Chances for biogenerics pathway bill dim in 2007

WASHINGTON —Does the generic drug industry have a shot this year at gaining entrée into the rarified and potentially lucrative world of bio-engineered medicines? Perhaps not, but key industry supporters on Capitol Hill are at least pledging to push for legislation that would open the way for generic versions of expensive bioengineered drugs in coming years.

Two members of Congress—including one of the authors of the original compromise legislation that gave rise to the modern multi-source drug market—warned generic industry leaders here they were unlikely to see biogeneric approval pathway legislation included in a major Food and Drug Administration funding and reauthorization bill now moving through Congress. But both lawmakers—as well as the head of the Generic Pharmaceutical Association—said prospects for a law creating a clear pathway for the approval of generic versions of expensive bioengineered medications remain strong in 2007 or 2008.

Addressing generic industry representatives at GPhA’s Annual Policy Conference Sept. 6, Rep. Henry Waxman, D-Calif., said chances for inclusion of biogeneric pathway language in the FDA Revitalization Act were “extremely slim,” despite support from such key lawmakers as Sen. Edward Kennedy of Massachusetts. The bill, which boosts the FDA’s drug-review and enforcement powers and reauthorizes the Prescription Drug User Fee Act passed the Senate earlier this year and is expected to pass the House when it comes up for a final vote.

That vote could come as early as this month, Waxman told generic industry leaders.

The final FDA funding bill is likely to significantly broaden the agency’s responsibility for long-term, post-approval drug outcomes and patient safety. To do so, it conveys new powers to the agency to regulate advertising and drug labeling, and to establish a surveillance system to analyze data and track long-term drug use and safety among millions of patients.

The bill also would extend the PDUFA program. PDUFA provides user-fee funds, paid by branded and biotechnology companies, to supplement federal funding for the FDA and help support the agency’s ongoing review programs for new drug applications. The user fee program must be reauthorized by Congress every five years, and is scheduled to expire Sept. 30.

That looming expiration of the user-fee act has added new urgency to Congress’ effort to pass the FDA Revitalization Act before the end of the month. But it’s also narrowed the window for inclusion of a biogeneric approval provision in the bill. Both Waxman and Rep. Frank Pallone, a New Jersey Democrat who also addressed GPhA members, warned that time was running out for the Senate and House to hammer out language for a biogeneric approval process and insert it into the FDA bill before it comes up for a vote.

Nevertheless, both lawmakers said they were determined to push for passage of a law to create that biogeneric approval procedure at the FDA. Underscoring their determination, they said passage could come either through its inclusion in another bill or as stand-alone legislation.

“We will try to come up with a consensus and try to work it out with the Senate this year,” said Pallone, who chairs the health subcommittee of the House Energy and Commerce Committee.

Waxman, a longtime friend of the me-too drug industry, joined with Utah Republican Sen. Orrin Hatch in 1984 to craft the Hatch/Waxman compromise bill, which established current patent life rules for branded drugs and the process for post-patent generic competition. He said he was “hopeful” that a biogeneric bill would pass before the end of the current Congress in 2008.

That strong support drew praise from GPhA president and chief executive officer Kathleen Jaeger. “For the countless Americans who are in need of safe and affordable life-saving biogenerics, it is imperative that Congress continue to move legislation forward. That’s why we were encouraged to hear from key members of Congress and their staffs … that they are totally committed to passing legislation,” she said.

“We’ve come a long way in a short period of time, but we still need to cross the finish line,” Jaeger added. “We will continue to work with bill co-sponsors in the coming months to move biogenerics legislation forward.”