New Medicare Law Brings Changes to Hatch-Waxman Act

The section of the Food, Drug and Cosmetic Act discussed in this article is commonly referred to using two different nomenclatures — either as FDCA §505, or as 21 USC §355. This paper employs the former notation.

On 18th August, 2003, new FDA regulations came into effect that limited brand-name companies to a single 30-month stay. For a number of reasons that will not be detailed herein, these regulations stood on highly questionable legal grounds. The AAP addresses this issue by amending the statute; it therefore not only supplants those portions of the recent FDA regulations, but also stands on a much firmer legal foundation.

As noted above, recent FDA regulations prevented multiple 30-month stays. See Note 2.

Indeed, the possibility of such future abuse by generics companies was considered a major criticism of the 18th August, 2003 FDA regulations.

35 USC §271 (e)(5).

FDCA §505 (j)(5)(C)(ii).

FDCA §505 (j)(5)(B)(iv)(II)(bb).

The statute does not address shared exclusivity in any other situation. This is distinct from FDA practice under the old law, which on occasion had permitted shared exclusivity when different ANDA applicants submitted different paragraph IV certifications at different times. It is of interest to note that a recent federal court decision struck down this FDA practice as contrary to law. Torpharm v FDA, Docket No. CA 03–2401 (2nd January, 2004, DDC).

These provisions are codified in the Medicare Bill in Subtitle B of Title XI, in sections 1111 to 1118. At the time of writing, it is not known into which section of the US Code these provisions will be placed.