[Federal Register: February 18, 2005 (Volume 70, Number 33)]
[Notices]
[Page 8379-8381]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18fe05-83]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0049]
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 report on the status of the
studies sponsors have agreed to or are required to conduct.
FOR FURTHER INFORMATION CONTACT: Beth Duvall-Miller, Center for Drug
Evaluation and Research (HFD-20), Food and Drug Administration, 5515
Security Lane, Rockville, MD 20852, 301-594-3937; or Robert Yetter,
Center for Biologics Evaluation and Research (HFM-25), Food and Drug
Administration, 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 requiring reports of certain postmarketing studies
(section 506B of the act (21 U.S.C. 356b)) for human drug and
biological products. Section 506B of the act 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.
In the Federal Register of 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 the timing for submission of
the annual progress reports. The final rule, published in the Federal
Register of October 30, 2000 (65 FR 64607), modified annual report
requirements for new drug applications (NDAs) and abbreviated new drug
applications (ANDAs) by revising 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 30, 2001. The regulations apply only to human drug and biological
products. They do not apply to animal drug or to 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 drug 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, or BLA. 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
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include the actual or projected dates for the following items: (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:
Pending: The study has not been initiated, but does not
meet the criterion for delayed;
Ongoing: The study is proceeding according to or ahead of
the original schedule;
Delayed: The study is behind the original schedule;
Terminated: The study was ended before completion, but a
final study report has not been submitted to FDA; or
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 the following items: (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 reports; (4) the status of
concluded postmarketing studies as determined by FDA; and (5) the
number of applications with open postmarketing commitments for which
sponsors did not submit an annual report within 60 days of the
anniversary date of U.S. approval.
Additional information about postmarketing study commitments made
by sponsors to CDER and CBER are provided on FDA's Web site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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 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 undergoing review for accuracy. The
report in this notice is updated annually while the Web site is 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, 2004. If a commitment did not have a schedule or 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 of this document 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 (Numbers as of
September 30, 2004)
------------------------------------------------------------------------
NDAs/ANDAs (% BLAs\1\ (% of
of Total) Total)
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Applicants with Open Postmarketing 54 46
Commitments
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Number of Open Postmarketing Commitments 1,191 288
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Status of Open Postmarketing Commitments .............. ..............
Pending 812 (68%) 69 (24%)
Ongoing 219 (18%) 114 (40%)
Delayed 15 (1%) 37 (13%)
Terminated 2 (<1%) 1 (<1%)
Submitted 143 (12%) 67 (23%)
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Concluded Studies (October 1, 2003, 157 62
through September 30, 2004)
Commitment Met 114 (73%) 45 (73%)
Commitment Not Met 0 0
Study No Longer Needed or 43 (27%) 17 (27%)
Feasible
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Applications with Open Postmarketing 18 (16%) 51 (66%)
Commitments with Annual Reports Due but
Not Submitted within 60 Days of the
Anniversary Date of U.S. Approval
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\1\ On October 1, 2003, FDA completed a consolidation of certain
products formerly regulated by CBER into CDER. The previous
association of BLA reviews only with CBER is no longer valid; BLAs are
now received by both CBER and CDER. Fiscal year statistics for CDER
BLA postmarketing study commitments will continue to be counted under
BLA totals in this table.
[[Page 8381]]
Dated: February 10, 2005.
Jeffrey Shuren,
Associate Commissioner for Policy.
[FR Doc. 05-3221 Filed 2-17-05; 8:45 am]
BILLING CODE 4160-01-S