Abstract
Legislation awaiting President Obama's signature sets up new measures for handling drug shortages and establishes a framework for industry to pay “user fees” for reviewing applications for generic drugs, including biosimilars.
Legislation sets measures to address drug supplies and accelerate decisions on generic drugs.
In a rare bipartisan mood, Congress has sent a bill with several new mandates for the U.S. Food and Drug Administration (FDA) to President Obama for his signature. Among its provisions, the legislation bolsters the procedures by which the agency handles drug shortages. It also extends the framework of “user fees”—under which companies pay the FDA for reviewing drug applications—to generic drugs.
In recent years, clinical trials and treatments have been increasingly plagued by shortages of many drugs, with a number of decades-old generic chemotherapies among the most severely affected. The bill requires drug manufacturers to let the FDA know 6 months before critical products are anticipated to run out and sets further guidelines for how the FDA publicly reports on shortages.
Erin Fox, PhD, director of the drug information service at the University of Utah's College of Pharmacy in Salt Lake City, comments that the legislation formalizes processes first put in place after the President issued an executive order addressing drug shortages in October 2011. “For the most part, manufacturers are complying and talking with the FDA early on, and the FDA can pursue various strategies to prevent shortages,” she says. “But it's still a Band-Aid solution.”
Although many people blame the FDA for drug shortfalls, “this is a very complex situation, and the FDA, particularly the drug shortages team, is making heroic efforts to do what it can,” she adds. “There are many players involved, and you can't blame it on one agency or one part of the supply chain.”
On the bright side, although 4 new chemotherapy shortages have cropped up this year and at least 30 chemotherapy agents remain in short supply, Fox sees signs that the crisis is easing slightly in oncology. “The very tough days of doctors having to halt clinical trials because there aren't enough drugs, or wondering if they can supply the drug they want to supply, or wondering if they have enough to finish the patient's regimen, are going away,” she says.
Among its other measures, the bill renewed the Prescription Drug User Fee Act, which aims to accelerate the drug approval process by allowing the FDA to collect fees from drug companies, thereby providing more resources for the approval process. The legislation's newly extended user fees cover not only conventional small-molecule generic drugs but also biosimilars (copies of biologic products), which should speed the much-anticipated entry of those therapeutics into the market. The same week the bill passed Congress, the U.S. Supreme Court's decision on the Affordable Care Act confirmed the provisions under which the FDA regulates biosimilars.
