Lawmakers seek faster approval process for shortage drugs, from AMEDnews.com

A House subcommittee adds legislative language on shortages to the user-fee reauthorization bill.

By Charles Fiegl, amednews staff. Posted April 30, 2012.

An expedited review track as well as studies on regulations and manufacturing are being considered as possible solutions to national shortages of certain drugs.

The House Energy and Commerce health subcommittee held an April 18 hearing on draft language addressing drugs in short supply. Lawmakers are seeking to add the provisions to the reauthorization of the Prescription Drug User Fee Act. The act, which expires this year, sets fees for Food and Drug Administration reviews of drug approval applications. The law sets performance goals for drug reviews while raising hundreds of millions of dollars from manufacturers seeking approval of their products.

• Fees support most of the drug review process
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Drug companies and public health advocates want federal lawmakers to use reauthorization of the 20-year-old law to tackle the drug shortage problem. There are 214 drugs in short supply, according to the American Society of Health-System Pharmacists.

Provisions in the subcommittee draft of the reauthorization legislation seek to end approval delays and improve FDA programs. The bill would establish quotas for drugs in shortage and establish expedited reviews of major manufacturing changes for drugs that are, or have the potential to be, in short supply.

“In talking with patients, manufacturers and providers, they tell me it is one of the best parts of the discussion draft and it will really help with shortages,” said Rep. Joe Pitts (R, Pa.), the subcommittee’s chair.

However, the FDA already has the authority to conduct these expedited reviews, Janet Woodcock, MD, director of the agency’s Center for Drug Evaluation and Research, told the subcommittee. But officials expedite a review only if notified earlier during the review process.

214 drugs were in short supply in April 2012. 

 

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