User Fees

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.

The House will vote as early as the week of June 4 on bills to repeal the health reform law's tax on medical devices and its ban on using HSAs and FSAs to purchase over-the-counter drugs, according to a May 25 internal memo from House Majority Leader Eric Cantor (R-VA).

The Senate Thursday (May 24) overwhelming passed the FDA user fee bill after rejecting highly controversial amendments aimed at limiting drug patent settlements and allowing certain drug imports from Canada. Stakeholders are now setting their sights on the House, which is expected to take up its version of the bill next week, followed by an informal conference to sort out the differences between the two bills.