Delays Threaten Drug Compounding Safety

By Walter F. Roche Jr.

Delays by federal regulators in fully implementing a 2013 law designed to regulate drug compounders is reckless and a threat to public health, according to the head of an advocacy group.
Michael Carome of Public Citizen said that officials of the U.S. Food and Drug Administration have taken more than six years and have yet to come up with a list of bulk drugs that drug compounders can use to safely produce their products.
Creation of the list was mandated in a 2013 federal law, the Drug Quality and Security Act (DQSA) passed in the wake of the deadly 2012 fungal meningitis outbreak. A proposed list has been created which is composed of drugs nominated for inclusion by interested parties, including so-called outsourcers who, under the law, are authorized to mass produce compound drugs without patient-specific prescriptions.
Carome said while he does believes the law has improved the overall regulation of pharmacy compounding, the failure to produce a definitive list of bulk drugs that meet the law's requirements has created a huge loophole.
"The FDA has implemented a blanket interim policy under which it has decided not to enforce a key provision (of 503B)," Carome wrote.
Public Citizen has expressed its concerns about FDA's "foot dragging" in letters to the FDA and members of Congress.
In a letter sent late last year to key congressional members Carome wrote that the failure of the FDA to draw up a definitive list was "indefensible, reckless, and a threat to public health."
He had said the same thing in a letter to the FDA a month earlier.
Carome also charged that the drugs were nominated for inclusion on the list "not to ensure that unmet clinical needs are satisfied but rather to meet commercial goals."
The FDA says that drawing up the mandated list is an agency priority.
"Hundreds of drugs were nominated for each list and we have been working to address those substances," FDA spokesman Jeremy Kahn wrote in response to questions. Kahn noted that the agency has issued a list of nine bulk drugs it has proposed to exclude from the list.
"FDA oversight of compounding continues to remain essential, because compounded drugs, while important to patients who need them, pose ongoing and serious risks if they are not manufactured properly," Kahn added.
He noted that the FDA continues to find cases in which patients suffer serious harm due to improperly compounded drugs.
"While some compounders work hard to meet quality standards including avoiding insanitary conditions, we recognize that there are still compounders that are not in compliance," he added.
In Congress bills to cut back some provisions of the 2013 law have been filed, but have not even come to a floor vote.
Backers of those bills have argued that the FDA's actions threaten to cut off the supply of needed compounded drugs. Those include special formulations of drugs to accommodate the needs of patients with allergies to components of mass manufactured drug products.
Liz Richardson of the Pew Charitable Trusts, which has taken an active role in the drug compounding issue, noted that a study by Pew found that state regulation of small compounders licensed by state pharmacy boards showed wide variation in the level of inspection and enforcement. She said an updated version of the study will be issued shortly. She noted that some states have acknowledged a lack of resources for compounding inspection and enforcement. And some state boards have yet to align their policies to the new federal law.
Richardson also expressed concern about the continuing discovery of illnesses caused by drug compounders who have failed to adhere to sterility and other minimum production standards.
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