Wednesday, October 24, 2012

Compounding the Problem

Just a few more questions, Mr. Miller.

The tragic fungal meningitis outbreak that killed 23 people triggered numerous federal investigations, including a criminal investigation. While these may be among the most serious inquiries the compounding industry has had to endure, they are not the first.

Exactly one year ago today your organization, the International Academy of Compounding Pharmacists, sent a memo to its members offering advice on how to sidestep a Food and Drug Administration analysis of a compound drug that they suspected might be substandard.

The FDA was concerned that the drug—used to reduce the risk of premature birth, called 17P—might be made with unapproved Chinese ingredients, so they were calling compounding pharmacists and requesting samples of the drug to test. As CEO of the trade association representing compounding pharmacists, whose Code of Ethics is “designed to … advocate acceptance of a personal obligation to the highest ethical and professional standards of conduct,” wouldn’t it have made more sense to help rather than hinder the FDA in this matter?

 There was no evidence that any of the calls pharmacies received were coming from a genuine governmental official.”

But the title of the memo was “F.D.A. Calling Compounders about 17-P.”

Regulators do not ‘call around’ asking for information. They come to a pharmacy with an official inspection form.”

But I’m reading the actual memo—I can send you the link if you’d like—it says:

“On Friday afternoon, IACP found out that the Food and Drug Administration is calling compounding pharmacies and asking questions about 17-P. … In some instances, the FDA representative has asked for ‘samples’ or if you have any 17-P already compounded and on your shelves.  … It is absolutely critical that you manage these calls and conversations carefully.”

The memo goes on to offer “some suggested responses” to “some of the questions we know have been asked of compounders.” Here, let me read you a few of the recommendations.

Do you compound 17-P?
Yes, upon receipt of a valid prescription from a prescriber.

If we give you a prescription, can you compound 17-P for us to test?
Even if our pharmacy received a prescription from a prescriber licensed in our state, we would not consider it a valid prescription because it would not be for a specific, legitimate patient.

Do you have samples of 17-P?
A dose of reality: If you write it,
it will appear on the Internet.
We do not compound or distribute "samples" of any of our prescription medications to anyone.

Do you have pre-made 17-P available? We would like to pick some up and test it.
We do not maintain compounded 17-P in stock because our pharmacy prepares 17-P upon receipt of a prescription from a patient or prescriber. If we have any 17-P prepared currently, it is awaiting pick-up for one of our patients.

Weren’t you concerned that the memo makes it look like you are encouraging your members to stonewall the FDA inquiry?

“There is not one word in that document that says do not comply with a regulator.”

That may be technically accurate. But there aren’t many words encouraging your members to be helpful either.

One last question, Mr. Miller. Have you ever heard the expression, “If you don’t want it on the front page of The New York Times don’t put it in print”?

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