Two House Members Introduce Bill To Allow FDA To Approve Generic Versions Of Biotechnology Medications

Main Category: Pharma Industry / Biotech Industry
Also Included In: Regulatory Affairs / Drug Approvals;  Biology / Biochemistry
Article Date: 18 Mar 2008 - 11:00 PDT

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Reps. Anna Eshoo (D-Calif.) and Joe Barton (R-Texas) on Thursday introduced a bill that would allow FDA to approve generic versions of biotechnology medications, CongressDaily reports. The legislation would provide brand-name biotech companies with at least 12 years, and possibly an additional 2.5 years, of market exclusivity before generic versions of their medications could reach the market (Edney, CongressDaily, 3/14). In addition, the bill would require clinical trials for generic versions of biotech medications, although FDA could waive the requirement (Wayne, CQ Today, 3/14).

The legislation also would exempt biotech medications that contain "select agents and toxins" -- such as Botox, which contains botulinum toxin type A -- in large part because of national security concerns (Ackley, Roll Call, 3/17). Under the bill, FDA could classify generic versions of biotech medications as interchangeable with brand-name versions at pharmacies, provided that the agency has developed guidance on the evidence required to prove interchangeability for a product class (CongressDaily, 3/14).

According to CQ Today, the legislation includes "more rigid conditions than proposed by competing Senate legislation (S 1695)" approved last June by the Senate Health, Education, Labor and Pensions Committee. The Senate bill would provide brand-name biotech companies with 12 years of market exclusivity before generic versions of their medications could reach the market. In addition, the legislation would require trials for generic versions of biotech medications, provided that they are not "needlessly duplicative or unethical."

Jim Greenwood, president of the Biotechnology Industry Organization, said of the House bill, "Importantly, the bill recognizes the need to protect patient safety by calling for a set of studies demonstrating the safety and efficacy of the follow-on product, including clinical and immunogenicity studies." Generic biotech companies would "like to see a shorter period of market exclusivity for brand-name manufacturers and say clinical testing should not be required for follow-on products," CQ Today reports (CQ Today, 3/14).

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