Friday, July 25, 2008

More of Salmon's Cogent Observations -- on the SEAS/Cancer Issue "Dear Doctor" Letter

This also appears in the comment-box for the original "Dear Doctor" letter post. I felt it (like the CafePharma post itself) deserved a wider audience -- so here is our exchange -- in full:

In the US any written material provided by a companay relating to an approved drug including advertising is 'labeling'.

This is what the Food Drug and Cosmetics Act has to say about labeling:
Food, Drug & Cosmetics Act

SEC. 502. [21 USC 352] Misbranded Drugs and Devices

A drug or device shall be deemed to be misbranded. . . .

(a) False or misleading label. If its labeling is false or misleading in any particular. . . .

(j) Health-endangering when used as prescribed. If it is dangerous to health when used in the dosage or manner or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof.

Now if Vytorin is paid for by Medicaid or Medicare the following is something else to consider.
18 USC § 371. Conspiracy to commit offense or to defraud United States

If two or more persons conspire either to commit any offense against the United States, or to defraud the United States, or any agency thereof in any manner or for any purpose, and one or more of such persons do any act to effect the object of the conspiracy, each shall be fined under this title or imprisoned not more than five years, or both.

If, however, the offense, the commission of which is the object of the conspiracy, is a misdemeanor only, the punishment for such conspiracy shall not exceed the maximum punishment provided for such misdemeanor. . . .


July 25, 2008 4:35 AM

Quick correction. Not only advertising but printed materials are considered labeling for determination of misbranding.
See FD&CA SEC. 201:
. . . .(m) The term "labeling" means all labels and other written, printed, or graphic matters (1) upon any article or any of its containers or wrappers, or (2) accompanying such article.

(n) If an article is alleged to be misbranded because the labeling or advertising is misleading, then in determining whether the labeling or advertising is misleading there shall be taken into account (among other things) not only representations made or suggested by statement, word, design, device, or any combination thereof, but also the extent to which the labeling or advertising fails to reveal facts material in the light of such representations or material with respect to consequences which may result from the use of the article to which the labeling or advertising relates under the conditions of use prescribed in the labeling or advertising thereof or under such conditions of use as are customary or usual. . . .

So if they only give out a letter about Cancer if requested, is this failure to reveal material facts? What about all the other clauses and the fact that it's illegal to introduce into interstate commerce a drug that's misbranded?

Discuss among yourselves.


July 25, 2008 4:52 AM


Condor said...

Salmon -- you've just gone where I was headed, next -- swimming up the very same river, it seems -- I'll likely highlight yours, in a new post, later today, and with it, predict that in perhaps only a few days' time, the FDA will "give Schering a call" about less than complete transparency -- i.e., reticence on material saftey information. . . .

Perhaps I'll caption it:

"How to help an ordinary train-wreck. . . catch fire, and explode, to boot!"

But make no mistake about it -- this looks to fit the Hassan-led Schering pattern, to a tee -- torture a very-dubious position until it is barely recognizable as attempted compliance with the applicable law -- and thus, put Schering into an even deeper hole, as opposed to digging Schering out of one.

Great post -- thanks for the research materials, Salmon!

July 25, 2008 6:32 AM

Feel free to chime in, any and or all of you wise FDA-heads looking in from Potomac, Maryland -- Host: -- ISP: Parklawn Computer Center / Dimes Hq. Seriously -- I welcome your observations. This seems right up the Agency's alley, doesn't it?

I would also welcome anonymous (or attributed) comments on any or all of this from the wise folks in Frederick, Maryland, at the National Institutes of Health (NIH) -- Host: -- ISP: National Institutes Of Health. . . .

I promise no individual's identity will ever be revealed -- similarly, I will never disclose whether someone inside (or outside) these groups posted any particular comment.

1 comment:

Anonymous said...


I think you're overconfident in the FDA if you think FDA will give them a call.

Things are constantly being sent out via spam and medical 'magazines' that include blatantly mislabeled material.

Having contacts at the FDA I have it on good authority that the very people at FDA who told companies no a priori to mislabeling still received these mislabelings at their FDA e-mail accounts are unable to do anything.

It's only when there's a public stink like with Singulair (Merck)will FDA do anything. (Not to pick on Merck but it's probably the best known example that I can think of.)

What people don't realize is the true impact of user fees. With the latest round of PDUFA IV approvals it's now over 50% of the FDA's total budget and was expected to rise over the next few years to over 80% of FDA's total budget. There are over 10,000 people who work at FDA yet only about 2000 work in the Center for Drugs (the rest are food etc.) Of these are not very many actual front line reviewers (maybe 1000).

Thus user fees are already paying for 100% of what FDA reviewers do. Since these are fees and not taxes they can only be used to pay for the specific things Pharma has negotiated for. So in practice these sort of things simply don't get looked at and if they do there are a million ways to game the system and drag it out for so long that it simply doesn't matter.

Look at how FDA has been giving the bum's rush to Grassley and Stupak and Rep. Stupak's is head of an FDA oversight committee and his own son died because of drug side effect that FDA appears to have been not been forthcoming on.

Recent FDA activity not withstanding typically this means the FDA is highlighting a concern in order to get patient to move to newer patented treatments, protect the company from lawsuits, mollify Congress or some other reason.

If you understand mechanisms and how things work there is so much information that FDA and companies themselves have released via the labeling itself from drugs of all classes that it tells the astute person exactly what to ask for in discovery. No inside information is needed. Just like with what you're doing it's largely right there and publicly available if you know how to read between the lines.