User Fees

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.

The final user fee bill on the Senate floor Monday (June 25) gives FDA discretion to include biologics in the legislation's drug shortage early notification requirements -- a move applauded by a coalition of pharmacists, providers, hospitals and patient groups that was upset the original House version of the bill didn't address the issue.

BOSTON -- Stakeholders involved in down-to-the-wire negotiations aimed at crafting compromise language on a drug track and trace system continue to press forward despite the provision's exclusion from the final FDA user fee legislation, as some companies will have to start coming into compliance with a California law by the end of the year if the state measure is not preempted by a federal standard.

The device provisions in the final FDA user fee bill are getting mixed reactions from industry and consumer safety advocates with both applauding the timeline for issuance of a Unique Device Identifier rule and addition of devices to FDA's Sentinel initiative, but raising competing concerns about FDA's new flexibility to reclassify devices.

House and Senate lawmakers who negotiated a final FDA user fee bill opted for a drug citizen petition payfor in lieu of a Risk Evaluation and Mitigation Strategy offset preferred by generic drugmakers, who last week accused branded drugmakers of actively lobbying against the REMS language.