User Fees

House lawmakers tweaked their FDA user fee legislation to expand a citizen petition response mandate to include biosimilars, a technical change they expect will reduce the bill's spending by $350 million over 10 years and make it compliant with pay-as-you-go rules, according to documents obtained by Inside Health Policy.

The House is slated to take up FDA user fee legislation Wednesday under suspension of the rules, followed by an informal conference between lawmakers in both chambers and a possible “ping pong” back and forth to pass a final bill that lawmakers hope to send to the president by July 4, according to sources and an internal GOP leadership memo.

Prior to voting in favor of FDA user fee legislation Thursday (May 24), the Senate took up nearly 20 amendments, with several passing by unanimous consent and the remainder either tabled, withdrawn or rejected. The following is a quick snapshot of the Senate votes leading up to final passage of the bill.

The Union of Concerned Scientists is already taking steps to recruit its own members to serve on FDA advisory committees in anticipation that regulated industry may try to increase its presence on the panels as a result of user fee provisions moving through Congress that lift caps on the number of conflicted experts that can participate. Consumer and safety advocates opposed lifting the caps, but were successful in adding provisions to the user fee bills that would require financial disclosure of these experts and increase recruitment efforts.

Senate Majority Leader Harry Reid (D-NV) delayed proceeding with the FDA user fee bill again Wednesday (May 23) saying there is a dispute on a Republican amendment. Sources said the more than 30 amendments filed in recent days will be whittled down, with votes expected on Sen. John McCain's (R-AZ) amendment on drug reimportation and Sen. Jeff Bingaman's (D-NM) proposal to curb drug patent settlements, among a few others.

Top lawmakers on the Senate health committee Tuesday (May 22) sought to alleviate concerns from California stakeholders and lawmakers about the potential creation of a drug track and trace system with weaker standards than the California pedigree law, saying a newly added user fee provision offering a drug tracking framework is nothing more than a placeholder as it would not preempt state law if left unchanged.

Senate health committee Chairman Tom Harkin (D-IA) and ranking Republican Mike Enzi (WY) reached agreement late Monday on a revised FDA user fee bill that includes a detailed framework for a drug trace and track system to be negotiated by FDA, lawmakers and stakeholders, and the lawmakers said they hope the bill will sail through the Senate this week with few amendments and reach the president's desk by the end of June.

Companies developing mobile medical applications, FDA and other stakeholders have come out against a last-minute addition to the Senate user fee bill that would require an outside working group report to Congress on a proposed regulatory framework for health information technologies before FDA could issue final mobile medical application guidance.

The Generic Pharmaceutical Association is urging Sens. Jeff Bingaman (D-NM) and David Vitter (R-LA) to scrap a an amendment curbing so-called pay-for-delay drug patent settlements, saying the group would no longer support the FDA user fee bill if the provision is added. The move comes as senators prepare to offer amendments to the user fee bill that is set to hit the floor on Monday, with sources saying the patent measure could be offered but is unlikely to be included in the final package (see related story).