Senate reauthorizes PDUFA, paving the way for a quick passage into law


Biggest impact is expansion of user fees paid to FDA by generic and medical device manufacturers; drug approvals could be accelerated by changed review process; federal drug pedigree rules are 'on life support' but could still pass

The FDA Safety and Innovation Act, as its current official title is known, passed the Senate by a 96-1 vote on May 25, following intense parliamentary actions to limit debate to specific items and to apply super-majority rules to some of the votes. Senate majority leader Henry Reid had threatened to table debate on the bill—essentially putting its vote off until later in the summer—unless the debate was limited. The core component of the law, a renewal of the Prescription Drug User Fee Act (PDUFA), is essential to the ongoing operations of FDA, because fees generated from drug applications now funds a significant portion of FDA operations. Over the next five years, according to federal estimates, drug manufacturers will pay $4.1 billion in user fees, and now generic makers will pay an estimated $1.6 billion, medical device makers $609 million, and biosimilar developers, $128 million.

An amendment brought by Sen. John McCain (R-AZ) to allow importation of drugs from Canada—an activity that has been proposed and rejected many times in recent years—was defeated by a 43-54 vote. Another amendment, brought by independent Sen. Bernard Sanders (VT) to heavily penalize manufacturers found to be guilty of fraud, was defeated by a 9-88 vote (Sanders was then the lone dissenting vote on the full bill).

FDA and various industry groups have been meeting in public and private forums for most of the past year working out the details of the legislation. At the beginning of this year, an industry group led by PhRMA, the Pharmaceutical Distribution Security Alliance, brought out an “RxTEC Act” proposal that would specify item-level serialization of drug packages, but only lot-level tracking of the drugs in commercial distribution (which is a step below a full track-and-trace system). This language currently exists as a draft element under consideration when the House and Senate versions of the bill will be considered; one industry insider says that RxTEC is “on life support.” Meanwhile, language strengthening drug-distribution regulation, and increasing penalties for distributing counterfeit drugs, was incorporated into the bill.

Another broad-reaching component of the bill revises FDA responsibilities for inspecting drug manufacturing sites, paving the way for broader and more frequent inspection of offshore facilities. FDA will also be able to use third-party auditors for these inspections. There is also a section focused on drug shortages: manufacturers will be required to provide a six-month warning for expected reductions or withdrawals from manufacturing a drug; and FDA will conduct further study of reducing or limiting shortage situations. Additionally, a working group is being set up to recommend best practices for labeling drugs for the visually impaired or handicapped. Finally, pathways for accelerating the development of rare-disease drugs, vaccines and biological are established.

UPDATE May 26: The office of Eric Cantor, House Speaker, posted an announcement that the House will take up debate on HR 5651, the Food and Drug Administration Reform Act of 2012, on May 30. If the bill passes, it then goes to conference to reconcile differences between the House and Senate versions.

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