por Brendon Nafziger
, DOTmed News Associate Editor | May 25, 2012
Lobbies for medical device makers and group purchasing organizations hailed the Senate's 96-1 vote Thursday to reauthorize the Food and Drug Administration user fee programs for medical devices and drugs. However, consumer groups are miffed that certain safety provisions didn't make it into the final bill.
The legislation extends a program the FDA has been using to collect fees from drug and device companies to pay for staff to review product applications. Under the new five-year agreement, the FDA will collect some $6.4 billion in fees from the companies.
The new bill also expands the program to cover generic drugs and biologics to help get them to the market sooner, among some other fresh requirements.
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The Healthcare Supply Chain Association, which represents the country's big GPOs, welcomed the bill, saying it was pleased that it requires pharmaceutical companies to alert the FDA if they foresee drug shortages, and also requires unique device identifiers, or UDIs, for medical devices, to better allow product recalls. UDIs were called for by a 2007 user fee renewal package, but have been held up a lengthy Office of Management and Budget review, the group said.
AdvaMed, the device lobby, said the related use fee program for devices, whose renewal was also in the bill, was simply "good for FDA; it is good for industry; and most of all, it is good for American patients."
But patient safety advocates are upset that the bill doesn't include protections they had been lobbying for. For instance, Consumers Union said it had wanted to prohibit the FDA from clearing medical devices through the 510(k) process if the device the new product is based on, called a predicate device, had been pulled from the market for safety reasons. The CU also wanted to beef up the FDA's ability to rescind products if post-market studies aren't done.
"Congress is missing the opportunity to fix a broken system that lets too many unsafe medical devices on the market and limits the FDA's ability to protect patients when problems arise," Lisa McGiffert, director of CU's Safe Patient Project, said in a statement.
The passage of the Senate bill came after some squabbling over more than a dozen amendments to the bill, including one to abolish the medical device excise tax
, many of which were scuttled. The tax repeal amendment, which apparently never even came up for a vote, was added by Sen. Orrin Hatch, a Utah Republican, who told Congress this week that "the medical device tax sits on the top of the list of foolish new Obamacare taxes."
The House is expected to tackle the FDA user fees, possibly by next week, and could adopt its own version of the bill or the Senate's.