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September 27, 2013

Proposed Compromise Compounding Bill Threatens Patient Safety by Allowing ‘Outsourcing Facilities’ to Manufacture Drugs Without New Drug Approval

Statement of Dr. Michael Carome, Director, Public Citizen’s Health Research Group

A year after a deadly disease outbreak linked to tainted compounded drugs distributed by the New England Compounding Center (NECC), Congress has reached agreement on a measure that would make it easier for companies like the NECC to manufacture substandard drugs like the one that caused the outbreak, without Food and Drug Administration (FDA) approval, under the guise of pharmacy compounding.

The bill, entitled the “Drug Quality and Security Act,” was released this week by leaders of the Senate and House of Representatives committees that oversee health policy, and represents an agreed compromise between both chambers. It has misleadingly been presented to the American public as something that improves federal oversight over compounding pharmacies.

Yet under existing law, the FDA already has authority to take action against pharmacies that, like the NECC, engage in illegal drug manufacturing. The FDA has failed to fully exercise this authority, claiming that the existing laws defining the line between traditional compounding and drug manufacturing are ambiguous and hard to enforce.

The FDA can do more to prevent another NECC-like disaster by being more aggressive in enforcing existing law. Congress also can help by passing a law that clarifies the line between drug manufacturing and compounding, and does other important things like requiring warning labels for compounded drugs, and giving the FDA authority to inspect pharmacy records.

Yet Congress has proposed a bill that does not do any of these things. Instead, it preserves the provisions that compounding pharmacies have abused under existing law and lax FDA oversight, and that they have used to produce unproven, unsafe drugs.

The bill also does something much worse. It creates a new category of companies, called “outsourcing facilities” that would be allowed to mass-produce standardized drug products without seeking FDA pre-market approval, particularly during drug shortages. This kind of large-scale production is not compounding; it is drug manufacturing, and it is illegal under current law.

In fact, under the compromise bill, any company that makes sterile drugs would be offered the voluntary option to register itself as an “outsourcing facility” and manufacture from raw active ingredients unapproved sterile and non-sterile drugs that appear on the FDA’s drug shortages list or on a “clinical need” list created by the FDA. This means even drug manufacturers that currently make FDA-approved drugs would, under this measure, have the ability to make and sell drugs to meet shortages and “clinical needs” without seeking premarket approval. Such approval is a critically important requirement under existing law that has helped to ensure the safety and quality of drugs for more than half a century.

Furthermore, the drugs made would not be labeled to warn health care providers and patients that the drugs have not been approved by the FDA. In fact, many of the drugs would have no federal labeling requirement at all.

The current approval process for new drugs is needed now more than ever to protect patients from the type of low-quality manufactured drugs that led to the NECC disaster and multiple other disease outbreaks. But a measure allowing drug manufacturers to make unapproved drugs to address drugs shortages or meet “clinical needs” is not a solution — it makes things worse. Congress should reject this bill and come back with a proposal that protects patients, rather than further endangering them.

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