Pharma relieved as Senate backs FDA fees
pharmafile | May 30, 2012 | News story | Business Services, Manufacturing and Production, Research and Development, Sales and Marketing | FDA, PDUFA, PhRMA, US
The US Senate has approved a law that will continue to allow pharma firms to help fund the FDA.
The Prescription Drug User Fee Act (PDUFA) was enacted in 1992 and has been renewed every five years since then.
In May the Senate voted 96-1 that the fifth incarnation of the Act should be renewed, and will see a 6% increase in fees – pharma and medical device firms will now pay around $6 billion to the FDA in user fees for the next five years, a major chunk of its revenue.
The Senate bill also empowers FDA staffers to take their inspections overseas, where the majority of drug ingredients are manufactured, whilst also aiming to reduce drug shortages and penalising counterfeiters.
Senator Bernie Sanders was the only one who didn’t vote for the renewal, claiming that it did not do enough to lower drug costs and help those from poorer backgrounds.
But the bill’s biggest controversy is that it allows pharma to fund its own regulator, throwing up questions over conflicts of interest.
But many regulators around the world now use this system, which includes the FDA’s European counterpart the EMA, and the US senators at least seem to have little problem with this.
Every renewal must pass through the US legislative system and it is always a nervous time for both the FDA and pharma, as the US regulator requires this funding boost to put through new drugs quickly.
But it is not a rubber stamp process and Congress has the ability to make changes to the previous PDUFA.
Both the pharma industry and the FDA have been urging Congress not to take any advantages away from the current system, and this lobbying has been effective in the Senate.
But the bill must now be passed by the House of Representatives for it to be formally ratified, and the FDA’s commissioner Margaret Hamburg has urged them to do this by 4 July, before the fourth PDUFA runs out.
There has been some delays in getting the bill renewed due to the FDA missing a submission deadline earlier this year, and it will be a close run thing to get the bill passed before this date.
Pharma funds helping drug reviews
Speaking earlier this year, Hamburg explained why the PDUFA is so important: “Before PDUFA was enacted by Congress in 1992, FDA’s review process was understaffed, unpredictable, and slow,” she said, adding that access to new medicines for US patients ‘lagged behind other countries’.
But the PDUFA has allowed the FDA to hire reviewers and support staff and to upgrade FDA information technology systems, she said.
All of this has allowed drugs to be approved more quickly, and for medicines to be safer – to go back to the old system would not be in the interests of patients or the industry, she added.
The US industry body PhRMA welcomed the vote. It said in a statement: “[The] Senate’s vote passing the FDA Safety and Innovation Act demonstrates bipartisan recognition of the importance of the Prescription Drug User Fee Act, an extremely successful programme that helps bring innovative medicines to patients.
“By reauthorising PDUFA, members of both sides of the aisle have taken an important step forward toward providing the FDA with much-needed resources and management tools to support patient safety and to promote innovation through increased consistency and efficiency in FDA’s science-based human drug review programme.”
Ben Adams
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