FDA has missed a key deadline to submit reauthorization of user fees, due to continuing debates between industry and the agency, according to Bloomberg. If they miss the new Feburary 15 deadline, Congress, particularly those up for reelection, will be asking why. 

And its not the first time reauthorization has been delayed. Senators Thomas Harkin (D-IA), and Michael Enzi (R-WY), asked  FDA in July to submit a reauthorization plan by Dec. 31 so that the panel would have adequate time to review the plan.

Timing is sensitive because current negotiations are the first to occur during an election year, when Congress typically leaves Washington by the end of July.

Fred Upton is the chair of the House Committee on Energy and Commerce, and he is up for reelection this year. You can bet the committee will be watching the negotiations carefully. Upton is a top recipient of campaign donations from pharmaceuticals/ health products companies and medical device companies.

Upton and other Congressional leaders could take over the negotiations if FDA and industry can't get their act together. But even if they do agree on user fees, will it really help industry? Check out an editorial I wrote last year, explaining why MDUFMA III won't really solve review problems.