Washington Editor

WASHINGTON - Rep. Henry Waxman (D-Calif.) Tuesday urged that follow-on biologics language be incorporated into a bill to renew the Prescription Drug User Fee Act (PDUFA) at a House subcommittee hearing, during which one witness also spoke in favor of a Senate proposal to markedly increase the amount of user fees dedicated to drug safety.

Reauthorizing PDUFA "gives us the opportunity" to tackle a number of FDA-related issues, Waxman said, adding that the agency "currently lacks several critical authorities."

High on his wish list for new FDA powers: creating a pathway for approving follow-on biologics that would give the agency case-by-case flexibility to determine whether such products require clinical testing. An already introduced bill, the "Access to Life Saving Medicine Act of 2007," or H.R. 1038, would do just that.

But critics consistently have charged that the proposal sacrifices safety standards for speed and savings, not to mention its disregard of pioneer drugmakers' intellectual property. Those naysayers found an ally in one of Waxman's colleagues, Rep. Anna Eshoo (D-Calif.), who spoke in favor of a clean PDUFA renewal process without any follow-on biologics attachments.

Noting the "many complexities" of biological products, she said the committee "needs to review that kind of legislation on a stand-alone basis."

In fact, Rep. Frank Pallone (D-N.J.), chairman of the health subcommittee of the House Energy and Commerce panel, told BioWorld Today that he's planning to hold a hearing on follow-on biologics. He added that "we haven't decided" whether to incorporate such language into a final PDUFA package, which FDA official Theresa Mullin told committee members preferably would be signed into law no later than mid-July to avoid personnel disruptions at the agency.

"The hearing is going to be on the issue itself," Pallone said, "because we really think it's important to spend some time with it."

Draft language on competing follow-on biologics legislation has begun circulating, but it's yet to be introduced officially. No such language was included in a draft of a broad FDA-related bill scheduled to be marked up today by the Senate Health, Education, Labor and Pensions Committee, the "Food and Drug Administration Revitalization Act," or S. 1082. (See BioWorld Today, April 16, 2007.)

Among that comprehensive bill's many proposals is a $50 million annual increase in user fees dedicated to post-approval safety on top of the $29 million in the industry-negotiated package put forth by the FDA, Bill Vaughan of the Consumers Union told BioWorld Today. That would amount to nearly $400 million in user fees for post-approval safety over the next five years to be covered by the next version of PDUFA, compared to a little more than $145 million currently.

He praised that proposed increase during his subcommittee testimony, as well as safety-related legislation that's been introduced by Waxman and Rep. Edward Markey (D-Mass.), the "Enhancing Drug Safety and Innovation Act of 2007," or H.R. 1561. Vaughan also expressed support for mandatory clinical trial data disclosure, as did several other witnesses.

Pallone promised a separate safety hearing relating to the extent to which such proposals would get incorporated into PDUFA's reauthorization bill.

Other discussion during the hearing included warnings about overemphasizing safety to the detriment of patient access; the FDA's plan to charge user fees for reviewing television advertisements; the agency's inability to mandate Phase IV study commitments; whether an increase in reported adverse events in recent years is tied to higher numbers of counterfeit drugs now in the country; PDUFA's impact on public perceptions of the FDA; and a desire to evenly fund its review activities between user fees and appropriated money.

Mullin, the agency's assistant commissioner for planning, said user fees currently pay for 58 percent of the agency's review process, and many observers believe that share will continue to increase.

The FDA first publicized its industry-negotiated PDUFA package earlier this year, a proposal that includes an increase in annual user fees to $392.8 million to account for more post-approval safety oversight, workload growth and escalating staff costs. A related fee-for-service item included in the request is aimed at collecting $6.3 million per year from companies that request FDA advertising reviews. (See BioWorld Today, Jan. 12, 2007.)

Today's Senate committee action on S. 1082 is related to reauthorizing PDUFA in tandem with establishing new safety regulations, setting up a nonprofit foundation to advance product development and enhance safety, requiring clinical trial registries and limiting FDA advisory committee members' conflicts of interest, as well as renewing medical device user fees and pediatric exclusivity laws.