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Off-Label Promotion and Whistleblowing

Whistleblowing and off-label promotion of drugs and devices have become hot topics because of the September 2 Pfizer settlement with the federal government. For those who were on vacation: Pfizer is paying $2.3 billion to settle criminal and civil complaints dealing with its marketing and sales practices on four drugs. They have also had to accept a stringent corporate integrity agreement with regard to pre-review and audit of its future marketing and sales activities.

While none of my views are specific to Pfizer, the company’s settlement provides an opportunity to comment on off-label promotion….and to encourage bio-pharma and medical device companies to engage in deeper soul-searching.

Marketing departments should be able to do better. Even if the clinical trial data is ambiguous, FDA is usually precise in the indications it approves. That limits the scope of claims that can be made by a company. The FDA’s promotion rules are far from perfect, but they are clear on most points. For virtually all medical products, it should not be hard for the sponsor to identify promotional claims and activities that are permitted.

Product marketing is a centralized function that requires employees to work together to develop programs and oversee initiatives. It is not an ad-hoc activity. I assume there are multiple sign-offs before any action is taken. Why are these safeguards failing? When things go wrong–which happens remarkably often–is it because everyone in the marketing department is drinking the same fatal Kool-Aid that sales are more important than laws and profits larger than penalties?

Sales practices are harder to control and will always leave companies vulnerable. I have often observed that there are three types of people: those who are shy, those who get over being shy, and salesmen. Medical products companies train sales staffs rigorously, re-train them often, and make them sign documents that attest to their knowledge of the marketing and sales restrictions on bio-pharmaceuticals and medical devices.

However, tens of thousands of sales reps have millions of interactions with prescribers. No matter how well trained and cautioned they are…there will be days when some reps cannot restrain their “inner salesman.” How do you guard against that?

Whistleblowers serve a societal function that might not be served any other way. This is painful for me to admit, since I believe so strongly in working within an organization to make things right. I worry that “running to Uncle Sam” might be perceived as a better option than having a candid and concerned conversation with your boss.

However, in many situations, there may be no other way to document certain types of corporate wrong-doing. For that reason, whistleblowing and the resulting qui tam lawsuits are encouraged as a matter of public policy.

My conclusion: it is difficult for bio-pharma and medical device companies to conduct business in a way that makes whistleblowing unnecessary. Nonetheless, FDA-regulated industry can do better than they are presently. We should expect medical product companies to serve patients, prescribers, and shareholders without breaking the law. For those who think the promotion rules are illogical or counterproductive, the remedy is to work for policy changes, not to ignore FDA rules.

I believe that leaders and staff of medical products companies are well-meaning and committed to improving the health of patients. It is detrimental to see off-label promotional activities that can be interpreted as blatant bad faith.

Am I missing factors that might lead to a different conclusion? I encourage readers to post constructive comments to set me straight.


Notes on the news:

  • My September 6th comments on President Obama’s options leading into tonight’s speech to Congress on health care reform and how that might affect FDA: http://www.fdamatters.com/?p=471
  • Senator Dodd has decided not to take the HELP chairmanship. Here are my August 30th comments on the other contenders and the trade-offs involved: http://www.fdamatters.com/?p=459

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