GPhA spotlights patent reformPush for biogenerics gathers steam

WASHINGTON —The generic drug industry and its advocates are turning up the heat in their campaign for a workable review and approval pathway at the Food and Drug Administration for biogeneric drugs.

At stake are billions of dollars in potential revenues for the off-patent drug makers that can adapt to the new era of biologically engineered medicines. But an even more pressing issue, said advocates of a biogeneric approval process, is the potential benefit to millions of patients who stand to gain from highly specialized—but often prohibitively expensive—bio-engineered drugs.

At present, no clear pathway exists at the FDA for the approval and marketing of generic versions of these drugs. But with President Bush giving at least tacit approval to the concept in his State of the Union address in January, a group called the Coalition for a Competitive Pharmaceutical Market is accelerating its two-year campaign to convince Congress, the White House and health policy makers to clear away the legal and regulatory hurdles that block that pathway.

CCPM is an organization of large national employers, health plans, pharmacy benefit managers, chain pharmacies, generic drug manufacturers and other stakeholders. Their goal: to improve consumer access to affordable generic medicines and promote “a vigorous, competitive prescription drug market.”

To that end, CCPM has unveiled a new ad on behalf of biogeneric pathway legislation, aimed at federal policy makers. The group has also launched a new, direct appeal to Michael Leavitt, secretary of the U.S. Department of Health and Human Services.

The CCPM ad, which first appeared in mid-February in the high-profile Capitol Hill publication Roll Call, calls on Congress to pass legislation empowering the FDA to create a biogeneric approval process. The ad also assails the branded drug manufacturing industry and the biopharmaceutical industry for their “empty” support of such legislation.

The letter to Leavitt, commended the Bush administration “for its recent support of granting the FDA explicit authority to approve abbreviated applications for generic biopharmaceuticals.”

In it, CCPM chairwoman Annette Guarisco called for a “workable FDA approval process” that gives the agency “the flexibility to determine on a case-by-case basis the data that the agency needs to approve both comparable and interchangeable products, as well as clear and timely resolution of patent disputes.”

One key member of CCPM is the Generic Pharmaceutical Association. In her address at the group’s annual meeting in Boca Raton, Fla., last month, GPhA president and chief executive officer Kathleen Jaeger echoed that call for quick action. “More than 70 diverse and powerful organizations share our goal to bring biogenerics to consumers,” she said.

“While we welcome the news that the administration has endorsed the fact that the FDA has the scientific expertise to establish a safe and workable approval pathway, the devil is in the details,” Jaeger asserted. “A pathway filled with roadblocks to access, including excessive market exclusivity provisions, is an empty promise for the countless patients who need these affordable life-saving medicines.”