Task Force Meeting: FDA and DOJ speak

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Next up at the National Task Force on CME Provider/Industry Collaboration conference was a panel consisting of Thomas Abrams of the Food and Drug Administration, and James Sheehan, Esq., with the Department of Justice. Abrams outlined what's going with drug promotion regulations, from direct-to-consumer to DDMAC enforcement actions. "Risk information—and the lack of including risk information in promotiono—is of great interest," he said. "Inadequate information on risk is DDMAC's biggest focus. It is the subject of the majority of letters DDMAC sends, and it is critical to public health. A lot of effort goes into the beneficial claims about drugs. The same effort needs to go into risks."


To highlight where DDMAC is on this, he explained that DDMAC sent 13 warning letters from July 2005 to June 2006, a 250 percent increase over the average of previous years. "The positive aspect is that the warning letters were effective in stopping illegal promotion. The negative is that we had to take these actions," he said. The most common violations are promotions that inadequately communicate the risks associated with a drug, include misleading effectiveness claims, and misleading comparative claims. He also ran through a couple of letters that were sent, and why they were necessary. After hearing a radio promotion of one drug, where patients are used to make some of what I thought were pretty outrageous statements, I was glad to know these guys are doing what they do.


    The bottom line is that we're dealing with patient health. It's important to give accurate, truthful, and balanced information.


Sheehan took the podium with his unique blend of scariness and practicality, seeing as his focus at the DOJ is uncovering fraud and false statements. "When you go to a car dealer, you guard is up," he explained. "When you go to a doctor, you have an expectation of trust. Same thing is true of an ad backed by the FDA." He walked through the differences between what the FDA and DOJ do (the FDA focuses on statements made that don't hold true to FDA findings; DOJ looks at how a company obtained approval through fraudulent of false actions): "If you hadn't cheated the FDA to get approval, we wouldn't be epaying for these drugs" through payee programs like Medicaid and Medicare, he said. "But for false or misleading off-label promotion, docs would not have used this drug," he added.


DOJ looks at false statements made in clinical trials, such as not reporting adverse events, problems with protocol compliance, that sort of thing. I loved this bit: "My favorite is 'lost to followup,'" he said. "No one ever dies in a clinical trial—they're just 'lost to followup.'" So, he asked, why should we prosecute based on the money, when FDA is about patient safety? Because fraud statutes are based on the concept of economic harm. Also, there is extensive case law on fraud and false claims, but not so much on FDA violations. At least, not yet.


Hot issues he predicts we'll see more of in the future:

  • Drugs and devices that are not easy to train docs about. Some doctors can't translate what they learn in training, say in a two-dimensional format, to the 3-D of a live patient, for example.

  • Relationships between companies, thought leaders, and referral sources are another hot topic. Recent corporate integrity agreements spell out that pharma companies can't offer payment, solicitation, or receipt of anything of value. DOJ will be looking at that to make sure it's being carried out in an above-board way.

  • Whistleblowers will continue to come forward.

  • Drug/device combination training will get closer scrutiny.


  • He concluded:


      One thing the ACCME regulations do is help to build that trust between patients and doctors. Fraud happens when that trust is let down.


    Update: I just saw this story in today's New York Times, and it seems to speak to Sheehan's first bullet point about training docs.

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