“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 to The 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."
The move by the House committee to probe the trade group comes after both the House and Senate held hearings into the compounding pharmacy scandal. The FDA has complained that it lacks the needed authority to pursue compounders, unless these operations engaged in interstate shipments of large quantities of medications, which NECC had allegedly done. The FDA was criticized for failing to take more aggressive action after a 2006 warning letter had been issued.
FDA commish Margaret Hamburg has sinced proposed two classes compounders for regulatory oversight: traditional and so-called non-traditional compounding. Traditional compounding refers to the recognized practice of mixing or altering ingredients for individual patients on an as-needed basis. But non-traditional compounding poses a higher risk that she argued would – and should – require federal government oversight, as opposed to state oversight.
Separately, Massachusetts health officials, who have also been criticized for failing to properly investigate NECC, has been scrambling to review its procedures and last week issued cease and desist notices to three compounding pharmacies found to have problems in how they prepared or stored drugs.
The Department of Public Health also replaced three of the 11 members of the Board of Pharmacy, including Sophia Pasedis, who is vp of regulatory affairs and compliance at Ameridose, which is owned by Barry Cadden and Gregory Conigliaro, who also own New England Compounding Center. It is not clear if the three new members have a pharmacy background (read here).