Drug Labeling Games: Skinny Labels Getting an FDA Assist

This article appeared in Pharmaceutical Compliance Monitor, March 7, 2014, and is reproduced with permission.

Hatch-Waxman turns 30 this year. One measure of its success has been the phenomenal growth and universal acceptance of generic drugs, which now account for over 80% of all prescriptions filled in the U.S. While much of the industry's success was designed to come at the expense of pioneer drug developers, some clearly was unintended. One example how Hatch-Waxman has unexpectedly titled the balance in favor of generics is the evolution of FDA policies toward method of use patents.

Because of the way Hatch-Waxman has been implemented, many drug use patents have become unenforceable and thus, effectively worthless. Not only does this rob patent owners of their intellectual property rights, but also undermines a core tenet of the 1984 legislation which was to spur the development of new drug therapies. Now, the FDA may be getting ready to deal another blow to brand drugs that depend on use patents for market protection.

The Hatch-Waxman Balance

Hatch-Waxman was a grand bargain struck on behalf of the public health. It "promised" pioneer drug companies that if they invested in developing new drug therapies they would receive limited marketing exclusivity and a fair opportunity to assert their patents prior to any generic approval for those therapies. In return, generics were "promised" that if they agreed not to market their drugs for new therapies protected by pioneer patents, they would be allowed to enter the market for nonpatented brand uses. Simply put, pioneers were given the clear expectation they would be able to recover their investments in new therapies even though generics might be on the market for the other approved uses.

To implement this intricate balance, the FDA adopted rules that required generic labels to be scrubbed of all information that would infringe the pioneer patent. Without safe and effective labeling for the patent protected use, "skinny labeled" generics could not lawfully be marketed in competition with the brand for that use. Unfortunately, the FDA had some other rules on its books that served to undermine the Hatch-Waxman balance. Instead of distinguishing between fully labeled and skinny labeled generics, the FDA adopted a therapeutic equivalence (TE) rating scheme that treated both types of generics equally.

Please read "Drug Labeling Games — Skinny Labels Getting an FDA Assist" for more information.

If you have any questions about this article or would like to discuss this topic further, please contact the author, Terry G. Mahn, or your Fish attorney.