Bill to improve compounding pharmacy falls short of protecting public health

92_ayannaBy Ayanna Johnson, Health Policy Associate

Legislation proposed to clarify the practice of compounding pharmacy falls short of protecting the public’s health. In early October, a deadly meningitis outbreak killed 55 individuals and caused 741 cases of fungal meningitis, as a result of shoddy practices and absent safeguards at a large compounding facility in Massachusetts. The proposed bi-partisan legislation from the Senate Health, Education, labor and Pension (HELP) Committee was drafted in response to this outbreak, but does not do enough to address public health threats. After a unanimous vote in the HELP committee this Wednesday, the bill, S.959 the Pharmaceutical Compounding Quality and Accountability Act, is now headed to the full Senate for deliberation.

Compounding pharmacies provide a unique service to consumers by reformulating medicines for patients with special medical needs that cannot be met by FDA-approved drugs. However, compounding processes can introduce new risk into the health care system, as evidenced by the tragedy this past fall. This proposed legislation attempts to clearly define compounding pharmacies. The legislation clarifies that traditional compounding pharmacies will continue to be regulated by the states and then creates a new category for large-scale drug compounders and calls these businesses “compounding manufacturers.” These businesses make sterile compounded drugs in advance of a prescription and sell them across state lines.

Though the FDA is given the authority to regulate the new class of compounding manufacturers, there are concerns that FDA’s authority is not complete and that the definition of compounding manufacturers is too narrowly defined. In order to qualify in this category a business must meet all three of the following criteria: 1. Compounds at least one sterile drug. 2. Compounds before receiving a prescription. 3. Ships (sells) those drugs interstate.   However, this definition leaves open several questions. What happens if a compounder operates only within one state, and does not ship across state lines?  Also this definition does not allow for monitoring of large compounding pharmacies that sell non-sterile oral drugs, such as those used in cancer treatment. There have been reports of contaminated, counterfeit, and inactive drugs in this class of non-sterile drugs as well.

The bill allows traditional compounders to be regulated under existing state law, which varies from state to state—a further loophole in the regulation. According to a recent Washington Post article, the FDA believes that the proposed legislation limits its authority to appropriately protect public health. In early May, I attended the Senate HELP Committee hearing on this legislation, where Dr. Janet Woodcock of the FDA stated that the FDA needs clarity on its oversight role, as well as, access to additional documents and records from compounders on adverse events. Additional ambiguity lies with a clause calling for licensed pharmacist oversight in compounding manufacturers.  Does the clause require a licensed pharmacist be present during manufacturing or just generally be aware of the practices?  And the bill does not provide for appropriate labeling of compounded drugs to alert both health care providers and consumers that they are administering or receiving, respectively, a compounded drug.

It remains to be seen what will happen with the bill, but hopefully it will be strengthened to appropriately protect the public.  A recent report released by the US PIRG, a consumer health group, identified a number of lapses in authority and oversight of compounded pharmacies, by analyzing FDA warning letters sent to compounding pharmacies from 2002 to 2012. Numerous instances of contaminated products, or drugs produced without FDA approval, and distributed to patients were identified along with loopholes that compounders have used to avoid legal ramifications. The Senate also conducted a similar investigation since the October outbreak, finding that 48 large-scale compounders sold drugs that were contaminated or produced in unsanitary conditions.

What’s clear is that compounding pharmacy has evolved significantly, and if not appropriately monitored, can lead to unnecessary public health crises. The Senate legislation lacks teeth; but there is a House Bill being proposed by Congressman Ed Markey (D-MA.), which seeks to address some of the shortcomings outlined here, including broader FDA authority of compounding manufacturers and more communication among state and federal government. The National Consumers League, along with members of the Patient, Consumer and Public Health Coalition, backs this new bill.

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One thought on “Bill to improve compounding pharmacy falls short of protecting public health

  1. This bill falls short of protecting public health, but not for the reasons stated. This bill is a big power grab for the FDA, and big drug companies. It is designed to limit competition for big drug companies from compounding pharmacies. Access to compounded BHRT in particular could be significantly impacted by this bill–in a negative way, for the consumer (not for the big drug companies!). Many women have found BHRT to be a life-saver–this bill puts access to compounded BHRT at risk.

    A big concern: estriol (the bioidentical hormone) has a USP-NF monograph, so legally it can be compounded. The bill would allow FDA to identify bulk ingredients (page 24 of the draft bill) as “drugs not suitable for compounding” even though they have a monograph as estriol does! This is a huge concern to me. In the past, the FDA has attempted to ban bulk bioidentical estriol at the request of a pharmaceutical company. The current language of the bill could allow FDA to regulate away my access to that critical medication. Let’s not forget: the regular prescription drugs that the FDA promotes as an alternative to bioidentical estriol have been proven to be very dangerous. This provision is a direct danger for millions of women who depend on bioidentical estriol.

    Complex dosage forms and bulk ingredients should only be banned by the FDA based on the standard that already exists under current law. The bill’s language should be amended to reflect this standard: that the FDA must “reasonably demonstrate an adverse effect on the safety or effectiveness of the drug product.” This standard already provides assurances for both consumer access and consumer safety.

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