Medical device and MedTech insights, news, tips and more

Medical Rep Rebuked by FDA for Misleading Statements during Doctor’s Lunch

October 30, 2018

fda image

The latest admonishment from the FDA’s promo police is an unusual one. In it, the agency scolds an Eisai sales rep accused of misleading healthcare professionals during a presentation on antiseizure drug Fycompa.

What’s different about the FDA’s latest untitled letter? It involves words spoken by a sales rep. It marks only the 14th time a warning or untitled letter has involved an oral statement, said Mark Senak, a public relations professional and Eye on FDA blogger. The last time a sales rep was involved was in 2012, according to his database of 329 letters dating back to 2004.

Exactly what the Eisai sales rep said is unclear, as much of the explanation of the offense is redacted in the letter. But the letter did note that the tip came from the FDA’s Bad Ad program and in this case seems clearly to be from someone who was in the room during the Eisai rep’s presentation.

Senak noted that this letter and another recent letter both came through the Bad Ad program, which encourages healthcare professionals to report instances of misleading drug promotion with a direct phone call or email to the Office of Prescription Drug Promotion (OPDP).

“For anyone who thought Bad Ads was a dormant program, it apparently is not,” Senak said via email. “The message to sales reps is that docs are listening and docs are reporting and when they do, the FDA may act.”

When asked if the sales rep letter might have a chilling effect on rep speech, Senak said he doesn’t think so. He noted that reps already go through training about communications boundaries and the letter doesn’t send any new messages in that regard.

The Eisai letter brings the total of OPDP enforcement letters for 2018 up to six, a tally that’s pulled ahead of 2017’s total of five letters. Letters have been on the decline over the past several years, although the agency sent 11 in 2016 and nine in 2015.

Read More at the Source: Careful, reps: Doctors are watching, FDA promo police’s latest rebuke shows | FiercePharma


By: Beth Snyder Bulik


A Speciality Recruiting Firm Exclusively Servicing The Medical Device Industry

Legacy MedSearch has more than 30 years of combined experience recruiting in the medical device industry. We pride ourselves on our professionalism and ability to communicate quickly and honestly with all parties in the hiring process. Our clients include both blue-chip companies and innovative startups within the MedTech space. Over the past 10 years, we have built one of the strongest networks of device professionals ranging from sales, marketing, research & , quality & regulatory, project management, field service, and clinical affairs.

We offer a variety of different solutions for hiring managers depending on the scope and scale of each individual search. We craft a personalized solution for each client and position with a focus on attracting the best possible talent in the shortest possible time frame.

Are you hiring?
Contact us to discuss partnering with Legacy MedSearch on your position.

 

More insights

March 7, 2024
FDA Clears Dexcom’s First Over-the-Counter Continuous Glucose Monitor
Learn More
March 1, 2024
FDA greenlights Boston Scientific’s Novel Drug-Coated Balloon for Coronary In-Stent Restenosis
Learn More
February 21, 2024
Sparrow BioAcoustics Launches Software That Turns a Smartphone into a Stethoscope 
Learn More

Begin your legacy now. We are your medtech and medical device talent advisory firm.