PDUFA bill passes Senate, heading for House debate
Phil Taylor, 29-May-2012
After 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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