The recent decision of the D.C. Circuit in Friedman v. Sebelius, No. 11-5028 (D.C. Cir. July 27, 2012), demonstrates the enforcement risk to pharmaceutical and medical device industry executives under the “responsible corporate officer” (RCO) doctrine. Under the RCO doctrine, officers, managers and in-house counsel employed by life sciences companies could face misdemeanor criminal liability and exclusion from Medicare and other federal health programs, even if they were not personally involved in wrongdoing. Indeed, an executive can be liable under the RCO doctrine even if they did not know that their organization had engaged in wrongdoing, so long as the executive should have known of the organization misconduct by virtue of the executive’s position within the organization.

The RCO doctrine originated in United States v. Dotterweich, 320 U.S. 277 (1943), in which the Supreme Court upheld the misdemeanor conviction of the … Read More »

On August 2nd, H.R. 6272, the “Trial and Experimental Studies Transparency (TEST) Act of 2012” was introduced in the House.  TEST would amend the Public Health Service Act to expand the clinical trial registry data bank.  Among other requirements, the bill would require all foreign clinical studies to meet the same requirements as domestic trials (if used to support an application for U.S. marketing).

Also, the bill would require that results from most covered trials be posted on the registry data bank within one year of the “primary completion date” of the trial.  Delayed submission of results up to two years after trial completion would be allowed for trials on drugs of devices that have no previous history of approval for use.  The National Institutes of Health (NIH) and the Food and Drug Administration (FDA) would be instructed to provide Congress … Read More »

It isn’t difficult to see that the main impact of social media penetration in our culture is an epidemic of oversharing. Americans under the age of 25 have a very different approach to privacy than, say, your average 30 year-old, and feel weirdly comfortable sharing details of their private lives.  E-mail is considered to be outlandishly formal, large scale sharing over social networks and texting is commonplace, and the barriers between personal and institutional communication are nearly non-existent.

This has led, predictably, to mass sharing of medical information online — even two years ago, news organizations were reporting on the rise of “e-patients” who talk to medical experts and amongst themselves in order to obtain treatment, piece of mind and/or the thrill of exposure.

Suddenly, there is widespread information about adverse outcomes and side effects, in every search that someone does for … Read More »

On August 3, 2012, Jesse Witten published an article on his thoughts on Eucomed’s code of ethics.

To read the entire article, click here.

For deal junkies, the next 5-10 years should be quite interesting in the life sciences/health care industry. We have already seen large pharmaceutical company consolidations, financial buyers investing in health care institutions and partnerships between payors and providers. And much of this before the Supreme Court decided that health care reform is here to stay.

What is driving this? Need, opportunity, cash and innovation. Pharmaceutical company brand drugs are losing their patent protection, the cost/risk of developing new drugs is enormous, heath care costs need to be controlled, people are living longer, health care reform is triggering new behaviors and strategies and, despite the difficult financial times, there is much cash available for investment. Also, much of the broader life sciences/health care industry has been slow in technology adoption, while technology and social media continues advancing, being available to a broader … Read More »