Tuesday, August 28, 2007

FDA in danger of being FEMA-ized

Burton J. Howard, chief of the Bureau of Chemistry's (now FDA) microchemical laboratory, is shown in the right foreground in this photo from the 1920s. Howard developed a quantitative method to detect mold in ketchup that proved to be indispensable in establishing food adulteration in court.

Grover Norquist was realizing his dream to "drown government in a bathtub" when he lobbied Congress to shrink agencies like the Federal Emergency Management Administration. FEMA had been riding high after being turned around by Republican appointee Frank Young, whose career hit its stride at FEMA. Other countries sent experts to the US to copy FEMA's efforts.

Then FEMA was underfunded, outsourced, ignored and effectively dismantled in time for Hurricane Katrina in 2005. Now another public service agency, the Food and Drug Administration (FDA), is in danger of the same fate: the Administration plans to close labs and outsource jobs.

Despite a glaring need for more resources, made apparent by dangers from contaminated imports like contaminated drugs fromChina, toothpaste made with anti-freeze, and pet food contaminated with melamine, the local county's school system in Montgomery County has more staff and a bigger budget than all the nation's food, drug, blood and device inspectors. Compare the NIH budget for 2007 of $28.6 Billion, with FDA's budget: FDA gets 1/20th of that, at under $1.5 billion.

When Congress refused to fully fund the Agency for decades, first drug manufacturers then device makers banded together to agree to pay fees to hire reviewers. Still, the funding law prohibits using those fees for compliance and inspection actions, and AIDS and bioterrorism initiatives continue to funnel resources away from the Agency's core functions.

Bush and his team have already forgotten the still-raw lessons from Katrina and the administration is making stealth progress on an initiative to reduce staff, close laboratories, and contract out the Agency's work.

FDA plans were - and still are - to close seven of its 13 laboratories. The politicians say fewer labs would be more efficient. However, Energy and Commerce investigators disagree with FDA's justification for the reorganization. The Tan Sheet, which covers OTC drugs, said it best:

"Despite repeated requests from the committee, FDA has failed to provide any analysis justifying this radical reorganization," Senior Investigator David Nelson, Investigative Counsel Kevin Barstow and Investigator Richard Wilfong say in written testimony.

"Since FDA has not provided an analysis demonstrating any cost-savings associated with the lab closures, their rationale implies that synergies exist in mega-labs; however, no documents have been produced by FDA to support that suggestion," the investigators say.

Additionally, they cite a Government Accountability Office report determining midsize labs are more efficient than mega-labs.

"FDA has failed to provide us with any independent cost-benefit analysis for their proposal," they say. "On the surface the proposed closings appear to be counterproductive and may needlessly increase taxpayers' costs."

When FDA refused to cooperate with Congressional questions, Congress threatened to prohibit use of any funds to implement the transfer. Margaret Glavin, associate commissioner for regulatory affairs at FDA, wrote in a letter to Office of Regulatory Affairs employees that she is "canceling plans for the rollout of all changes to our organizational structure." According to WaPo, "Two House members from Michigan, Reps. John D. Dingell (D) and Bart Stupak (D), hailed the e-mail as an indication of FDA's decision to "abandon" its reorganization. But agency spokeswoman Julie Zawisza denied that the agency had canceled its plans." WaPo: "FDA spokeswoman Julie Zawisza said in an e-mail that Friday's announcement left open the possibility of future changes."

In addition to the closures, FDA has added an initiative to outsource the jobs in the field offices. These offices are often the place where industry comes face-to-face with Agencies in the FDA districts and where laboratory tests to confirm preliminary results are performed. According to Forbes:

The government's chief health regulatory agency is reviewing more than 300 positions in more than 20 cities to determine whether they could be performed cheaper and better by the private sector. A decision is expected next month, according to FDA documents.

An initial list of positions under review included lab technicians and field office workers who work at FDA facilities where food and medical products are inspected for safety.

The vast majority of FDA experts, in a survey that includes experts inside and outside the FDA, agree the FDA does not have the strong leadership it needs. FDA needs a leader who will demand full funding for FDA.

GovExec 08/20/2007
Federal Times 08/20/2007
DailyKos Diary

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