA’s vigorous protection of patient 

privacy. We note that we have revised 

the phrase ‘‘patient-specific material’’ to 

‘‘information regarding individual 

patients.’’ We believe that this language 

more precisely reflects the intended 

notion of protection of patient privacy. 

In addition, we have reworded the 

paragraph so that it says that a 

‘‘pharmaceutical company 

representative may not attend a medical 

center conference where information 

regarding individual patients is 

discussed,’’ where the proposed rule 

had said that a ‘‘sales representative is 

not allowed to attend a medical center 

conference where patient-specific 

material is discussed.’’ The new 

phrasing is consistent with now 

designated paragraph (g)(3) and does not 

change the meaning. 

Another comment suggested that VA 

clarify that this rule is implemented in 

the spirit of supporting appropriate 

pharmaceutical company representative 

access to VA facilities and staff. We 

agree with the spirit of this comment. 

VA fully intends to continue our 

positive relationships with 

pharmaceutical companies and 

pharmaceutical company 

representatives in the future. However, 

there is no need to revise the rule to add 

such a statement. 

Comments That Provisions of the Rule 

are Redundant, or are Governed by 

Other Law or Guidance 

As discussed earlier in this 

rulemaking, some commenters indicated 

that portions of the rule are unnecessary 

because the regulated behavior is also 

subject to other laws and/or regulations. 

For example, one comment stated that 

we need not regulate the provision of 

gifts or food to VA employees, because 

pharmaceutical company 

representatives are already subject to 

other ethical guidelines that address the 

behavior of pharmaceutical company 

representatives in this regard. We make 

no changes based on these comments. 

Such other laws and/or regulations are 

consistent with our regulation, and 

certainly restating the requirements in 

our own regulation does not adversely 

affect anyone, notwithstanding the 

commenters’ characterization of these 

provisions as being ‘‘redundant.’’ 

Moreover, centralizing the relevant 

information in a single regulation will 

have administrative benefits. Other 

commenters objected to portions of the 

rule that they perceived as conflicting 

with or being duplicative of other laws 

and regulations. We address these 

comments below. 

The limitations on the pharmaceutical 

company provision of food and gifts to 

VA employees are consistent with 

Standards of Ethical Conduct applicable 

to Executive Branch Employees, and 

restating the requirements in our own 

regulation provides clarity and does not 

adversely affect anyone, 

notwithstanding the commenters’ 

characterization of these provisions as 

being ‘‘redundant.’’ To the extent that 

industry ethical standards impose 

similar requirements on their sales 

representatives, we note that such 

restrictions may be revised by industry. 

Moreover, centralizing the relevant 

information in a single regulation will 

have administrative benefits. One 

commenter stated that the rule’s criteriafor-use requirements can conflict with 

the FDA’s approval of certain 

prescribing information, also known as 

‘‘labeling.’’ We make no changes based 

on these comments. While FDA 

approves drugs for certain purposes or 

uses based on the population at large 

and potential uses for the drug, VA 

further considers how a certain drug 

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unique patient population. While VA 

criteria-for-use may be more specialized 

or tailored than FDA-approved labeling, 

such criteria-for-use will not contradict 

FDA-approved labeling. If a 

pharmaceutical company representative 

believes that VA criteria-for-use 

contradicts FDA-approved labeling, that 

representative should seek clarification 

from the VISN Pharmacist Executive, or 

Chief of Pharmacy Services, or designee. 

One commenter stated that VA should 

consider alternatives to the requirement 

that VA officials in the field review all 

educational programs and associated 

materials because the materials are 

already regulated by FDA, and the 

review requirement would place a large 

administrative burden on VA facilities. 

Another commenter requested that VA 

exclude from the rule educational 

materials that FDA does not require 

companies to disseminate, but does 

require to be submitted for FDA review, 

because a second layer of review is 

redundant and may undermine FDA’s 

expertise if VA reaches a conclusion 

that differs from FDA. We decline to 

make any changes based on this 

comment. Pharmaceutical company 

representatives should only be 

distributing material that conforms with 

Federal laws and regulations including 

those administered by the FDA. 

Whether an educational program and 

associated materials are appropriate for 

a scheduled event is a narrower 

question. For example, a pharmaceutical 

company representative may seek 

approval for an educational program 

regarding a diabetes drug, but also wish 

to include materials related to a blood 

pressure drug. The VA approval 

authority could deny approval of the 

materials based on the inclusion of 

irrelevant material. However, this denial 

would not be a second review of the 

content of the FDA-approved material. 

One commenter recommended that 

VA provide an appropriate staff member 

with discretionary authority to permit 

manufacturer-sponsored programs due 

to their potential benefit to patients. We 

reject this recommendation because the 

final rule presents pharmaceutical 

company representatives and companies 

with a clear procedure, described in 

proposed paragraph (d), now designated 

paragraph (f), to obtain approval for 

such programs at VA facilities. VA 

facilities’ highest priority must at all 

times be to provide direct care to its 

patients, and must have the ability to 

limit the quantity and timing of 

programs so as not to impede clinicians’ 

ability to provide care. It is inevitable 

that limited openings and competing 

programs will require that VA facilities 

determine which option is most 

clinically appropriate for its patients. 

For example, a VA facility may schedule 

a program detailing a new flu 

vaccination just before the start of flu 

season because it is timely and will 

impact a greater number of patients at 

their individual facility, rather than host 

a requested program about prenatal care. 

We note that the program about prenatal 

care need not be rejected outright and 

may be considered for a future date. 

Paragraph (f) will ensure that the 

clinical interests of VA’s patients at 

each facility remain the most important 

factor in determining whether to permit 

educational programs and materials at 

VA facilities. 

Another comment suggests that the 

requirement in proposed paragraph 

(d)(5), now designated paragraph (f)(4), 

that allows qualified VA pharmacy staff 

to grant exceptions to the logo display 

limitations may lead to unequal 

application in the field and should be 

removed. We disagree with this 

comment. Each VA medical facility 

must consider the needs of its 

individual patient populations in 

reaching determinations about 

educational materials, and we do not 

intend to limit their discretion by 

requiring VAMC acceptance or rejection 

of such materials. We note as well that 

the rule has specific standards that will 

prevent or minimize the potential for 

unequal application in the field, which 

include that the logo or name need not 

be removed if it is inconspicuous or if 

legal requirements (e.g., trademark 

requirements) make removal 

impractical. As explained previously, 

we have also added the statement that 

‘‘this requirement does not apply to 

labeling required by the Food and Drug 

Administration,’’ so as to ensure that 

this provision of the regulation does not 

conflict with FDA laws and regulations. 

One commenter objected to the 

prohibition on labeling drug samples as 

‘‘samples,’’ because that restriction 

contradicts with the Prescription Drug 

Marketing Act, which requires samples 

to be labeled as such. We agree with this 

comment and have removed the 

prohibition on labeling drug samples as 

‘‘samples.’’ 

Recommended Policy Changes 

One commenter requested an 

exception for the distribution of 

information about new molecular 

entities to certain VA decision-makers, 

including the VISN Pharmacist 

Executives, Chiefs of Pharmacy, 

specialty physicians and formulary 

decision-makers for each VAMC and 

VISN. As discussed above, the rule does 

in fact authorize the promotion of new 

molecular entities under proposed 

paragraph (c)(3), now designated 

paragraph (e). New molecular entities 

may be promoted at the discretion of a 

VISN Pharmacist Executive, Chief of 

Pharmacy Services, or designee. We do 

not believe it is necessary—or the best 

use of VA’s resources—to limit the 

Executive’s discretion in selecting a 

designee, or to require in all VISNs that 

the individuals described by the 

commenter be authorized to make this 

decision. 

We have revised the definition of 

‘‘new molecular entity’’ in proposed 

paragraph (a). The proposed rule 

defined the term as ‘‘an active 

ingredient that has never before been 

marketed in the United States in any 

form,’’ which would be a virtually 

impossible standard to measure, as there 

is no clear way to determine whether an 

ingredient has ‘‘ever’’ been marketed ‘‘in 

any form.’’ Therefore, we have revised 

the definition of the term to read: ‘‘a 

drug product containing an active 

ingredient that has never before 

received U.S. Food and Drug 

Administration approval.’’ Because VA 

lacks the expertise of FDA to 

independently analyze new molecular 

entities for safety and other purposes, 

we rely on those determinations already 

made by FDA regarding such entities. 

This revision should clarify some of the 

commenters’ confusion as to the 

definition of new molecular entities, 

and in addition no longer defines the 

term in connection with marketing. 

A separate comment was that VA 

should not require authorization by 

VISN Pharmacist Executives or the 

Chief of Pharmacy for promotion of nonVANF drugs, because each VA Medical 

Center could potentially adopt a 

different administrative approach, 

which may lead to educational disparity 

among VA staff. We reject this 

suggestion and continue to grant each 

VISN the flexibility to determine 

whether the promotion of a non-VANF 

drug is appropriate given the needs of 

its unique patient population. Adopting 

a single national policy regarding the 

promotion of non-VANF drugs would 

negatively impact patient care because 

VA medical centers must consider the 

specific needs of their patient 

population based on unique geographic 

and other demographic factors. For 

example, drugs such as certain 

antibiotics can and should be treated 

differently for rural and urban 

populations in order to maximize the 

effectiveness of the drug. Other 

examples would include facilities 

located in communities in which a 

particular illness is more prevalent, 

such as certain respiratory infections, or 

facilities that focus on the treatment of 


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a specific disease or disability. A single 

national policy would prove too rigid to 

meet the needs of VA patients at the 

local level. 

Another commenter stated that VA 

should presumptively disallow 

educational programs and materials 

focusing on non-VANF drugs or drugrelated supplies because promotion of 

such drugs can undercut the legitimacy 

of VA’s medical formulary. We do not 

agree with the commenter to the extent 

that the comment can be read to suggest 

that non-VANF drugs without criteriafor-use should never be promotable. We 

believe that the provisions of newlydesignated paragraph (d) contain 

sufficient safeguards on promotion of 

such drugs and drug-related supplies. 

On the other hand, one comment 

suggested that VA not discourage the 

dissemination of educational programs 

or associated materials that focus on 

non-VANF drugs or drug-related 

supplies, because physicians only stand 

to better serve their patients by having 

access to such information. We have 

made several modifications to the rule 

to clarify the requirements for 

educational programs and associated 

materials regarding (1) a drug, drugrelated supply, or new therapeutic 

indication for a drug that is already on 

the VANF, but has not yet been 

reviewed by VA; or (2) non-VANF drugs 

or drug-related supplies without 

criteria-for-use. Specifically, we have 

revised the substance of proposed 

paragraph (d)(6), now designated 

paragraph (f)(5), to require submission 

and approval of educational programs 

and associated materials regarding a 

drug, drug-related supply, or 

therapeutic indication to the VA 

medical facility’s Chief of Pharmacy 

Services or designee. In turn, we 

removed the requirement that such 

educational programs and materials be 

clearly identified as discussing a new 

drug, drug-related supply, or 

therapeutic indication. We believe that 

submission to and approval by the Chief 

of Pharmacy Services or designee will 

ensure that such educational programs 

and associated materials are suitable. 

Similarly, we have revised the 

substance of proposed paragraph (d)(7), 

now designated paragraph (f)(6), to 

permit educational programs and 

associated materials regarding nonVANF drugs or drug-related supplies 

without criteria-for-use only if those 

drugs or drug-related supplies may be 

promoted under newly designated 

paragraph (d), which contains the 

requirements for promotion of nonVANF drugs or drug-related supplies 

without criteria-for-use. This revision 

removes the language from the proposed 

rule stating that such educational 

programs and associated materials ‘‘are 

discouraged.’’ Again, we believe that the 

review and approval procedures for 

these educational programs will ensure 

that these educational programs and 

associated materials are suitable. 

One commenter requested that VA 

require direct comparison between 

industry-sponsored and non-sponsored 

sources in any disclosure. We agree 

with this comment with respect to 

educational programs and associated 

materials and added a new paragraph 

(f)(2) requirement that such a 

comparison be made where both 

industry-sponsored and non-sponsored 

sources of information exist for FDAapproved uses of a particular drug. We 

believe that such a comparison will 

provide VA staff with the ability to 

review the full range of data that exists 

for a particular drug within the limits 

established by FDA through 

comprehensive research, which will 

enable them to make the best decisions 

for VA patients. This commenter also 

suggested that VA educational material 

requirements should include a uniform 

format for disclosure of industry 

sponsorship. Additionally, the 

commenter recommended that VA 

regulate the format of disclosures in 

accordance with findings that maximize 

the effectiveness of disclosures on 

reducing the influence of marketing 

over physicians’ decision-making. VA 

acknowledges the potential advantages 

to a uniform format and increased 

knowledge about the impact of 

disclosures, but these recommendations 

are beyond the scope of this particular 

rulemaking. 

One commenter suggested that VA 

change the requirement that educational 

programs and materials must not 

contain company names or logos, stating 

that the requirement in proposed 

paragraph (d)(1) that such materials 

disclose any industry sponsorship, 

directly conflicts with proposed 

paragraph (d)(5), which states that no 

company names or logos may appear on 

patient educational materials. We make 

no changes based on this comment and 

note that the provision in proposed 

paragraph (d)(1) relates to introductory 

remarks and announcement brochures 

for educational programs. In contrast, 

proposed paragraph (d)(5) pertains to 

patient education materials. Therefore, 

we do not agree that any conflict exists 

between the two provisions. We note 

that proposed paragraphs (d)(1) and (5) 

are now designated as paragraphs (f)(1) 

and (4). 

With respect to the limitation in 

proposed paragraph (d)(5), now 

designated paragraph (f)(4), on name 

and logos on patient educational 

materials, one commenter argued that 

smaller drug manufacturers will be 

unable or unwilling to produce 

literature specifically for VA due to cost. 

We note again that this rule applies only 

to in-person activities, and that 

companies (large or small) who do not 

wish to comply with paragraph (f) are 

free to continue to distribute their 

materials through other means. 

Nevertheless, we have inserted a 

sentence to clarify that proposed 

paragraph (d)(5), now designated as 

paragraph (f)(4), concerning logos, ‘‘does 

not apply to labeling required by the 

Food and Drug Administration.’’ 

According to one commenter, VA 

should permit physicians to grant 

meetings with pharmaceutical company 

representatives in patient care areas, 

particularly where working with a 

physician in a patient care area is 

necessary. We make no changes based 

on this comment. VA is committed to 

protecting patient privacy and generally 

does not find it appropriate for a 

pharmaceutical company representative 

to attend a meeting in a patient care 

area. However, we note that at many VA 

medical facilities, the offices for key VA 

staff members working in the emergency 

rooms are physically located within the 

emergency room itself. We do not 

intend to prevent qualified VA staff 

from holding meetings with 

pharmaceutical company 

representatives in their offices simply 

because the office is within the 

emergency room. We therefore have 

clarified that the patient-care area of the 

emergency room does not include staff 

offices that may be located in the 

emergency room by adding a 

parenthetical to that effect after 

‘‘emergency rooms’’ in the list of 

‘‘patient-care areas’’ under paragraph 

(h)(5), which was proposed paragraph 

(f)(7). 

Another commenter suggested that 

VA should permit brochures in patient 

waiting areas because there is no 

disruption to treatment, and 

recommended that literature meeting 

FDA requirements should be 

presumptively permissible, and the 

display of a company’s logo should not 

be restricted. We decline to permit 

brochures in patient waiting areas and 

have moved this prohibition from the 

section of the rule discussing 

educational programs and associated 

materials to the section of the rule 

discussing conduct of pharmaceutical 

company representatives more generally 

to clarify that distribution of such 

educational material is limited not only 

in connection with an educational 

program. This provision is now located 


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at paragraph (h)(6) and states: 

‘‘Pharmaceutical company 

representatives may only distribute 

materials on-site at the time and 

location of a scheduled appointment or 

educational program. In no 

circumstances may materials be left in 

patient care areas.’’ We believe that the 

prohibition on placement of materials in 

patient care areas is necessary because 

manufacturer-sponsored brochures may 

not be consistent with VA’s drug 

therapy management processes and 

could lead to confusion. VA 

occasionally determines that for the 

purposes of its patient population, the 

best use of a given drug may be for a 

specific use, rather than the broad array 

of conditions that FDA may have 

approved the drug for. Therefore, 

patients may become confused if 

promotional materials appear 

inconsistent with the VA clinician’s 

appropriate use of the drug. Providing 

brochures in patient waiting areas could 

also create a perceived VA bias for or 

against certain products. 

A commenter asserted that proposed 

paragraph (d)(3) would have a negative 

effect on patient care by preventing 

distribution of materials regarding 

Patient Assistance Programs (PAPs). 

Proposed paragraph (d)(3) stated that 

‘‘[p]romotional materials are not to be 

placed in any patient care area.’’ As 

explained above, this provision was 

moved to a different part of the rule, is 

now designated as paragraph (h)(6), and 

states: ‘‘Pharmaceutical company 

representatives may only distribute 

materials on-site at the time and 

location of a scheduled appointment or 

educational program. In no 

circumstances may materials be left in 

patient care areas.’’ Patients who are 

using a particular drug and who require 

information distributed specifically to 

them through a PAP will not be affected 

by this paragraph; however, the 

distribution of such materials will have 

to be performed in accordance with the 

regulation. Under the regulation, PAPrelated materials may be distributed 

directly by a pharmaceutical 

representative on-site pursuant to a 

scheduled appointed or approved 

educational program, or indirectly via 

mail. This will have no negative impact 

on patient care because VHA has always 

ensured, and will continue to ensure, 

that patients obtain any information 

necessary for their care. 

A commenter asserted that the rule 

can be read to apply to drug company 

provision of items in connection with 

research trials. We emphasize that the 

marketing or in-person solicitation of 

any approved drug is governed by this 

regulation. This will have no impact, 

however, on the process for approving 

research protocols; it simply affects 

when and how materials concerning 

drugs are marketed on-site at VA 

facilities. 

Finally, a commenter raised a concern 

that the regulation will undermine the 

ability of Federal Supply Schedule 

(FSS) contractors to market products 

that are on the FSS. Placement of a 

product on the FSS merely affects the 

price that VA will pay for the product. 

It has no impact on the in-person 

solicitation or promotion of that drug 

within VHA facilities. Whether or not a 

drug is on the FSS should not authorize 

a company’s sales representative to 

behave differently from representatives 

of drugs that are otherwise recognized 

or approved for distribution to VA 

patients. 

Comments Regarding the Disciplinary 

Process 

We received a number of comments 

regarding the proposed disciplinary 

process, including a suggestion to 

remove proposed paragraph (g) in its 

entirety. We make no changes to the 

disciplinary process based upon the 

comments because such a process is 

necessary to protect patient safety, as 

well as VA staff’s ability to provide the 

highest quality services to patients. We 

also note that VA does not intend to 

impose sanctions except as necessary to 

prevent future impropriety. However, it 

is important that we maintain the ability 

to do so. Although we decline to change 

the disciplinary process described in the 

proposed rule, we have made 

organizational changes to the 

disciplinary section of the rule to more 

clearly describe the process. 

Specifically, proposed paragraph (g) has 

been designated as paragraph (i) and 

now includes headings. We revised the 

heading of the entire paragraph from 

‘‘Failure to properly promote drugs or 

drug-related supplies within VA’’ to 

‘‘Non-compliance’’ because this heading 

is both more concise and accurate. We 

have also made non-substantive 

language changes for purposes of clarity. 

For example, we have removed the 

terminology referring to ‘‘sales force’’ 

and ‘‘regional managers’’ and instead 

use the defined term ‘‘pharmaceutical 

company representative’’ in the interest 

of clarity and consistency. In addition, 

we have removed the phrase 

‘‘commercial visits’’ and refer only to 

‘‘visits’’ as the modifier ‘‘commercial’’ is 

unnecessary. 

A commenter suggested that VA 

clarify in the supplementary 

information of this rulemaking that most 

often problems between VA and 

pharmaceutical company 

representatives will be resolved 

informally and that formal action 

should be limited. We agree with this 

comment and further note that VA seeks 

to continue the traditionally amicable 

nature of interaction with 

pharmaceutical company 

representatives and companies at both 

the national and local levels. We make 

no changes to the regulation based upon 

the comment. 

Another commenter stated that VA 

should provide clear guidance on which 

circumstances would justify a penalty to 

an entire sales force as opposed to an 

individual representative, as well as 

what would justify a penalty extending 

to other VA facilities. The commenter 

also requested clarification on what is 

meant by ‘‘permanent revocation of 

commercial visiting privileges.’’ We do 

not believe that the provisions are 

ambiguous. VA will analyze violations 

on a case-by-case basis. The rule 

provides sufficient notice of the 

acceptable and unacceptable behavior of 

pharmaceutical company 

representatives on VA property, and the 

distribution of materials while on VA 

property. The rule also provides 

sufficient direction as to the process that 

VA will follow when we are required to 

formally address non-compliant 

behavior. However, in response to the 

request for greater clarity, we have 

revised the rule so that rather than refer 

to ‘‘instances of widespread 

misconduct’’ in proposed (g)(3), 

paragraph (i)(2) now refers to ‘‘multiple 

instances of misconduct.’’ The word 

‘‘widespread’’ could be misinterpreted 

to refer to the geographical location of 

the misconduct, rather than the 

recurrence of misconduct. 

A commenter stated that proposed 

paragraph (g), now designated as 

paragraph (i), denies pharmaceutical 

companies due process, and suggests 

that VA require the opportunity for a 

hearing before revoking a representative 

or company’s ability to speak with 

physicians at a VA facility. Another 

commenter requested that VA only limit 

restrictions to the specific VA facility in 

which the noncompliance with this rule 

occurred. We make no changes to the 

rule based on these comments. Due 

process concerns are not present here 

because revocation of visiting privileges 

would not deprive a pharmaceutical 

company representative of a 

constitutionally protected property 

interest. Further, we believe that the 

processes described in paragraph (i) are 

reasonable. Under paragraph (i), a 

pharmaceutical company representative 

and/or his or her supervisor is given 

notice of the noncompliance and the 

Director’s interim action, a 30-day 


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window to respond to such notice, and 

a final written order detailing the 

circumstances of the violation and the 

reasons for the final action. Further, a 

pharmaceutical company is also given 

an opportunity for review of that final 

written order by the Under Secretary for 

Health. We have added to the first 

sentence of paragraph (i)(3) the word 

‘‘either’’ to further clarify that the 

Director’s final order must ‘‘either’’ 

confirm the action in the notice ‘‘or’’ 

specify another action. 

Other related comments stated that 

VA should be required to notify the 

company of the noncompliance of one 

of its representatives. We believe that 

the burden to notify the company is 

properly placed on the pharmaceutical 

company representative. However, this 

rule does provide that VA will notify 

the appropriate manager or supervisor 

of the pharmaceutical company 

representative in instances where VA 

has found multiple instances of 

misconduct by an individual or 

multiple representatives. 

One commenter asked that penalties 

‘‘[g]enerally * * * not be enforced 

during the notice period.’’ Again, the 

regulation provides clear notice of what 

behaviors are unacceptable. The type of 

enforcement that would occur during 

the notice period would be restriction of 

an individual pharmaceutical company 

representative’s access to a facility or 

facilities. We believe that this minimal 

restriction must be enforced during the 

notice period in order to prevent 

recurrence or escalation of the behavior 

at issue. 

Additionally, we disagree with one 

commenter’s assertion that the activities 

governed under this rule do not pose a 

security risk. VA has three primary 

objectives in limiting the privilege of 

pharmaceutical company 

representatives’ promotional activities 

in VA facilities. First, our primary 

purpose in creating this rule is the 

protection of our patients’ safety. 

Second, we seek to protect the integrity 

of VA’s National Formulary and criteriafor-use. Third, we aim to protect the 

amount of time that VA clinicians have 

to commit to their patients. We believe 

that actions by pharmaceutical company 

representatives that violate any of the 

provisions of this rule threaten these 

goals. 

Finally, a commenter asked whether a 

permanent revocation could be subject 

to subsequent review. We note again 

that such revocation may be appealed 

by the pharmaceutical company 

representative or company to the Under 

Secretary for Health within 30 days of 

the order for revocation. 

Legal Arguments 

One commenter contends that the 

proposed rule would violate the First 

Amendment protection of free speech 

by requiring that drugs and drug-related 

products, which are non-VANF and 

which have no criteria-for-use, may be 

promoted only if ‘‘the promotion is 

specifically permitted by the VISN 

Pharmacist Executive, or Chief of 

Pharmacy Services or designee.’’ 

Specifically, the commenter 

maintains that the proposed rule’s 

procedure for obtaining permission to 

promote such drugs and drug-related 

products results in a content-based 

restriction on free-speech which ‘‘denies 

patients the benefit of their doctor’s 

most informed judgment on what is the 

right approach for their individual 

situation.’’ The commenter states that 

VA has not explained how the above 

approval requirements are related to the 

goals enunciated in the proposed rule 

and advocates for decision authority to 

be given to VA medical departments 

and practitioners rather than pharmacy 

management. 

We do not agree with the contention 

that the proposed procedures violate the 

First Amendment guarantee of free 

speech and thus reject the commenter’s 

recommendations that VA give the 

decision authority to medical staff 

departments and practitioners rather 

than to pharmacy management. We do, 

however, believe that it is necessary to 

clarify the basis for these procedures. 

First, this additional procedural 

requirement on promotion of non-VANF 

drug and drug-related supplies without 

criteria-for-use in VA hospitals is not a 

restriction of First Amendment free 

speech rights. We know of no right to 

discuss products with Government 

officials acting in their official capacity. 

Specifically, the commenter does not 

contend that certain government 

property, which is open to other 

speakers, has been closed to 

pharmaceutical company 

representatives for use in 

communicating with private individuals 

or public officials not acting as such 

who might be willing to listen to them. 

Rather, the commenter appears to be 

claiming that pharmaceutical company 

representatives have an entitlement to a 

Government audience, VA physicians, 

so that they can express their views on 

non-VANF products without criteriafor-use. VA does not have an affirmative 

duty under the Constitution to listen to 

these views, nor is the Department in 

any way restricting pharmaceutical 

company representatives from 

communicating these views to members 

of the public, including VA physicians 

in their personal capacity, in a proper 

forum for free speech. VA hospitals are 

not such a forum. 

Additionally, there is an important 

rationale supporting our proposal for 

more restrictive procedures for 

promotion of non-VANF drugs without 

criteria-for-use to VA doctors at VA 

facilities. That rationale is primarily 

based on the need to maintain and 

enhance patient safety. The VANF is a 

list of drugs that are approved either for 

general use or with specific criteria-foruse. They are placed on the VA National 

Formulary through a rigorous and 

scientifically-based process, in which 

patient safety is paramount with cost 

being a secondary consideration. 

In this process, VA’s Medical 

Advisory Panel (MAP), which includes 

physicians from both VA and the 

Department of Defense, and the VISN 

Pharmacist Executives (VPE) Committee 

reviews drugs and drug related supplies, 

including new molecular entities to 

determine their appropriate use in the 

VA patient population. An evidencebased process is used to determine such 

appropriate use, with the primary 

factors being patient safety and 

therapeutic value; improved access to 

pharmaceuticals; promotion of a 

uniform pharmacy benefit; and 

reduction in the acquisition cost of 

drugs when feasible. The VANF 

supplants the local and VISN 

formularies which previously existed. 

This migration to a National Formulary 

has allowed VA to rely more uniformly 

on evidence-based drug evaluations 

further enhancing patient safety. 

The MAP and VPEs also contribute 

valuable experience and expertise in 

meeting the unique medication therapy 

needs of Veterans on an ongoing basis. 

For example, VA uses this expertise to 

closely manage a drug marketed for 

smoking cessation due to the potential 

for significant adverse drug events in 

patients with certain clinical 

characteristics that are over represented 

in the VA patient population. Drugs that 

are not approved for the National 

Formulary, also known as nonformulary drugs, may still be prescribed 

in specific instances via VA’s formal 

non-formulary request process. 

As a participant in the process to 

determine which drugs will appear on 

the VANF, and the appropriate uses for 

each, the VISN Pharmacist Executive, in 

consultation with the local Chief of 

Pharmacy, who has ultimate 

responsibility for prescribing practices 

at his or her facility, are the officials 

best-suited to determine when to allow 

promotion of Non-VA VANF products 

without criteria-for-use. Having an 

official with region-wide responsibility 


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13006 Federal Register / Vol. 77, No. 43 / Monday, March 5, 2012 / Rules and Regulations 

for prescribing also better serves VA’s 

ability to maintain uniform prescribing 

practices, which, as discussed above, 

has allowed VA to rely more uniformly 

on evidence-based drug evaluations. 

Under the proposed rule, pharmacy 

management, the VA professionals with 

the detailed knowledge and expertise to 

make the decision on promotion of 

drugs that are non-VANF without 

criteria-for-use would be given the 

authority to make the decision. They 

would be acting in accord with input 

received from VA physician members of 

the MAP based on their review of 

available evidenced-based drug 

evaluations and thus best protect VA 

patients. 

Another commenter requested that 

VA ‘‘distinguish between solicitation of 

sales and provision of information about 

a product and allow uncensored visits 

by representatives who abide by VA 

time, place and manner conditions on 

meetings with the public.’’ We make no 

changes based on this comment. First, 

this rule specifically precludes the 

application of VA’s general prohibition 

against solicitations to pharmaceutical 

company representatives’ promotion of 

drugs. VA strictly prohibits solicitation 

under 38 CFR 1.218(a)(8), yet this rule 

permits promotion, including 

educational activities, by 

pharmaceutical company 

representatives within the parameters 

set forth in the rule. Second, this rule 

sets precisely those ‘‘time, place and 

manner conditions’’ that the commenter 

requested. If the pharmaceutical 

company representative complies with 

the provisions of this rule, then an onsite, in-person visit will be granted. We 

note that pharmaceutical company 

representatives are not communicating 

with a public audience when speaking 

with VA staff in their professional 

capacities. On-duty VA staff, including 

health professionals charged with the 

duty to care for VA’s patients, must be 

able to work without disruptions, and 

VA appropriately limits the public’s 

access to VA facilities and staff to 

protect the safety and privacy of VA 

patients. 

Commenters suggested that VA 

consult with the United States General 

Services Administration before 

implementing a rule that may interfere 

with contracts between VA and 

companies under the FSS rate, at which 

companies are willing to sell in 

exchange for marketing opportunities. 

We note that in the instance that this 

regulation interferes with any existing 

contracts, the terms of those contracts 

will continue to be honored. However, 

VA is not aware of any contracts that 

exist with any pharmaceutical 

companies that contain provisions like 

those mentioned by the commenter and 

we therefore make no changes to the 

rule at this time. 

One commenter recommended that 

VA preempt local policies that may treat 

pharmaceutical company 

representatives who discuss prohibited 

topics as criminal trespassers. We 

decline to make any changes to the rule 

based on this comment for the following 

reasons. Currently, § 1.218, regarding 

security and law enforcement at VA 

facilities, describes general behavior 

that is prohibited on the grounds of VA 

property, and authorizes criminal 

sanctions in certain circumstances. 

Under § 1.218, persons who are not 

authorized to enter or remain on VA 

property are subject to a fine and/or a 

term of up to 6 months in prison. Under 

this final rule, § 1.220, VA may 

ultimately suspend or revoke visiting 

privileges for a pharmaceutical 

company representative or multiple 

representatives. Any such determination 

could be appealed to the Under 

Secretary for Health under paragraph 

(i)(5). If such suspension or revocation 

were imposed, then those 

representatives would not be authorized 

to enter VA property and would be 

subject to the sanctions listed in 

§ 1.218(b). 

At the same time, we note that this 

rule does indeed preempt all existing 

local policies that contradict this rule, 

as requested by the commenter. If the 

policy described by the commenter 

violates the rule then it is no longer 

lawful or effective; however, we have 

not been able to authenticate the 

memorandum described by the 

commenter. 

A commenter suggested that VA 

‘‘adopt[ ] a uniform format for 

disclosure of industry sponsorship.’’ We 

are unsure what is intended by this 

comment, but it appears that the 

commenter is requesting that VA adopt 

formats adopted by the Journal of the 

American Medical Association. We 

believe that this rule provides clear 

national guidance on disclosures, and 

the policies expressed in the rule are 

based on the particular needs of VA. As 

a government-run, national health care 

provider employing a wide variety of 

medical professionals and treating 

primarily our nation’s veteran 

population, we believe that it is 

appropriate to adopt specific guidelines 

relevant to our national practice. We 

make no changes based on this 

comment. 

Effect of Rulemaking on Local Policies 

Some commenters recommended that 

VA explicitly preempt local policies 

with this rulemaking, or clarify that the 

new national policy will replace all 

existing local policies and provide 

substantive guidelines to the field. The 

commenters do not provide, and we are 

not aware of, any examples of official 

VA statements of policy (such as 

directives or handbook provisions) that 

conflict with this rule. If we were aware 

of such conflicts, we would specifically 

rescind such statements. Further, this 

regulation as a matter of law preempts 

any inconsistent local policies. 

To the extent that VA employees in 

the field require further guidance than 

that provided in the rule, VA will issue 

policy directives and handbooks. This 

rule does not prevent the issuance of 

such guidance if such guidance is not in 

conflict with this rule. In fact, the 

existence of this regulation will provide 

VA a legal basis to issue and implement 

such non-regulatory guidance. 

Title 38 of the Code of Federal 

Regulations, as revised by this final 

rulemaking, represents VA’s 

implementation of its legal authority on 

this subject. Other than future 

amendments to this regulation or 

governing statutes, no contrary rules or 

procedures are authorized. All existing 

or subsequent VA guidance must be 

read to conform with this rulemaking if 

possible or, if not possible, such 

guidance is superseded by this 

rulemaking. 

Executive Order 12866 and 13563 

Executive Orders 12866 and 13563 

direct agencies to assess the costs and 

benefits of available regulatory 

alternatives and, when regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety 

effects, and other advantages; 

distributive impacts; and equity). 

Executive Order 13563 (Improving 

Regulation and Regulatory Review) 

emphasizes the importance of 

quantifying both costs and benefits, 

reducing costs, harmonizing rules, and 

promoting flexibility. Executive Order 

12866 (Regulatory Planning and 

Review) defines a ‘‘significant 

regulatory action,’’ which requires 

review by the Office of Management and 

Budget (OMB), as ‘‘any regulatory action 

that is likely to result in a rule that may: 

(1) Have an annual effect on the 

economy of $100 million or more or 

adversely affect in a material way the 

economy, a sector of the economy, 

productivity, competition, jobs, the 

environment, public health or safety, or 

State, local, or tribal governments or 

communities; (2) Create a serious 

inconsistency or otherwise interfere 


tkelley on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 77, No. 43 / Monday, March 5, 2012 / Rules and Regulations 13007 

with an action taken or planned by 

another agency; (3) Materially alter the 

budgetary impact of entitlements, 

grants, user fees, or loan programs or the 

rights and obligations of recipients 

thereof; or (4) Raise novel legal or policy 

issues arising out of legal mandates, the 

President’s priorities, or the principles 

set forth in this Executive Order.’’ 

The economic, interagency, 

budgetary, legal, and policy 

implications of this regulatory action 

have been examined and it has been 

determined to be a significant regulatory 

action under Executive Order 12866. 

Unfunded Mandates 

The Unfunded Mandates Reform Act 

of 1995 requires, at 2 U.S.C. 1532, that 

agencies prepare an assessment of 

anticipated costs and benefits before 

issuing any rule that may result in 

expenditure by State, local, or tribal 

governments, in the aggregate, or by the 

private sector, of $100 million or more 

(adjusted annually for inflation) in any 

given year. This final rule has no such 

effect on State, local, or tribal 

governments, or on the private sector. 

Paperwork Reduction Act 

This final rule does not contain any 

collections of information under the 

Paperwork Reduction Act (44 U.S.C. 

3501–3520). 

Regulatory Flexibility Act 

The Secretary hereby certifies that 

this final rule will not have a significant 

economic impact on a substantial 

number of small entities as they are 

defined in the Regulatory Flexibility 

Act, 5 U.S.C. 601–612. This final rule 

will not cause a significant economic 

impact on health care providers, 

suppliers, or other small entities. The 

rule generally concerns the promotion 

of drugs by large pharmaceutical 

companies and only a small portion of 

the business of such entities concerns 

VA beneficiaries. Therefore, pursuant to 

5 U.S.C. 605(b), this amendment is 

exempt from the initial and final 

regulatory flexibility analysis 

requirements of sections 603 and 604. 

Catalog of Federal Domestic Assistance 

Numbers 

The Catalog of Federal Domestic 

Assistance numbers and titles are 

64.009 Veterans Medical Care Benefits, 

64.010 Veterans Nursing Home Care and 

64.011 Veterans Dental Care. 

Signing Authority 

The Secretary of Veterans Affairs, or 

designee, approved this document and 

authorized the undersigned to sign and 

submit the document to the Office of the 

Federal Register for publication 

electronically as an official document of 

the Department of Veterans Affairs. John 

R. Gingrich, Chief of Staff, Department 

of Veterans Affairs, approved this 

document on October 4, 2011, for 

publication. 

List of Subjects in 38 CFR Part 1 

Administrative practice and 

procedure, Archives and records, 

Cemeteries, Claims, Courts, Crime, 

Flags, Freedom of Information, 

Government employees, Government 

property, Infants and children, 

Inventions and patents, Parking, 

Penalties, Privacy, Reporting and 

recordkeeping requirements, Seals and 

insignia, Security measures, Wages. 

Dated: February 29, 2012. 

Robert C. McFetridge, 

Director of Regulation Policy and 

Management, Office of the General Counsel, 

Department of Veterans Affairs. 

For the reasons set forth in the 

preamble, the Department of Veterans 

Affairs amends 38 CFR part 1 as follows: 

PART 1—GENERAL PROVISIONS 

■ 1. The authority citation for part 1 

continues to read as follows: 

Authority: 38 U.S.C. 501(a), and as noted 

in specific sections. 

■ 2. Add § 1.220 to read as follows: 

§ 1.220 On-site activities by 

pharmaceutical company representatives at 

VA medical facilities. 

(a) Scope. This rule governs on-site, 

in-person promotional activities, 

including educational activities, by 

pharmaceutical company 

representatives at VA medical facilities. 

It does not apply to the distribution of 

information and materials through other 

means. 

(b) Definitions. For the purposes of 

this section: 

Criteria-for-use means clinical criteria 

developed by the Department of 

Veterans Affairs (VA) at a National level 

that describe how certain drugs may be 

used. VA’s criteria-for-use are available 

to the public at www.pbm.va.gov. 

Exceptions may be applied at the local 

level for operational reasons. 

Drug or drugs means: 

(1) Articles recognized in the official 

United States Pharmacopoeia, official 

Homeopathic Pharmacopoeia of the 

United States, official National 

Formulary, or any supplement to any of 

them; 

(2) Articles intended for use in the 

diagnosis, cure, mitigation, treatment, or 

prevention of disease in man or other 

animals; 

(3) Articles (other than food) intended 

to affect the structure or any function of 

the body of man or other animals; and 

(4) Articles intended for use as a 

component of any article specified in 

paragraphs (1), (2), or (3) of this 

definition. 

Drug-related supplies means supplies 

related to the use of a drug, such as test 

strips or testing devices, inhalers, 

spacers, insulin syringes, and tablet 

splitters. 

New molecular entity refers to a drug 

product containing an active ingredient 

that has never before received U.S. Food 

and Drug Administration approval. 

Non-promotable drugs are drugs 

designated by VA as non-promotable on 

http://www.pbm.va.gov. A list of the 

drugs or drug-related supplies classified 

by VA as non-promotable may be 

requested by contacting the VA medical 

facility’s Chief of Pharmacy Services. 

Non-VANF drugs or drug-related 

supplies means drugs or drug-related 

supplies that do not appear on the 

VANF. 

Pharmaceutical company 

representative means any individual 

employed by or contracted to represent 

a pharmaceutical manufacturer or 

retailer. 

VA medical facility means any 

property under the charge and control of 

VA used to provide medical benefits, 

including Community-Based Outpatient 

Clinics and similar facilities. 

VA National Formulary (VANF) drugs 

and/or drug-related supplies means any 

drug or drug-related supply that appears 

on the VA National Formulary (VANF). 

The VANF is available at 

www.pbm.va.gov, or may be requested 

by contacting the VA medical facility’s 

Chief of Pharmacy Services. 

Veterans Integrated Service Network 

(VISN) means one of the networks of VA 

medical facilities located in a particular 

region as designated by VA. 

(c) Promotion of drugs and drugrelated supplies. Notwithstanding 

§ 1.218(a)(8), VA will allow promotion 

of VANF drugs and drug-related 

supplies, and non-VANF drugs and 

drug-related supplies with criteria-foruse, on-site and in-person at VA 

medical facilities if all of the following 

are true: 

(1) Drugs or drug-related supplies are 

discussed, displayed and represented 

accurately; 

(2) The promotion has significant 

educational value and does not 

inappropriately divert VA staff from 

other activities that VA staff would 

otherwise perform during duty hours, 

including patient care and other 

educational activities; and 


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(3) The drug or drug-related supply 

has not been classified by VA as nonpromotable. 

(d) Promotion of non-VANF drugs and 

drug-related supplies without criteriafor-use. Non-VANF drugs and drugrelated supplies without criteria-for-use 

may be promoted only if the 

requirements of paragraphs (c)(1) 

through (3) of this section are met and 

the promotion is specifically permitted 

by the VISN Pharmacist Executive, or 

Chief of Pharmacy Services, or designee. 

(e) Promotion of a new molecular 

entity. A new molecular entity may be 

promoted only if the requirements of 

paragraphs (c)(1) through (3) of this 

section are met and the promotion is 

specifically permitted by the VISN 

Pharmacist Executive, or Chief of 

Pharmacy Services, or designee. Such 

permission will be automatically 

revoked if the new molecular entity is 

subsequently designated nonpromotable. Such permission must be 

reconsidered if the new molecular entity 

is denied VANF status. 

(f) Educational programs and 

associated materials. For purposes of 

this section, an educational program is 

a pre-scheduled event or meeting during 

which a pharmaceutical company 

representative provides information 

about a drug or drug-related supply. All 

educational programs and associated 

materials must receive prior approval 

from the person at the VA medical 

facility to whom such approval 

authority has been delegated under local 

policy, usually the Chief of Pharmacy 

Services. All materials associated with a 

proposed educational program must be 

provided at least 60 days before the 

proposed date of the educational 

program or distribution of associated 

materials, unless VA agrees in an 

individual case to a different date, so 

that a determination of their suitability 

can be made. The approval authority 

will deem suitable any educational 

program and associated materials if it is 

part of a risk evaluation and mitigation 

strategy or other duty imposed by the 

Food and Drug Administration. 

Otherwise, educational programs and 

associated materials will be deemed 

suitable if the approval authority 

determines that they conform to the 

following requirements: 

(1) Industry sponsorship must be 

disclosed in the introductory remarks 

and in the announcement brochure. 

Sponsorship includes any contribution, 

whether in the form of staple goods, 

personnel, or financing, intended to 

support the educational program. 

(2) If industry-sponsored and nonsponsored sources of data or other 

analytical information exist for FDAapproved uses of a particular drug, a 

direct comparison between the two 

sources must be disclosed in the 

introductory remarks and in the 

announcement brochure. 

(3) The educational program does not 

solicit protected health information or 

patient participation in pharmaceutical 

company-sponsored programs, except as 

may be required by Federal laws and 

regulations such as an educational 

program that is part of a risk evaluation 

and mitigation strategy required by the 

Food and Drug Administration. 

(4) Patient educational materials must 

not contain the name or logo of the 

pharmaceutical manufacturer or be used 

for promotion of a specific medication, 

unless the VA Pharmacy Benefits 

Management Service determines that 

the logo or name is inconspicuous and 

legal requirements (e.g., trademark 

requirements) make their removal 

impractical. However, this requirement 

does not apply to labeling required by 

the Food and Drug Administration. 

(5) Educational programs and 

associated materials regarding a drug, 

drug-related supply, or a new 

therapeutic indication for a drug that is 

already on the VANF but has not yet 

been reviewed by VA, must be 

submitted by the pharmaceutical 

company or pharmaceutical company 

representative to the VA medical 

facility’s Chief of Pharmacy Services or 

designee. 

(6) Educational programs and 

associated materials focusing primarily 

on non-VANF drugs or drug-related 

supplies without criteria-for-use are 

permitted only if those drugs or drugrelated supplies may be promoted under 

paragraph (d) of this section. 

(g) Providing gifts, drugs or other 

promotional items to VA employees or 

facilities. 

(1) General. No pharmaceutical 

company representative may give, and 

no VA employee may receive, any item 

(including but not limited to 

promotional materials, continuing 

education materials, textbooks, 

entertainment, and gratuities) that 

exceeds the value permissible for 

acceptance under government ethical 

rules (5 CFR 2635.204(a)). However, 

such items may be donated to a medical 

center library or individual department 

for use by all employees, in accordance 

with medical center policy. Gifts in 

support of VA staff official travel may be 

accepted by the Department subject to 

advance legal review in accordance with 

31 U.S.C. 1353, 41 CFR part 304, and 

VA policy regarding such gifts. 

(2) Samples of drugs and drug-related 

supplies. Pharmaceutical company 

representatives must submit samples of 

drugs and drug-related supplies for 

approval to the person at the medical 

facility to whom such responsibility is 

delegated under local policy, usually 

the Director. All usage information 

pertaining to these drugs or drug-related 

supplies must be forwarded to the VISN 

Pharmacist Executive or VISN 

Formulary Committee. All samples of 

drugs or drug-related supplies must be 

delivered to the Office of the Chief of 

Pharmacy Services for proper storage, 

documentation and dispensing. Drug or 

drug-related supply samples may not be 

provided to VA staff for their personal 

use. 

(3) Donations of food. Pharmaceutical 

company representatives may not 

provide food items of any type or any 

value to VA staff (including volunteers 

and without compensation employees) 

or bring food items into VA medical 

facilities for use by non-VA staff (e.g., 

employees of affiliates). 

(h) Conduct of pharmaceutical 

company representatives. In addition to 

the other provisions in this section, 

pharmaceutical company 

representatives must conform to the 

following: 

(1) Contacts must be by appointment 

only. In order to minimize the potential 

for disruption of patient care activities, 

a pharmaceutical company 

representative must schedule an 

appointment before each visit. Access to 

VA medical facilities by a 

pharmaceutical company representative 

without an appointment is not 

permitted under any circumstances. VA 

medical facilities may develop a list of 

individuals or departments that may not 

be called-on by pharmaceutical 

company representatives. A 

pharmaceutical company representative 

must not attempt to make appointments 

with, or leave any materials for, 

individuals or departments on the list. 

The list may be obtained at the VA 

medical facility office of the Chief of 

Pharmacy Services. A pharmaceutical 

company representative visiting a VA 

medical facility for a scheduled 

appointment may not leave promotional 

materials for, or initiate requests for 

meetings with, other VA staff; however, 

pharmaceutical company 

representatives may respond to requests 

initiated by VA staff during the visit. 

(2) Paging VA employees. A 

pharmaceutical company representative 

may not use the public address (paging) 

system to locate any VA employee. 

Contacts using the electronic paging 

system (beepers) are permissible only if 

specifically requested by the VA 

employee. 

(3) Marketing to students. 

Pharmaceutical company 


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Federal Register / Vol. 77, No. 43 / Monday, March 5, 2012 / Rules and Regulations 13009 

representatives are prohibited from 

marketing to medical, pharmacy, 

nursing and other health profession 

students, including residents. 

Exceptions may be permitted when 

approved by, and conducted in the 

presence of, the staff member providing 

clinical supervision. 

(4) Attendance at conferences. A 

pharmaceutical company representative 

may not attend a medical center 

conference where information regarding 

individual patients is discussed or 

presented. 

(5) Patient care areas. Pharmaceutical 

company representatives generally may 

not wait for scheduled appointments or 

make presentations in patient-care 

areas, but may briefly travel through 

them, when necessary, to meet in a staff 

member’s office. Patient-care areas 

include, but are not limited to: 

(i) Patient rooms and ward areas 

where patients may be encountered; 

(ii) Clinic examination rooms; 

(iii) Nurses stations; 

(iv) Intensive care units; 

(v) Operating room suites; 

(vi) Urgent care centers; 

(vii) Emergency rooms (but not staff 

offices that may be located in them); or 

(viii) Ambulatory treatment centers. 

(6) Distribution of materials. 

Pharmaceutical company 

representatives may only distribute 

materials on-site at the time and 

location of a scheduled appointment or 

educational program. In no 

circumstances may materials be left in 

patient care areas. 

(i) Non-compliance. 

(1) General. The visiting privileges of 

a pharmaceutical company 

representative or multiple 

representatives may be limited, 

suspended, or revoked by the written 

order of the Director of the VA medical 

center of jurisdiction if the Director 

determines the pharmaceutical 

company representative(s) failed to 

comply with the requirements of this 

section. 

(2) Notice of interim action. The 

Director will notify the pharmaceutical 

company representative of the 

noncompliance and of the Director’s 

interim action under paragraph (i)(4) of 

this section. The Director will also 

notify the supervisor of the 

pharmaceutical company 

representative(s) if there have been 

multiple instances of misconduct. The 

notice will offer 30 days to provide a 

response; however, the interim action 

will be enforced effective the date of the 

notice. 

(3) Final written order. At the end of 

the 30-day period for a response, or after 

the Director receives a timely response, 

the Director will issue to the 

pharmaceutical company representative 

and supervisor a final written order 

either confirming the action taken as 

indicated in the notice, or specifying 

another action to be taken under 

paragraph (i)(4) of this section. The 

written order may also state that the 

Director has determined that no further 

action is required. Any final written 

order issued by the Director shall 

include a summary of the circumstances 

of the violation, a listing of the specific 

provisions of this section that the 

pharmaceutical company 

representative(s) violated, and the bases 

for the Director’s determination 

regarding the appropriate action. Notice 

concerning a final written order 

suspending or permanently revoking the 

visiting privileges of multiple 

pharmaceutical company 

representatives shall include specific 

notice concerning the right to review of 

the Director’s order by the Under 

Secretary for Health. 

(4) Actions. Actions that may be 

imposed under this section include 

limitation, suspension, or permanent 

revocation of visiting privileges at one 

or more VA medical facilities. In 

determining the appropriate action, the 

Director shall consider the requirements 

of this section, the circumstances of the 

improper conduct, any prior acts of 

misconduct by the same pharmaceutical 

company representative, any response 

submitted by the pharmaceutical 

company representative or their 

supervisor under paragraph (i)(2) of this 

section, and any prior written orders 

issued or other actions taken with 

respect to similar acts of misconduct. 

(5) Review. The pharmaceutical 

company may request the Under 

Secretary’s review within 30 days of the 

date of the Director’s final written order 

by submitting a written request to the 

Director. The Director shall forward the 

initial notice, any response, the final 

written order, and the request for review 

to the Under Secretary for a final VA 

decision. VA will enforce the Director’s 

final written order while it is under 

review by the Under Secretary. The 

Director will provide the individual 

who made the request written notice of 

the Under Secretary’s decision. 

(Authority: 38 U.S.C. 501) 

[FR Doc. 2012–5279 Filed 3–2–12; 8:45 am] 

BILLING CODE 8320–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 80 

[EPA–HQ–OAR–2011–0542; FRL–9642–3] 

RIN 2060–AR07 

Regulation of Fuels and Fuel 

Additives: Identification of Additional 

Qualifying Renewable Fuel Pathways 

Under the Renewable Fuel Standard 

Program 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Withdrawal of direct final rule. 

SUMMARY: EPA published a direct final 

rule on January 5, 2012 to amend the 

Renewable Fuel Standard program 

regulations. Because EPA received 

adverse comment, we are withdrawing 

the direct final rule. 

DATES: Effective March 5, 2012, EPA 

withdraws the direct final rule 

published at 77 FR 700, on January 5, 

2012. 

FOR FURTHER INFORMATION CONTACT: 

Vincent Camobreco, Office of 

Transportation and Air Quality 

(MC6401A), Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW., 

Washington, DC 20460; telephone 

number: (202) 564–9043; fax number: 

(202) 564–1686; email address: 

camobreco.vincent@epa.gov. 

SUPPLEMENTARY INFORMATION: EPA 

published a direct final rule on January 

5, 2012 (77 FR 700) to amend the 

Renewable Fuel Standard program 

regulations. The amendments would 

have expanded Table 1 of § 80.1426 to 

identify additional renewable fuel 

production pathways and pathway 

components that could be used in 

producing qualifying renewable fuel 

under the Renewable Fuel Standard 

program. We stated in that direct final 

rule that if we received adverse 

comment by February 6, 2012, that we 

would publish a timely withdrawal in 

the Federal Register. We subsequently 

received adverse comment on several of 

the changes included in the revised 

Table 1 of § 80.1426. Since the 

regulatory amendment in the direct final 

rule was a single Table including all 

changes, withdrawal based on the 

adverse comments we have received 

requires withdrawal of the entire 

revised Table. EPA intends to address 

all comments in a subsequent final 

action, which will be based on the 

parallel proposed rule also published on 

January 5, 2012 (77 FR 462). 

As stated in the direct final rule and 

the parallel proposed rule, we will not 


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