The House of Representatives today
passed significant reforms to the Food and Drug Administration’s drug safety
review system. Part of a comprehensive FDA bill, the bill was a compromise
between Senate and House legislation that passed overwhelmingly earlier this
year. The bill, which includes strong consumer protections, will be voted on in
the U.S. Senate tomorrow.
Statement by Maryland PIRG Policy Advocate, Johanna
Neumann:
“The drugs in our medicine
cabinets will be safer because of today’s Congressional action. The reforms are
the type of strong medicine needed to protect all Americans from unsafe
drugs. The drug industry opposed many of these safety reforms, but in the
end there were too many headlines about dangerous drugs. Congress had to
act, and we’re pleased they did. In recent years safety problems with
drugs like Vioxx, Paxil and Avandia have made consumers question whether the
drugs they are taking to keep themselves healthy are causing more harm than
good. The reforms strengthen the FDA’s drug safety review process, and
they hold drug makers more accountable to consumers. For a number of
years, the FDA’s system for reviewing the safety of drugs has been
broken. Today’s action by Congress takes steps to solve our drug safety
problems.”
The Food and Drug Administration
Amendment Act will:
Make
more information about drug studies available to researchers, doctors and
patients by posting the results of most clinical trials on-line.
Drug makers will no longer be able to bury unflattering studies about a
drug’s side effects.
Strengthen
conflicts-of-interest rules for scientists who serve on FDA drug safety
panels by limiting the number of scientists with financial ties to drug
makers by 25 percent over five years.
Grant
the FDA the authority to issue fines of up to $10 million for drug makers
who fail to complete follow-up safety studies. In the past, drug makers
failed to complete drug safety studies nearly 70 percent of the time.
Add
$225 million from drug industry user fees for follow-up safety studies
(post-market drug safety reviews). This is a significant increase in
user fees being dedicated to drug safety.
Congress must pass the Food and
Drug Administration Amendment Act by September 30 to avoid layoffs at the
FDA. The bill includes prescription drug user fee reauthorization that
provides nearly $400 million of the Food and Drug Administration’s $1.5 billion
budget.
