Wednesday, July 23, 2014
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FDA does not anticipate furloughs if automatic budget cuts hit

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.

FDA does not anticipate furloughs if automatic budget cuts hit

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.

“All of that will add up to slowing the market entry of cost-saving generics,” said Claire Sheahan, vice president of communications for the Generic Pharmaceutical Association.

The White House said cuts to the AIDS Drug Assistance Program could result in 7,400 fewer patients having access to life-saving HIV medications, and approximately 424,000 fewer HIV tests could be conducted by Centers for Disease Control through state organizations, which could result in increased future HIV transmissions, deaths from HIV, and costs in health care.

In a Feb. 1 letter to Sen. Barbara Mikulski (D.- Md.), Attorney General Eric Holder said the Justice Department’s plans to cut $1.6 billion from its budget included furloughs of up to 14 days for FBI agents and analysts, some of whom investigate health-care fraud. Using data on past case loads, local U.S. Attorneys Offices would handle 2,600 fewer cases — 1,000 criminal and 1600 civil. Previously completed cases brought in $14 billion in criminal and civil penalties in fiscal year 2012.

“While some of the effects would be felt in Washington, D.C.,” Holder wrote to Mikulski, “the impact would be most severe at the local level as our investigative offices, prosecutors, the U.S. Marshals, and the federal courts work to implement these spending reductions in coordination with each other.”

 

 

 

David Sell
About this blog
David Sell blogs about the region's pharmaceutical industry. Follow him on Facebook.

For Inquirer.com. Portions of this blog may also be found in the Inquirer's Sunday Health Section.

Reach David at dsell@phillynews.com.

David Sell
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