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Angie Drakulich was editorial director of Pharmaceutical Technology.
Last week, it was reported that the US Food and Drug Administration may start outsourcing jobs to private companies.
Washington, DC (Aug. 29)-Last week, it was reported that the US Food and Drug Administration may start outsourcing jobs to private companies. According to the Associated Press, the federal agency was reviewing some 300 positions in 20 cities to see whether those jobs could be performed better or cheaper by the private sector.
The positions in question are largely administrative, not those involved in inspections, FDA Spokesman Chris Kelly told AP. But some people were disturbed by the news, which came on the heels of negative reports across the United States regarding the safety of products made in China and the competency of FDA to inspect manufacturing facilities abroad.
“I think it is a disgrace, given the recent crises we have experienced with our food supply and other imports, that FDA would entertain the idea of outsourcing this work,” said Colleen M. Kelley, president of the National Treasury Employees Union (NTEU), in an Aug. 22 press release. NTEU is the largest independent federal union in the country and represents more than half of FDA’s 9000 employees.
NTEU says FDA told them that it had identified 332 positions as “commercial” in nature-which means they do not have to be performed by government employees-and that it intended to review those positions for possible contracting out, according to the NTEU release. Kelley criticized FDA’s lack of transparency in making the decision and also questioned whether or not the full scope of work of the identified employees was being considered. “Federal employees contribute far more to their agencies’ missions and the American taxpayers than can be captured in a job description,” she stated.
Just two days after NTEU’s statement, US Representatives John D. Dingell (D-MI) and Bart Stupak (D-MI) sent a letter to FDA Commissioner Andrew C. von Eschenbach questioning the merits of the outsourcing plan. The two Congressmen, who have criticized FDA’s actions several times this year, including the agency’s review of dietary supplements and its process for generic drug approvals, called the agency’s plan to outsource jobs “hasty and injudicious,” according to an Aug. 29 AP report. Reps. Dingell and Stupak suggested FDA wait for the final recommendations of the Import Safety Working Group, which was established under the Department of Health and Human Sevices (HHS) in light of the recent contaminated Chinese products found in the US, Panama, and other countries during the past 18 months.
FDA has not responded yet to the Congressmen’s letter, but Kelly said in a statement that FDA remains “committed to our dedicated work force and continue to improve operational efficiency directed at protecting the health and safety of the American public.” Kelly also told AP last week that the agency is obligated to support the competitive sourcing initiatives set by the Office of Management and Budget and HHS.
NTEU influenced FDA’s recent decision to halt its plan to close more than half of its US laboratories. The closures were scheduled as part of the ongoing reorganization of the agency’s Office of Regulatory Affairs.