By Jeffrey Young - 08/02/07 07:08 PM EDT
Wednesday marked the deadline for the agency to warn pharmaceutical and medical-device reviewers and other employees that their jobs might be in jeopardy because legislation extending their funding, which expires Sept. 30, has not been finalized.
Spokeswomen for FDA’s drug and device offices did not respond to calls for comment or say whether the agency had issued the layoff notices to employees or their union representatives.
The Senate and the House overwhelmingly passed their bills in May and July, respectively. The legislation would authorize the FDA to collect $392.8 million in user fees from drug makers and $287 million from device companies over five years. The funds are used to review new products for potential FDA approval.
Congressional aides emphasized that staff-level talks have been productive and that House and Senate negotiators are confident they can complete the bills in early September. The measures also would give the FDA more authority to enforce drug-safety standards.
“The congressional leaders want to make sure that their intention and commitment to reauthorize these bills is clearly communicated to the FDA leadership,” a House Energy and Commerce Committee aide said. The aide added that lawmakers from both chambers regularly have briefed FDA Commissioner Andrew von Eschenbach of the progress of the talks. At present, lawmakers are not planning to pass a short-term extension, the aide said.
Nevertheless, the stated policies of the FDA and the Office of Personnel Management (OPM) appear to require federal agencies to issue notices within 60 days of the possibility of layoffs.
According to these FDA and OPM rules, employees under threat of layoffs for budgetary or other reasons must receive a reduction-in-force notice 60 days before they might be laid off.
“Employees separated by a reduction in force are entitled to written notice of at least 60 full days before the effective date of the release,” FDA acting Chief of Staff Susan Winckler wrote in a letter to Energy and Commerce Committee Chairman John Dingell (D-Mich.) in April. Winckler specified that the notices could be delivered as early as July 31.
The FDA has maintained all year that the user fee programs should be reauthorized by mid-July at the latest. According to the agency, the process leading up to issuing layoff notices takes eight to 10 weeks.
FDA officials, lawmakers and industry lobbyists have used the Sept. 30 deadline as a motivating tool as the bills progressed through the House and Senate this year.
Last Friday, for example, Senate Health, Education, Labor and Pensions Committee ranking member Mike Enzi (R-Wyo.) penned a letter to Majority Leader Harry Reid (D-Nev.) and Minority Leader Mitch McConnell (R-Ky.) warning of layoffs.
“If the drug and device user fee programs are not renewed prior to the recess, FDA will have no choice but to send what is known as ‘Reduction In Force’ or layoff notices to hundreds of FDA employees,” Enzi wrote, predicting that some of these employees would leave the agency for other jobs as a result.
Congressional aides and lobbyists indicated that the agency might opt not to abide by federal rules regarding these notices and decline to issue the letter.
The FDA also is required to notify the National Treasury Employees Union (NTEU), which represents some FDA workers, of pending layoffs. The FDA has not contacted the union about the reduction-in-force notices, according to an NTEU spokeswoman.
In a written statement made to The Hill in June, NTEU President Colleen Kelly complained that the FDA had not been adequately forthcoming as it went about negotiating the reauthorization framework with the drug and device industries earlier this year. “The agency should have been more proactive in briefing both Congress and NTEU on the timeline for reauthorization early in this process,” she wrote.
Congress and the FDA faced a similar predicament in 1997 when working on the first reauthorization of the drug user fee program. Congress did not pass its bill until Nov. 19 of that year, nearly two months after the end of the fiscal year.
The FDA did not issue layoff notices at the time and Congress enacted a short-term extension of the authorization, but not before uncertainty set in among FDA employees, according to a former senior official. “The anxiety level was certainly high and a number of reviewers left as a result, and replacing them was a problem,” ex-FDA official William Hubbard wrote in an e-mail. Hubbard now works as a consultant with the Coalition for a Stronger FDA, a group that supports boosting the agency’s budget.
The FDA has only had to issue reduction-in-force notices once in its history, according to the agency’s website. In 1952, cuts in FDA appropriations led the agency to let go of about 100 employees.