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Written by Sarah Dodge, International Academy of Compounding Pharmacists, Vice President of Government Affairs

Being IACP’s lobbyist in Washington means I deal not only with Congress and its staff, I also follow and oversee all the goings-on at the federal agencies… FDA, DEA, etc.

You probably heard or saw the recent  press-release from the FDA announcing their response to  a “study” which KV Pharmaceutical conducted to claim that their manufactured product Makena was better than compounded 17-P.  I was reading that about 10 minutes after it came out and called their press office for more information.  An interesting conversation because by the time I hung up, I thought “déjà vu all over again.” Click here to view Businessweek article.

I was immediately reminded of my first days on the staff of IACP when we tried diligently to get information from the FDA about their efforts to eliminate the rights of compounding pharmacists to compound medications with estriol in lieu of dispensing the Wyeth-manufactured Premarin. At the time, Wyeth had filed a “citizens’ petition” (which should have been called a BRAND NAME DRUG COMPANY  petition, but I digress) with the FDA asking them to prohibit the use of compounded estriol for menopausal women.

What absolutely confounded me was the information shared by the FDA (verbally) with Capitol Hill staff, yet nobody could ever quite put their hands-on or otherwise receive any factual proof of these cases – information which the FDA claimed proved that the use of compounded estriol (aka, bioidentical hormones) caused major “red flag” health incidents and other reports of “adverse health events” related to the use of estriol.

Despite these indications from the FDA, IACP staff and members were well aware of the use of estriol in Wyeth products outside of the United States. Thus, it became quickly apparent that – as long as Wyeth was the entity using estriol (overseas in this case), the product was safe. However, when compounding pharmacists used the product, it was “not safe” as alleged by the FDA and (conveniently) Wyeth.

To date, IACP has never received from the FDA, Hill Staff or any other entity factual information about any alleged adverse events or alleged cancer diagnoses as a result of the use of estriol as the agency originally alleged. Curiously, the FDA never mentioned or noticed or took any action against the carcinogenic effects of equilin, a metabolite of conjugated estrogens.  And the literature shows that equilin does increase cancer rates.  Court cases came and went and the industry largely thought that this issue was behind us…only to see it rear its head again and again in various other drug cases.

Today, the drug in question is compounded 17-P, which is used to prevent pre-term labor for pregnant mothers. KV Pharmaceutical has done everything in their power (from issuing cease and desist letters to compounders to making outrageous allegations in a desperate attempt to drive up their stock prices) to mitigate the use of 17-P. The latest round of litigation actually comes from shareholders of KV’s drug, Makena, (the brand-name medication approved by the FDA under the Orphan Drug Act and which sells for over 200% of the compounded medication price) against KV Pharmaceutical for “falsely” providing information to shareholders of factors made to inflate the price of Makena stock.

I immediately knew that we were seeing a repeat of the earlier and similar efforts of Wyeth.

In an effort to orchestrate consumer, regulatory and Congressional outrage about the use of 17-P in lieu of the branded product, Makena, KV Pharmaceutical alleged to the FDA that they were aware due to their own “internal testing” of sub-par and potentially harmful compounded 17-P. They told the FDA that it needed to do its own study of compounded 17-P to protect the public with the end result that the action would lead to an “endorsement” of Makena as the “better” drug. Because, as we all know, compounds are unsafe, illegal, subpotent, dangerous, insert-your-own-defamatory-adjective-here.

It gets murkier from there.

When IACP made multiple inquiries to the FDA which had formally come out on the side of compounded 17-P as an alternative (and which prompted CMS to permit reimbursement for it through state Medicaid programs would reimburse for the product), it became readily apparent that either 1) these KV “tests” were non-existent or 2) they were so secretive, that the agency couldn’t publicly acknowledge the existence or proof of such tests. Please excuse the cynic in me, but why is it a bit hard for me to believe that compounding pharmacists would readily put their compounded product in the hands of the very company who seeks to shut them down with regard to their compounding of 17-P?

After many inquiries to the FDA, that cynicism has not been relieved – not only do they claim (the very FDA staffers who are the contact people on their press release) not to know anything about the KV study, but to know nothing about the FDA’s own “study.” When IACP pressed further to get the “facts” on why the FDA was conducting field tests on bulk active pharmaceutical ingredients (APIs) made to compound 17-P, even the agency could give no clear answer.

The “concerns” that were expressed about the compounded product came from KV and the actual compounders involved were readily giving samples to FDA staff who visited their respective pharmacies. The only problem was, who called for the witch hunt and what was their legitimate basis for such an investigation? According to the FDA, they don’t even know the parameters of the their own 17-P “study” nor what they plan to do with the samples collected.  There’s no publicly accessible methodology, no independent laboratories or academic centers involved, just “we’re doing a study, trust us.”

 Yeah, right. All in all, I believe this is more of the same from the FDA.

Despite intense Congressional; physician group; and press speculation about KV’s tactics and extremely high price points for the Makena product,  KV continues at their end-game of creating a cloud of doubt with no definitive proof around their perceived “competitors.” I ask you, when is the FDA going to be fully transparent about information they allegedly receive and what they do (as an agency) to protect public health as opposed to protecting the stock prices of the drug manufacturers who align themselves so closely with the agency? It is time to demand answers to the troubling questions raised by KV Pharmaceutical and their ilk.