Dec. 17, 2013 Public Citizen to FDA: Stop Making Misleading Statements About Compounded Drugs Made by Outsourcing Facilities FDA Is Urging Health Care Providers to Use Compounded Drugs From Outsourcing Facilities Without Explaining the Risks

WASHINGTON, D.C. – The U.S. Food and Drug Administration (FDA) must stop making misleading statements that could lead health care providers to treat patients with compounded drugs without understanding that they are not as safe as FDA-approved drugs, Public Citizen saidin a letter to the agency today.

In a Dec. 2 blog post, FDA Commissioner Margaret Hamburg wrote that recently enacted legislation (the Drug Quality and Security Act of 2013) will enable certain pharmacy compounders to register with the FDA and become outsourcing facilities, making them subject to federal manufacturing standards, records inspections and certain other requirements. “To that end, we will be encouraging healthcare providers and health networks to consider purchasing compounded products from facilities that are registered with FDA,” she wrote.

And on Dec. 3, Jane Axelrad, associate director for policy at the FDA’s Center for Drug Evaluation and Research, made a similar statement during an Office of Health and Consumer Affairs conference call.

But outsourcing facilities, while subject to some federal requirements, are not subject to new drug approval requirements or other important federal provisions that help ensure that medicines are safe and effective.

 “As a result, your statement appears to be a broad endorsement of pharmaceutical products produced by outsourcing facilities, even in cases where FDA-approved products are also available to treat patients,” wrote Dr. Michael Carome, director of Public Citizen’s Health Research Group, and Sarah Sorscher, an attorney with the group.

Compounded drugs traditionally are those individually tailored for a specific patient to meet a medical need that cannot be met by an FDA-approved product. However, a new industry has cropped up in which companies calling themselves pharmacy compounders have engaged in what is essentially drug manufacturing: making standardized, mass-produced drugs and shipping them throughout the country. The Drug Quality and Security Act allows these manufacturers to voluntarily register with the FDA as “outsourcing facilities” and legally manufacture unapproved drugs under only a subset of the federal requirements that otherwise apply to mainstream drug manufacturers.

The dangers of compounded drugs became clear with last year’s outbreak associated with compounded steroids produced by the New England Compounding Center (NECC). To date, 751 patients have become ill and 64 have died after receiving injections from three lots of contaminated steroids produced by the NECC, even though an FDA-approved version of the same steroid was available at the time of the outbreak.

Public Citizen hopes that the FDA will step up enforcement under the new Drug Quality and Security Act to enhance the safety and quality of compounded products. Yet health care providers and patients should remain aware that no compounded product, whether made by an outsourcing facility or a traditional compounder, is FDA-approved. These products should not be used when FDA-approved alternatives are available.

“Many people, even some physicians, assume that if something is regulated by the FDA, it has been approved for safety and efficacy prior to marketing,” Carome said. “With outsourcing facilities, this will not be the case. Using unapproved products when FDA-approved products are available exposes patients to needless risk, particularly when the drug products are intended to be sterile and injected.”

Public Citizen urges the FDA to: 1) correct the commissioner’s blog post and other similar misleading agency statements; 2) encourage health care providers to carefully consider whether there is a legitimate clinical need for the non-FDA-approved product that outweighs the risks associated with using an unapproved drug to treat patients; and 3) coordinate with the medical community on a broader campaign to educate physicians on the relative risks associated with treating patients with drugs obtained from traditional compounders or outsourcing facilities compared to treating patients with FDA-approved products. Such a campaign could include public safety announcements, communications to physicians and patients published on the FDA’s website, blog posts and articles in major medical journals written by agency officials familiar with the issue.

The letter is available at http://www.citizen.org/hrg2175.