Key senators unveil bill to bolster drug safety

Key senators unveil bill to bolster drug safety - Yahoo! News

The legislation is meant to strengthen the U.S.
Food and Drug Administration's oversight of the safety of medicines after they reach the market. The FDA was widely criticized for its handling of Merck & Co. Inc.'s withdrawn arthritis pill
Vioxx, pulled after it was linked to heart attacks and strokes, and other widely-used drugs.

"FDA has post-approval authorities now, but they are not
always the ideal tools to do what is needed," a summary of the
bill said.

FDA spokeswoman Susan Bro said the agency was committed to
ensuring product safety and efficacy. "We stand ready to
provide technical assistance on their bill as it moves through
the process," she said.

A draft version calls for drug makers and the FDA, prior to
a drug's approval, to set strategies to manage risks once the
product reaches the market. The bill creates a dispute
resolution process with deadlines if the parties fail to agree
on a plan.

Once the plan was in place, the FDA could fine companies
that knowingly violate the safety monitoring plan. Penalties
would range from $15,000 to $250,000 per violation. If the FDA
pursued multiple violations at once, the total penalty would be
capped at $1 million.

Drug makers would need to meet with the FDA at least once a
year during the first three years a drug is on the market to
review the plans, the bill summary said.

The measure also would require companies to publish results
from late-stage and post-approval studies in a public database,
as well as list earlier trials. Drugs that have not had that
information in the databases could not be reviewed by the FDA.