[Federal Register Volume 63, Number 134 (Tuesday, July 14, 1998)]
[Notices]
[Pages 37890-37891]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-18690]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98D-0481]
Guidance for Industry on 180-Day Generic Drug Exclusivity Under
the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic
Act; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``180-Day Generic Drug
Exclusivity Under the Hatch-Waxman Amendments to the Federal Food,
Drug, and Cosmetic Act.'' The purpose of the guidance is to inform the
public of FDA's application of the 180-day generic drug exclusivity
provisions of the Federal Food, Drug, and Cosmetic Act (the act) in
light of recent court decisions on the issue.
DATES: Written comments may be submitted on the guidance document by
October 13, 1998. General comments on the agency guidances are welcome
at any time.
ADDRESSES: Copies of the guidance are available on the Internet at
``http://www.fda.gov/cder/guidance/index.htm.'' Submit written requests
for single copies to the Drug Information Branch (HFD-210), Center for
Drug Evaluation and Research, Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857. Send one self-addressed adhesive
label to assist that office in processing your request. Submit written
comments on the guidance to the Dockets Management Branch, (HFD-305),
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT: Jerry Phillips, Center for Drug
Evaluation and Research (HFD-610), 7500 Standish Pl., Rockville, MD
20855, 301-827-5846.
SUPPLEMENTARY INFORMATION: A requirement of FDA's regulations
implementing the 180-day generic drug exclusivity provisions of the act
has recently been successfully challenged in court. Section
314.107(c)(1) (21 CFR 314.107(c)(1)) applies and interprets section
505(j)(5)(B)(iv) of the act (21 U.S.C. 355(j)(5)(B)(iv)). Section
314.107(c)(1) contains the ``successful defense'' provision, which
requires an abbreviated new drug application (ANDA) applicant to be
sued for patent infringement and to prevail in the litigation in order
to receive the 180-day period of marketing exclusivity. Two recent
circuit court decisions, Mova Pharmaceutical Corp. v. Shalala, No. 97-
5082, 1998 U.S. App. Lexis 7391 (D.C. Cir. Apr. 14, 1998) and Granutec,
Inc. v. Shalala, No. 97-1873 and No. 97-1874, 1998 U.S. App. LEXIS
6685, (4th Cir. Apr. 3, 1998), held that the ``successful defense''
requirement was not supported by the act. The effect of these
decisions, together with a June 1, 1998, order of the district court in
Mova, is that FDA will not enforce the ``successful defense''
provisions of Sec. 314.107(c)(1).
FDA intends to formally remove the ``successful defense''
provisions from Sec. 314.107(c)(1), but that process is not complete.
Following withdrawal of the regulatory provision, FDA expects to begin
a rulemaking to issue new
[[Page 37891]]
regulations under section 505(j)(5)(B)(iv) of the act. In the meantime,
the agency must make exclusivity decisions for ANDA's that are nearing
approval. Until such time as the rulemaking process is complete, FDA
will regulate directly from the statute and will make decisions on 180-
day generic drug exclusivity on a case-by-case basis.
The guidance is intended to provide industry with information on
how FDA is applying section 505(j)(5)(B)(iv) of the act in light of the
decisions in Mova and Granutec. The agency will revise this guidance as
additional interpretations are made.
The guidance is being implemented immediately without prior public
comment because the guidance is needed to explain FDA's application of
the statute in light of recent court decisions. However, the agency
wishes to solicit comment from the public and is providing a 90-day
comment period and establishing a docket for the receipt of comments.
This guidance is a level 1 guidance consistent with FDA's good
guidance practices (62 FR 8961, February 27, 1997). It represents the
agency's current thinking on 180-day generic drug exclusivity under the
Hatch-Waxman Amendments. It does not create or confer any rights for or
on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the act.
Interested persons may submit written comments on the guidance to
the Dockets Management Branch (address above). Two copies of any
comments are to be submitted, except that individuals may submit one
copy. Comments are to be identified with the docket number found in
brackets in the heading of this document. The guidance and received
comments may be seen in the office above between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: July 7, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-18690 Filed 7-13-98; 8:45 am]
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