Today the Food and Drug Administration (FDA) approved a rule to eliminate unnecessary roadblocks to approval of generic drug products so that consumers have more meaningful choices among medicines. The FDA's actions respond, in part, to the Federal Trade Commission's July 2002 Study, Generic Drug Entry Prior to Patent Expiration, that described industry practices that delay FDA approval of generic drug products. I applaud the FDA's action to promote the timely approval of low-cost generic drug alternatives.
The FTC study identified eight drug products in which brand-name companies, by listing patents in the Orange Book after a generic applicant had already filed an application, blocked FDA approval of generic alternatives to those brand-name products for up to an additional 30 months. The final rule, if upheld against legal challenge, limits the delay of FDA approval of a generic application to a single 30-month period. If this rule had been in place, the brand name company would not have obtained an additional 30-month stay in seven of the eight instances the FTC study identified.
The final rule also tightens the Orange Book patent listing requirements in several ways. It prohibits brand-name companies from listing certain types of patents in the Orange Book, and it requires brand-name companies to perform additional studies before listing other types of patents the FTC identified as being particularly problematic. These revisions will help ensure that patents unrelated to the brand-name drug product do not form the basis for unwarranted delay of generic drug approval.
The Commission remains vigilant to ensure that the generic drug approval process is not gamed to delay consumer access to generic drug products.