User Fees

The Obama administration is asking appropriators to include in upcoming funding legislation a provision allowing FDA to fully collect user fees associated with medical devices, generic drugs, biosimilars, animal drugs and tobacco products, according to a document obtained by Inside Health Policy that lists “anomalies” the White House Office of Management and Budget recently sent to lawmakers.

FDA officials said Friday (Sept. 21) they plan to start the generic drug user fee program regardless of the outcome of congressional efforts to allow fee collection, as the lack of an appropriations measure affects when -- not if -- the fees will be collected.

The House passed by unanimous consent late Wednesday (Sept. 19) a measure that would allow FDA to collect all of the generic drug user fees authorized in the recently enacted FDA Safety and Innovation Act, but the bill does not address other user fees, including for medical devices and biosimilars.

An agreement on a federal drug track and trace measure is not likely to come before the August recess as initially hoped, but discussions among stakeholders, lawmakers and FDA are ongoing and will likely continue in September, with negotiators now hoping to conclude talks by the end of the year, according to a key stakeholder group.

Key FDA reforms -- such as tools to prevent drug shortages and antibiotic exclusivity incentives -- are immediately available following the July 9 enactment of the FDA Safety and Innovation Act mans, but the agency must also develop several policies in the coming years on a slew of hot-button issues ranging from social media regulation to antibiotic development.

Stakeholders watching the reauthorization of the Pandemic and All-Hazards Preparedness Act expressed concern this week that the bipartisan bill reauthorizing HHS medical countermeasure programs could become a Christmas tree for other provisions that failed to make it into the final FDA user fee bill, including a drug track and trace measure.

Lawmakers are continuing to push legislation to address the drug shortage problem that did not make it into FDA Safety and Innovation Act, but sources said outstanding proposals to curb the gray market and change reimbursement for some medications are not likely to gain much traction in the coming months.

A citizen petition payfor in the recently passed FDA Safety and Innovation Act will likely do little to cut down on the number of citizen petitions filed by brand pharmaceutical companies targeting generic drugs, according to a law professor who recently published a study that found legislation enacted in 2007 to curb these petitions has not been successful.

The FDA Safety and Innovation Act cleared Congress with a 92 to 4 Senate vote Tuesday (June 26) after Sen. Richard Burr (R-NC) spoke for hours on the Senate floor pointing out shortfalls of the bill, which he said was unnecessarily rushed through Congress ahead of the Supreme Court ruling on health reform and, given extra time, could have resolved several issues, including the creation of a federal track and trace system.