It’s A Crime: FDA Fails To Debar Criminals
5 CommentsBy Ed Silverman // February 12th, 2008 // 1:26 pm
The agency isn’t bouncing researchers and drugmakers that commit crimes when seeking approval for medications, according to Republicans on the House Energy & Commerce Committee. Their newly issued report cites a laundry list of FDA sins of omissions and commissions that raise numerous questions about the agency’s willingness to pursue corruption. (Take a look).
“More than 15 years ago, Congress passed a law to let the FDA kick out companies and individuals from the drug industry convicted of crimes related to the FDA approval process,” writes Congressman Joe Barton, a Texas Republican. “When it comes to excluding the worst of the worst - convicted felons - FDA’s debarment process seems to be nonexistent. It is inexcusable that the FDA can’t quickly debar convicted felons.”
Of course, it doesn’t help that the FDA lacks authority to debar a brand-name drugmaker. In other words, if a generic drugmaker was convicted of falsifying data in an abbreviated drug application and a brand-name drugmaker did the same thing, the FDA could debar only the generic maker. Nonetheless, the minority report scathingly cites various problems with the FDA’s performance. Here are some excerpts….
“After more than 15 years, the FDA hasn’t debarred a single generic drugmaker and has brought only one debarment action against an individual in the animal drug industry. In some instances, the FDA failed to pursue corporations or iindividuals who submitted or assisted in the submission of drug producdt applications, even when convicted of crimes that make them subject to debarment. In some instances, there was reason to believe the convicted criminals, who should have been debarred, continued to be involved in the industry…
“In some instances, FDA’s efforts to institute a mandatory debarment against individuals have resulted in a debarment being rescinded, because the agency didn’t bring charges by a five-year deadline required by law. The committee also alleges the FDA hasn’t initiated debarment proceedings against individuals consistently. And the agency failed to debar individuals convicted of crimes relating to misconduct before other federal agencies. The FDA also limited its debarment authority to violations related to product applications; the FDA won’t debar for post-approval crimes like counterfeiting.
“The agency debarred 71 people over 15 years, but 32 were involved in the generic drug scandal of the late 1980s. Over the last 5 years, the debarment rate is only 2.5 per year, and the FDA used its authority only nine times over 15 years. From FDA enforcement reports between fiscal years 2003 and 2005, the staffers compiled a list of 40 people convicted of crimes who “could have and should have been” debarred. There were no debarments since Jan. 30, 2007.
“The FDA appears to have adopted an ad hoc approach when carrying out its responsbility to debar corporations and individuals who have engaged in misconduct relating to the approval or regulation of drug products,” the report says. And the agency “has either failed to devote, or does not have, sufficient staff and resources to review cases and issue debarment notices in a timely manner when it is required.”
The staffers offer several examples to bolster their contention, and here is one…
“The Federal conviction of Dr. Mary (Marty) Sawaya in 2004 for providing false statements to the FDA is a prime example of FDA’s failure to take enforcement action against individuals who have engaged in misconduct with respect to drug products. Sawaya, who conducted clinical drug studies, had done so without a medical license and had provided at least two false medical licenses to FDA as part of Investigational New Drug (IND) applications.
“In the Office of Criminal Investigations Fiscal Year 2004 report, OCI states that, as a result of her conviction, Sawaya was sentenced to 24 months probation and “disqualified from participating in any clinical drug study. “Despite stating that she was disqualified in the OCI report, minority staff was unable to find any mention of Sawaya’s disqualification in FDA’s disqualification list, debarment list, or other FDA documents.
“Further, Minority Staff uncovered other evidence which suggests that Sawaya actively continues to practice medicine and conduct clinical research. In 2004, just one month after Sawaya pleaded guilty to making false statements, she moderated a talk on hair loss on www.hairlosstalk.com. In the summer of 2006, she spoke at a meeting of the Pearl Network, an organization of practitioners engaged in clinical research. In a pamphlet from the meeting, Sawaya is described as “speak(ing)at the closing session about past successful outcomes of (Practice-Based Research Network) research.”
“Finally, Sawaya’s biography is listed at www.hairloss-research.org, a site that claims to be maintained by an organization named MPB Research. Her biography states that “Dr. Sawaya’s current clinical research is…focused on cutaneous cancers…and malignant melanoma.” If Sawaya’s biography is accurate and up-to-date, there is reason to believe that she is continuing to participate in clinical trials despite being convicted for making false statements to the FDA in IND submissions.
“The FDA’s failure to initiate debarment proceedings is baffling, given that the requirements for mandatory debarment are clearly met. Further, the FDA’s decision not to pursue debarment contradicts the purpose of the Generic Drug Enforcement Act: to restrict future conduct and bolster public confidence in drug safety.”
Jack2
I love it when republicans, who stopped increasing FDA funding (and in inflation adjusted dollars decreased FDA funding) then criticize the FDA for not being able to meet all of its obligations.
Matt
The bottom line here is a bunch of politicians identified a problem: expect no solutions…
Of course the FDA has been letting things slide - they’re funded in part by Big Pharma.
Justice in Michigan
This is fascinating in a hundred ways. Barton, like Mike Ferguson, has been one of the top recipients of pharma money over the years. So why has it become so “popular” recently for Republicans to chastise FDA for non-enforcement?
Here is my theory. One of the arguments of the pro-preemption crowd is that, even without civil liability, companies and indidivudals will still be held accountable by FDA’s Office of Criminal Investigation (OCI) and Justice Dept. But the reality is - for anyone who’s looked into this - is that such enforcement virtually never happens, and - when it does - it is usually tickles on the wrist. Every pro-preemption brief makes a melodramatic much of what the FDA “can do” to non-compliant companies. What those briefs do not say, however, is that FDA almost never does those things.
Given those facts, FDA preemption has even less claim as rational policy than otherwise. The full escape from accountability that it would provide becomes starkly obvious. Yet most of these Republicans, at least in the past, have strongly supported preempiton.
The absence of FDA enforcement becomes a very “inconvenient truth” in that context. So perhaps that explains some of what we’re now seeing, as much as I would prefer to view it as conversion experiences or something in the water cooler.
Tom
Logistically speaking, I’m curious how you would “kick a drug company out” of the drug industry. Admittedly, I haven’t had time to read the report and probably missed the legal explanation. But in the absence of extraordinary circumstances, if there’s proven criminal activity, why not focus on the individuals responsible instead of an entire organization? Does it make sense to shut down a company, cut off patients from their medicines, toss thousands of uninvolved workers into the streets, and burn the shareholders? Reminds me of my fourth grade gym teacher. If one kid broke the rules, the whole class spent the next hour doing push-ups and squat-thrusts.
Justice in Michigan
Tom - Right. That is why debarment applies only to generic companies as companies, so no one would be prevented from access to a needed med.. In my own post, I was referring to the whole range of sanctions (significant fines, etc.) through which FDA _could_ hold a company accountable - those are the scenarios that preemption defenders evoke that virtually never happen. The wider context was what else may be involved with “Republicans getting tough on enforcement against drug companies” (which is how the headline would read).
As far as debarment against generic companies, we would be talking about some version of the generic drug scandal of the 80s - conspiracy and cover-up planned across a company’s management (not a few “bad apples”), the systematic use of bribery, false reporting, etc across those levels, and so on.