Sanofi Files 'First-Of-A-Kind' Lawsuit Against FDA Over OTC Drug

In a bid to blunt competition to its newly approved over-the-counter Nasacort allergy spray, Sanofi has filed a lawsuit against the FDA in hopes of preventing the agency from publicly releasing labeling and packaging information. The drugmaker claims this material is proprietary and doing so would spill trade secrets, even though the FDA is required to publish approval information on its web site. The move appears to be a “first-of-its-kind lawsuit,” according to Kurt Karst, a director at the Hyman, Phelps & McNamara law firm, who also runs the FDA Law blog, where the action was first reported. He noted “FDA procedures have called for the prompt publication of approval information” and that agency watchers were puzzled the information was not on the web site following the October 13 approval (which you can read here). Apparently, Sanofi was haggling with the FDA over publication and filed suit last week after being informed the information would become publicly available on November 12. Why lock horns with the FDA? Sanofi was not granted marketing exclusivity for its OTC Nasacort spray, and argues that releasing information before its Chattem unit launches the product next year could give competitors an edge. Without marketing exclusivity, generic rivals will be free to launch competing medicines, provided the labeling matches the labeling on the underlying reference product – the prescription version of Nasacort 24 Hour spray. In approving the OTC version, the ...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs