FDA HIRING FREEZE PROHIBITS EMPLOYEE TRANSFERS BETWEEN CENTERS
FDA HIRING FREEZE PROHIBITS EMPLOYEE TRANSFERS BETWEEN CENTERS, according to agency guidelines that were disseminated to FDA senior staff on July 14. Intra-agency transfers are among five personnel actions that are prohibited under the agency-wide freeze, which was instituted on July 1 ("The Pink Sheet" July 13, T&G-8). In addition to Center transfers, other actions "frozen" under the guidelines are: ** "all new appointments to FDA of full-time, part-time, or temporary individuals not currently employed in the agency" ** "all expansion of part-time tours to full-time tours" ** "all full-time expert appointments" ** and "any other action that would add to the [full-time equivalent] expenditure of the agency," unless it is excluded on a case-by-case basis by the commissioner's office. There will be an allowance for exceptions to the freeze in a limited number of cases. FDA Senior Advisor for Management and Systems Mary Jo Veverka will review requests for exceptions, which "will be granted only in cases where high priority program requirements justify an exemption," according to the guidelines. "It is anticipated such cases will be few," the guidelines state. In a memo accompanying the guidelines, Veverka said that exemption applications should include "a discussion of the impact of FDA programs of not approving the request." Veverka maintained that the freeze is necessary at this time "because indications from various levels in [HHS], and the House action on our FY 1993 appropriation (which, at a minimum, we can anticipate will be repeated in the Senate), leave us very little choice." On June 30, the House passed an appropriations bill that would give FDA a 2.5% budget increase in fiscal year 1993 to $744.1 mil. ("The Pink Sheet" June 29, T&G-7). Veverka added that the agency's "first priority is to maintain FDA's ceiling for FY 1993 at the level of 8,924 FTEs. We are currently above that level, however, and in order to get there we must impose a freeze on new appointments and other actions that would add to the agency's FTE expenditure." During the freeze, FDA is still planning to hire some of the 50 new employees promised to the Center for Biologics Evaluation and Research, FDA Commissioner Kessler and Veverka reported at a July 13 roundtable discussion for the trade press. Veverka said that "of the 50, I believe that [for] 37 of these, our commitments have already been made." Enumerating actions that "are not presently frozen but will be carefully monitored," the guidelines identify: ** "extension of temporary appointments" ** "return from leave without pay" ** "appointments of advisory committee members and intermittent consultants" ** "conversions of temporary employees to permanent status" ** "overtime" ** and "any other action that will not add to the FTE expenditure of the agency." A firm job offer from FDA's division of human resources management prior to July 1 also will be honored. In addition, FDAers have indicated that the agency's effort to hire 100 additional criminal investigators will not be subject to the hiring freeze. Veverka noted that "we may have to revisit these guidelines both for those actions not now frozen, and for any exceptions granted" if FDA receives "more stringent guidance" from HHS or if "congressional action on our FY 1993 budget dictates further action on our part." Veverka pointed out that "it is also possible that we may have to consider [FTE] ceiling reallocations, reductions in centrally funded items and in center operating funds, in order to make maximum use, from an overall agency perspective, of whatever flexibilities are left to us with regard to FTEs and dollars." Veverka added that she will meet with center executive officers "to review our options in the next few weeks."
You may also be interested in...
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth