User Fees

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.

Senators who sponsored drug shortage legislation urged lawmakers reconciling the two versions of FDA user fee bills to include House and Senate enforcement mechanisms as well as language subjecting biologics to early notification requirements, according to a letter sent Thursday (June 14).

A diverse group of stakeholders appears to be making progress in its press for lawmakers to include biologics in the final user fee bill's drug shortage early notification requirements and to clarify that human plasma protein therapies and their recombinant analogs are subject to the requirement, with a pharmacy stakeholder saying congressional staff has signaled these drugs, along with older medicines, likely will be included in the final bill.

FDA proposed a drug pedigree system -- expected to start at the lot level but evolve to the unit level -- during a closed-door discussion with user fee negotiators Monday (June 11) aimed at coming up with a compromise drug track and trace proposal for inclusion in the final user fee package, sources said.

A bicamerical investigation into the pharmaceutical gray market has led two Democratic lawmakers to call on House and Senate leaders negotiating a final FDA user fee package to include a national pedigree system and stronger standards for pharmaceutical wholesale distributors, with the lawmakers arguing that an industry-crafted track and trace proposal may not stop unscrupulous companies from exploiting drug shortages to price gouge hospitals and other providers.

Lawmakers working to craft a user fee provision aimed at curbing illegal online pharmacies are now embracing toned-down language that calls for a Government Accountability Office report on the dangers of these websites, following concerns from telemedicine and physician groups that inclusion of a more-aggressive legislative proposal could have interfered with legitimate telehealth services and the doctor/patient relationship.

An FDA official said although the agency is not ready to create the kind of track and trace system for medical devices as stakeholders are currently developing for pharmaceuticals, there is a possibility that devices could be required to have serial numbers in the future.