In the latest salvo fired over the controversial FDA proposed rule that would permit generic drug ANDA holders to unilaterally change their drug product warnings, Senator Lamar Alexander, Ranking Member, Committee on Health, Education, Labor & Pensions and Congressman, and Bob Goodlatte, Chairman of the Judiciary Committee asked the Office of Management and Budget’s Administrator of the Office of Information and Regulatory Affairs (OIRA) to explain a few things about the FDA position.

They asked for an explanation of how the FDA could reach a conclusion that the proposed rule does not violate the “sameness” provisions of the Hatch-Waxman Act, how the economic impact analysis appeared to ignore certain big ticket items like liability expenses and other labeling costs associated with the proposed rule, as well as why the FDA really changed its mind about its own long-held position that generic applicants were not permitted to do so, which it has stated over and over ever since the passage of the Hatch-Waxman Act, in its Amicus brief in the Mensing case and in various petition responses and Guidance documents the Agency has issued over the last 30 years.

They also asked for a briefing by OIRA to address the issues raised in the letter.

A complete copy of the letter is here.

So another Congressional inquiry is now open to see just how and why the FDA changed its stripes on this tiger.  Let’s hope enough is being done to undo the potential damage of this proposed rule to the American public and the industry.