House panel criticizes FDA for slow approval of generic drugs

Members of the House Agriculture Appropriations Subcommittee ripped into acting Food and Drug Administration Commissioner Andrew Von Eschenbach Thursday over what they said was inadequate funding for the generic drug approval process.

Both Democrats and Republicans called for swifter approval of generic drugs for the marketplace, which they said could save millions for the government in reduced Medicare and Medicaid costs as well as easing the pocketbook pinch of ordinary Americans. Recent news reports have documented a backlog of more than 800 drugs awaiting approval by the FDA for generic sales.

The fiscal 2007 budget for FDA is $1.95 billion, a 3.8 percent increase above the previous year. But virtually all of the increases are in programs such as pandemic preparedness and protecting the food supply from terrorist attacks. It proposes about $26 million for the office that oversees generics, about the same as fiscal 2006.

Subcommittee members also took Von Eschenbach to task for other budget cuts, including a program that informs the public about how to avoid getting sick when eating raw oysters and for continuing delays in approval of the so-called Plan B emergency contraceptive for over-the-counter sales.

But it was the generic drug approval program which drew the most fire. Agriculture Appropriations Subcommittee ranking member Rosa DeLauro, D-Conn., chided the agency for not asking for more money, citing the 800-drug backlog and only 200 workers devoted to the program.

"We want to work with you to get the resources you need to speed this process," she said, saying generics cost less, particularly for senior citizens on a fixed income. Rep. Jo Ann Emerson, R-Mo., also cited the flat-funding of the generic drug process and said with such a large backlog "it's critical that we move these drugs to market."

Emerson also called on the agency to make it easier for generic drug makers to compete with brand-name manufacturers which, she said, sometimes repackage their brand-name drug with a generic label on it, giving it an unfair advantage over other generics because it looks more like the brand name consumers are used to.

"I don't think 'first generics' are an impediment to others," Von Eschenbach replied.

Eschenbach's strongest sparring came with Rep. Sam Farr, D-Calif., over the agency's refusal to approve "Plan B" for over-the-counter sales. Farr and DeLauro accused the agency of playing politics with the approval of the drug, which has been languishing since 2001.

Eschenbach said the agency's last hurdle is to go over hundreds of comments it has received about the process.

Farr countered that in some rulemakings overseen by the committee, agencies have received hundreds of thousands of comments and it has not taken years to review.

"We need a decision because you are losing your credibility," Farr said. "It's time to step in and make a decision." Eschenbach said a decision would be made, consistent with "scientific rigor and discipline" but did not give the committee a timetable.