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Federal Register Report and FDA Web Site on Postmarketing Studies

The Food and Drug Administration today announced two measures to inform the public about the status of manufacturers' commitments to carry out further clinical studies following the FDA's approval of certain drugs and biological products.

One of the measures, the publication of FDA's first annual Federal Register (FR) report on these postmarketing studies, covers commitments that are required by the FDA as well as those voluntarily accepted by the manufacturers. The FDA requires postmarketing studies for all products that receive accelerated approval because they provide meaningful therapeutic benefit for patients with serious or life-threatening diseases for which there is no other available therapy. The agency approves these products on an accelerated basis provided that the manufacturer meets two conditions.

One requirement is that the drug or biological product must be shown in pre-approval clinical trials to have an effect on a surrogate endpoint -- for example, the size of a tumor -- that is believed to provide a health benefit for the patient. The other prerequisite for an accelerated approval is that the manufacturer agrees to perform additional studies after the approval to determine if the surrogate did indeed predict the expected clinical benefit, such as increased survival or other aspects of the treatment.

The agency may also request a postmarketing study to develop information that, although not essential for approval, is important for improving the use of the product, product quality, or consistency in product manufacturing. These voluntary commitments are agreed to in writing by the applicants.

In addition to the FR report, which is mandated by the FDA Modernization Act of 1997, the FDA is posting on its Web site (www.fda.gov/cder/pmc) a searchable database with most of the same information. The database includes open postmarketing study commitments that have been made with the FDA's Center for Biologics Evaluation and Research (CBER), and commitments concluded with the Center for Drug Evaluation and Research (CDER) since January 1, 1991. Both the FR notice and the Web site list study commitments addressing clinical safety, clinical efficacy, clinical pharmacology, and nonclinical toxicology. Not included are certain other postmarketing commitments, such as those concerning chemistry and manufacturing and controls, and there is no listing of proprietary information. The Web site, which lists only commitments that have been reviewed by FDA for accuracy, will be updated with new postmarketing commitments each July, October, January and April. Additional information about this site is available on the search page and in "Frequently Asked Questions (FAQs)".

Manufacturers are required to submit annual status reports on postmarketing study commitments for approved drugs, and for certain licensed biological products. Each report must include, among other information, a description of the postmarketing study commitment, a schedule for its completion, and a characterization and brief description of its current status. The schedule is expected to include the projected dates for the initiation and the completion of the study, and for the submission of the final study report to FDA. Manufacturers are also required to categorize the current status of the commitment using a defined set of terms. The state of other types of postmarketing commitments, such as those concerning chemistry, manufacturing and controls, are also required to be reported to the FDA, but are not for public disclosure because they contain trade secrets or commercial confidential information the FDA is not allowed to make public.

The FR document defines the status of 1,339 open manufacturers and 223 open postmarketing study commitments for biological products by 44 manufacturers. Of the open postmarketing drug studies, 820 (61%) are yet to be initiated; 285 (21%) are ongoing; 25 (2%) are delayed; 8 (1%) have been terminated before completion but the manufacturers have not submitted a final study report; and 201 (15%) have been either completed or terminated, and the FDA has received the final study report. Also in the drug area, annual reports for 289 (22%) of the open postmarketing commitments are overdue.

Of the open postmarketing biological studies, 67 (30%) are yet to be initiated; 102 (46%) are ongoing; 17 (8%) are delayed; 2 (1%) have been terminated without a final study report; and 35 (16%) have been either completed or terminated, and the FDA has received the final study report. Also in the biologicals area, annual reports for 77 (35%) of the open postmarketing commitments are overdue.

In addition, the FR notice lists 349 concluded postmarketing commitments for drugs and 52 for biological products. Two hundred forty (69%) of the drug studies and 47 (90%) of the biological studies met the commitments; 109 (31%) of the drug studies and 4 (8%) of the biological product studies were no longer needed or not feasible; and no concluded drug study and only 1 (2%) of the biological product studies failed to meet the sponsor's commitment.

FDA believes that today's report leaves considerable room for improvement, by manufacturers as well as the FDA, in making sure that postmarketing study commitments are completed in a timely manner, and that important new data from the studies are promptly incorporated into product labeling. FDA is continuing to implement new internal procedures to ensure better tracking and follow-up of postmarketing commitments, and to make certain that the final study reports are reviewed and acted upon in timely manner.

FDA also has initiated new procedures to ensure that new postmarketing commitments clearly describe the nature of the study and the specific timelines for submission of the study protocol, initiation of the study, and submission of the final study report.

The database can be found at www.fda.gov/cder/pmc/.

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