[Federal Register: May 21, 2003 (Volume 68, Number 98)]
[Notices]
[Page 27822-27823]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21my03-52]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 03N-0170]
Report on the Performance of Drug and Biologics Firms in
Conducting Postmarketing Commitment Studies; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA) is required, under the
Food and Drug Administration Modernization Act of 1997 (Modernization
Act), to report annually in the Federal Register on the status of
postmarketing study commitments made by sponsors of approved drug and
biological products. This is the agency's first report on the status of
the study commitments that sponsors have agreed to conduct and for
which an annual status report on the study has been received by FDA.
FOR FURTHER INFORMATION CONTACT: Kim Colangelo, Center for Drug
Evaluation and Research (HFD-20), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-3937; or Robert Yetter,
Center for Biologics Evaluation and Research (HFM-25), 1400 Rockville
Pike, Rockville, MD 20852, 301-827-0373.
SUPPLEMENTARY INFORMATION:
I. Background
Section 130(a) of the Modernization Act (Public Law 105-115)
amended the Federal Food, Drug, and Cosmetic Act (the act) by adding a
new provision (section 506B of the act (21 U.S.C. 356b)) requiring
reports of postmarketing studies for human drugs and biological
products. Section 506B provides FDA with additional authority to
monitor the progress of a postmarketing study commitment that an
applicant has been required or has agreed to conduct by requiring the
applicant to submit a report annually providing information on the
status of the postmarketing study commitment. This report must also
include reasons, if any, for failure to complete the commitment.
On December 1, 1999 (64 FR 67207), FDA published a proposed rule
providing a framework for the content and format of the annual progress
report. The proposed rule also clarified the scope of the reporting
requirement and timing for submission of the annual progress reports.
The final rule, published on October 30, 2000 (65 FR 64607), modified
annual report requirements for new drug applications (NDAs) and
abbreviated new drug applications (ANDAs) by establishing Sec.
314.81(b)(2)(vii) (21 CFR 314.81(b)(2)(vii)). The rule also created a
new annual reporting requirement for biologics license applications
(BLAs) by establishing Sec. 601.70 (21 CFR 601.70). These regulations
became effective on April 26, 2001. The regulations apply only to human
drugs, including biological drugs. They do not apply to animal drugs or
to licensed biological products that also meet the definition of a
medical device.
Sections 314.81(b)(2)(vii) and 601.70 apply to postmarketing
commitments made on or before enactment of the Modernization Act
(November 21, 1997) as well as those made after that date. Sections
314.81(b)(2)(vii) and 601.70 require applicants of approved drugs and
biological products to submit annually a report on the status of each
clinical safety, clinical efficacy, clinical pharmacology, and
nonclinical toxicology study that is required by FDA (e.g., accelerated
approval clinical benefit studies) or that they have committed to
conduct either at the time of approval or after approval of their NDA,
ANDA, BLA, or supplement. The status of other types of postmarketing
commitments (e.g., those concerning chemistry, manufacturing,
production controls, and studies conducted on an applicant's own
initiative) are not required to be reported under Sec. Sec.
314.81(b)(2)(vii) and 601.70 and are not addressed in this report. It
should be noted, however, that applicants are required to report to FDA
on these commitments made for NDAs and ANDAs under Sec.
314.81(b)(2)(viii).
According to the regulations, once a postmarketing study commitment
has been made, an applicant must report on the progress of the
commitment on the anniversary of the product's approval until the
postmarketing study commitment is completed or terminated and FDA
determines that the postmarketing study commitment has been fulfilled
or that the postmarketing study commitment is either no longer feasible
or would no longer provide useful information. The annual progress
report must include a description of the postmarketing study
commitment, a schedule for completing the study commitment, and a
characterization of the current status of the study commitment. The
report must also provide an explanation of the postmarketing study
commitment's status by describing briefly the postmarketing study
commitment's progress. A postmarketing study commitment schedule is
expected to include the actual or projected dates for: (1) Submission
of the study protocol to FDA, (2) completion of patient accrual or
initiation of an animal study, (3) completion of the study, and (4)
submission of the final study report to FDA. The postmarketing study
commitment status must be described in the annual report according to
the following definitions:
[sbull] Pending: The study has not been initiated, but does not
meet the criterion for delayed;
[sbull] Ongoing: The study is proceeding according to or ahead of
the original schedule;
[sbull] Delayed: The study is behind the original schedule;
[sbull] Terminated: The study was ended before completion, but a
final study report has not been submitted to FDA; or
[sbull] Submitted: The study has been completed or terminated, and
a final study report has been submitted to FDA.
Databases containing information on postmarketing study commitments
are maintained at the Center for Drug Evaluation and Research (CDER)
and the Center for Biologics Evaluation and Research (CBER).
Information in this report covers any postmarketing study commitment
that was made, in writing, at the time of approval or after approval of
an application or a supplement to an application, including those
required (e.g., to demonstrate clinical benefit of a product following
accelerated approval) and those agreed to with the applicant.
Information summarized in this report includes: (1) The number of
applicants with open (uncompleted) postmarketing commitments, (2) the
number of open postmarketing commitments, (3) the status of open
postmarketing commitments as reported in Sec. 314.81(b)(2)(vii) or
Sec. 601.70 annual
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reports, (4) the status of concluded postmarketing studies as
determined by FDA, and (5) the number of open postmarketing commitments
for which FDA did not receive an annual report.
Additional information about postmarketing study commitments made
by sponsors to CDER and CBER are provided on FDA's Web site at http://www.fda.gov/cder.
Like this notice, the site does not list
postmarketing study commitments containing proprietary information. It
is FDA policy not to post information on the Web site until it has been
reviewed for accuracy. The information currently available on the site
includes only postmarketing study commitments made since January 1,
1991. The numbers published in this notice cannot be compared with the
numbers resulting from searches of the Web site. This notice
incorporates totals for all postmarketing study commitments in FDA
databases, including those made prior to 1991 as well as those
undergoing review for accuracy. The report in this notice will be
updated annually while the Web site will be updated quarterly (in
April, July, October, and January).
II. Summary of Information From Postmarketing Study Progress Reports
This report summarizes the status of postmarketing commitments as
of September 30, 2002. If a commitment did not have a schedule and a
postmarketing progress report was not received, the commitment is
categorized according to the most recent information available to the
agency.
Data in table 1 are numerical summaries generated from FDA
databases. The data are broken out according to application type (NDAs/
ANDAs or BLAs).
Table 1.--Summary of Postmarketing Study Commitments To CBER and CDER
(Numbers as of September 30, 2002)
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NDAs/ANDAs (% of total) BLAs (% of total)
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Applicants with open postmarketing commitments 126 44
================================================================================================================
Number of open postmarketing commitments 1,339 223
================================================================================================================
Status of open postmarketing commitments ............................ ............................
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[sbull] Pending 820 (61%) 67 (30%)
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[sbull] Ongoing 285 (21%) 102 (46%)
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[sbull] Delayed 25 (2%) 17 (8%)
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[sbull] Terminated 8 (1%) 2 (1%)
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[sbull] Submitted 201 (15%) 35 (16%)
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Concluded studies 349 52
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[sbull] Commitment met 240 (69%) 47 (90%)
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[sbull] Commitment not met 0 (0%) 1 (2%)
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[sbull] Study no longer needed or feasible 109 (31%) 4 (8%)
================================================================================================================
Open postmarketing commitments with annual report 289 (22%) 77 (35%)
due but not received
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Dated: May 12, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-12720 Filed 5-20-03; 8:45 am]
BILLING CODE 4160-01-S