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12/11/2000

FDA Wants Phase IV Results

Kate Traynor

The Food and Drug Administration (FDA) said it will meet next year's requirement to make the results of postmarketing, or Phase IV, studies public by posting findings on the agency's Web site.

This plan, along with a new schedule of dates by which drug manufacturers must submit postmarketing data to FDA, may help the agency meet its October 2001 deadline for giving Congress summaries of Phase IV study findings. The public disclosure and congressional reporting requirements for Phase IV studies are mandated by the FDA Modernization Act of 1997.

Under the terms of Phase IV agreements, drug manufacturers agree to provide FDA with postmarketing surveillance information such as drug stability, safety, and efficacy data. Safety concerns discovered during postmarketing surveillance could prompt FDA to withdraw approval of a drug—as could, in theory, failure of a manufacturer to meet its reporting commitments.

 Postmarketing Rule Delayed

FDA announced in the Feb. 20 Federal Register that the effective date of the postmarketing study rule has been delayed for 60 days. The new effective date gives manufacturers until April 30 to submit postmarketing reports that were previously due Feb. 27. Reports previously due Aug. 27 are now due Oct. 26. The 60-day delay was instituted to give the Bush administration's Health and Human Services Department staff time to review this and other federal regulations enacted late last year.

According to the plan described by FDA in the Oct. 30 Federal Register, the initial status reports for Phase IV studies of drugs approved for marketing in the United States after Nov. 21, 1997, are due at the agency by Feb. 27, 2001, or within a year of the approval date. Subsequent annual reports are due on the anniversary of the drug’s U.S. approval.

Initial status reports on drugs approved before Nov. 21, 1997, are due by Aug. 27, 2001. Thereafter, annual reports are due on the anniversary of the initial U.S. approval date.

The reporting requirement applies to all drugs and certain biological products for which manufacturers have Phase IV study obligations. Annual reports are required until FDA deems that the Phase IV study is complete. Reports must include all of the information requested in the manufacturer’s agreement with FDA, along with relevant information that the manufacturer has found on its own.

Once the reporting schedule goes into effect, FDA expects to receive about 462 summaries of Phase IV studies for drugs and 86 for biological products.

FDA's Web site will provide general information such as the drug’s name, manufacturer, and dosage under study. In addition, the Web site will describe each manufacturer’s Phase IV commitment, the projected end of the study period, and the current status of the study.

FDA will also require from manufacturers—but not make public—a description of the study protocol, study results, and reports of unexpected adverse drug reactions.

At present, Phase IV study information is scarce, according to the consumer advocacy group Public Citizen. In a letter sent in April to FDA Commissioner Jane E. Henney, M.D., the group described compliance with Phase IV reporting requirements by pharmaceutical companies as "grossly inadequate."

After examining FDA records for new drug entities with postmarketing commitments made since 1994, Public Citizen found no evidence that any of these Phase IV studies were completed by the end of 1999. According to Public Citizen, the approval of 28 specific drugs by FDA since 1996 was granted solely because the manufacturers promised to complete Phase IV studies.

In the letter, Public Citizen said that it strongly supports the use of Phase IV studies to provide important information about drug safety and possible adverse events associated with drug use.