[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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