FDA Criminal Division to Increase Prosecutions

In many posts on this blog, Roy Poses has lamented the fact that there are no personal repercussions for healthcare executives embroiled in malfeasance and scandals.

He recently wrote:

So, here we go again ... To repeat, seemingly ad infinitum, these are just the latest in a now long parade of settlements and guilty pleas and criminal convictions, sometimes involving charges like bribery, fraud, or kickbacks, that serve as reminders of poor behavior by myriad health care organizations. As we have previously noted, these settlements seem to have little deterrent effect on future bad behavior. (Note that many large health care organizations have settled or plead guilty in several major cases since we started commenting on such settlements.) Usually, the companies involved only need to pay fines, and no individual who performed, directed or approved unethical or illegal acts will suffer any negative consequences. I submit once again that such fines are viewed merely as costs of doing business by the affected companies, and do not deter future bad behavior. Until the people who approve, direct, and perform unethical or illegal acts pay some penalties, expect such acts to continue. I again suggest that to truly reform health care, we need rigorous regulation of health care organizations that has the power to deter unethical behavior that may risk patients' health.

The companies of the bad actors are fined; the fine is considered a "cost of doing business"; but personal actions against the responsible executives engaged in malfeasance do not usually occur. Dr. Poses feels healthcare reform cannot occur under these conditions, and I agree.

Apparently, so do others at high levels:

FDA Criminal Division to Increase Prosecutions
Wall Street Journal
March 4, 2010

By ALICIA MUNDY

WASHINGTON—The Food and Drug Administration 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.

In a letter to Sen. Chuck Grassley (R., Iowa), 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."

Misdemeanor prosecutions are a start; however, some of the behaviors seem to my uninformed legal mind to perhaps be more felonious in nature...

An FDA official said the agency has the authority to prosecute corporate executives for criminal actions within their companies under a provision called "strict liability." He said the government doesn't have to show intent to defraud in order to get a conviction. He added that the provision is an important tool that hasn't been used much in recent years.

As has been noted repeatedly on this blog.

A report set to be released Thursday 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

... The report said the FDA "has relied largely on the OCI director to determine which aspects of OCI's operations and investigations are made known to FDA's top management."

The GAO also said the FDA's criminal unit has fallen short compared with other agencies in developing performance standards.

This clearly must be corrected.

The FDA officials largely agreed with the assessment and in the letter 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.

I know where they can look to find cases ... here, for example.

... In 2008, Rep. Joe Barton (R., Texas) criticized the Office of Criminal Investigations, saying its budget had increased while its workload stagnated.

I think the many posts on healthcare corruption here and elsewhere suggest that the workload of the Office of Criminal Investigations needs to pick up quite substantially, if the behaviors are to be discouraged and the actors shown that the penalties are not just a "cost of doing business" (unless one is willing to acquire a criminal record or go to jail for one's company as a "cost of doing business", that is).

It is my hope that one day this increased vigilance will be extended to the healthcare IT industry.

-- SS