User Fees
This article was originally published in SRA
Executive Summary
Job loss fears at US FDA
Job loss fears at US FDA
US Food and Drug Administration (FDA) commissioner Andrew von Eschenbach has warned there could be huge job losses at the agency if Congress fails to complete the reauthorisation of the drug and device user fee programmes by 21 September.
If Congress fails to act by that date, the FDA will be forced to begin issuing reduction-in-force (RIF) notifications to up to 2,000 employees explaining that funding for their positions will expire, Dr von Eschenbach said in a 14 September letter to Mike Enzi, the Republican senator for Wyoming who is the ranking member of the Senate Health, Education, Labor and Pensions Committee1. The FDA's lack of authority to continue to collect user fees and the resulting financial impact on the agency would affect nearly 2,000 federal employees' jobs, the commissioner said. It could also “cripple the agency's critical public health roles of approving and ensuring the safety of drugs, devices and food”.
Temporarily extending the programmes to allow continued negotiation - as some legislators have apparently have suggested doing - would not be a solution, Dr von Eschenbach said. Continuing uncertainty about the future would cause FDA employees to seek work outside of the agency, the commissioner said. He added that, when Congress failed to reauthorise the drug user fee programme on time in 1997 and instead passed an extension, “the delay caused departures to the extent that it took 18 months for FDA to return to full staffing levels”. The repeat of a similar situation would be “devastating” to the agency.
The current device and drug user fee programmes, which together provide roughly one-quarter of the budget of the FDA2, are due to expire on 30 September.
Both the Senate and the House of Representatives have passed legislation reauthorising the user fee programmes - the Food and Drug Administration Revitalization Act (S 1082) in the case of the Senate and the Food and Drug Administration Amendments Act (HR 2900) in the case of the House3,4. And while key congressional offices have been in negotiations to iron out differences in the two versions in an attempt to come up with a final legislative package, a number of issues remain5,6.
According to Senator Enzi, consensus has been reached “on all but a handful of issues”7. Senate proposals in the legislation under review which promoted the establishment a regulatory framework for biosimilars or follow-on biologics were originally seen as a key obstacle in the negotiations8. Biosimilars are off the table for now, however, and the remaining key issues concern, among other things, aspects of the Best Pharmaceuticals for Children Act (BPCA)9. [The bills approved by the House and Senate would reauthorise the BPCA and the Pediatric Research Equity Act (PREA) in addition to the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Modernization Act (MDUFMA).]
Extending the user fee programmes is “not an option”, Senator Enzi said. A staff “exodus” would be a disaster for the agency and for public health, and he was working hard to reach an agreement with colleagues in the House and Senate to ensure that did not happen. “I believe if we roll up our sleeves and leave party politics aside, we can solve these outstanding concerns in a bipartisan manner.”
References
1. Letter from Andrew von Eschenbach and Mike Leavitt to Senator Mike Enzi, 14 September 2007
2. Email from Andrew von Eschenbach to staff, August 2007
3. The Regulatory Affairs Journal - Devices, 2007, 15(3), 213-214
4. The Regulatory Affairs Journal - Devices, 2007, 15(4), 290-291
5. Statement from Senator Mike Enzi in reaction to 14 September letter from FDA commissioner, September 2007
6. Personal communication, Senate HELP committee, 18 September 2007
7. See Reference 5
8. The Regulatory Affairs Journal - Pharma, 2007, 18(8), 582-583
9. See Reference 6