February 06, 2007
Bill would end ‘authorized’ generics
Legislation reintroduced in the Senate aims to curb an increasingly common practice by pharmaceutical firms: authorized generics.
The Fair Prescription Drug Competition Act of 2007 (S.438) would make it illegal to introduce an authorized generic during the 180-day exclusivity period granted by Congress for a generic manufacturer who successfully challenges a patent. Veteran senator Jay Rockefeller IV (D-WV) introduced the bill along with co-sponsors Charles Schumer, (D-NY), Patrick Leahy (D-VT) and Herb Kohl (D-WI).
Rockefeller said the six-month period is “crucial” for generics firms, giving them added revenue “to recoup their costs, fund new patent challenges where appropriate, and ultimately pass savings onto consumers.”
Rockefeller first introduced the bill last July as S.3695 and has since been appointed chairman of the Health Subcommittee of the Senate Finance Committee in the new Congress.
Generics company Mylan Laboratories, which has advocated for the legislation, said branded generics disrupt "the natural balance between innovation and access to affordable medicines that Congress intended.”
Mylan operates a subsidiary, Mylan Pharmaceuticals, in Morgantown, WV.
The 180-day exclusivity period was set up by the Hatch-Waxman legislation in 1984.
"Under the current regulatory scheme, brand name companies can authorize generic companies to manufacture and sell generic versions of a drug during the 180-day exclusivity period,” said Jay Lessler, a pharma patent attorney with the New York law firm of Darby & Darby. “In recent years, this loophole has been frequently exploited by brand name companies."
Companies that have done so include Pfizer, which introduced a discounted generic version of its brand name antidepressant Zoloft through its Greenstone division after the drug lost patent protection last June. Pfizer's version competed against Ivax’s generic version during the 180-day exclusivity window. Merck authorized Dr. Reddy’s to launch authorized generics of Zocor and Proscar, two of its branded drugs that lost patent protection.