By Ed Silverman // December 10th, 2012 // 10:00 am
This was bound to happen. Amid the ongoing scandal over compounding pharmacies and regulatory oversight, the House Energy & Commerce Committee is now investigating the trade group of compounding pharmacies over concerns the organization may have deliberately instructed its members a year ago to impede an FDA review of ingredients used for a compounded medication.
“Allegations that your association may have encouraged compounding pharmacists to attempt to impede FDA from evaluating the efficacy and safety of their products, if true, raise serious concerns about your actions,” the committee wrote in a letter late last week to the International Academy of Compounding Pharmacists.
The missive was sent in light of an alarming outbreak of fungal meningitis that was traced to a Massachusetts compounding pharmacy, which was allegedly shipping large quantities of medicines to hospitals and physicians in numerous states, raising concerns about the ability of the FDA and state regulators to properly oversee compounders and confusion over their authority to do so. As of last week, there were 541 cases, including 36 deaths (see this).
The committee is referring to an issue that took place last year, when KV Pharmaceuticals asked the FDA to review samples of active pharmaceutical ingredients that the drugmaker alleged raised concerns about potency and purity of compounded versions of its Makena treatment for premature birth. Makena caused a separate controversy over the pricing of its drug (back stories here and here).
Early last year, you may recall, the FDA approved Makena, which is a form of progesterone that, for many years, was offered by compounding pharmacies. But KV was granted marketing exclusivity because approval was made under the Orphan Drug Act and the drugmaker, which was accused of price gouging, threatened to take compounding pharmacies to court.
The FDA agreed to review the samples provided by KV Pharma, as well as others from various API supplires and compounding pharmacies, although the agency later determined that the samples did not reveal any safety problems (read here). KV Pharma responded by suing the FDA, although it lost the lawsuit (back story).
Meanwhile, the IACP reportedly instructed members to be less than forthcoming and suggested they respond to FDA requests by saying, “We do not compound or distribute ‘samples’ of any of our prescription medications to anyone,” according toThe New York Times. If a compounded drug was found on site, IACP suggested pharmacists should say a patient was coming to get the medicine (here is the committee letter).
A spokesman for the IACP sends us this statement: “We strongly disagree with the conclusions contained in The New York Times story that was referenced in the Committee’s request. Moreover, it has diverted attention away from the cooperative efforts of the Academy in working to prevent a future tragedy as that caused by NECC and the failure of swift and decisive action by the Massachusetts Board of Registration in Pharmacy and the federal Food and Drug Administration. IACP’s submitted documents will not only refute the conclusions conveyed in the Times story but will also include correspondence with their reporters that clearly state the facts of the situation in question.”
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1 comment:
The IACP has some "good" member pharmacies, but also has its share of "rogue" pharmacies that engage in large scale manufacturing (without manufacturers' licenses) and wholesale distributing of drugs (without wholesale distributor's licensees). Instead of ensuring its members follow the law and put patient safety first, the IACP has behaved the way most trade groups do. It has vigorously defended even the "bad apples" as they faced off against the FDA and state pharmacy boards.
Well, now the bad bananas are spoiling the whole bunch. Good pharmacies will
have extra regulatory burdens because this trade organization refused to police itself.
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