Washington Editor

WASHINGTON - FDA Commissioner Mark McClellan told a House subcommittee Thursday that legislation to close loopholes in the Hatch-Waxman Act is not necessary.

Indeed, during a House Appropriations Subcommittee hearing called to discuss President Bush's fiscal year 2004 FDA budget request, McClellan spent most of his time fielding questions about prescription and generic drugs, and other FDA-related policies under the Bush administration.

Among the first topics dealt with was Bush's generic drug plan introduced in the form of an FDA rule days before the November elections. The plan would limit pharmaceutical companies to one 30-month extension on a patent, and would restrict patents to active ingredients, drug formulations and uses of a drug. McClellan said that plan would take care of any loopholes in Hatch-Waxman, so new legislation was not needed. (See BioWorld Today, Oct. 22, 2002.)

The proposed rule was published for comment in late December, and according to McClellan, it likely will be finalized sometime this spring.

However, Sen. Chuck Schumer (D-N.Y.) late Wednesday introduced legislation (Greater Access to Affordable Pharmaceuticals) to reform Hatch-Waxman, the 1984 act that created the generic drug industry. Schumer's legislation, authored with Sen. John McCain (R-Ariz.), includes a provision similar to Bush's regarding the single 30-month extension. (See BioWorld Today, March 6, 2003.)

Thanks to lobbying on the part of the biotechnology industry, biologics are not included under Hatch-Waxman. However, the generics industry has vowed to include the innovative products down the road.

Subcommittee members grilled McClellan about the price of drugs even as the commissioner made an attempt to talk about other budget issues, like the president's BioShield plan, an effort to develop and make available modern, effective countermeasures against biological and other dangerous agents. (See BioWorld Today, Feb. 4, 2003.)

"Homeland security is not what people are talking about on Main Street," Rep. Sam Farr (D-Calif.) told McClellan. "When I go home on the weekends, people ask me, Why are prescription drugs so expensive?'"

When asked whether he believes a prescription drug plan is necessary, McClellan said "yes," adding that the budget includes $13 million to help improve access to generic drugs, which account for nearly 50 percent of all drugs prescribed. Much of the funding will go toward supporting 40 new employees in the generics division (30 are application reviewers).

To help seniors gain access to more affordable prescription drugs, Sen. Byron Dorgan (N-N.D.) on Wednesday introduced legislation to allow the reimportation of FDA-approved drugs from Canada.

Asked by the subcommittee what his thoughts are on reimportation, McClellan said, "We are very concerned about the safety and efficacy of any drug that doesn't go through the FDA."

While the commissioner didn't spend a lot of time discussing details of Bush's proposed budget, he took a few minutes at the beginning of the meeting to hit the highlights.

The total request is $1.7 billion, including $1.4 billion in budget authority and $307 million in user fees (the Prescription Drug User Fee Act). Bush's proposal represents a $59 million, or 7 percent, increase over the current budget.

The budget includes $249.8 million in user fees from the biologics and drug industry, a $26.9 million increase over the current year.