FDA Warning – Time to get personal

In a move guaranteed to send shock waves around the industry, FDA lawyers just announced that CEOs of pharmaceutical companies could face prosecution for off-label drug marketing.

The FDA’s Deputy Chief of Litigation, Eric Blumberg, said, “Unless the government shows more resolve to criminally charge individuals at all levels in the company, we cannot expect to make progress in deterring off-label promotion. It’s clear we’re not getting the job done with large, monetary settlements.”

Although the lawyer didn’t specify when the agency will start to implement sanctions, he warned company executives not to wait until the first charges are brought.

If you’re a corporate executive or are advising a corporate executive, now is the time to comply,” continued Blumberg.

Non-compliance with the order could result in executives incurring fines of up to $100,000 and up to one year in jail. In addition, regulators could also bar individuals from working in the drug industry.

Prosecuting executives for violations of the federal Food, Drug and Cosmetic Act falls under the Park Doctrine, a long forgotten, and rarely used statute named after the 1975 U.S. Supreme Court case against a retail food chain president.   In essence, the Park Doctrine allows prosecutors to hold CEOs responsible for the crimes of their underlings, even if they had no specific knowledge of their actions, on the general principle that CEOs have a responsibility to ensure that their organizations follow the law.

For small companies with rigorous compliance in place this should not be a problem, but for the giant pharma entities with upwards of 100,000 employees is it realistic, let alone possible, for the CEO to make sure they’re all obeying the law?

If you’re a CEO of a pharma company, or an employee who would like to stay employed, then look no further than SRxA.  We are here to help you through the complexities or compliance and create worry-free marketing and educational initiatives, guaranteed to help you and your boss sleep at night.

Contact us today for further information.

No excuse for sleeping on the job!

SRxA Word on Health bloggers know just how hard pharmaceutical and business execs work. The deadlines, the late nights, the weekends and of course, the crazy travel schedules. With all this sleep deprivation you’d think we’d all be forgiven the occasional lapse of judgment.

Not so, says a new study!

Research conducted at Washington State University into the effects of sleep deprivation on executive functioning and published in the January 2010 issue of the journal Sleep has yielded surprising results.

The study looked at 23 subjects, who spent 6.5 consecutive days in a controlled laboratory environment. One group was kept awake for two consecutive nights, while the other was on a normal sleep schedule.

Three times during the experiment, subjects were asked to complete a series of executive tasks that measured working memory, scanning efficiency, resistance to proactive interference and verbal fluency.

The research psychologists found that working memory -a key element of executive functioning- was essentially unaffected by as much as 51 hours of total sleep deprivation. Instead, they saw a degradation of non-executive components such as information intake.

Follow-up studies will examine how distinct components of decision making are affected by sleep deprivation and how this influences the overall decision-making. Ultimately, this may lead to development of interventions that will improve decision-making in emergency responders, police officers, and military personnel for whom getting enough sleep is often not an option.

Meanwhile, with tiredness no longer an acceptable excuse for bad business decisions, we wonder if this mean the end of the executive power-nap?!?