PDUFA bill passes Senate, heading for House debate

US flag and gavelAfter much political wrangling, the FDA Innovation and Safety Act (S. 3187) was passed by the US Senate this week, bringing the legislature a step towards re-authorisation of the Prescription Drug User Fee Act (PDUFA).

The next stage is for the House of Representatives to debate and vote on its own version of the bill - which is pretty close to the Senate version in content - which is expected to take place next week.

As its name suggests, the main thrust of PDUFA is to provide funding for the FDA via user fees from brandname pharma, medical device and now generic drug manufacturer. However, other legislation has traditionally piggy-backed on the PDUFA, and the 2012 bill is no exception.

PDUFA V also covers incentives for paediatric research, measures to extend the FDA's authority over the supply chain and increasing the agency's accountability and transparency, as well as mechanisms to alleviate drug shortages.

Track-and-trace placeholder

As reported earlier, there was no mention of track-and-trace of medicinal products in the Senate (and indeed House) bills, although observers close to the process have told SecuringPharma that negotiations are still ongoing to try to attach a traceability amendment to both the Senate and House bills before PDUFA is passed.

The Senate bill does however include a placeholder on traceability to allow further discussion and hopefully consensus on a way forward.

One source told us that the Pharmaceutical Distribution Security Alliance (PDSA) industry lobbying group - which proposed its own lot-level traceability model called RxTEC (Pharmaceutical Traceability Enhancement Code; see our articles here and here) - will try to influence the PDUFA legislation through the comment phase.

The Senate bill also includes a system to track and recall medical devices via the use of a unique device identifier (UDI).

Increased penalties for counterfeiters supported…

Meanwhile, a bipartisan amendment that would increase the penalties for counterfeit drugs has also been adopted into the Senate bill. The amendment would dramatically increase the penalties for drug counterfeiting (see our article here), with a sliding scale for first offenders, repeat offenders and institutions found guilty of trafficking.

The amendment was proposed to meet the recommendations made by Intellectual Property Enforcement Coordinator (IPEC) Victoria Espinel and the Obama administration's Counterfeit Pharmaceutical Inter-agency Working Group.

…but Canadian import amendment blocked

One controversial amendment proposed by Senator John McCain would have allowed the importation of prescription drugs from Canada, but was rejected by the Senate. The amendment would have allowed Americans to fill their prescriptions using cheaper medicines sourced from Canadian pharmacies, but was rejected on the grounds that it could increase the vulnerability f the US supply chain to counterfeit medicines.

The Partnership for Safe Medicines has applauded that defeat, saying that importation "would erode the FDA's ability to regulate prescription medicines and open the door for more criminals to operate bogus online pharmacies that prey upon our citizens."

Assuming the House version also passes, the two bills must be brought into a single, aligned format before PDUFA V can be forwarded to President Obama for signature, with reports indicating an informal deadline of early July for this to occur. The current PDUFA expires on September 30.

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