To Burr, with Love
BioCentury reports that Senator Richard Burr (R-N.C.) threatened Thursday to delay reauthorization of medical device and prescription drug user fee legislation unless FDA implements steps to improve and speed product reviews. Speaking at a Senate committee on Health, Education, Labor and Pensions hearing, Burr said user fees, especially for medical devices, have not improved FDA performance and expressed skepticism that increasing user fees would improve the situation. He said reauthorization will become "a very slow and laborious process" unless the new legislation has measurement tools to track whether a fee system produces better outcomes
HELP committee Chairman Sen. Tom Harkin (D-Iowa) pushed back, saying that safety and efficacy are more important than speed to market. He also said FDA is understaffed and underfunded, so more money could improve its review performance.
They’re both right.
PhRMA wants dedicated biosimilars funding
The merits of creating a dedicated appropriation for biosimilars reviews has emerged as a point of contention in closed door FDA-hosted biosimilars user fee stakeholder discussions. In a July 24 letter from the Pharmaceutical Research and Manufacturers of America (PhRMA) to FDA, the trade association came down solidly on the side of creating a funding stream for biosimilar reviews that is separate from PDUFA-funded drug reviews.
PhRMA also called for a separate biosimilars user fee "trigger," or minimum amount Congress must allocate for biosimilars reviews to enable FDA to spend user fees. A trigger was built into PDUFA with the goal of making user fees supplement, not replace, federal funding. The law creating a biosimilars pathway called for FDA to fund biosimilars reviews from PDUFA funds until October 2012, when biosimilars user fees are expected to kick in. Applying PDUFA to biosimilars past October 2012 would drain resources from reviews of innovative medicines, according to the PhRMA letter.
Lack of money is the root of all evil.
-- George Bernard Shaw
