Generic industry still hopeful for FDA biogeneric legislation

WASHINGTON Two key lawmakers told generic industry leaders here that it was unlikely that biogeneric approval pathway legislation would be included in a major Food and Drug Administration funding and reauthorization bill now moving through Congress. But the head of the Generic Pharmaceutical Association said prospects for a law creating a clear pathway for the approval of generic versions of expensive bio-engineered medications remain strong in 2007 or 2008.

Addressing generic industry representatives at GPhA’s Annual Policy Conference Thursday, Rep. Henry Waxman, D-Calif., said chances for inclusion of biogeneric pathway language in the FDA Revitalization Act were "extremely slim," despite support from key lawmakers like 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 later this month when it comes up for a final vote.

The final FDA funding bill is likely to significantly broaden the agency’s responsibility for long-term, post-approval drug outcomes and safety, with new powers to regulate advertising and drug labeling and establish a surveillance system to analyze data and track long-term drug use and safety among millions of patients. But 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 biogeneric pathway legislation, either through its inclusion in another bill or as stand-alone legislation. Waxman—one of the authors of the original Hatch/Waxman compromise bill in 1984 that established current patent life rules for branded drugs and the process for post-patent generic competition—also said he was "hopeful" that a biogeneric bill would pass before the end of the current Congress in 2008.

That strong support prompted kudos 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 today that they are totally committed to passing legislation," she said Thursday.

"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."