24316 Federal Register / Vol. 61, No. 94 / Tuesday, May 14, 1996 / Notices

broadcast advertising. (This information

has colloquially been referred to as the

‘‘major statement.’’)

If FDA required or permitted more

limited risk information in place of the

current brief summary, what specific

information should be included? What

criteria should be used by

manufacturers and the agency to

identify the ‘‘major’’ risk information for

any particular product? FDA is also

interested in empirical research that

specifically addresses the issues of how

much and what kind of risk information

can and should be communicated in

DTC advertising of prescription drug

and biological products.

2. Some comments suggested that risk

information could be communicated to

consumers through standardized general

disclosures. This kind of disclosure

would not reference particular

characteristics of a product. Instead,

such statements would reference one or

more general risks, such as the fact that

all prescription drug and biological

products have side effects; that they are

only available from a physician or other

prescribing health care professional;

that they have significant benefits, but

may have significant risks; that patients

should discuss product risks with a

physician, etc.

Such disclosures, however, are

susceptible to habituation or ‘‘wearout,’’ which results in the viewer

quickly learning to ignore the message,

thus lowering its effectiveness. In

addition, such messages may not be

perceived as risk messages at all, but

instead interpreted as reassurances. If

the latter is the case, these messages

would not fulfill the purpose of the brief

summary requirement, which helps

ensure that advertising conveys a

balanced impression about the product’s

benefits and risks.

FDA solicits comments on the

effectiveness of such standardized

general disclosures at transmitting risk

information. FDA is especially

interested in any research that addresses

the issue of the effectiveness of general

risk disclosures of the type described

above.

3. Promotional materials appear in

very different media that each have

distinctive characteristics (e.g., print,

broadcast, telephone communications,

facsimile, Internet). Should FDA require

or permit different disclosures for

consumer-directed promotion of

prescription drug and biological

products that appears in different

media, to reflect the capabilities of these

varying media, or should the disclosure

be the same regardless of medium? For

example, should print media contain

longer and more complete information

than broadcast media because such

information could be made readily

available at minimal cost and because

consumers of print media may be more

willing, able, and/or desirous of

obtaining more complete information?

4. Different products have different

degrees of effectiveness. In some cases,

a product that works for a relatively

small percentage of the appropriate

patient population is approved either

because it is the only available therapy

for a condition; because all other

therapies for the condition also have

only modest benefits; or because it has

relatively few risks. Should FDA require

the communication of the degree of

product effectiveness in DTC

promotion? How could this information

be communicated most effectively?

5. It has been suggested that toll-free

telephone numbers are one way that

product sponsors could make required

information available to audiences. FDA

requests comments and information

from consumers, health professionals,

product sponsors and other interested

individuals regarding: (a) How useful

toll-free numbers are as a mechanism for

obtaining or disseminating information

about medical products, and (b) the

costs to a sponsor of using toll-free

numbers as a means of disseminating

information.

FDA welcomes comments on all of

the issues described above and

especially invites the submission of

relevant empirical research.

Dated: May 8, 1996.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 96–12022 Filed 5–13–96; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 96E–0043]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; EPIVIRTM

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

EPIVIRTM and is publishing this notice

of that determination as required by

law. FDA has made the determination

because of the submission of an

application of the Commissioner of

Patents and Trademarks, Department of

Commerce, for the extension of a patent

which claims that human drug product.

ADDRESSES: Written comments and

petitions should be directed to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Brian J. Malkin, Office of Health Affairs

(HFY–20), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–443–1382.

SUPPLEMENTARY INFORMATION: The Drug

Price Competition and Patent Term

Restoration Act of 1984 (Pub. L. 98–417)

and the Generic Animal Drug and Patent

Term Restoration Act (Pub. L. 100–670)

generally provide that a patent may be

extended for a period of up to 5 years

so long as the patented item (human

drug product, animal drug product,

medical device, food additive, or color

additive) was subject to regulatory

review by FDA before the item was

marketed. Under these acts, a product’s

regulatory review period forms the basis

for determining the amount of extension

an applicant may receive.

A regulatory review period consists of

two periods of time: A testing phase and

an approval phase. For human drug

products, the testing phase begins when

the exemption to permit the clinical

investigations of the drug becomes

effective and runs until the approval

phase begins. The approval phase starts

with the initial submission of an

application to market the human drug

product and continues until FDA grants

permission to market the drug product.

Although only a portion of a regulatory

review period may count toward the

actual amount of extension that the

Commissioner of Patents and

Trademarks may award (for example,

half the testing phase must be

subtracted as well as any time that may

have occurred before the patent was

issued), FDA’s determination of the

length of a regulatory review period for

a human drug product will include all

of the testing phase and approval phase

as specified in 35 U.S.C. 156(g)(1)(B).

FDA recently approved for marketing

the human drug product EPIVIRTM

(lamivudine). EPIVIRTM in combination

with Retrovir (zidovudine) is

indicated for the treatment of human

immunodeficiency virus infection when

therapy is warranted based on clinical

and/or immunological evidence of

disease progression. Subsequent to this

approval, the Patent and Trademark

Office received a patent term restoration

application for EPIVIRTM (U.S. Patent

No. 5,047,407) from Glaxo Wellcome,

Inc., and the Patent and Trademark

Office requested FDA’s assistance in

determining this patent’s eligibility for

patent term restoration. In a letter dated

March 1, 1996, FDA advised the Patent

and Trademark Office that this human
Federal Register / Vol. 61, No. 94 / Tuesday, May 14, 1996 / Notices 24317

drug product had undergone a

regulatory review period that the

approval of EPIVIRTM represented the

first permitted commercial marketing or

use of the product. Shortly thereafter,

the Patent and Trademark Office

requested that FDA determine the

product’s regulatory review period.

FDA has determined that the

applicable regulatory review period for

EPIVIRTM is 1,582 days. Of this time,

1,448 days occurred during the testing

phase of the regulatory review period,

while 134 days occurred during the

approval phase. These periods of time

were derived from the following dates:

1. The date an exemption under

section 505(i) of the Federal Food, Drug,

and Cosmetic Act (21 U.S.C. 355(i))

became effective: July 21, 1991. The

applicant claims July 24, 1991, as the

date the investigational new drug

application (IND) became effective.

However, FDA records indicate that the

IND effective date was July 21, 1991,

which was 30 days after FDA receipt of

the IND.

2. The date the application was

initially submitted with respect to the

human drug product under section

505(b) of the Federal Food, Drug, and

Cosmetic Act: July 7, 1995. The

applicant claims June 29, 1995, as the

date the new drug application (NDA’s)

for EPIVIRTM (NDA’s 20–564 and 20–

596) were initially submitted. However,

FDA records indicate that NDA’s 20–

564 and 20–596 were submitted on July

7, 1995 (the date the User Fee checks

were received by the agency). Both

NDA’s were originally received by the

agency on June 30, 1995,

unaccompanied by the appropriate User

Fee checks. Review of a NDA does not

begin until the correct amount of User

Fee money has been received by the

agency from the sponsor of the NDA.

3. The date the application was

approved: November 17, 1995. FDA has

verified the applicants’s claim that

NDA’s 20–564 and 20–596 were

approved on November 17, 1995.

This determination of the regulatory

review period establishes the maximum

potential length of a patent extension.

However, the U.S. Patent and

Trademark Office applies several

statutory limitations in its calculations

of the actual period for patent extension.

In its application for patent extension,

this applicant seeks 836 days of patent

term extension..

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before July 15, 1996, submit to the

Dockets Management Branch (address

above) written comments and ask for a

redetermination. Furthermore, any

interested person may petition FDA, on

or before November 12, 1996, for a

determination regarding whether the

applicant for extension acted with due

diligence during the regulatory review

period. To meet its burden, the petition

must contain sufficient facts to merit an

FDA investigation. (See H. Rept. 857,

part 1, 98th Cong., 2d sess., pp. 41–42,

1984.) Petitions should be in the format

specified in 21 CFR 10.30.

Comments and petitions should be

submitted to the Dockets Management

Branch (address above) in three copies

(except that individuals may submit

single copies) and identified with the

docket number found in brackets in the

heading of this document. Comments

and petitions may be seen in the

Dockets Management Branch between 9

a.m. and 4 p.m., Monday through

Friday.

Dated: April 26, 1996.

Stuart L. Nightingale,

Associate Commissioner for Health Affairs.

[FR Doc. 96–12092 Filed 5–13–96; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 95E–0408]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; TRUSOPT

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

TRUSOPT and is publishing this

notice of that determination as required

by law. FDA has made the

determination because of the

submission of an application to the

Commissioner of Patents and

Trademarks, Department of Commerce,

for the extension of a patent which

claims that human drug product.

ADDRESSES: Written comments and

petitions should be directed to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

rm. 1–23, 12420 Parklawn Dr.,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Brian J. Malkin, Office of Health Affairs

(HFY–20), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–443–1382.

SUPPLEMENTARY INFORMATION: The Drug

Price Competition and Patent Term

Restoration Act of 1984 (Pub. L. 98–417)

and the Generic Animal Drug and Patent

Term Restoration Act (Pub. L. 100–670)

generally provide that a patent may be

extended for a period of up to 5 years

so long as the patented item (human

drug product, animal drug product,

medical device, food additive, or color

additive) was subject to regulatory

review by FDA before the item was

marketed. Under these acts, a product’s

regulatory review period forms the basis

for determining the amount of extension

an applicant may receive.

A regulatory review period consists of

two periods of time: A testing phase and

an approval phase. For human drug

products, the testing phase begins when

the exemption to permit the clinical

investigations of the drug becomes

effective and runs until the approval

phase begins. The approval phase starts

with the initial submission of an

application to market the human drug

product and continues until FDA grants

permission to market the drug product.

Although only a portion of a regulatory

review period may count toward the

actual amount of extension that the

Commissioner of Patents and

Trademarks may award (for example,

half the testing phase must be

subtracted as well as any time that may

have occurred before the patent was

issued), FDA’s determination of the

length of a regulatory review period for

a human drug product will include all

of the testing phase and approval phase

as specified in 35 U.S.C. 156(g)(1)(B).

FDA recently approved for marketing

the human drug product TRUSOPT

(dorzolamide hydrochloride).

TRUSOPT is indicated in the

treatment for elevated intraocular

pressure in patients with ocular

hypertension or open-angle glaucoma.

Subsequent to this approval, the Patent

and Trademark Office received a patent

term restoration application for

TRUSOPT (U.S. Patent No. 4,797,413)

from Merck & Co., Inc., and the Patent

and Trademark Office requested FDA’s

assistance in determining this patent’s

eligibility for patent term restoration. In

a letter dated January 26, 1996, FDA

advised the Patent and Trademark

Office that this human drug product had

undergone a regulatory review period

and that the approval of TRUSOPT

represented the first permitted

commercial marketing or use of the

product. Shortly thereafter, the Patent

and Trademark Office requested that

FDA determine the product’s regulatory

review period.

FDA has determined that the

applicable regulatory review period for

TRUSOPT is 2,101 days. Of this time,

1,736 days occurred during the testing

phase of the regulatory review period,

while 365 days occurred during the

approval phase. These periods of time

were derived from the following dates: