Lawmakers seek faster approval process for shortage drugs

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

By Charles Fiegl — Posted April 30, 2012

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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.

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.

The legislative proposal would call for studying and producing annual reports on drug shortages. A study would determine the characteristics of drugs that have gone into actual shortage and systemic high-risk factors, such as drug pricing, federal payments and numbers of manufacturers. Federal regulations and regulatory practices also would be reviewed.

The number of critical drug shortages has risen to the level of a national health emergency, the American Medical Association has said. Shortages adversely affect drug therapy and threaten patient care and safety.

“To provide the best quality care to patients, physicians need to be able to obtain the right drugs at the right time,” said AMA President-elect Jeremy A. Lazarus, MD. “The AMA will continue to work with Congress and other stakeholders to develop and implement strategies that will prevent and more effectively resolve shortages when they occur.”

The AMA also sent the House Energy and Commerce Committee an April 19 letter thanking lawmakers for including provisions that would provide incentives to antibiotic manufacturers for developing and marketing the next generation of antibiotics.

The Association is alarmed that the number of manufacturers has dropped, while the current regulatory framework for approvals remains complex and lengthy.

“For manufacturers of other drugs and biologics, market approval and the subsequent exclusivity period allow for a return on the up-front [research and development] and regulatory approval costs,” the letter states. “However, in contrast, clinical best practice often dictates that the newest antibiotic serve as the treatment of last resort.

“Thus, the value of the market exclusivity afforded to antibiotic innovators under the current regulatory approval process is greatly diminished by clinical practice designed to combat antibiotic resistance.”

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Fees support most of the drug review process

The Food and Drug Administration spent nearly $1 billion for the reviews of drug approval applications in fiscal 2010. Fees raised under the Prescription Drug User Fee Act represented 62% of the agency’s funding for reviews that year.

FDA component Fiscal 2009 Fiscal 2010
Center for Drug Evaluation and Research $585.4 million $640.5 million
Center for Biologics Evaluation and Research $170.4 million $176.4 million
Field inspection and investigation research $36.5 million $35.0 million
Agency general and administrative costs $63.1 million $80.0 million
Total $855.4 million $931.8 million
Total from appropriations $343.4 million $358.6 million
Total from fees $512.1 million $573.3 million

Source: “FY 2010 PDUFA Financial Report,” Food and Drug Administration, June 2011 (link)

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