An Association for Accessible Medicines release (here) reports that the AAM “thanked the House Energy and Commerce Committee for marking up Q1/Q2 legislation previously introduced by Representatives by Congressmen [sic] Dunn of Florida and Mullin of California. The bipartisan and bicameral legislation was included in the 2024 year-end spending bill and was reintroduced this Congress.”
I think it’s great, but will it become law? There have been numerous attempts to pass similar legislation over the years. We’ve blogged extensively about the issue here, here, here, here, here, here, here, and here. Well, I’m sure you get the point! There has been a lot of talk at the FDA, in industry, in the legislature, as well as in our blog about fixing this problem, which is a not only an important issue but one still without a permanent fix.
Since the passage of Hatch-Waxman, the FDA has talked about this issue and the Agency still has a bee in its bonnet about it not being fixed. Throughout the years and, as identified in the AAM press release as well, the Q1/Q2 issue has gotten close to a legislative fix but (for some unknown reason) a fix has never made it across the finish line to passage. Will this try be successful? It would certainly make life at the FDA and in industry easier!
