Good Promotional Practices Blog

I attended a few very interesting meetings recently with Epstein Becker & Green/FDLI and the Healthcare Businesswomen’s Association and learned how dramatically the space is changing just this calendar year.

FDA has announced that they are revamping their criminal prosecution department to increase prosecutions of Life Science executives and managers. From the WSJ:

1. In a letter to Sen. Chuck Grassley (R., Iowa), the FDA says an internal committee has recommended that the FDA and its Office of Criminal Investigations "increase the appropriate use of misdemeanor prosecutions, which allows responsible corporate officials to be held accountable and is a valuable enforcement tool."

2. An FDA official said the agency has the authority to prosecute corporate executives for criminal actions within their companies under a provision called "strict liability." He said the “government doesn't have to show intent to defraud in order to get a conviction.” He added that the provision is an “important tool that hasn't been used much in recent years.”

Lanny Breuer, Assistant Attorney General for Criminal Division of the DOJ, speaking during the American Bar Association National Institute on White Collar Crime meeting:

1. “We also are striving to innovate in how we do business. That could mean utilizing data and intelligence more strategically, or it could mean – as we've seen in a couple of prominent cases recently – going undercover. However we do it, we will be more targeted, more creative, and more strategic in where and how we look for criminal conduct.”

2. “… largest single prosecution of individuals in the history of DOJ's enforcement of the FCPA. It thus vividly illustrates one cornerstone of our FCPA enforcement policy: the aggressive prosecution of individuals. Put simply, the prospect of significant prison sentences for individuals should make clear to every corporate executive, every board member, and every sales agent that we will seek to hold you personally accountable for FCPA violations.”

3. “Because this is a model that works, we are devoting resources to expanding our Strike Force operations. The Strike Force, which started operations in Miami and Los Angeles, is now operating in Detroit, Houston, Brooklyn, Tampa, and Baton Rouge as part of the DOJ and HHS-led Healthcare Fraud Prevention & Enforcement Action Team, or ‘HEAT’ as it is known. Nationwide, more than 500 defendants have been charged by the Strike Force in cases involving approximately $1.1 billion in fraudulent claims submitted to Medicare.”

4. “We are especially concerned about increased disparity in white-collar sentencing. It is not uncommon for a health care fraud defendant to be sentenced to 15 or more years in one district court, while, in the same week, another defendant in another court involved in a larger fraud is sentenced to a very short prison term. A few weeks ago, the Ninth Circuit affirmed a 25-year sentence for a fraudster involved in a $40 million fraud just a few days after another defendant on the East Coast who had been involved in a $1 billion fraud was sentenced to just five years.”

Read the Lanny Breuer’s entire speech.
 

I have just reached my first year anniversary with Prolifiq and was reflecting back on my move into the software arena. A few weeks before I joined Prolifiq, I was driving with Krista, my then eight-year-old niece, in the back seat. Krista asked me why I was changing jobs, and I was describing how I was simultaneously nervous and excited because of the huge leap from 20 years in medical device marketing into this new sales content management software company. 

Wikipedia defines collaboration as: a recursive process where two or more people or organizations work together in an intersection of common goals — for example, an intellectual endeavor that is creative in nature—by sharing knowledge, learning and building consensus.

Yesterday, Prolifiq announced a “partnership” with Portland, OR based EthicsPoint software (see press release here). This partnership is driven by our desire to address the compliance requirements associated with the dissemination of scientific, educational and promotional material by the sales forces of Life Sciences companies.

Epstein Becker & Green partner Steve Skwara has analyzed the corporate integrity agreements (CIAs) between Life Science companies and the Federal Government and has made the following conclusion:

“Specifically, the CIAs require policies and procedures that include a process whereby an alert is triggered when certain systematic threshold of sales representative facilitated medical information requests are exceeded.  These thresholds can include, for example, an inordinate number of requests for “off-label” information from a particular sales representative.  They might also include other indicia of potentially improper conduct.”

Skwara’s full analysis of the implications of these CIAs is discussed in his whitepaper which can be found here.

Prolifiq and EthicsPoint decided to collaborate in order to address these requirements and to provide Life Science companies a means to “inoculate” themselves through the use of pro-active policies and procedures. Prolifiq manages the process whereby salespeople disseminate information. Should salespeople exceed “thresholds”, Prolifiq will “trigger” an alert to a company’s EthicsPoint application. The compliance officers then have a means to monitor, investigate and resolve potential compliance violations in real time.

This relationship recognizes the strength of both companies’ products and people, and provides a way to address these stringent regulatory requirements in a very forward-looking way. Vaccination is always a good thing (see: Vitamin. Vicodin. Vaccine).