Author: Alicia Mundy

The FDA plans to increase prosecutions of pharmaceutical and food industry executives as part of an effort to refocus its criminal division, which has been under attack in Congress and is criticized in a new government report, the WSJ said this morning.

In a letter to Sen. Chuck Grassley, the FDA says an internal committee has recommended that the FDA and its Office of Criminal Investigations “increase the appropriate use of misdemeanor prosecutions, which allows responsible corporate officials to be held accountable and is a valuable enforcement tool.”

A report set to be released today by the Government Accountability Office, Congress’s watchdog arm, says the Office of Criminal Investigations has operated autonomously for years with little or no accountability to top FDA officials. It said the investigations office’s whose budget rose 73% between 1999 and 2008 to $41 million, has fallen short compared with other agencies in developing performance standards.

The FDA officials largely agreed with the assessment and in the letter to Grassley, it said the agency is “developing meaningful performance measures” for the criminal office as part of an initiative begun in August. The FDA said it wants the criminal office to share information with FDA leaders regularly, and to do a better job picking cases.

Last year federal appellate Judge Richard Posner in Chicago slammed the government over a case originated in the FDA’s criminal office against a salad-dressing wholesaler. The government charged the wholesaler with changing the labels on 1.6 million bottles of salad dressing to extend their shelf life, and in 2007 won a conviction for “misbranding.”

The wholesaler contended that the FDA had no regulations covering such labeling, and Judge Posner agreed. “The testimony of the FDA’s employee was not just improper and inadmissible but incoherent,” the judge said in his opinion.

Update: You can see the GAO report here and other GAO info here.

You probably wouldn’t put Microsoft on the list of companies in the market to hire former FDA officials, but the software giant snagged a top medical-device regulator today.

Donna-Bea Tillman, head of the office of device approvals, says her jump to Microsoft isn’t as unusual as it may seem. She told colleagues in a memo she has long had “a love for all things computer.”

Tillman elaborated in an interview with the Health Blog, saying she moonlighted writing software programs for engineering and biomedical experiments when she was in graduate school at Johns Hopkins doing biomedical engineering. “This is a match made in heaven,” she said of her new job.

Microsoft, Google and other technology companies are trying to get in on the medical information-technology bonanza, which was given a boost with $20 billion in last year’s economic stimulus package. Microsoft is also trying to get its Washington health group a higher profile.

IT can play a big part in comparative effectiveness research for medical treatments, Tillman said, adding, “If you want to buy a car, you can get information comparing everything in Consumer Reports, but I can’t get that if I get a disease.”

Image: iStockphoto