Senate, House OK drug short-supply warning system

Health care organizations largely back the legislation, which calls on manufacturers to give the federal government advance notice of potential shortages.

By Jennifer Lubell — Posted June 1, 2012

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Legislation to reauthorize the Prescription Drug User Fee Act for another five years has garnered support from health care organizations for containing new provisions to mitigate drug shortages, although some groups said certain key provisions still were missing from the bill.

The law sets fees, paid by drugmakers, and performance goals for Food and Drug Administration reviews of drug approval applications. The Senate approved the $6.4 billion legislation to reauthorize the statute on May 24 by a vote of 96-1. The House on May 30 passed its own version of the bill by a vote of 387-5, and the two versions must be reconciled before the measure can go to the White House for President Obama’s signature.

“This bill can literally save lives — ensuring that Americans have access to crucial medicines and medical devices,” said the Senate bill’s sponsors, Sens. Tom Harkin (D, Iowa) and Mike Enzi (R, Wyo.), the leaders of the Senate Health, Education, Labor and Pensions Committee. “It will keep patients safer by modernizing the FDA’s inspection process for foreign manufacturing facilities, while also improving access to new and innovative medicines and devices.”

The American Medical Association and other health care organizations lauded the bill for including a new drug shortage “early warning” system, which would call on manufacturers to notify the FDA at least six months before a lifesaving drug is discontinued or if there’s a meaningful disruption in the supply of that drug due to a manufacturing interruption.

“National drug shortages threaten patients, compromising their ability to access the drugs they need when they need them,” AMA President Peter W. Carmel, MD, said after the Senate passage. “The AMA is pleased that the Senate has passed legislation to address this issue and that the bill also includes provisions to incentivize the development of next-generation antibiotics.”

The FDA would be required to issue regulations within 18 months on reporting requirements for potential short-supply drugs, said David Fox, a partner in the life sciences practice of global law firm Hogan Lovells. Another interesting aspect of the bill is that it would require the agency to take into account the possibility of causing a drug shortage before taking an enforcement action against a manufacturer, Fox said.

The American Society of Hematology supported the early warning system but was concerned that certain products used for the treatment of hemophilia and other bleeding disorders were exempted from the early reporting mandate. There are more than 200 drugs currently in short supply, according to the American Society of Health-System Pharmacists.

Drug shortages are a contributing factor to rising health care costs, Blair Childs, senior vice president of public affairs for the Premier healthcare alliance, said after the Senate passage of the bill. With advance notice, the FDA “will be empowered to act and consider alternative sources of supplies, thereby alleviating many of the issues that contribute to shortages,” Childs said.

The legislation also would renew and strengthen several laws to improve the safety and effectiveness of pediatric drugs and medical devices used in children, according to the American Academy of Pediatrics.

But the Consumers Union said the legislation fell short on some patient safety protections. Missing from the bill is a provision that would prevent medical devices with known safety problems from being used as the basis for approving new devices, the group stated.

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