User Fees

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.

A provision included in the Senate user fee bill that would allow FDA to more easily reclassify devices is emerging as a possible point of contention as Congress prepares to resolve differences between the user fee bills passed by both chambers, sources said.

Lawmakers must now resolve a wide range of discrepancies between House and Senate FDA user fee legislation that include differences in the generic drug pay-fors, drug track and trace language and several medical device provisions following the House's overwhelming passage of FDA user fee bill Wednesday.

Government watchdog groups are urging House lawmakers to remove or substantially narrow a user fee provision that allows FDA to withhold from the public drug inspection data it obtains from foreign and domestic regulators, with the push emerging before FDA user fee legislation comes to a vote Wednesday (May 30).

FDA officials said they will continue developing drug authentication and pedigree systems if a federal drug track and trace mandate does not end up in final user fee legislation, but acknowledged there are legal limitations that prevent the agency from converging differing state laws into a national standard.