Interest group urges speedup in generic biopharm approvals

Drug Store News,  Oct 10, 2005  by James Frederick

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WASHINGTON -- Extending its campaign to open bioengineered drugs to multisource competition, a generic drug advocacy group as drafted a letter urging Food and Drug Administration commissioner Dr. Lester Crawford--who has since resigned--to open an abbreviated approval pathway for generic biopharmaceuticals.

The group, called the Coalition for a Competitive Pharmaceutical Market, asked Crawford to spearhead creation of "a definitive regulatory process to expedite approval of generic biopharmaceuticals." Further, CCPM asserted that the commissioner has "sufficient legal authority" to proceed.

Such a speedup of the drug approval process has a precedent, the group noted in its Sept. 19 letter. Skyrocketing prescription drug costs threaten the ability of individuals and ... employers to provide or obtain affordable health coverage," CCPM chairman Annette Guarisco reminded Crawford. "One of the most effective policies has been to assure speedy market approval of safe and effective generic drugs.

"CCPM believes that a similar process is needed for safe and effective biopharmaceuticals, and that the FDA already has the authority to develop an abbreviated approval process," Guarisco added. And, she reminded Crawford of his own public comments "asserting that '[the FDA] now [has] the science to fashion a generic biologics program.

CCPM is composed of 21 high-profile companies and interest groups, including the National Association of Chain Drug Stores, the Generic Pharmaceutical Association, the Food Marketing Institute and the Pharmaceutical Care Management Association. Among the employers and manufacturers in the coalition are General Motors, Ford and DaimlerChrysler, Blue Cross/Blue Shield Association, Aetna, CaterPillar, Eastman Kodak, Caremark, Teva USA, Watson Pharmaceuticals, Alpharma, Barr Laboratories, Ranbaxy and Ivax Pharmaceuticals.

Data from some of those member companies, Guarisco asserted, "support the critical need for generic biopharmaceuticals. Based on the dramatic cost increases bioengineered drugs can bring to employer-sponsored health plans and assuming that "generic versions of the top five biopharmaceuticals would yield a 20 percent savings, she added, "The total savings for the U.S. health care system would be nearly $2 billion annually" with an expedited approval system in place.

On the group's Web site, www.therightprescription.org, a position statement urges changes to anti-terror legislation that, if enacted as currently written, would stifle generic competition, according to the coalition. "Congress is considering legislation that threatens consumer access to generic drugs. BioShield II, legislation crafted to ensure a quick, effective response to biological or chemical attacks on the United States contains several anticompetitive provisions that give excessive incentives to brand name drug companies, while forcing generic manufacturers out of the market," the group states.

"Meanwhile, an entire class of pharmaceuticals called biopharmaceuticals--or drugs that are derived from living sources and used in the fight against cancer, multiple sclerosis, diabetes and many other conditions and diseases--lacks a clear pathway for the development and approval of generic versions," the coalition statement asserts. "With prices of biopharmaceuticals exceedingly high compared to traditional pharmaceuticals, Congress must establish a definitive, efficient approval process within the U.S. Food and Drug Administration for biogenerics in order to ensure consumer access to these life-saving drugs.

"It's time to tell our lawmakers that generic drugs save lives," the CCPM notes.

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