[Federal Register Volume 66, Number 98 (Monday, May 21, 2001)]
[Notices]
[Pages 27983-27984]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-12615]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0103]


Issues Associated With the Intersection of 180-Day Generic Drug 
Exclusivity and Pediatric Exclusivity; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is establishing the 
public docket identified in brackets in the heading of this document to 
receive comments related to the interpretation of provisions of the 
Federal Food, Drug, and Cosmetic Act (the act) and regulations 
governing the intersection of 180-day generic drug exclusivity and 
pediatric exclusivity. To date, there has not been a situation where 
pediatric exclusivity and 180-day generic exclusivity have actually 
overlapped. However, FDA has received a large number of inquiries about 
its interpretation of these provisions and, therefore, is establishing 
this docket to give the public an opportunity to comment on these 
issues.

DATES: Submit written or electronic comments by June 20, 2001.

ADDRESSES: Submit electronic comments to http://www.fda.gov/ohrms/dockets/default.htm. Submit written comments to the Dockets Management 
Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852. 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.

FOR FURTHER INFORMATION CONTACT: Rose Cunningham, Center for Drug 
Evaluation and Research (HFD-6), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-5468, FAX 301-594-5493.

SUPPLEMENTARY INFORMATION:

I. Background

    Recently FDA has been asked to evaluate the intersection of 180-day 
generic drug exclusivity and pediatric exclusivity, specifically with 
respect to whether the exclusivity periods should run concurrently or 
consecutively. FDA has received written correspondence and telephone 
inquiries from pharmaceutical firms, organizations, individuals, and 
members of Congress concerning FDA's interpretation of these 
provisions. FDA is seeking broader public comment on the intersection 
of these two statutory provisions.
    The 180-day generic drug exclusivity provision was created by the 
1984 Drug Price Competition and Patent Term Restoration Act (also known 
as the Hatch-Waxman Amendments), enacted on September 24, 1984. This 
provision, contained in section 505(j)(5)(B)(iv) of the act (21 U.S.C. 
355(j)(5)(B)(iv)), provides an incentive for generic drug applicants to 
challenge innovator patent claims and thereby speed the entry of 
generic competition onto the market. This benefit is available to the 
first abbreviated new drug application (ANDA) received that is a 
substantially complete application that contains a ``paragraph IV'' 
certification. This type of certification states the ANDA applicant's 
belief that a patent listed for the innovator drug is invalid or 
unenforceable or that the ANDA product seeking approval will not 
infringe a listed patent. Under the terms of the statute, 180-day 
generic drug exclusivity is triggered by and begins to run from either: 
(1) A court decision finding the challenged patent invalid, 
unenforceable, or not infringed; or (2) the date of first commercial 
marketing of the ANDA drug product, whichever is earlier. During the 
180-day generic drug exclusivity period, FDA is prohibited

[[Page 27984]]

from approving a subsequently filed ANDA containing a paragraph IV 
certification.
    Pediatric exclusivity was created by the passage of the Food and 
Drug Administration Modernization Act, enacted on November 21, 1997. 
This provision, contained in section 505A of the act, provides an 
incentive for innovator companies to perform and submit to the agency 
pediatric studies that may produce health benefits in the pediatric 
population. This benefit is available to a new drug application holder 
for the submission of pediatric studies in response to a written 
request issued by the agency. Pediatric exclusivity extends for 6 
months existing patent and/or exclusivity protection on the innovator 
drug and begins to run on the date the existing patent and/or 
exclusivity protection on the innovator drug would otherwise expire. 
ANDAs referencing the innovator drug may not be approved during the 
pediatric exclusivity period.
    FDA seeks public comment on whether pediatric exclusivity runs 
concurrently or consecutively with 180-day generic drug exclusivity 
when a favorable court decision in a paragraph IV patent challenge 
lawsuit is issued less than 180 days before the beginning of or during 
the pediatric exclusivity period.

II. Request for Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written comments by June 20, 2001. 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. Received comments may be seen 
in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: May 14, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-12615 Filed 5-15-01; 4:12 pm]
BILLING CODE 4160-01-S