Senate and House Introduce Bills Prohibiting Authorized Generics

    By Donald Zuhn --

Recently, a number of bills that would significantly impact the biotech and pharma industry have been introduced in Congress.  These bills include the Preserve Access to Affordable Generics Act (S. 369), which would prohibit brand name drug companies from compensating generic drug companies for delaying the entry of generic drugs into the market; the Promoting Innovation and Access to Life-Saving Medicine Act (H.R. 1427), which would create a follow-on biologics regulatory pathway in the U.S.; and the Patent Reform Act of 2009 (S. 515 and H.R. 1260), which would make a number of important changes to Title 35.

Lost in the introduction of these bills was the introduction of the Fair Prescription Drug Competition Act (S. 501 and H.R. 573), which would prohibit the marketing of authorized generic drugs.  In particular, the new legislation would amend § 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 355) to add a new subsection prohibiting the holder of a New Drug Application (NDA) from manufacturing, marketing, selling, or distributing an authorized generic drug, either directly or indirectly, or authorizing any other person to manufacture, market, sell, or distribute an authorized generic drug.  The House bill, which was introduced on January 15, was sponsored by Representative Jo Ann Emerson (R-MO) and co-sponsored by Representatives Marion Berry (D-AR), Dennis Moore (D-KS), and Zach Wamp (R-TN).  The Senate bill, which was introduced on February 26, was sponsored by Senator John D. Rockefeller, IV (D-WV) and co-sponsored by Senators Sherrod Brown (D-OH), Daniel Inouye (D-HI), Herb Kohl (D-WI), Patrick Leahy (D-VT), Charles Schumer (D-NY) Jeanne Shaheen (D-NH), and Debbie Stabenow (D-MI).

For additional information regarding this and other related topics, please see:
• "Waxman Introduces Follow-on Biologics Bill," March 11, 2009
• "Senate and House Introduce New Patent Reform Legislation," March 3, 2009
• "Bill to Prohibit Reverse Payments Introduced in the Senate," February 4, 2009

Comments

[Gallant]

Sorry to ask such a stupid question, but I don't get the point of this legislation--it appears that it would only help generic manufacturers compete with innovator companies who are trying to break into the generic market, possibly with their own generic version of their own innovative biologic. Right? I don't understand who else it would help--unless the argument is that patients are better served by a generic manufacturer who is not the innovator, because maybe their prices would be lower--but then why not put a price cap on generics (or innovative biologics). (????)

[Donald Zuhn]

Gallant:

I believe the thinking behind this legislation is that an innovator company, which used its exclusivity period to market a therapeutic, would be able to use this brand recognition to retain a large portion of the market once the exclusivity period ends (i.e., patients might be more willing to use the innovator's generic drug than the generic company's version of the drug). As a result, generic companies might be less willing to take on innovators (or fewer generic companies might be willing to do so), which ultimately would reduce generic competition. Thanks for the comment.

Don