Compounding the problem

"Jeez, Dr. Miller, did you just let one fly?" "Maybe I did. Maybe I didn't. But without the smoking gun, you can't pin it on me."you don't have any evidence so you can pin it on me." Last year, a Massachusetts compounding pharmacy released a contaminated batch of steroid medication which triggered a nationwide fungal meningitis outbreak that killed 61 people and sickened 750 more.

Now the US Senate is moving forward with legislation that would force the compounding industry to comply with federal regulations and require them to meet the “good manufacturing practices” that regular ol’ pharmaceutical manufacturers have to adhere to.

In recent testimony before the Senate, David Miller, CEO of the International Academy of Compounding Pharmacists, testified that, “We applaud the steps the Committee and the U.S. Senate are taking to ensure that compounded medications are as safe as they can be.”

But two years ago, the same David Miller sent out a memo to his members on how to stonewall federal inspections of their labs and medicines. The following interview is fictional. HOWEVER, all of Mr. Miller’s quotes are real … and accurately recounted.

Just a few more questions, Mr. Miller.

In 2011, just one year before this tragic fungal meningitis outbreak occurred, your organization sent a memo to its members offering advice on how to sidestep a Food and Drug Administration analysis of a another compound drug that they suspected might be substandard.

The FDA was concerned that the drug, 17P—used to reduce the risk of premature birth—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, 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 your 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:

http://iacprx.affiniscape.com/associations/13421/files/FDA17P%20Member%20Alert.pdf

“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?

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”?

The lesson: If you post it, email it, tweet it, or take a picture of it and give it a retro look before sending it to your bestie, it will never … ever go away. Just because you pull it off your website doesn't mean it's disappeared.

*It took us a little while to find this, maybe five or six minutes.