DeLauro to Introduce Legislation Enabling FDA Oversight Of Compounding Pharmacies
Meningitis Outbreak another Example of a Failed Regulatory Patchwork
NEW HAVEN, CT—Congresswoman Rosa DeLauro (CT-3) announced today she will be introducing legislation to strengthen the Food and Drug Administration (FDA)’s authority to ensure the safety of drugs from compounding pharmacies. Such a facility is at the root of the current fungal meningitis outbreak that has killed 11 people and sickened 119 in nine states. These pharmacies are intended to create customized versions of medicine for specific patients, not bulk production of medications, such as the estimated 17,000 steroid injections tied to the outbreak. Currently the pharmacies are licensed and overseen by a patchwork of state agencies and the FDA’s guidance to states on licensing such pharmacies was last updated in 2002. The pharmacy that produced the potentially contaminated drug responsible for the current outbreak has surrendered its license to the Massachusetts State Board of Pharmacy and all compounds from the facility have been recalled.
DeLauro also sent a letter to Health and Human Services Secretary Kathleen Sebelius requesting information about the gaps in our drug safety system posed by compounded products and the need to better protect patients, including those enrolled in Medicare. “I believe this outbreak and corresponding recall make clear that strong Federal authority is needed over these large scale compounding pharmacies to ensure that patients receive safe and effective drugs, that we better monitor adverse events associated with these drugs, and that there is a single entity responsible for verifying appropriate marketing and safe drug production,” she wrote. “It is also critical that Federal and State partners responsible for this oversight have the resources and capacity needed to complete this work.”
DeLauro is a senior Democrat on the House of Representatives committee that funds the FDA and a longtime champion for strengthening oversight responsibilities and increased funding for the agency. Details on the recall may be found hereand information on the fungal meningitis outbreak may be found here.
The letter is as follows:
October 9, 2012
The Honorable Kathleen Sebelius
Department of Health and Human Services
200 Independence Avenue, S.W.
Washington, D.C. 20202
Dear Secretary Sebelius:
I write today out of grave concern regarding the ongoing outbreak of fungal meningitis that has been linked to an epidural injection of a compounded drug. As of today, more than 100 cases of fungal meningitis, including 11 deaths, have been linked to a specific steroid injection drug produced by a single compounding pharmacy center. This outbreak and the corresponding recall of products from the New England Compounding Center expose dramatic gaps in our drug safety standards that create an unnecessary risk to the public health.
I believe this outbreak and corresponding recall make clear that strong Federal authority is needed over these large scale compounding pharmacies to ensure that patients receive safe and effective drugs, that we better monitor adverse events associated with these drugs, and that there is a single entity responsible for verifying appropriate marketing and safe drug production. It is also critical that Federal and State partners responsible for this oversight have the resources and capacity needed to complete this work.
As you know, drug compounding is traditionally viewed as the creation of a specific drug for a particular patient when there is not an alternative approved by the Food and Drug Administration (FDA). Compounded drugs may play a valuable role for some patients and their health care providers based on the patients’ specific health needs. A 2001 FDA survey, however, found that products from compounding pharmacies had a “higher than expected” failure rate, thus indicating that they may convey a different risk than other pharmaceutical products. Another FDA survey conducted in 2006 identified clear concerns about the safety, potency, and uniformity of some compounded drugs.
Moreover, some compounding pharmacies have evolved into large scale operations that produce sizeable quantities of some drugs. For example, cases in the current outbreak are spread across nine states and more than 17,500 doses of the potentially contaminated drug were shipped to twenty-three states. At the same time, the FDA lacks clear authority for ensuring the safety of these products and last updated its guidance for industry in 2002.
Because of the current vague patchwork of Federal and State oversight and regulation of these pharmacies, consumers are left at risk and often unaware of the differences between these products and others. I believe that we must do more to ensure the safety of these products for American consumers, to make certain that consumers have the information they need to make an informed choice, and to verify that Medicare is accurately reimbursing for the use of these products sometimes used by our nation’s seniors.
In light of these concerns and my intent to work to improve the safety of these products, I would appreciate your timely response to the following questions:
· How is your Department reaching out to health care providers and their patients to ensure that such a large possible patient population is quickly and efficiently notified that their health may be at risk?
· How can your Department work with State partners to ensure that compounding pharmacies and centers follow safe preparation techniques to minimize the risk of contaminated products entering the marketplace?
· Which laboratory standards does the Department consider to be the premier standard for these pharmacy facilities? How can the Department strengthen oversight of these centers and work to ensure that the facilities comply with appropriate laboratory standards?
· Within your Department’s existing authority, how can HHS encourage reporting of adverse events with compounded drugs and monitor those adverse events? Would additional authority, requiring the reporting of these adverse events, enable the agency to better protect the public health and quickly communicate with patients and health care providers?
· What authorities does your Department believe it needs to ensure that non-traditional compounding centers, such as the center involved in this latest outbreak and recall, are appropriately regulated at the Federal level?
· How does your Department ensure the safety and efficacy of compounded drugs that are prescribed for patients enrolled in Medicare and reimbursed by the program?
· How does your Department conduct outreach to Medicare patient and health care providers to convey the risk of compounded drugs?
· How does your Department ensure that Medicare reimbursements do not inadvertently incentivize the use of compounded drugs?
Thank you for your prompt attention to this critical public health issue. I look forward to your response to these questions and to our continued work to ensure the safety of the drugs used to treat American patients and to prevent future outbreaks like these.
ROSA L. DeLAURO
Member of Congress