PDUFA bumps its way toward passage

At presstime, two major important Washington actions were still hanging at the precipice: the reauthorization of the Prescription Drug User Fee Act (PDUFA; known as the FDA Reform Act of 2012 in one of its current versions); and a decision from the US Supreme Court on the Affordable Care Act—Obamacare. Despite some last-minute maneuvering by various industry and legislative interests, PDUFA was expected to be on President Obama’s desk by July 4. What happens when the Supreme Court ruling comes down is anyone’s guess.

Both the House and the Senate passed their versions of PUDFA by wide margins. Differences between the two bills get resolved in conference, and then the approved bill goes to the White House. Although the bills were passed quickly, they represented months of strenuous efforts by multiple interests; early on there was a concern that these issues would squelch timely passage. In mid-June, a dispute broke open over how Risk Evaluation and Mitigation Strategies—REMS—are to be handled by generic as opposed to branded-pharma suppliers.

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.

The Senate bill, S. 1387, included language the RxTec Act—language proposed by a consortium of manufacturers, distributors and retailers to allow for serialization of drugs at the unit level, and tracking of them at the lot level when a suspected diversion or counterfeit intrusion has occurred. The final language of the Senate bill specifies that the serialization requirement will go into effect “not later than 4-1/2 years” after passage of the bill—which would seem to be January 2017. On its face, this schedule would push the timeline for complying with California’s e-pedigree rules by two years—and while California included a clause in its legislation (when passed in 2008) saying that any federal rulemaking would pre-empt state rules, the Senate version includes its own clause specifying that its rulemaking “shall not trigger” the California pre-emption.

Moreover, the RxTec provisions are less strict than those of California, whose overall goal is to be able to track the movement of a drug unit from the point of manufacturer to the shelf of a pharmacy stockroom, on demand. If the Senate language remains in the final law, the picture for industry compliance will remain muddled until all this is sorted out.

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 biologics are established.