[Federal Register: February 18, 2005 (Volume 70, Number 33)]
[Page 8379-8381]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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.


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.


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 
    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 
    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)
Applicants with Open Postmarketing                    54              46
Number of Open Postmarketing Commitments           1,191             288
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%)
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%)
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
\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]