FDA Practice Partners With FGR Practice to Deliver Successful Client Outcomes

A pharmaceutical company legal client wanted to raise its profile and eminence. Buchanan’s Federal Government Relations team was engaged to provide introductions to members of Congress, and in 2014 was able to secure a visit from Congresswoman Jan Schakowsky (D-IL) to one of the client’s facilities outside Chicago. The relationship-building between DC and the company’s senior executives paid off. The increased attention helped the company get an abbreviated new drug application for an oral solution pain medication approved in June 2015 with the support and pressure of key congressional members. The client’s parent company was also one of several Indian pharmaceutical companies which have been subject to FDA regulatory action that has prevented approval of U.S. applications for their products. The coordinated efforts between the FDA and Government Relations teams resulted in U.S. approval for the U.S. operation of an Indian company under FDA scrutiny.

A specialty pharmaceuticals client has been waiting for a response from DEA on its application to continue clinical trials on several cannabinoid products to treat life-altering conditions such as epilepsy. In the wake of unresponsiveness from DEA, Buchanan’s Federal Government Relations team was brought on to tap its strong network on both sides of the aisle, as well as its understanding of current legislative initiatives around medical marihuana. The Government Relations team arranged a campaign of phone calls and letters from congressional offices of the House and the Senate to the DEA inquiring as to the status of the client’s applications. Ultimately, Buchanan was successful in eliciting a response from DEA resulting in approval from the FDA for the client’s clinical trials and the DEA for the use of all product produced by its contractors. In so responding, DEA officials acknowledged the impact the Congressional calls and letters had made.