Here's more on FDA reform:
House Passes FDA Overhaul Bill
WASHINGTON, Oct 08 (Reuters) - The US House of Representatives passed the
once controversial bill to streamline and overhaul operations at the Food and Drug
Administration by voice vote Tuesday.
The bill passed once Republicans and Democrats worked out compromises on a wide
array of issues of concern to both the agency and the drug and device makers it
regulates. The bill now goes to conference with the Senate, which passed its version of
the measure September 24th.
Congress is under pressure to complete action on the bill, because it includes a 5-year
reauthorization of the Prescription Drug User Fee Act, which technically expired on
October 1.
Citing the importance of the renewal of the popular program that has helped cut review
times for new drugs almost in half, the Clinton administration issued a statement
Tuesday morning saying it "...has no objection..." to passage of the bill "...at this time."
But the statement did go on to say that the administration "...continues to have major
concerns with the bill," including a contention that the provision allowing "third-party"
review of medical devices is "too broad," and could permit even potentially dangerous
devices to be examined by non-FDA reviewers.
Republicans and Democrats in the House, however, heaped praise on the measure.
"We have given the FDA the tools it needs to alleviate the suffering of American
patients," said Rep. Michael Bilirakis (R-Florida), chairman of the subcommittee that
oversees FDA. Added Rep. John Dingell (D-Michigan), "This bill serves the interests
of the consuming public."
The bipartisan show of support was made possible by two last-minute compromises
worked out since the House Commerce Committee approved the measure in
September. One would permit FDA to order medical device manufacturers to extend
post-market surveillance by up to 3 years, and even longer under certain conditions.
The other would refine a compromise reached earlier regarding the agency's ability to
look beyond manufacturers' stated use of a device in determining safety and efficacy.
Under the compromise, a device could continue to be marketed for the purpose stated
on the label, even if the FDA believes that it will be used for another purpose. This can
occur as long as the label states the alternative purpose as an explicit contraindication
while the safety and efficacy of that alternative purpose is evaluated.
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