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Kennedy: Generic Biotech Will Be In PDUFA Legislation
By Fawn Johnson
Congress Daily
April 19, 2007
Senate Health, Education, Labor and Pensions Chairman Kennedy said Wednesday that a generic biotech bill will be included in must-pass legislation reauthorizing user fees for the FDA. "At some time, it will be part of this legislation. It will be part of it," Kennedy said.
Including language on generic biotech drugs in the Prescription Drug User Fee Act reauthorization bill greatly increases the chances that FDA will have the authority to approve generic versions of biotech drugs this year.
PDUFA expires Sept. 30, and the FDA would lose a sizeable chunk of its budget without the user fees paid by brand name pharmaceutical companies to expedite reviews of new drugs.
Kennedy is circulating draft legislation to create a pathway for the FDA to approve generic versions of biotech drugs, but the bill includes some protections for the brand-name drug industry that are not in a similar measure sponsored by Sens. Hillary Rodham Clinton, D-N.Y., and Charles Schumer, D-N.Y.
The PDUFA reauthorization bill passed the HELP panel Wednesday without the generic biotech language. Without that piece, the committee's debate was largely focused on drug safety issues. Kennedy included drug safety language and provisions about pediatric tests for pharmaceuticals in the PDUFA bill.
The PDUFA measure could be on the floor within a few weeks, Kennedy said. He has not indicated when his panel will mark up the bill on generic biotech drugs.
In the House, Energy and Commerce Health Subcommittee Chairman Frank Pallone, D-N.J., told CongressDaily Wednesday that he will not decide whether to include the follow-on biologic bill in PDUFA until the committee holds hearings on the issue. The hearings will give him a sense of support for the follow-on biologic legislation, he said.
Pallone said he wants the PDUFA bill to be completed by July to head off the possibility that the FDA would need to lay off employees. An FDA reduction-in-force is required by law, with a 60-day notification period, if the user fee statute is not reauthorized. "We have to get this done and on the president's desk in that period," Pallone said. "What we add on will depend on that."
Meanwhile, Sen. Tom Coburn, R-Okla., added another wrinkle for floor consideration of the PDUFA bill when the committee unexpectedly passed his amendment to impose FDA regulation of medical marijuana.
Coburn said the active ingredient in marijuana is available in pill form and regulated by the FDA, but the smoked version is not. According to Coburn, 12 states have authorized use of smoked marijuana for medical purposes, which he said serves no purpose in improving patient health.
Kennedy asked Coburn to withdraw his amendment and save it for the floor, but Sen. Judd Gregg, R-N.H., pointed out the amendment might not be considered germane. By accepting Coburn's amendment, the debate on medical marijuana could occur on the floor even if Senate leaders immediately file a cloture motion to end debate.
Kennedy pledged to work with Coburn on the proposal.
Sen. Barack Obama, D-Ill., entered the markup room as the committee was voting on Coburn's amendment. "I'm here," he announced, before voting against the amendment. "This may be the one vote you may want to miss," Kennedy joked.
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