On April 25, 2012, the Senate Health, Education, Labor and Pensions (HELP) Committee approved the FDA Safety and Innovation Act to send to the full Senate in May. The legislation passed by the HELP Committee reauthorizes the Prescription Drug User Fee Act (PDUFA); the Medical Device User Fee Act (MDUFA); the Best Pharmaceuticals for Children Act (BPCA); and the Pediatric Research Equity Act (PREA). The reauthorization also includes two new user fee programs – the Generic Drug User Fee Act (GDUFA) and the Biosimilar User Fee Act (BSUFA).
However, the Senate’s markup of the bill differs from the bill moving through the House, namely the FDA’s mission. The House Energy and Commerce Health Subcommittee leadership issued a committee print and delayed a markup of the bill until May 8. The House had proposed that the FDA’s mission statement be changed from an agency focused primarily on bringing to market safe, new medical products to include factoring in the economic impact its decisions may have when it approves or denies drugs and medical devices. While this aspect of the bill has gained some traction in the House, the Senate seems reluctant to take up the issue, as its markup of the FDA user fee reauthorization bill is devoid of such language.
Both bills included language for development of new antibiotics to combat drug-resistant germs. Although, there seems to be substantial bipartisan support for expanded protection against generic competition to some antibiotic drug makers, the disagreement is more pronounced on whether whether those incentives will apply only to drugs that treat “serious or life-threatening conditions,” as the Senate bill does, or to almost any antibiotic, as the House prefers.
The Senate HELP Committee also adhered to its strategy of advancing the markup of the legislation as quickly as possible, by delaying consideration of a bipartisan amendment to allow U.S. consumers to buy prescription drugs from approved online pharmacies in Canada.
Passage of the bill in the Senate seems all but certain now with any obstacles emanating from the House.