you’re correct, the supplement industry is regulated by the FTC and they do a pretty pitiful job (possibly because they’re outside their realm of experience in evaluating the claims and are unable to understand that, on the rare occasion the cited clinical studies have actually been conducted, they haven’t been conducted using the actual product being advertised). Not that I have a great deal of faith in the FDA, I do think FDA regulation of OTC supplements/vitamins, etc. would be a marked improvement from the lax governance by the FTC.

I agree that OTC and other supplements ought to be factually accurate. As I understand it though - DTC advertising of OTC drugs are monitored by the FTC, not the FDA. And some have been getting dinged lately for unsupported claims - like the “male enhancement” drug whose name has slipped my mind - Enzyte? They had to change their ad.

With all due respect, ads for pharmalot in the star-ledger (and vice versa) are very different from DTC issues. A reader is capable and permitted to decide for him/herself whether to read or subscribe to either publication. patents, in general, neither have the experience or training to know enough about prescription pharmacologic interventions to decide when it is safe and appropriate for them to do so (heck, most people take way too much latitude with their use of OTCs and so-called supplements). As such, these drugs are dispensed only with a prescription from a licensed HCP. DTC is used to sway people to self diagnose, pressure their HCP to prescribe and/or find someone else who will get them access if their HCP will not. In a health care setting, people are patients, not just consumers.

IMNSHO, DTC advertising of any and all systemically available treatments (including OTC drugs, “nutritional supplements” and vitamins) should be limited to those that meet GMP standards and should be required to be factually accurate. No manufacturer should be able to advertise and make claims for their product that have not been substantiated (i.e. “in clinical studies, people lost significant weight. . .” with a small disclaimer that the claims have not been approved by the FDA).

Sometimes, NJ Issues trump,.. Sorry to say ,.Michigan Issues. Hope you undersatand.

Takes one to know one!.. If I were you, I wouldnt read anything into my conversation with Ed…. Its a NJ thing,… An Issue unfamiliar to you. Gee,.. thought you got hit by a bus!…

Response:

1. Yes, but the preemptors were arguing their case when the situation was as above. So, from their perspective, the change was irrelevant.

2. FDA may technically have that authority, but will they use it? What degree of delay will be provided through a process of company appeals, hearings, reviews, etc. etc. etc.

My guess is that may be about as easy to squeeze out fourteen months delay in the situation now as during the situation then.

This is precisely the kind of case that, ideally, should be the one upon which the Supreme Court rules on preemption. Here we have FDA’s own Advisory Committee recommending a label change with CV warning. Then the famous fourteen months. During which what happened? Was this careful scientific review of available data? A conscientious attempt by the experts, in FDA and company, asessing the issues, pooling the studies, weighing the risks and benefits, to come up with the most appropriate label?

Or was it something entirely different.

Most of us have read the descriptions (especially in the WSJ) of what actually transpired during those fourteen months. It provides a pretty good picture of how the time was actually used, what the motives and tactics were on Merck’s side, how they fared (very well, thank you), and so on.

So you have to imagine the same process, but entirely without the possibility of civil liability. None whatsoever.

Does anyone imagine the Vioxx label would _ever_ have changed? Before APPROVe? I would genuinely love to hear the scenario in which it would have.

That was a very Diplomatic response!!

Since Pharmalot is owned by The Star-Ledger, it will get promoted in its pages. But the editorial content is run independently of the effort to hunt and gather info to place in the newspaper, and vice versa.

ed at Pharmalot