16962 Federal Register / Vol. 60, No. 63 / Monday, April 3, 1995 / Rules and Regulations

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 20

[Docket No. 93N–0334]

Protecting the Identities of Reporters

of Adverse Events and Patients;

Preemption of Disclosure Rules

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending its

public information regulations to help

ensure that the identities of those who

report adverse events associated with

human drugs, biologics, and medical

devices, and the identities of patients

are held in confidence and not disclosed

by FDA or by manufacturers that

possess these reports. This final rule

preempts the establishment or

continuation in effect of any State or

local law, rule, regulation, or other

requirement that requires or permits

disclosure of such identities. This action

is being taken to maintain the agency’s

ability to collect information about

safety risks of FDA-regulated products

and is vital to the protection of the

public health.

DATES: This final rule will become

effective on July 3, 1995.

FOR FURTHER INFORMATION CONTACT:

Philip L. Chao, Office of Policy (HF–23),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–443–2831.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of June 3, 1993

(58 FR 31596), FDA announced the

availability of a new form for reporting

adverse events and product problems

associated with human drug products,

biological products, medical devices,

and other FDA-regulated products. The

new form was part of MedWatch, FDA’s

new Medical Products Reporting

Program, which is intended to facilitate

the reporting of adverse events and

product problems for all FDA-regulated

products by the entire health care

community (manufacturers, distributors,

user facilities, and health care

professionals).

The MedWatch program features two

versions of the form for reporting

adverse events and product problems.

One version, FDA Form 3500A, is used

by manufacturers, distributors, and user

facilities to report adverse events as

required under Federal statutes or FDA

regulations. The other version, FDA

Form 3500, is available for use by health

professionals, such as physicians,

physician assistants, pharmacists, and

nurses, for voluntary reporting.

FDA uses adverse event reports from

health professionals and industry to

identify possible problems in marketed

products. Based on the reports, the

agency evaluates the seriousness of the

health hazard, takes corrective action if

necessary, and communicates that

action to the health professional

community. Corrective action can be in

the form of labeling changes, such as the

addition of new precautions, boxed

warnings for serious hazards, and

product recalls or withdrawals. FDA

may also elect to notify health

professionals, industry, and others of

important information through Medical

Alerts, Safety Alerts (for medical

devices), the FDA Medical Bulletin, and

‘‘Dear Doctor’’ or ‘‘Dear Health

Professional’’ letters.

The success of the MedWatch

program depends in large part on

voluntary reporting of adverse events

from health professionals, either

directly to the agency or to other entities

who report to the agency. As stated in

the preamble to the proposed rule of

January 27, 1994 (59 FR 3944) (the

January 1994 proposal), voluntary

reporting has revealed significant

adverse events and drug interactions

associated with products that could not

be identified during preapproval testing.

For example, voluntary reporting

contributed to the removal of the

antibiotic temafloxacin (Omniflox) from

the market and to the development of

warning labeling for latex products.

Voluntary reporting also led to research

concerning the danger of concurrent use

of the antihistamine terfenadine

(Seldane) when taken with either the

antifungal ketoconazole or the antibiotic

erythromycin.

To ensure meaningful reporting under

the MedWatch program, the agency

proposed to enhance safeguards for

protecting the identities of persons who

voluntarily submit adverse event

reports, as well as the identities of the

patients experiencing those adverse

events, to FDA and to manufacturers (59

FR 3944 at 3946 to 3947). The January

1994 proposal would also protect the

voluntary reporting system through a

regulation that preempts the

establishment or continuation in effect

of any State or local law, rule,

regulation, or other requirement that

requires or permits disclosure of such

identities.

This document makes final the

requirements published in the January

1994 proposal.

II. Comments on the Proposed Rule

FDA received 31 comments on the

January 1994 proposal. In general, the

comments supported the proposed rule,

although some comments suggested

expanding the rule to include

mandatory adverse event reports, and

other comments sought additional

protection from disclosure.

A. General Comments

1. Three comments suggested that

FDA revise the rule to prevent persons

who receive adverse event reports from

disclosing those reports to other parties.

The comments noted that the proposed

rule was silent on such disclosures.

FDA declines to accept the comments’

suggestion. The agency notes that, under

the rule, persons receiving adverse

event reports would be those who have

obtained consent to disclosure under

§ 20.63(f)(1)(i) (21 CFR 20.63(f)(1)(i)), are

engaged in medical malpractice

litigation involving the voluntary

reporter (§ 20.63(f)(1)(ii)), or have

requested disclosure under

§ 20.63(f)(1)(iii). Consequently, a person

receiving the adverse event report under

this rule would either have obtained

consent for the disclosure from both the

voluntary reporter and subject, or, in the

case of medical malpractice litigation,

already would have disclosed, through

court documents, information

surrounding the adverse event.

FDA has amended the rule, however,

to state that voluntary reports that are

made available to the subject of an

adverse event under § 20.63(f)(1)(iii)

will not include the names of any other

individuals, including that of the

voluntary reporter. This change

provides further protection against

disclosure in the small number of

circumstances where the voluntary

reporter is not a physician or health care

professional known to the patient. FDA

believes this clarification will encourage

adverse event reporting and does not

deny critical information to the subject

of the report because the subject will

ordinarily know the name of the

physician who has performed the

procedure or prescribed medication.

2. One comment would revise the rule

by adding a new paragraph to declare

that the production of adverse event

reports containing identifying

information, during the discovery phase

in litigation, does not constitute

‘‘disclosure’’ under the rule if all parties

to the litigation agree that the party

receiving the adverse event report will

not record the identifying information,

will not attempt to contact the persons

identified in the report, and will remove

identifying information from any
Federal Register / Vol. 60, No. 63 / Monday, April 3, 1995 / Rules and Regulations 16963

adverse event report that the party

copies.

FDA declines to amend the rule as

suggested by the comment. The

mechanism described by the comment

would be inappropriate due to wide

variations among state court procedures,

and the resulting inconsistencies in

applying such a mechanism would

discourage, rather than encourage,

health care professionals from reporting

adverse events. The intent of the rule is

to ensure that individuals who are not

the reporters or other persons identified

in the reports do not have access in any

way to the identifying information,

except in specifically described

circumstances. Allowing such

individuals to view the identifying

information in the context of discovery

would not achieve this purpose and

would discourage voluntary reporting.

3. One comment said FDA should

seek statutory changes to prevent the

release of information in addition to

issuing a rule.

The agency disagrees that statutory

changes are necessary. As stated in the

preamble to the January 1994 proposal

and elsewhere in this document, FDA

believes it has sufficient legal authority

to preempt State and local laws, rules,

regulations, and other requirements that

would permit or require the disclosure

of the identities of health care

professionals who voluntarily report

adverse events and the patients or other

individuals named in those reports.

Although Congress did not expressly

preempt State law in this area, the

agency finds Federal preemption to be

appropriate because such State or local

laws, rules, regulations, or other

requirements would impede FDA’s

ability to monitor product safety after

approval to ensure that human drug

products, biologics, and medical devices

are safe and effective for their intended

uses. (See 59 FR 3944 at 3948 to 3949).

Thus, under principles of preemption

law, congressional intent to preempt

State law can be inferred.

4. One comment focused on nuclear

medicine and said that FDA should not

disclose adverse event reports to the

Nuclear Regulatory Commission (NRC)

because NRC publishes reports of

‘‘misadventure,’’ and such reports often

include the physician’s and patient’s

names. The comment said that FDA

should assume sole jurisdiction over

nuclear medicine.

FDA declines to accept the comment.

The agency notes that current

regulations (21 CFR 20.85) already

establish conditions on disclosures to

other Federal government departments

and agencies and that ‘‘[a]ny disclosure

* * * shall be pursuant to a written

agreement that the record shall not be

further disclosed by the other

department or agency except with the

written permission of the Food and

Drug Administration.’’ As for assuming

sole jurisdiction over nuclear medicine,

the issue of NRC and FDA jurisdiction

goes beyond the scope of this

rulemaking.

5. One comment asserted that the rule

would actually make more information

available to the public because it would

make an entire adverse event report

available. The comment claimed that

such disclosure would be contrary to

the goal of protecting confidentiality

and recommended that FDA instead

expand § 20.111 (21 CFR 20.111),

pertaining to data and information

submitted voluntarily to FDA, to protect

adverse event reports held by

manufacturers from disclosure and to

preempt State and local laws and

regulations.

FDA believes the comment

misinterprets the rule. Section 20.111

describes the types of data and

information submitted voluntarily to

FDA that are available for public

disclosure. In general, under

§ 20.111(c)(3), adverse reaction reports,

product experience reports, consumer

complaints, and ‘‘other similar data and

information’’ shall be disclosed except

for certain identifying information. The

identifying information that is deleted

from the record varies, depending on

whether the information was submitted

by a consumer, the product’s

manufacturer, or a third party. For

example, if a consumer submitted the

record, the agency would not disclose

the identity of the consumer. If a

manufacturer submitted the record, the

agency would not disclose the identity

of the person using the product or any

third party involved in the report or the

manufacturer’s identity. (See

§ 20.111(c)(3)(i) through (c)(3)(iii)).

In contrast, § 20.63 establishes

exemptions from disclosure

requirements. These exemptions are to

be read in conjunction with any

conditions imposed under § 20.111.

Specifically, § 20.63(f) would authorize

the agency and manufacturers

possessing adverse event reports to

withhold the names of voluntary

reporters and other persons identified in

such reports, regardless of whether a

consumer, manufacturer, or other party

submitted a voluntary report.

Furthermore, § 20.63(f) permits

identities to be disclosed under three

limited exceptions: (1) The voluntary

reporter and the person identified in the

report (or the person’s legal

representative) consent, in writing, to

disclosure; (2) a court orders disclosure

during medical malpractice litigation

involving the voluntary reporter and the

person experiencing the adverse event;

and (3) the individual who is the subject

of the report requests the report. These

exceptions are reasonable and practical

because it would make little sense to

withhold the identities of the parties

named in an adverse event report if

those same parties consent to disclosure

or are engaged in litigation or, in cases

where the party requesting the report

was the subject of the report, must

already be aware that he or she is

identified in a report.

Thus, while the final rule arguably

discloses more information (in the form

of identifying information) than

§ 20.111, that additional information is

disclosed to persons who either

submitted the voluntary report, have

consented to disclosure, or know that a

report pertaining to their own adverse

experience exists. Furthermore, while

§ 20.111 describes data and information

that are available for disclosure,

§ 20.63(f) establishes exemptions to

disclosure. A preemption provision,

which essentially establishes another

exception to disclosure, would be more

appropriate in § 20.63.

6. The January 1994 proposal referred

to voluntary reporters submitting

adverse event reports. Proposed

§ 20.63(f) also stated that it did not

affect disclosure of the identities of

reporters required by statute or

regulation to make adverse event reports

and that disclosure of identities of such

reporters would be ‘‘governed by the

applicable statutes and regulations.’’

Seven comments asked FDA to expand

the rule to include mandatory adverse

event reports required by the Safe

Medical Devices Act or other statutes.

The comments said that persons who

are required to submit adverse event

reports should enjoy the same

protection offered by the rule to those

who voluntarily submit reports. One

comment even claimed that, under the

rule, voluntary reports enjoyed greater

protection than mandatory reports, and

this difference could deter compliance

with mandatory adverse event reporting

requirements.

The agency does not believe it can or

should expand the rule as requested by

these comments. The policy and final

rule are intended to protect voluntary

reporting. FDA assumes that those

subject to mandatory reporting

requirements established by Congress or

by Federal regulation comply with those

requirements and will continue to do so.

The agency also notes that different

standards for treatment of disclosure of

required and voluntary information is

an established part of disclosure law.
16964 Federal Register / Vol. 60, No. 63 / Monday, April 3, 1995 / Rules and Regulations

(See Critical Mass Energy Project v.

NRC, 644 F.Supp. 344 (D.D.C. 1986),

vacated and remanded, 830 F.2d 278

(D.C. Cir. 1987), summary judgment

granted, 731 F.Supp. 554 (D.D.C. 1990),

rev’d & remanded, 931 F.2d 939 (D.C.

Cir. 1991), vacated & reh’g en banc

granted, 942 F.2d 799 (D.C. Cir. 1991),

vacated, 975 F.2d 871 (D.C. Cir. 1992)

(en banc), cert. denied, 113 S.Ct. 1579

(1993).)

B. Comments on Specific Provisions in

the Proposal

7. Proposed § 20.63(f) would prohibit

disclosure of the names and any

identifying information, including the

reporter’s address or the name or

address of the reporter’s institution, that

would lead to the identification of the

reporter or the persons named in a

voluntary adverse event report, by FDA

or by a manufacturer possessing such

reports in response to any request.

Four comments would amend

§ 20.63(f) to prohibit adverse event

reports from being admissible into

evidence unless the facility, individual,

or physician who made the report knew

that the report contained false

information. The comments said such a

prohibition would be consistent with

section 519(b)(3) of the Federal Food,

Drug, and Cosmetic Act (the act) (21

U.S.C. 360i(b)(3)) regarding mandatory

reports from device user facilities.

The agency declines to accept the

comments’ suggestion. In general,

§ 20.63(f) is intended to protect against

the disclosure of information that would

identify a voluntary reporter or a person

who may have experienced an adverse

event. This policy is designed to

encourage voluntary adverse event

reporting by health care professionals

and others. The agency’s policy

regarding disclosure of voluntarily

submitted adverse event reports has

been, and continues to be, that such

reports are publicly available after

deletion of identifying information. (See

§ 20.111(c); see also 39 FR 44602 at

44628 to 44629, December 24, 1974

(rejecting comments seeking to limit

dissemination of adverse reaction

reports and consumer complaints).) This

is consistent with the agency’s

obligations under the Freedom of

Information Act, and the agency,

therefore, declines to revise the rule to

limit disclosure of adverse event

reports.

8. Two comments would expand

§ 20.63(f) to include demands and

orders to disclose adverse event reports.

The comments explained that a person

seeking an adverse event report could

do so by request to the agency or

manufacturer or, in other contexts,

demand or seek a judicial order

requiring the agency or manufacturer to

provide the reports.

FDA agrees and has modified the rule

accordingly.

9. As noted earlier, proposed

§ 20.63(f) would not affect disclosure of

the identities of reporters required by

statute or regulation to make adverse

event reports and expressly stated that

disclosure of the identities of such

reporters ‘‘is governed by the applicable

statutes and regulations.’’ Three

comments suggested that FDA modify

§ 20.63(f) to refer to ‘‘federal statutes

and regulations’’ because, as written, the

rule could arguably be interpreted as

being inapplicable to disclosures

required by State law or regulation.

FDA agrees and has modified the rule

accordingly.

10. One comment asked FDA to

clarify the rule’s relationship to existing

FDA regulations governing information

exchanges between the agency and

manufacturers.

The rule does not affect information

exchanges between FDA and

manufacturers. Nor does the rule alter or

diminish any regulatory requirements

for manufacturers regarding submission

of adverse event reports. The rule is

directed to requests by third parties for

adverse event reports.

11. The proposed rule created three

exceptions to the policy against

disclosing the identities of the voluntary

reporter and the person who

experienced the adverse event.

Proposed § 20.63(f)(1)(i) contained the

first exception and would allow the

identities to be disclosed if both the

voluntary reporter and the person

identified in the report (or that person’s

legal representative) consented, in

writing, to disclosure.

Two comments requested that FDA

modify or delete the provision. The

comments asserted that the provision

could prompt third parties to request or

demand that FDA or a manufacturer

seek consent from the voluntary reporter

or the person identified in the report

because the agency and the

manufacturer would know their

identities. The comments would either

delete the provision or modify the rule

to contain a specific prohibition against

courts and State agencies seeking to

have FDA or manufacturers obtain

consent from the voluntary reporter or

patient.

In response to these comments, FDA

has amended § 20.63(f)(1)(i) to state that

the agency and manufacturers shall not

be required to seek consent on behalf of

requesters. As stated in § 20.63(f) and

also in § 20.111, the identities of the

voluntary reporter and any other person

named in an adverse event report shall

not be disclosed by FDA or by

manufacturers except in limited

situations. If third parties could request

or demand that FDA or manufacturers

seek consent from the voluntary reporter

and/or person named in the report, the

practical effect would be to eliminate

the protection given by FDA’s

regulations. In addition, the

administrative burden of such

procedures, in response to third party

requests, would detract from agency

resources devoted to investigation and

assessment of adverse event reports.

Consequently, FDA has not in the past

and will not entertain such requests,

and the burden of seeking consent from

the voluntary reporter and the person

identified in the adverse event report

will continue to rest on the party

requesting the adverse event report and

identifying information.

12. Proposed § 20.63(f)(1)(ii) would

permit disclosure of the identities of the

voluntary reporter and a person named

in an adverse event report ‘‘pursuant to

a court order in the course of medical

malpractice litigation involving both the

person who experienced the reported

adverse event and the voluntary

reporter.’’

Three comments would delete

§ 20.63(f)(1)(ii). According to the

comments, the provision would

encourage plaintiffs to name multiple

defendants in medical malpractice cases

in order to obtain the identities of

persons in an adverse event report.

FDA declines to delete the provision

as requested. The agency does not share

the comments’ underlying assumption

that the possible existence of a

voluntary adverse event report will

prompt plaintiffs to bring a malpractice

suit against every person who might

have submitted a voluntary adverse

event report, especially when the only

information that the plaintiff would

gain, under § 20.63(f)(1)(ii), would be

his or her own name and the name of

the voluntary reporter. If a plaintiff did

engage in such tactics, some

jurisdictions might consider it to

constitute an abuse of process and

impose sanctions against the plaintiff or

the plaintiff’s attorneys.

FDA also notes that if a plaintiff knew

that a report specific to his or her

adverse event existed, the plaintiff

would obtain more substantive

information regarding the adverse event

under § 20.63(f)(1)(iii).

13. One comment would delete

§ 20.63(f)(1)(ii). The comment stated

that § 20.63(f)(1)(ii) was unnecessary

because a person who experienced an

adverse event could obtain a copy of the
Federal Register / Vol. 60, No. 63 / Monday, April 3, 1995 / Rules and Regulations 16965

adverse event report under

§ 20.63(f)(1)(iii).

The agency disagrees with the

comment. The two provisions serve

different purposes. Many adverse event

reports contain little or no identifying

information about the person who

experienced the reported adverse event,

and the person who experienced the

adverse event may be unaware that he

or she had been the subject of an

adverse event report. Thus, under

§ 20.63(f)(1)(ii), if a person who

experienced an adverse event were

engaged in medical malpractice

litigation, he or she could seek a court

order to obtain identifying information,

and thus determine whether he or she

had been the subject of an adverse event

report. In contrast, § 20.63(f)(1)(iii)

presumes that the individual requesting

a report already knows that a report

exists and that the individual is ‘‘the

subject of the report.’’

14. Two comments sought

clarification of § 20.63(f)(1)(ii),

particularly the ‘‘identities’’ that would

be disclosed. The comments indicated

that § 20.63(f)(1)(ii) could be interpreted

as permitting disclosure of the identities

of all persons experiencing an adverse

event who were named in a report by

the voluntary reporter. The comments

suggested revising the provision to limit

disclosure to the identities of the

voluntary reporter and the person

experiencing the adverse report

provided that both were parties in the

malpractice litigation.

FDA agrees that the identities of

persons who experienced an adverse

event but are not parties to the medical

malpractice litigation should not be

disclosed and has revised the rule

accordingly.

15. Proposed § 20.63(f)(1)(iii) would

permit disclosure of a voluntarilysubmitted adverse event report to an

individual who is the subject of the

report.

One comment would modify the

provision to require notice to the

voluntary reporter.

FDA believes that an individual who

is the subject of an adverse event report

should be entitled to the report without

prior notice to the voluntary reporter.

Additionally, providing notice to the

voluntary reporter would confer little

benefit because there is no mechanism

to allow the voluntary reporter to

withdraw or amend a voluntarily

submitted adverse event report once it

has been submitted. Furthermore, as

stated above, the suggested change is

unnecessary in light of the agency’s

revision to the rule, which clarifies that

the report will be disclosed to the

subject of the report without inclusion

of any other names, including that of the

voluntary reporter.

16. One comment would make reports

inadmissible as evidence unless the

facility or reporter knew that the

information contained in the report was

false. Another comment would revise

§ 20.63(f)(1)(iii) to state that, ‘‘The report

shall be disclosed to the individual who

is the subject of the report upon request

in any litigation regarding the adverse

event referred to in the report and in

which the individual is a party.’’ The

comment asserted that manufacturers

should not have to assume the burden

of responding to a potentially large

number of requests from patients for

adverse event reports.

FDA disagrees with the comments. As

stated above, the agency believes that an

individual who is the subject of an

adverse event report should be entitled

to the report itself. Such access to the

report should not be conditioned on the

existence of false information in the

report or on litigation.

17. One comment would revise

§ 20.63(f)(1)(iii) to state that, ‘‘The

report, but not the identity of the

voluntary reporter or of any other

person named in the report, shall be

disclosed to the individual who is the

subject of the report upon request.’’ The

comment claimed that this change

would be consistent with the protection

of identities under § 20.63(f)(1)(i) and

(f)(1)(ii).

The agency agrees with the comment

and has amended the rule to state that

the report will exclude the identities of

other persons. As mentioned earlier,

this additional protection for the

voluntary reporter is unlikely to limit

the information available to most

subjects of adverse event reports

because they are likely to know already

the identity of the voluntary reporter.

FDA agrees that the identities of any

other persons named in the report

should also be protected in order to

maintain their privacy or preserve the

confidentiality of any relationships

between the voluntary reporter and

other persons. Therefore, the agency has

revised § 20.63(f)(1)(iii) to exclude the

identities of any other person, aside

from the person requesting the report,

named in an adverse event report.

III. Descriptiom of the Final Rule

The final rule creates a new § 20.63(f)

to prevent FDA and manufacturers of

human drug products, biologics, or

medical devices from disclosing the

names and any information that would

identify the voluntary reporter or any

other person named in a voluntarilysubmitted adverse event report. The rule

interprets ‘‘information’’ as including

‘‘the name, address, institution, or any

other information that would lead to the

identities of the reporter or person

identified in the report.’’ The rule does

not apply to the identities of reporters

required by statutes (such as the Safe

Medical Devices Act or the National

Childhood Vaccine Injury Act) to

submit reports to FDA and does not

alter any disclosure requirements under

those statutes.

The final rule also creates three

exceptions to the prohibition against

disclosure. Under § 20.63(f)(1)(i), the

identities may be disclosed to a third

party if both the voluntary reporter and

the person who is identified in the

report consent, in writing, to disclosure.

As stated above, persons who seek

disclosure of such identities have the

burden of obtaining consent; the agency

will not seek such consent itself. Under

§ 20.63(f)(1)(ii), identities may be

disclosed pursuant to a court order in

the course of medical malpractice

litigation involving both the person who

experienced the adverse event and the

voluntary reporter. Section

20.63(f)(1)(iii) would make the report,

except for the identities of any other

persons identified in the report,

available to the individual who is the

subject of the report, upon request.

Section 20.63(f)(2) preempts the

establishment or continuation in effect

of any State or local law, rule,

regulation, or other requirement that

permits or requires disclosure of the

identities of the voluntary reporter or

other person identified in an adverse

event report, except as otherwise

provided by § 20.63(f)(1).

IV. Legal Authority

A. Principles of Preemption Law

Under the Supremacy Clause of the

Constitution (U.S. Constitution, Art. VI,

clause 2), State laws that interfere with

or are contrary to Federal law are

invalid. (See Gibbons v. Ogden, 22 U.S.

(9 Wheat.) 1, 211 (1824).) Federal

preemption can be express (stated by

Congress in the statute) or implied.

Implied preemption can occur in

several ways. Preemption may be found

‘‘where the scheme of federal regulation

is sufficiently comprehensive to make

reasonable the inference that Congress

‘left no room’ for supplementary state

regulation’’ (Hillsborough County v.

Automated Medical Laboratories, Inc.,

471 U.S. 707, 713 (1985), quoting Rice

v. Santa Fe Elevator Corp., 331 U.S. 218,

230 (1947)), or where ‘‘the federal

interest is so dominant that the federal

system will be assumed to preclude

enforcement of state laws on the same

subject’’ (Rice v. Santa Fe Elevator
16966 Federal Register / Vol. 60, No. 63 / Monday, April 3, 1995 / Rules and Regulations

Corp., 331 U.S. 218, 230 (1947); see

Hines v. Davidowitz, 312 U.S. 52

(1941)).

Federal preemption may also be

found where Federal law conflicts with

State law. Such conflict may be

demonstrated either when ‘‘compliance

with both federal and state [law] is a

physical impossibility’’ (Florida Lime

and Avocado Growers, Inc. v. Paul, 373

U.S. 132, 142–143 (1963)), or when

State law ‘‘stands as an obstacle to the

accomplishment and execution of the

full purposes and objectives of

Congress’’ (Hines v. Davidowitz, 312

U.S. at 67). State law is also preempted

if it interferes with the methods by

which a Federal law is designed to

reach its goals. (See International Paper

Co. v. Ouellette, 479 U.S. 481, 494

(1987); Michigan Canners & Freezers

Ass’n v. Agricultural Marketing &

Bargaining Bd., 467 U.S. 461, 477–478

(1984).)

Additionally, ‘‘‘a federal agency

acting within the scope of its

congressionally delegated authority may

preempt state regulation’ and hence

render unenforceable state or local laws

that are otherwise not inconsistent with

federal law’’ (City of New York v. FCC,

486 U.S. 57, 63–64 (1988) (quoting

Louisiana Public Service Comm’n v.

FCC, 476 U.S. 355, 368 (1986)). ‘‘Federal

regulations have no less preemptive

effect than federal statutes’’ (Fidelity

Federal Savings and Loan Ass’n v. de la

Cuesta, 458 U.S. 141, 153 (1982)).

When an agency’s intent to preempt is

clearly and unambiguously stated, a

court’s inquiry will be whether the

preemptive action is within the scope of

that agency’s delegated authority

(Capital Cities Cable, Inc. v. Crisp, 467

U.S. 691, 700 (1984); Fidelity Federal

Savings, 458 U.S. at 154). If the agency’s

choice to preempt ‘‘represents a

reasonable accommodation of

conflicting policies that were committed

to the agency’s care by the statute [the

regulation will stand] unless it appears

from the statute or its legislative history

that the accommodation is not one that

Congress would have sanctioned

(‘‘United States v. Shimer, 367 U.S. 374,

383 (1961)). In Hillsborough County, the

Supreme Court stated that FDA

possessed the authority to promulgate

regulations preempting local laws that

compromise the supply of plasma and

could do so (Hillsborough County, 471

U.S. at 721). FDA believes it has similar

authority to preempt State and local

laws, rules, regulations, and other

requirements that compromise the

adverse reporting systems that are

essential to postmarketing surveillance

and protection of the public health.

B. Conflicts Between State Disclosure

Laws and Federal Law

Conflicts between State and local

disclosure laws and Federal laws and

regulations on adverse event reporting

justify FDA’s preemption of State and

local law. Although Congress did not

expressly preempt State law in this area,

FDA finds preemption is appropriate

because such State and local laws

significantly interfere with the methods

by which the Federal laws and

regulations achieve their goals.

FDA is the Federal agency charged

with protecting citizens by helping

ensure that human drug products,

biologics, and medical devices are safe

and effective for their intended uses. To

further this purpose, Congress

established elaborate mechanisms for

the Federal government to permit the

marketing of new drugs, biologics, and

medical devices and to monitor the

safety of these products after their

approval. (See 21 U.S.C. 355 and 360; 42

U.S.C. 262.) Pursuant to these statutory

provisions, FDA has established an

extensive regulatory scheme to monitor

the safety and effectiveness of human

drug products, biologics, and medical

devices. (See 21 CFR 310.305, 314.80,

600.80, and 803.1 through 803.36.)

State and local rules of civil

procedure, rules of evidence, and other

laws and regulations that permit

discovery or require disclosure of a

voluntary reporter’s or patient’s identity

hinder FDA’s monitoring scheme. While

other FDA regulations may preserve the

confidentiality of some voluntary

reporters and the patients identified in

an adverse event report, the same report,

when in a manufacturer’s possession,

may be subject to State and local

disclosure laws. Such possible

disclosure will deter voluntary reporting

by health professionals directly to

manufacturers. In addition, the threat of

disclosure may chill the willingness of

reporters to provide information to FDA

because the agency may share details

about a report with a manufacturer in

order to investigate the report further.

Thus, this final rule preempts State and

local disclosure laws, rules, regulations,

and other requirements in order to

eliminate obstacles to increased and

enhanced voluntary adverse event

reporting by health professionals. FDA

has determined that the public health

value of such reporting outweighs the

individual needs of plaintiffs to

discover the identities of a voluntary

reporter or a patient, other than the

plaintiff, who is the subject of the

report.

The final rule focuses solely on

protecting the identities of the voluntary

reporter, the patient, and any other

person identified in the report. The final

rule does not preempt State or local

laws that require disclosure of the

substance of adverse event reports. FDA

does not believe that disclosure of the

substance of adverse event reports will

impede its ability to collect such

information. Indeed, FDA routinely

releases the full substance of all

voluntary adverse event reports upon

request after deleting identifying

information. (See § 20.111(c)(3)(iii).)

The final rule also does not affect an

individual’s ability to obtain specific

information about reports concerning

his or her own reaction to a product,

particularly when the individual is a

plaintiff in a medical malpractice

lawsuit and a court grants discovery of

the plaintiff’s records.

C. Legal Authority for the Final Rule

As discussed in the preamble to the

proposed rule, there are various

statutory provisions that authorize FDA

to collect information about regulated

products after the products are being

legally marketed. These statutory

authorities establish FDA’s mandate to

obtain information about the safety and

effectiveness of drugs, devices, and

biological products in order to

determine whether continued use of

these products presents an unreasonable

risk to consumers. Through preemption

of conflicting State and local rules that

permit or require disclosure of

voluntary reporter and patient

identities, this rule removes an obstacle

to full and accurate reporting of adverse

events, and enhances the agency’s

ability to implement the surveillance

authorities assigned to FDA.

Under section 505(k) of the act (21

U.S.C. 355(k)), an applicant who has an

approved new drug application (NDA)

or abbreviated new drug application

(ANDA) ‘‘shall establish and maintain

such records, and make such reports *

* * of data relating to clinical

experience and other data or

information, received or otherwise

obtained by such applicant with respect

to such drug’’ as required by regulations

or order. Under section 505(e) of the act,

failure to establish a system for adverse

event reports or to make reports

required by regulation or order

constitutes grounds for withdrawing

approval of the NDA or ANDA. Under

these provisions of the act as well as

others, such as the misbranding and

adulteration provisions, FDA

promulgated regulations requiring

specified drug adverse event reporting

(21 CFR 314.80, 310.305). (See 50 FR

11478, March 21, 1985). As stated in the

proposed rule, the voluntary system of
Federal Register / Vol. 60, No. 63 / Monday, April 3, 1995 / Rules and Regulations 16967

adverse event reporting that generates

and supplements these required

submissions is critical to the agency’s

post-market monitoring capabilities.

For medical devices, section 519 of

the act requires manufacturers,

distributors, and device user facilities to

submit certain adverse event reports to

FDA and authorizes the agency to

require, by regulation, reports to assure

that a medical device is not adulterated

or misbranded and ‘‘to otherwise assure

its safety and effectiveness.’’ As stated

in the preamble to the proposed rule, in

addition to reports required by the Safe

Medical Devices Act, FDA maintains a

voluntary device problem reporting

program. (See 59 FR 3944 at 3945.)

Voluntary medical device reports have

been an important part of FDA’s

postmarketing surveillance system for

medical devices and have prompted the

agency to take action on several

occasions. For example, in 1991,

voluntary reports to FDA resulted in an

alert to health professionals to

potentially fatal hypersensitivity to latex

products. A voluntary report from a

physician about two patients who

experienced blindness after the use of

an ophthalmic device during eye

surgery resulted in an FDA investigation

and the recall and removal of the device

from the market. This final rule is

intended to ensure that such voluntary

medical device reporting continues.

Furthermore, sections 505(k) and 519

of the act provide that regulations and

orders issued with respect to

postmarketing reporting requirements

for drugs and devices ‘‘shall have due

regard for the professional ethics of the

medical profession and the interests of

patients * * * ’’ (21 U.S.C. 355(k) and

360i). The confidentiality of the

physician-patient relationship is a basic

tenet of medical ethics. The final rule,

which protects both patient and reporter

identities, is in furtherance of and

consistent with these requirements of

the act.

Additional authority to regulate

adverse event reporting for biologics can

be found in section 351 of the Public

Health Service Act (the PHS act).

Section 351 of the PHS act provides

regulatory authority over biologics, and,

pursuant to this section and other

statutory authorities, the agency

promulgated general adverse experience

reporting requirements for licensed

biological products, as well as

requirements for manufacturers or

collection facilities to report deaths

related to complications in blood

collection or transfusion. (See §§ 600.80

and 606.170(b) (21 CFR 600.80 and

606.170(b)); 59 FR 54034, October 27,

1994).)

The number and the quality of

required reports that FDA receives from

manufacturers and distributors

ultimately depend upon voluntary

reporting by health professionals. As

FDA explained in the proposed rule,

manufacturers and distributors cannot

report adverse events if they do not find

out about them from the health

professionals who observed or were

advised of the events. Disclosure of

patient or reporter identities serves as a

significant disincentive for voluntary

reporting by health professionals;

preemption of State and local disclosure

rules that permit or require such

disclosure eliminates an impediment to

agency oversight of the postmarketing

safety of products under its jurisdiction.

The final rule, therefore, which is

necessary to implement postmarketing

surveillance statutory authorities, is also

authorized under the general

rulemaking authority set forth in section

701(a) of the act (21 U.S.C. 371(a)).

V. Environmental Impact

The agency has determined under 21

CFR 25.24(a)(8) that this action is of a

type that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

VI. Executive Order 12612: Federalism

FDA has examined the effects of this

final rule on the relationship between

the Federal government and the States,

as required by Executive Order 12612

on ‘‘Federalism.’’ The agency concludes

that preemption of State or local rules

that permit disclosure of the identities

of the voluntary reporter or persons

identified in an adverse event report for

human drug products, biologics, and

medical devices is consistent with this

Executive Order.

Executive Order 12612 recognizes that

Federal action limiting the discretion of

State and local governments is

appropriate ‘‘where constitutional

authority for the action is clear and

certain and the national activity is

necessitated by the presence of a

problem of national scope’’ (section

3(b)). The constitutional basis for FDA’s

authority to regulate the safety and

efficacy of human drug products,

biologics, and medical devices is the

statutes created by Congress to regulate

products affecting the public health.

Congress’s decision to vest FDA with

the authority to establish a regulatory

scheme to monitor the safety of these

products demonstrates Congress’ view

that the safety of human drug products,

biologics, and medical devices is a

problem of national scope (21 U.S.C.

355(k) and 42 U.S.C. 262)).

Executive Order 12612 expressly

contemplates preemption where there is

a conflict of State and Federal authority

under a Federal statute. (See section

4(a).) State and local rules of civil

procedure, rules of evidence, and other

rules and regulations that permit or

require disclosure of the identities of

those who report adverse events

associated with human drug products,

biologics, and medical devices impede

FDA’s ability to monitor the safety and

efficacy of these products. The

guarantee of confidentiality of the

reporters’ and patients’ names is

necessary to assure meaningful

reporting of adverse events.

Additionally, Congress specified that

Federal regulations issued to monitor

the safety of drug products ‘‘shall have

due regard for the professional ethics of

the medical profession and the interests

of patients.’’ (See 21 U.S.C. 355(k) and

360i.) State and local rules and

regulations that permit or require

disclosure of the identities conflict with

this requirement by jeopardizing

confidentiality and the physicianpatient relationship.

Executive Order 12612 also requires

that any Federal preemption be

restricted to the minimum level

necessary to achieve the objectives of

the statute pursuant to which the

regulations are promulgated (section

4(c)). The final rule is narrowly drawn

and focuses solely on protecting the

identities of the reporter and patient and

other individuals named in the report.

The final rule does not preempt State

and local laws that require disclosure of

the substance of the adverse event

reports.

As required by sections 3(a) and 4(e)

of Executive Order 12612, FDA

consulted the appropriate State officials

and organizations and gave States an

opportunity to participate in the

proceedings to preempt State and local

laws. This opportunity came through

publication of the January 1994

proposal and through notice sent to

each State’s Attorney General. The

agency received no comments from any

State regarding the contents or the

concepts expressed in the January 1994

proposal.

Thus, FDA concludes that the policy

expressed in this final rule has been

assessed in light of the principles,

criteria, and requirements in Executive

Order 12612; that this policy is not

inconsistent with that Order; that this

policy will not impose additional costs

or burdens on the States; and that this

policy will not affect the States’ ability
16968 Federal Register / Vol. 60, No. 63 / Monday, April 3, 1995 / Rules and Regulations

to discharge traditional State

governmental functions.

VII. Analysis of Impacts

FDA has examined the impacts of this

final rule under Executive Order 12866

and the Regulatory Flexibility Act (Pub.

L. 96–354). Executive Order 12866

directs agencies to assess all 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,

and other advantages; distributive

impacts; and equity). The agency

believes that this final rule is consistent

with the regulatory philosophy and

principles identified in the Executive

Order. In addition, the final rule is not

a significant regulatory action as defined

by the Executive Order and so is not

subject to review under the Executive

Order.

The Regulatory Flexibility Act

requires agencies to analyze regulatory

options that would minimize any

significant impact of a rule on small

entities. The final rule would preempt

the establishment or continuation in

effect of any State or local law, rule,

regulation, or other requirement

requiring or permitting disclosure of the

identities of persons reporting adverse

events associated with the use of human

drugs, biological drug products, and

medical devices and patients’ identities.

Thus, the agency certifies that this rule

will not have a significant economic

impact on a substantial number of small

entities. Therefore, under the Regulatory

Flexibility Act, no further analysis is

required.

List of Subjects in 21 CFR Part 20

Confidential business information,

Courts, Freedom of information,

Government employees.

Therefore, under the Federal Food,

Drug, and Cosmetic Act, the Public

Health Service Act, and under authority

delegated to the Commissioner of Food

and Drugs, 21 CFR part 20 is amended

as follows:

PART 20—PUBLIC INFORMATION

1. The authority citation for 21 CFR

part 20 continues to read as follows:

Authority: Secs. 201–903 of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C.

321–393); secs. 301, 302, 303, 307, 310, 311,

351, 352, 354–360F, 361, 362, 1701–1706,

2101 of the Public Health Service Act (42

U.S.C. 241, 242, 242a, 242l, 242n, 243, 262,

263, 263b–263n, 264, 265, 300u–300u–5,

300aa–1); 5 U.S.C. 552; 18 U.S.C. 1905.

2. Section 20.63 is amended by

adding new paragraph (f) to read as

follows:

§ 20.63 Personnel, medical, and similar

files, disclosure of which constitutes a

clearly unwarranted invasion of personal

privacy.

* * * * *

(f) The names and any information

that would identify the voluntary

reporter or any other person associated

with an adverse event involving a

human drug, biologic, or medical device

product shall not be disclosed by the

Food and Drug Administration or by a

manufacturer in possession of such

reports in response to a request,

demand, or order. Information that

would identify the voluntary reporter or

persons identified in the report

includes, but is not limited to, the name,

address, institution, or any other

information that would lead to the

identities of the reporter or persons

identified in a report. This provision

does not affect disclosure of the

identities of reporters required by a

Federal statute or regulation to make

adverse event reports. Disclosure of the

identities of such reporters is governed

by the applicable Federal statutes and

regulations.

(1) Exceptions. (i) Identities may be

disclosed if both the voluntary reporter

and the person identified in an adverse

event report or that person’s legal

representative consent in writing to

disclosure, but neither FDA nor any

manufacturer in possession of such

reports shall be required to seek consent

for disclosure from the voluntary

reporter or the person identified in the

adverse event report or that person’s

legal representative; or

(ii) Identities of the voluntary reporter

and the person who experienced the

reported adverse event may be disclosed

pursuant to a court order in the course

of medical malpractice litigation

involving both parties; or (iii) The

report, excluding the identities of any

other individuals, shall be disclosed to

the person who is the subject of the

report upon request.

(2) Preemption. No State or local

governing entity shall establish or

continue in effect any law, rule,

regulation, or other requirement that

permits or requires disclosure of the

identities of the voluntary reporter or

other person identified in an adverse

event report except as provided in this

section.

Dated: March 24, 1995

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 95–8066 Filed 3–31–95; 8:45 am]

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