Washington Editor

WASHINGTON - New drug safety legislation has dropped in the House, courtesy of Reps. Henry Waxman (D-Calif.) and Edward Markey (D-Mass.), and their bill is stricter than the current Senate proposal.

That's troubling for many in the drug industry who worry about the potential financial fallout more FDA regulations could have on the approval process. It also bothers their allies in the patient advocacy community, who fear that both the House and Senate bills go too far in their risk-management mandates and could inhibit access to new therapies.

In particular, representatives of patients with chronic and life-threatening conditions who generally have high risk-tolerance thresholds feel their constituents' voices aren't being heard.

"The reality of it is a disaster," Ellen Sigal, founder of Friends of Cancer Research, told BioWorld Today. Ever diplomatic, she lauded the lawmakers' overall intent to create a better safety system, as did several speakers at a Wednesday event hosted by her organization to brief congressional staffers on unintended consequences of overdone safety legislation.

But all of them offered an alternative to requiring risk-management plans across the board: the better use of broad databases such as insurance company records to track how drugs are being used in medical practice and quickly identify safety signals.

In short, improving the FDA's safety oversight capabilities can be achieved by "increasing the monitoring system on the back end," after drugs are approved and in wider population use, said Robert Young, president of the Fox Chase Cancer Center in Philadelphia. Implementing new regulations to take effect upon drug approvals would make regulators "super cautious," he told BioWorld Today, and that would fail to address the need for increased vigilance on unexpected adverse events.

However, among the Waxman-Markey bill's primary conditions are requirements on drug reviews seven years after they have been on the market, part of a risk evaluation and mitigation strategy (REMS). Additional aspects call for reviewing reports on drugs at least once a year for the first three years after approval, disseminating such information to physicians and limited product distribution in some cases.

The measure, H.R. 1561, also would restrict direct-to-consumer advertising for the first three years a product is on the market, slap a special label on new drugs and allow the FDA to impose heavier fines on drugmakers for failing to comply with various requirements, including adherence to a clinical trials registry.

A spokesperson in Markey's office told BioWorld Today that the congressmen, both of whom serve on the House Energy and Commerce Committee, expect their bill to be "in play contextually" with that panel's review of the Prescription Drug User Fee Act (PDUFA). As that law's renewal continues to move through Congress, it clearly has become a vehicle to which some measure of drug safety reform is certain to stick.

But the FDA's deputy commissioner and chief medical officer, Janet Woodcock, warned of the potential cost of over-regulating. "We have to be careful we don't do more harm by decreasing innovation," she said at the briefing, later adding that "whatever happens, one size does not fit all."

Each of the Waxman-Markey bill's REMS-related recommendations goes a step beyond a proposal from Sens. Edward Kennedy (D-Mass.) and Mike Enzi (R-Wyo.), S. 484, which is being debated in the Senate Health, Education, Labor and Pensions Committee as part of a broad PDUFA reauthorization package. Both bills seem more aligned on other aspects, namely the creation of an entity to better advance the Critical Path Initiative, requiring more information for a clinical trials registry and results databases and tightening disclosure rules for FDA advisory committees.

These safety bills include "all the building blocks" for bettering the FDA, former Medicare boss and FDA commissioner Mark McClellan said at the briefing.

He especially emphasized the opportunity for legislators to help the FDA dig into data mining on drugs in the post-approval setting instead of forcing the agency to apply restrictions on every drug instead of on an as-needed basis.

"You can build that network; you can build that infrastructure," he said of using databases. "This is something that's feasible today."