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Smooth Sailing For FDA User Bill

by Britt E. Erickson , Cheryl Hogue
December 24, 2012 | A version of this story appeared in Volume 90, Issue 52

Congress made it a top priority this year to pass the FDA Safety & Innovation Act (S. 3187), a bill that reauthorizes FDA to collect fees from the pharmaceutical and medical device industries to help accelerate the review of new drugs and devices. After numerous hearings this year, the bill cleared both the House of Representatives and Senate in June and was then signed into law by President Barack Obama.

The legislation allows FDA to collect user fees from industry for five years, beginning in fiscal 2013. Such fees provide about 60% of FDA’s drug review budget and 20% of its device center budget. The bill also authorizes, for the first time, user-fee programs for generic drugs and biosimilars—the generic equivalents of biologic drugs. In addition, it permanently authorizes two programs aimed at increasing the safety and effectiveness of drugs and medical devices for children.

Concerns of drug shortages and the safety of an increasingly globalized drug supply chain also prompted lawmakers to tack on several regulatory reforms to the FDAuser-fee bill.

Also part of the user-fee law is a provision that criminalizes a host of designer drugs. The law bans virtually all synthetic marijuana compounds, two stimulants sold as bath salts, and nine hallucinogens called 2C substances for the two-carbon bridge that links a benzene ring and an amino group in these compounds.

FDA was on the congressional radar again this fall because of a multistate outbreak of fungal meningitis, linked to a Massachusetts-based compounding pharmacy that produced injectable steroids. Lawmakers questioned whether the agency has sufficient oversight of compounding pharmacies. Such pharmacies typically mix small batches of drugs and are regulated at the state level, whereas large-scale drug manufacturers are regulated by FDA.

Lawmakers believe that the pharmacy responsible for the meningitis outbreak, the New England Compounding Center, was operating as a drug manufacturer under the guise of a compounding pharmacy.

Hearings related to FDA oversight of compounding pharmacies were held in both the Senate and House after news of the outbreak. In addition, last month Rep. Edward J. Markey (D-Mass.) introduced H.R. 6584. The bill would preserve state regulatory authority for small compounding activities and ensure that pharmacies operating as drug manufacturers are regulated by FDA.

Earlier this month, House lawmakers sent a letter to the International Association of Compounding Pharmacies, questioning whether the industry group has a history of encouraging compounding ­pharmacies to impede FDA from evaluating their prod­ucts.



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