Thursday, February 28, 2013

FDA does not anticipate furloughs if automatic budget cuts hit POSTED: Wednesday, February 27, 2013, 6:52 AM David Sell

If automatic federal budget cuts kick in Friday, patients, pharmaceutical companies — and the authorities paid to protect the first group and watch over the second — could be effected soon and over time.
Evaluations of drugs and medical devices might take longer as the Food and Drug Administration curtails operations. Patients might not get some medicine. Philadelphia Airport handles shipments of products and executives in the globalized drug business, so customs inspections, screening of passengers and air traffic control might delay delivery of both. Philadelphia has also been a hub of investigation and prosecution of health-care fraud, and the Justice Department expects temporary furloughs for employees.
The White House said Sunday night that the legally mandated cuts (yes, “sequestration”) would mean cuts of 13 percent for defense programs and 9 percent for non-defense programs through the end of the fiscal year on Sept. 30. Last fall, the Office of Management and Budget estimated that an 8.2 percent cut for FDA would amount to $318 million.
“A sequestration of the magnitude contemplated, and this late in the budget year, will have public health consequences for an agency that is already making every dollar count,” FDA spokeswoman Erica Jefferson said Tuesday.
As of Tuesday, Jefferson said, the FDA did not anticipate furloughing employees, but will meet its tighter budget through cost cuts in travel and training, contracts and collaborations. The FDA has a regional office in Philadelphia, and 13 foreign offices in Asia, Europe, Latin America, Africa and the Middle East, but overseas inspections could be impacted.
User fees paid by branded and generic drug companies were meant to help fund the FDA’s evaluation process, but budget cuts won’t help that effort.
There were goals for such approval decisions previously, but no new timetable has been established.
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