Drug Industry, FDA user-fee deal fails to fix drug
Safety crisis; New laws and real funds are needed
WASHINGTON, Jan. 11 /PRNewswire-USNewswire/ -- A
proposed user-fee deal negotiated in private between
the pharmaceutical industry and the FDA earmarks
some funds for drug safety, but Consumers Union says
the Administration must significantly fund
comprehensive safety efforts, and Congress must pass
new laws, to adequately protect the public from
dangerous drugs.
"At a time when countless drugs have safety
problems, it isn't enough to just rely on money paid
by the pharmaceutical industry to fund needed drug
safety reforms," said Bill Vaughan, senior policy
analyst for Consumers Union, publisher of Consumer
Reports.
"To address the wholly inadequate drug safety
system, consumers need a commitment from the
Administration to completely fund drug safety, and
new laws that will ensure we don't have any more
Vioxx-type disasters," Vaughan said.
The FDA announced today that it reached an agreement
with the drug industry on extending the Prescription
Drug User Fee Act, or PDUFA. Congress first passed
PDUFA in 1992 to speed up the drug approval process
by approving drugs more quickly in exchange for the
industry helping to fund the approval process. The
original act has been extended twice and is slated
to expire this year unless Congress reauthorizes it
(PDUFA IV).
The proposal calls for industry to pay $393 million
annually to the FDA, an increase of $87 million over
the previous PDUFA agreement. Of the increase, $29.3
million is earmarked for drug safety efforts over
the life-time of a drug.
Vaughan said designating some user fees toward
post-market safety is a positive step, but noted it
is still a fraction of the overall amount the drug
industry pays FDA to get its drugs on the market
quicker.
"Using a small portion of industry fees for safety
sends a good message, but we must give FDA the
power, and the resources, to adequately ensure
safety," Vaughan said.
Consumers Union supports legislation introduced in
the last Congress (S. 3807, HR 2090) that would
reform drugs safety laws and give the FDA more power
to require drug makers to perform post-market safety
studies once problems arise. CU also backs public
reporting of clinical trial results, so patients and
doctors know about side effects and drug risks.
Currently, the drug industry is not required to make
trial results public.
"More funding for drug safety is critical, but to
adequately protect consumers, the FDA has to have
the authority to require the drug industry to do the
safety work," Vaughan said.
The PDUFA proposal also hopes to collect $6 million
in additional fees from industry to fund review of
direct-to-consumer advertising. FDA said that within
five years, it hopes to have advertisements reviewed
within 45 days of submission to ensure they are
accurate and balanced.
Vaughan said more vigorous review of DTC
advertisements is a good step, but noted ads are
submitted to the FDA for review on a voluntary
basis, and drug companies currently can run ads as
soon as they submit them.
"A company could blanket the airwaves with ads for
45 days before the
FDA finishes its review. Even if the ads are pulled,
a lot of folks will
now be asking their doctor for that drug, which
could have risks that
weren't fully explained," he said.