Friday, February 09, 2007 Capitol
Hill Watch
Congress Likely To Approve FDA Prescription Drug
Safety Reforms in 2007
The Baltimore Sun on Friday examined how
Democrats' takeover of Congress and the expiration of a law that requires
drug manufacturers to pay user fees to FDA "is driving a flurry of activity that could lead to
major changes" in the agency's drug safety policies. The 2004 market
withdrawal of Vioxx because of safety issues led to a number of
initiatives that did not "radically alter the way the government handles
new drugs," the Sun reports. However, FDA officials last
month "kicked off the recent spate of proposals" with a plan that would increase user fees to pay for the safety
monitoring of drugs after they reach the market. FDA officials also
proposed new user fees to cover the cost of reviewing direct-to-consumer
advertisements. Last week, FDA officials announced additional safety
measures, including a pilot program to monitor the side effects of
recently approved drugs; a newsletter about the medicines; and a program
to detect side effects by studying large medical databases. FDA critics
have said that the agency's proposals "were really designed to pre-empt
more radical moves by Congress," the Sun reports. Sens. Chuck
Grassley (R-Iowa) and Christopher Dodd (D-Conn.) are sponsoring a bill (S
467) that would create an independent office at FDA to monitor the
safety of drugs that have reached the market. A separate proposal (S
484) by Senate Health,
Education, Labor and Pensions Committee Chair Edward Kennedy (D-Mass.)
and ranking member Michael Enzi (R-Wyo.) would require drug regulators and
companies to develop plans to monitor each new drug for side effects
during its first three years on the market. In addition, a coalition of
drug companies, advocacy groups and former policymakers is urging Congress
to raise funding by $40 million per year for five years. President Bush's
fiscal year 2008 budget proposal includes an additional $11 million for
drug safety.
Comments
"If you're going to be serious about drug safety,
you've got to spend the money. You can't do this on the cheap," said
William K. Hubbard, a former FDA associate commissioner who is helping the
coalition. Sheila Burke, who chaired an Institute of Medicine panel that last year recommended changes at FDA, said, "You have an odd
configuration of the stars that may lend itself to resolution this year."
Grassley said, "Congress will act on FDA-related legislation this year,
and meaningful structural reforms to the agency need to be a part of what
Congress does with regard to drug safety." Kennedy in a statement said,
"We need a more effective system to identify and assess the serious risks
of drugs, inform health care providers and patients about such risks, and
manage or mitigate these risks as soon as they are detected." Scott
Lassman, senior assistant general counsel for the Pharmaceutical Research and
Manufacturers of America, said, "What FDA needs is not new authority.
What it needs is more resources and a more modernized approach, and that's
what [the agency's user fee proposal] would do" (Rockoff, Baltimore
Sun, 2/9).