In a rare move, the FDA has mandated Bayer Pharmaceuticals to run ads correcting misperceptions they’ve created with their ad campaign for Yaz Birth control pills. (via NY Times)
Yaz is FDA-approved as contraception and for treatment of PMDD, a very severe form of PMS that occurs in only about 3% of women. Yaz is also FDA-approved to treat acne. But the Yaz ad targets the common premenstrual symptoms such as irritability, breast pain and bloating – symptoms most women have at one time or another – and implies that Yaz will maintain clear skin. Basically, Bayer is targeting healthy women with typical premenstrual symptoms and no acne.
Think of it as if the makers of Prozac started to target their adertisements to folks having a bad day.
Bayer has taken the same approach in pushing their pill to doctors, assuming we’ll prescribe off label for PMS instead of reserving their pill just for women with PMDD. And in this, they are right. We docs love to find a reason to pick one pill, any pill really, over another. It makes us feel like we’re using our brains and not just blindly throwing a dart at a formulary list. Of course, we have no clinical trial data to support our choice, just a bit of logic that if you want birth cntorol pills and this pill is good for PMDD (and believe me, it does work, though not for everyone), why not try this one? For these patients, the primary indication for treament is contraception, not PMS. The problem with the Yaz ad is that it promotes the non-contraceptive effects of Yaz over the contraceptive effects, and targets them to healthy women.
Unfortunately, we will never know if Yaz treats the milder forms of PMS, because the FDA will not allow clinical trials for PMS – just PMDD. So it’s a bit of a catch-22 for Bayer. I don’t feel sorry for them, though. It’s not like they don’t already have 3 indications for their pill – contracetpion, acne and PMD. They just got greedy for market share. The FDA has very clear guidelines, and Bayer has been flaunting these for a long time now. They deserve this unusual mandate.
What will be interesting is seeing how the new ads affect sales of Yaz. Or how many phone calls I get from worried patients already taking Yaz. Because I’m sure the ad will end with the usual “talk to your doctor” disclaimer.
It will also be interesting to see what the lawyers do with this one. This ad is basically a “Come and get us!” from Bayer to the plaintiffs attorneys. Look for lawyers ads soon.
So why wouldn’t the FDA let folks do research on pms?
Is it that other formularies haven’t demonstrated that they work for pmdd or whatever, or have they been demonstrated not to?
Okay, just so you know, it would be interesting to learn how you recommend a specific bcp, and how you decide to make changes based on side effects and all. (In case you don’t already have enough to keep busy!)
I think that you will find a greater trend with the FDA to crack down on claims made in ads. They have issued warning letters to the big guys in greater frequency lately, and they are trying to overcome the bad press they have had to face over ensuring safety of drugs. The Heparin and melamine examples from China are two such blemishes that are driving a vigilence campaign for the FDA.
There will be some legal implications, but the patients really have to prove harm. So in this particular circumstance, Bayer is promoting off-label use of LESS severe circumstances, not more severe or entirely different.
Bayer definitley crossed the line by not advertising to the consumers that suffer from acne and PMDD directly.
There is a huge component to this discussion that hasn’t always been brought up, and that is the reality that governmental policy and politics plays a big role here. If rules weren’t set up so severly, and the spirit of the law was emphisized more, then the loophole management approach to the DTC effort would for sure be minimized. There needs to be a better balance than the “splitting hairs” approach to compliance we see all too often. It would be great if the FDA had to clear all DTC ads before they went out, but frankly, the FDA is so slow to respond to what they are already dealing with that this is currently not plausible. Too bad, because it could be a path to much better relationships between the medical community, pharma and government – all of whom seem to be at each others’ throats. I will call this my “can’t we all just get along?” policy approach.
Bardiac-
I don’t know the fda thinking on why, I just know from having aprticpated in clinical trials of yaz when it first was studied that the FDA requires PMDD and not PMS to be studied.
In general, the FDA does not distinguish between pills and from what I’ve heard, have nixed head to head comparison studies, so it is really very difficult for pill makers to differentiate themselves from one another.
As to the last question, it’s really so individual. In general, if a woman has tried it before and liked it, I don;t see a reason to change her. If its cheap and on her formulary that’s as good a reason as another. We usually talk it out and see what’s important to her and I try my best to predict which pill she will like based on hw my previous patients have done.
Thanks for reading.
Thanks 🙂
So, does that make bcp prescriptions especially susceptible to pharmacy rep advertising and stuff for those folks/clinics who let reps bring in lunches or whatever?
i don’t really understand why direct-to-consumer ads are legal for Rx meds. it just makes no sense that something so potentially dangerous that it must be regulated and can only be had by Rx should be pushed in the same way as brands of cereal. [actually, i’m aware that the advertising/promotion efforts are FAR more sophisticated with meds.]
shruggling is right, that lawsuits can go nowhere unless there is harm done.
i wonder if you might write sometime on PMDD, and how it differs from PMS?
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