The US House of Representatives' Energy and Commerce Subcommittee on Health meets 8 May to conduct its markup process for various user fee bills, including the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Act (MDUFA).
The markup process has already seen an enormous amount of activity and some surprising developments. Regulatory Focus summarizes those developments for you here:
The House Energy and Commerce Committee Subcommittee on Health will meet 8 May at 10:00 a.m. to begin its markup process for an as-yet-unnamed bill. The bill is comprised of nine sections dealing with PDUFA, MDUFA, generic drugs, biosimilar drugs, drug shortages, regulatory reforms, reforms to the US Food and Drug Administration (FDA) and medicines taken by children.
The Hill reports Congress is "moving quickly" on the bill despite numerous concerns that the legislation could be held up. While the subcommittee votes 8 May on the markup, the full Energy and Commerce Committee is likely to meet on 10 May to markup the same bill.
Politico reports the House user fee legislation is deemed to be "must pass" by so many legislators that it is resisting attempts by some interests to use is as a vehicle to advance their own agendas, including de-funding the Patient Protection and Affordable Care Act. "There are very powerful and very well-financed interests here that would be extremely upset if this were to get bogged down," said John Rother, president of the National Coalition on Health Care.
BioCentury reports the House version of the user fee legislation is moving closer to the Senate's version after the House version dropped provisions that would have altered FDA's mission statement to include job creation as one of its mandates.
The Pink Sheet reports the House draft would give FDA "direct authority over importers," allowing it to destroy counterfeit drugs when they are seized by customs officials.
Congressional Quarterly reports the entire process could encounter resistance once the legislation eventually reaches the Senate floor, potentially leading to "a protracted floor fight."
Mass Device reports the legislation has shed a medical device provision sought by Sen. Jeff Markley (D-OR) to give FDA the authority to "reject 510(k) applications based on recalled devices".
Forbes has a great overview of the user fee legislation and what's at stake for both FDA and the pharmaceutical and medical device industries.
FDA Law Blog notes the legislation would shorten "505(q) petition response timeframes" and "require timely responses to reference listed drug withdrawal petitions."
Regulatory Focus reported on 1 May that the Government Accountability Office (GAO) found FDA to be meeting its existing PDUFA goals under existing legislation.
Regulatory Focus has an overview of all of the House Energy and Commerce Committee's existing hearings on the proposed user fee legislation.
Regulatory Focus also has coverage of the Senate's markup of the FDA Safety and Innovation Act, which passed the markup process on 26 April.