HOUSE DRUG SAFETY BILL GIVES FDA MORE AUTHORITY THAN SENATE VERSION

Reps. Henry Waxman (D-Calif.) and Edward Markey (D-Mass.) have introduced legislation they say goes further to strengthen the FDA's drug safety review processes than the bill's counterpart in the Senate.

The "Enhancing Drug Safety and Innovation Act," H.R.1561, would give the FDA a "full complement of tools" to improve drug safety, using S.484 as its basis, Waxman said. The House bill would increase the agency's authority over postmarketing drug safety, adding more transparency to the review process and strengthening the mandatory clinical trial database proposed in S.484.

While saying that S.484, sponsored by Sens. Edward Kennedy (D-Mass.) and Mike Enzi (R-Wyo.), is "a significant step forward," Waxman added that his bill expands on several of S.484's recommendations.

For example, H.R.1561 would allow the FDA to ban direct-to-consumer advertising for new drugs for up to three years following approval, up from two years in the Senate bill. Both bills would require the agency to review drug products after three years on the market, but the House bill adds another review after seven years. Many side effects take that long to detect, the bill's sponsors noted.

The House bill would also increase the amount of monetary fines the FDA can impose on drug companies that do not comply with requirements. H.R.1561 has a minimum fine of $50,000, while the Senate bill sets the minimum at $15,000.

In addition, H.R.1561 would create a public record of any disputes brought to the Drug Safety Oversight Board and add more clinical trial information to clinical trials registry and results databases. The House bill also adopted a recommendation from the Institute of Medicine to put a symbol on product packaging so consumers can identify which drugs are new to the market.

( http://www.fdanews.com/did/6_57/ )