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Sep 29, 2008
 |  BioCentury  |  Regulation

FDA Triages its new powers

Sponsors of 16 drugs that FDA has determined meet criteria for converting voluntary risk management plans into legally enforceable risk evaluation and mitigation strategy (REMS) plans met the Sept. 21 deadline for submitting a proposed REMS, FDA officials told BioCentury last week.

There is no timetable for reviewing the REMS proposals and FDA will not make them public until it has approved them. But based on how the agency has exercised its new post-market authorities in the first year under the Food and Drug Administration Amendments Act of 2007, it seems unlikely to pile on new restrictions.

FDA is not routinely applying the most restrictive provisions of FDAAA, such as limiting which patients can receive a drug or which physicians can prescribe it. There have been only two really extensive REMS.

On the other hand, the agency has imposed a lot of mandatory post-market clinical trials, and it has demonstrated a willingness to use strengthened powers over labeling to cut short negotiations and impose specific language over the objections of sponsors.

Since the mandated March 25, 2008, start date for REMS, FDA has approved about 102 NDAs, BLAs and supplements to NDAs and BLAs. A total of 13 had REMS, but this figure is misleading because it includes cases in which the manufacturer was simply required to distribute information to patients and physicians (see "Acting on REMS," A15).

FDA has used the most onerous REMS provisions, restrictions on the use or distribution of a product, only twice. In both cases, approvals of Entereg alvimopan from Adolor Corp. and GlaxoSmithKline plc, and Nplate romiplostim from Amgen Inc., it is likely the agency would have approved the products with voluntary risk management programs (RiskMaps) if it had not had the power to require the more restrictive REMS.

Janet Woodcock, director of the Center for Drug Evaluation and Research, told reporters...

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