FDA Bills To Help Fix Drug Shortage Problem.

CBS News  (5/8) reports, "There's been a nationwide shortage in life-saving cancer drugs for children. The Food and Drug Administration (FDA) tells CBS News that 14 drugs are in short supply." FDA commissioner Dr. Margaret Hamburg said to CBS News, "The industry has to not be afraid to let the FDA know if they have a problem so that we can get in there and work with them and fix it before it results in a shortage." Meanwhile, "The FDA said that the two bills that are languishing in Congress would help fix the problem by requiring drug companies to give the agency early warnings."

        FDA User Fee Bill May Get Through Congress Before June. Politico  (5/7, Norman) reports, "A major Food and Drug Administration user fee bill is so 'must-pass' that it's unlikely to get entangled in more GOP efforts to defund or repeal the 2010 health law." In fact, "there's a bipartisan push to get the FDA bill -- negotiated with the medical device and pharmaceutical industries -- enacted ahead of the Supreme Court ruling on the health reform law expected in June." That is because of fears of "paralysis that will set in as the elections draw near."

        The Hill  (5/8, Baker) reports in its "Healthwatch" blog, "The House Energy and Commerce Committee's Health Subcommittee is set to mark up its FDA bill Tuesday, and lawmakers are hoping to convene a full-committee markup just two days later." Also, "Energy and Commerce Republicans released their bill Friday, and seemed to steer clear of the biggest potential fault lines -- such as proposals to alter the FDA's core mission." An official with the Pharmaceutical Research and Manufacturers of America "said the process has gone 'really smoothly' so far."

        CQ  (5/8, Attias, Subscription Publication) reports the bill "is expected to garner bipartisan support." Both the bill up for consideration today and the Senate's version "would reauthorize the user fee programs that help fund the FDA's reviews of prescription drugs and medical devices, as well as create programs for generic drugs and generic biologic drugs, or biosimilars."