On Wednesday, the House voted 387-5 to approve an amended version of a bill (HR 5651) that would reauthorize and modify FDA's prescription drug and medical device user-fee programs, The Hill's "Floor Action Blog" reports (Kasperowicz, "Floor Action Blog," The Hill, 5/30).
House and Senate leaders now will move to reconcile the differences between the House bill and a Senate version (S 3187) of the legislation, which was approved last week (Yukhananov, Reuters, 5/30).
Democrats and Republicans consider the legislation a "must pass" measure and are aiming to deliver a final bill to President Obama by July 4 (Khatami, CQ Today, 5/30).
Details of the Bills
Both measures would reauthorize for five years the user-fee programs, which are scheduled to expire at the end of September. They include provisions to address drug shortages, improve drug supply chain safety and establish new user-fee programs for generic and generic biologics, or biosimilar drugs. However, they differ on issues such as medical device regulation and incentives for manufacturers to create new antibiotics (California Healthline, 5/29).
Earlier this week, the Congressional Budget Office estimated that the House bill would reduce the federal deficit by $370 million over 10 years, bringing it closer to the Senate version, which CBO said would cut the deficit by $363 million over a decade (California Healthline, 5/30).
The Congressional Research Service this week issued a comprehensive analysis outlining the similarities and differences between the current law, the House-passed bill and the Senate-passed bill (Daly/Zigmond, Modern Healthcare, 5/30).
Boehner Ties Legislation to Efforts To Repeal Health Reform Law, Create Jobs
House Speaker John Boehner (R-Ohio) on Wednesday tied the FDA user-fee programs reauthorization bill to Republican efforts to repeal the federal health reform law and suggested that measure would help create jobs, The Hill's "Healthwatch" reports.
In remarks before the House vote, Boehner said, "Because of the lack of predictability, consistency, transparency and efficiency at [FDA], U.S. device and drugs jobs have gone overseas and foreign patients, not U.S. patients, have been the first to benefit from U.S. innovation." He added that the bill includes "reforms to ensure patients receive quality care and timely access to new therapies while promoting innovation and job creation" (Baker, "Healthwatch," The Hill, 5/30).