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AHA calls user fee compromise bill 'concrete step forward' in dealing with drug shortages

June 25, 2012

The House last Wednesday approved by voice vote a compromise five-year reauthorization of the Food and Drug Administration’s (FDA) user fee programs.

The AHA called House passage of the “Food and Drug Administration Safety Act” a “concrete step forward” in helping to avert critical prescription drug shortages.

The legislation, S. 3187, merges House- and Senate-passed measures, and is the product of a negotiated agreement by House and Senate leaders. The Senate is expected to clear the compromise measure this week and send it to the president to sign into law.

S. 3187 contains several provisions to combat prescription drug shortages, including requiring the secretary of Health and Human Services to maintain a publicly available updated list of all drugs experiencing shortages.

The legislation would require drug makers to report drug discontinuations and supply interruptions to the FDA; expand FDA reporting on drug shortages; expedite applications to manufacture shortage drugs; and authorize a new user fee program to speed approval of generic drugs.

The legislation will “help ease the strain that hospitals across the country have faced in dealing with drug shortages,” said AHA President and CEO Rich Umbdenstock.

Senate and House lawmakers announced they had reached agreement on the bill on June 18.

Their negotiations followed the House’s approval of its version of the bill May 30, and the Senate’s approval of its version May 24.

Among other provisions, the compromise legislation would create a task force to develop a strategic plan for preventing and mitigating drug shortages. The task force would consult with hospitals, clinicians, patients and supply chain members on interagency coordination, communication and decision making as it relates to drug shortages.

S. 3187 also contains the House-passed bill’s provision on repackaging non-controlled drugs in short supply within the same health system. The AHA and other health care organizations had urged congressional leaders to include that measure in the compromise bill.

Under repackaging, hospitals, for example, might conserve and extend existing supplies of drugs by transferring a drug from a larger container into a smaller ready-to-use container, such as a syringe. FDA regulations only allow hospitals to repackage drugs for use within the same building, but under S. 3187 other hospitals in the system can share the short-supply drugs to help better manage drug shortages.

Every five years, Congress has to reauthorize the FDA’s authority to help fund its approval process for life-saving drugs and medical devices by collecting user fees from the companies it regulates. FDA’s current authority expires Sept. 30. User fees for drugs were first authorized in 1992 under the “Prescription Drug User Fee Act.”

Efforts to combat drug shortages escalated last year when 250 medicines were in short supply, up from 56 in 2006. Hospitals and physicians have been forced to postpone care or use less effective drugs or more costly alternatives to compensate for shortages.