FDA Power Over Authorized Generics

In Mylan Pharmaceuticals, Inc. v. USFDA, the Fourth Circuit affirmed the district court's dismissal of Mylan Pharmaceuticals' petition to the FDA. Mylan's petition requested a ruling that under a provision of the Federal Food, Drug, and Cosmetic Act (FFDCA) an authorized generic drug could not be sold until Mylan's generic drug had been on the market for 180 days. The court concluded that the FFDCA does not grant the FDA the power to prohibit the marketing of generic drugs authorized by the pioneer drug maker during the 180-day exclusivity period afforded to a drug company in Mylan's position.

Mylan was the first applicant to file a paragraph IV Abbreviated New Drug Application (ANDA), presenting a drug that was the biological equivalent to Proctor & Gamble Pharmaceuticals' pioneer drug, Macrobid. Mylan's application was approved, and they were given the statutory 180-day exclusivity period created in the FFDCA, which allows the ANDA recipient to sell its drug without other generic competition for 180 days. Subsequent to Mylan's ANDA approval, Proctor & Gamble granted a third party a license to sell a generic version of the pioneer drug, Macrobid. This strategy appeals to the pioneer drug maker because the drug maker benefits from the sales of the authorized generic and authorizing the third party generic staves off possible competition from the ANDA applicant.

The authorized generic sales proved detrimental to Mylan's sales of their generic drug. The question before the Fourth Circuit in this case was whether the FFDCA empowers the FDA to prohibit sale of authorized generics during the 180-day exclusivity period. The court held that although the introduction of an authorized generic may reduce the benefit of the 180-day exclusivity period awarded to the first ANDA applicant, the FFDCA gives no legal basis for the FDA to prohibit the encroachment of authorized generics on that exclusivity.

(contributed by Catherine Runion)