Summer officially began. The days have, by seconds only, begun to grow shorter. Storms threaten on a nearly daily basis. Humidity is a constant companion. And today was the last day of school in my neighborhood making me happy once again not to be a parent.
And here is a little of what happened in our world this week:
- Supreme Court Strikes Down Vermont Law on Data Mining – For some time there has been a concerted effort on the part of states to curb or regulate various types of marketing practices by pharmaceutical companies. One such effort pioneered by Vermont was aimed at the practice of tracking prescriber patterns so that the information could inform the sales efforts of pharmaceutical companies. The case went all the way to the Supremes who counted it out in a 6-3 vote saying that the Vermont ban violated commercial free speech.
- FDA Publishes Study on Consumer Understanding of RX Drug Ads - And speaking of marketing, the FDA this week published results from three studies that the agency undertook to examine consumer understanding of the information contained in drug ads. In the first study, a serious risk was added to the first and second page of the ad. In the second study, additional information about side effects was included on the second page. The third study tested four different brief summary formats: Traditional (block text paragraphs), Question and Answer (with headings framed in the form of questions), Highlights (based on the highlights section of the physician labeling), and Prescription Drug Facts Box (resembling the current Over the Counter Drug Facts label). Key findings of the studies include: (i) Adding a serious risk did not hinder people’s understanding of the risk information; (ii) Including additional information about how often side effects occur and how long they may last did not hinder people’s understanding of the risk information; and (iii) Participants who viewed the Drug Facts format were better able to recall risks than those who saw the traditional format.
- Call for FDA to Enunciate Standards for Weight Loss Drug Development - Today’s Washington Post carried an op-ed that made an excellent point to anyone who has followed the rocky path of anti-obesity drug development. The piece points up the fact that three such drugs were brought forward for consideration this year, but none have been approved because none, of course, are risk free. While the level of risk acceptable for obesity drugs is not clear, the level of risk associated with the obesity epidemic is quite clear. The author calls on FDA to enunciate some guidance for drug developers because so many lives depend on it.
That’s it for me this week. Have a wonderful summer weekend wherever you are.