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FDA Commissioner Makary to Announce Radical Overhaul of Drug Advertising Landscape

NOLA Dude

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In a sweeping move poised to reshape America's contentious prescription drug advertising industry, FDA Commissioner Dr. Marty Makary has announced plans to send out thousands of enforcement letters targeting misleading pharmaceutical promotions.

This initiative, revealed in Makary’s interview with me for the Sept. 14 edition of “Full Measure with Sharyl Attkisson,” marks the first comprehensive enforcement effort in decades since direct-to-consumer drug ads were legalized in the U.S. in 1997—one of only two countries worldwide, alongside New Zealand, that permits such advertising.

....Makary's plan extends beyond TV to social media influencers and online pharmacies, where paid promotions often ignore side effects entirely. "They're never advertising generic drugs. They're advertising drugs that are super expensive, that are jacked up 10 times more expensive in the US than other wealthy countries say in Europe," he said.

The commissioner stressed that the FDA will ensure "claims by pharmaceutical companies match the data" without violating First Amendment rights, but he made clear this isn't a ban—it's a robust enforcement of existing rules. He noted that more can be accomplished with “honey” than “fire.”

He also observed that, although ads are not being banned, he foresees that drugmakers will not advertise certain medicines at all when they have to fairly and accurately disclose risks in those ads.

...A key element of the overhaul targets a long-exploited loophole allowing certain products, particularly vaccines, to be advertised as "educational" without mentioning risks, as long as complications are listed elsewhere, like on a website.

This has been needed for a while. I wish they could ban them but there are 1st amendment considerations as well as a SCOTUS decision to work around.
 
Every ad I see on TV lists the risks associated with each drug.
What is this person talking about?
 
Sternly worded letters?

Gosh…that’s SO powerful.

Those Pharma companies will simply add more tiny print on the bottom of a screen/ad I suspect.
 
It has been a long time and drug companies know full well that any advertising that does not meet strict FDA guidelines opens them up to HUGE fines and penalties. Quite often, they will actually seek formal FDA prior approval before airing or printing ANY promotional material.

I know this because I was a drug rep and my drug was promoted directly to patients on TV. Our managers read us the riot act regarding making ANY unapproved claims regarding our materials. First offense was $50k, rep fired, and it went up from there. According to my sources within the industry, they have gotten even more restrictive. When I was a rep, we could leave bunches of ball point pens in doctors' offices with our drug name on them. No more! We would buy the entire office lunch just so they would listen to our pitch while they ate. No more!
 
Sternly worded letters?

Gosh…that’s SO powerful.

Those Pharma companies will simply add more tiny print on the bottom of a screen/ad I suspect.
Nobody in pharma dismisses a sternly worded letter from the FDA.

You wouldn’t believe the size of the fires that have been lit under my ass over those letters.
 
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