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PR Newswire - Press Release
Senate Passes Drug-Safety Reforms to Prevent Future Vioxx-type Disasters; House Urged to Act on Strong Drug Safety Bill
First significant drug safety measure in 45 years; focus moves to House
WASHINGTON, May 9 /PRNewswire-USNewswire/ -- The Senate today
overwhelmingly passed significant prescription drug safety reforms to give the
Food and Drug Administration more power to deal with unsafe medicines on the
market, moving the issue of drug safety to the House, where a strong bill has
been introduced but has yet to be considered.
"The Senate should be congratulated for passing reforms to ensure patients
and doctors know more about the risks of their medicines," said Bill Vaughan,
senior policy advisor for Consumers Union, publisher of Consumer Reports. "The
leadership of Senators Kennedy and Enzi on drug safety reform has been
invaluable to getting this through the Senate."
"Too many lives have been lost because the FDA has been too slow to act,
or didn't have the power to change a warning label or require a follow-up
safety study. It's now up to the House to get the strongest possible reforms
approved so patients can have faith in the medicines they take each day,"
Vaughan added.
S 1082, passed by a 93-1 vote, gives the FDA power to change drug labels
and require post-market studies for drugs that have safety problems. It also
requires drug makers to register most of their clinical trials - although the
legislation gives the FDA 2 1/2 years to develop guidelines for making some,
but not all, clinical trial results public.
Consumers Union is urging the House to pass language to make all clinical
trial results public immediately to prevent drug companies from downplaying
studies which reveal harmful side effects, as was the case with Vioxx and
Paxil.
On the issue of direct-to-consumer advertising, an original provision in
the Senate bill giving the FDA power to restrict advertising for new drugs
with safety indications was removed. It was replaced with a much weaker
measure that only allows the FDA to fine companies ($150,000 per violation)
for ads that are false or misleading when it comes to disclosing a "serious
health risk." With new drugs, serious health risks often aren't clear until a
drug has been on the market for years and used by millions, which is why
having the DTC moratorium option is critical for safety.
"While it's important FDA has the power to hold a drug company's feet to
the fire when it comes to misleading ads, we'd urge the House to support
restrictions on massive ad campaigns for those new drugs with early danger
indications," Vaughan said. "There is nothing in the First Amendment that
guarantees drug companies can push medications with health risks on the
public. When a company can make more than a million dollars a day in drug
sales, a $150,000 fine for running a misleading advertisement won't have much
impact."
HR 1561, introduced by Reps. Waxman and Markey, contains many of the
Senate provisions, but makes more clinical trial results available more
quickly, and allows for a three-year advertising moratorium on new drugs with
safety issues. It is unclear whether that bill will move alone or be attached
to a broader drug-user fee renewal measure like the Senate version.
"The House bill has some stronger safety measures that would close
loopholes the drug industry could exploit when it comes to making risk
information public," Vaughan said.
In the Senate bill, an amendment offered by Sen. Grassley (R-Iowa), to
give the FDA's drug safety office a higher profile by giving it joint
decision-making with the Office of New Drugs over drugs on the market lost by
just one vote. CU supported the amendment because those in the FDA responsible
for safety "are often overwhelmed, ignored, or even told to be quiet."
The Senate also approved amendments that would:
* Impose higher fines on companies that fail to comply with risk
mitigation strategies, such as performing post-market safety studies. "We have
seen repeated violations of drug-company promises to comply with FDA requests,
and the agency desperately needs tools to ensure companies keep these
promises," Vaughan said.
* Help get affordable generic medicines on the market more quickly by
blocking the frivolous use of citizen petitions to delay the entry of generics
on the market. Only three of 42 citizen petitions answered between 2001 and
2005 raised issues that merited changes in the agency's policies about a drug,
yet they can often delay generic getting on the market.
* Improve food safety by developing a registry of dangerous food
contamination incidents, and work with states to strengthen standards and
procedures to improve safety of processed produce. The amendment from
Sen. Durbin (D-Ill.) also directs FDA to issue processing, ingredient and
labeling standards for pet food.
"The is a useful first step, but Congress needs to do much, much more if
we are to avoid continued problems like we have had this year with spinach,
peanut butter, and pet food," said Sally Greenberg, senior policy analyst.
"Food safety, like drug safety, is a major concern for American families, and
consumers want strong laws to ensure their food is as safe as possible."
Consumers Union supports legislation that would give the FDA mandatory
recall authority over tainted food -- currently food recalls are
voluntary -- and the creation of a single food agency to coordinate oversight
of safety functions, which currently is split among 15 federal agencies.
Sens. Dorgan and Snowe's drug reimportation proposal was effectively
negated by an amendment requiring the FDA to certify all reimported drugs
safe, which the FDA has been reluctant to do. Consumers Union urges Congress
to reconsider drug reimportation later this session to provide some immediate,
needed financial relief for Americans who can't afford their medications.
"Reimportation is an important interim step to immediately helping those
Americans who can't afford their needed medications, but long-term solutions
to spiraling drug costs are still needed," Vaughan said. "Congress and the
administration should enact domestic drug price negotiation laws like those
the Veterans Administration uses to ensure all of us can purchase at home the
safest and most affordable medications available."
Contact: Bill Vaughan or Susan Herold, 202-462-6262
SOURCE Consumers Union
-0- 05/09/2007
/CONTACT: Bill Vaughan or Susan Herold, both of Consumers Union,
+1-202-462-6262/
CO: Consumers Union
ST: District of Columbia
IN: HEA MTC
SU: CSR FDA LEG POL
CA-RS
-- DCW078 --
4726 05/09/2007 13:56 EDT http://www.prnewswire.com
Copyright © 2004 PR Newswire All rights reserved.
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