WELCOME TO PRESCRIPTION PULSE and to the midterm elections of 2022. Other items: Two other bills could also be in the lame-duck mix - a mental health package and a Senate HELP pandemic preparedness bill - or they could just as easily slip into the next Congress. Retiring Senate HELP Committee ranking member Richard Burr (R-N.C.) is the lead Senate Republican on the bill, and FDA Commissioner Robert Califf has already signaled the FDA is ready to go it alone in the absence of legislative action. Should Democrats lose control of the chamber, cosmetics and supplements likely become more difficult to push through.īut the effort to revamp the regulation of laboratory-developed and diagnostic tests, known as the VALID Act, may have legs regardless of who runs what next Congress. The big question mark: That would be the future of the three so-called super riders - overhauls of dietary supplements, cosmetics and diagnostics regulation - proposed by Senate Democrats. That includes legislative provisions, such as increasing diversity in clinical trials and overhauling the agency’s accelerated approval pathway for new drug indications, the latter of which may benefit from the recent example of the FDA’s advisory committee meeting on withdrawing the preterm birth drug Makena from the market, said Reshma Ramachandran, FDA task force chair at Doctors for America. 16.įDA riders, super and non: While it’s still too early to tell which party will control which chamber, we’re hearing from lobbyists talking with Hill staff that House Energy and Commerce Republicans are committed to pushing for the riders they agreed to with Democrats this summer in their version of the FDA user fee package, which ultimately fell away in favor of a clean reauthorization in September.
But the fallout will also surely seep into how Congress handles the lame-duck session, set to culminate in an omnibus spending bonanza by Dec. WHAT DOES THE ELECTION MEAN FOR THE LAME DUCK? - Today’s ballot box results will determine to a great extent how Washington approaches health care and pharma policy from January until the 2024 presidential contest. After today's elections, Congress will have a long list of health care issues to resolve during its lame-duck session.
0 kommentar(er)
