[Ip-health] WSJ: Senators to Propose New Safety Tactics for FDA

[Amy Nunn]

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Senators to Propose New Safety Tactics for FDA

By ANNA WILDE MATHEWS
June 21, 2006

http://online.wsj.com/article/SB115084546439685697.html?mod=health_home_stor
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WASHINGTON -- The leaders of the Senate committee that oversees the Food and
Drug Administration plan to unveil legislation that would substantially
change how the agency reviews medications.

The bill is being prepared by Michael Enzi, the Wyoming Republican who heads
the Senate Committee on Health, Education, Labor and Pensions, and its
ranking Democrat, Edward Kennedy of Massachusetts. The two lawmakers' views
are particularly important as Congress prepares to consider legislation next
year to renew the industry-user fees that fund many of the FDA's operations.

The drug-safety bill prepared by Sens. Kennedy and Enzi is keyed to that
user-fee renewal, and would likely depend on increases in the fees. Details
could change before the final version emerges in the next several weeks. The
senators aim to get a vote on the bill this year, but if that doesn't happen
in the abbreviated election-year Congress, it could provide a framework for
drug-safety provisions in next year's user-fee legislation.

Mr. Enzi said the bill would "raise the bar to ensure that safety is not an
afterthought, but a given" and "restore public confidence in the FDA's
process of reviewing the benefits and risks of prescription drugs." Mr.
Kennedy said the bill would give the agency "a complete set of tools to
address the safety of drugs post-approval, including giving the FDA
authority to require post-approval labeling changes and safety studies."

Though drug makers may object to aspects of the bill, they are under
pressure to back some drug-safety changes. In a statement, the
Pharmaceutical Research and Manufacturers of America said the organization
can't fully comment on the bill because it hasn't been formally introduced,
but that drugs already are "subject to rigorous safety and effectiveness
reviews" by the FDA.

An FDA spokeswoman said it "welcomes additional ideas on improving oversight
of drug safety," and the agency has safety initiatives already under way.

Other drug-safety bills also have emerged. Legislation co-sponsored by
Senate Finance Committee Chairman Charles Grassley (R., Iowa) and Sen.
Christopher Dodd (D., Conn.) would restructure the agency, creating a FDA
center focused on the safety of drugs already on the market and granting the
agency substantial new powers.

The latest bill is expected to require the FDA to have a plan for evaluating
and mitigating the potential risks of every drug it approves, congressional
staff members said. The plan would have to be re-evaluated at least once a
year for the first three years a drug is on the market.

The bill also would give the FDA new authority to ensure the safety of
drugs, which could be used as part of the risk-mitigation plans. Drug
manufacturers would be able to go through an FDA dispute-resolution
procedure if they object to the agency's proposed risk-mitigation
strategies. The plans could include requirements that drug makers do studies
or keep registries after their medicines go on the market; limit
direct-to-consumer advertising or impose disclosure requirements on it; and
limit use or distribution of a drug.

Currently, the FDA sometimes uses such tactics for drugs seen as risky, but
the agency typically has to use the leverage it has over drug approval to
negotiate the restrictions with manufacturers. Its authority to impose them
isn't clear-cut. The bill would amp up the regulators' power by giving the
FDA a new ability to impose fines on companies that don't adhere to the
risk-mitigation plans.

The bill also would require drug makers to register their clinical trials in
a public government database and make the results of the advanced studies
public. It would authorize some resources for an FDA effort to spearhead
research on drug evaluation.



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