The PharmaCertify™ Team

“We’re having a heat wave. A tropical heat wave.” A huge section of the country is baking. Triple digits temps…high humidity...”might as well be walking on the sun.” However, you are happily sitting in your air conditioned space reading about the hot news of the week. Kudos to you! You have the right idea. Crank that A/C up and grab an iced beverage as you kickback and enjoy this week’s PharmaCertify Week in Review.

The hot topic this week has to be the announcement of an FDA proposal to regulate mobile apps related to health and medical needs. (It was really just a matter of time, wasn’t it?) The proposal would only target certain apps, and the agency will be seeking comment on the proposal. The types of apps the agency is concerned with are those that act as an accessory to an already regulated medical device, and those that turn a mobile device into a regulated medical device through the use of attachments, sensors or other devices.

A physician in Massachusetts may have been feeling a little hot under the collar as he wrote a response to a Rhode Island news website article about the financial relationship between doctors and the pharmaceutical industry. The website ran the usual and customary article about the conflicts of interest when doctors accept a meal, speaking fees, etc. from pharmaceutical manufacturers, along with a tally of the reported spend on state physicians, using data from public databases such as ProPublica. The doctor responded by acknowledging that yes, there have been issues, but those times are in the past. He went on to say that insurance companies have a bigger influence on what doctors write than any marketing ploy by a pharmaceutical company. He also defended the value of the relationship in that it keeps busy physicians up to date on new medications and therapies.

A report predicts the slowdown in FCPA enforcement actions in the first half of the year is only temporary and we can expect the DOJ to heat things back up the second half of the year. The report cites the unusual number of FCPA jury trials as the likely reason for the slow down.

State laws were on the hot seat this week as Maine’s legislature voted for the repeal of three of its reporting laws. The aptly named, An Act to Make Certain Prescription Drug Disclosure Laws Consistent with Federal Law, repealed Maine’s disclosure laws on marketing costs, prices of drugs subject to the Medicaid Drug Rebate Program and negative findings in clinical studies. In Vermont, a state auditor has tallied the cost of defending the state’s data mining law, which was recently declared unconstitutional by the Supreme Court. The auditor’s tally may be incomplete, as the court can still assign costs to the state as the losing party in the case. The auditor says the case could end up costing the state as much as $2 million.

We wrap up the news this week with a story involving the always hot button issue of off-label marketing. A California woman is suing Stryker and Medtronic, claiming the off-label marketing of their spinal fusion products has left her with debilitating injuries from excessive bone growth.

There are the hot topics in this week’s news. We’d like to take moment to remind you of our “hot of the press” new module, Good Promotional Practices. The module covers the essential topics for your commercial teams in a way that supports your values-based program. To learn more, please visit http://www.pharmacertify.com/commercial_compliance/good_promotional_practices.asp.

Whew! The mercury is still climbing as we wind it down and head for the weekend. Keep cool everyone, and we’ll see you back here next week.