May 22, 2103
The Honorable Edward J. Markey
Energy and Commerce Committee
U.S. House of Representatives
Washington, DC 20515
Dear Congressman Markey,
As members of the Patient, Consumer, and Public Health Coalition, we strongly support the Verifying Authority and Legality in Drug (VALID) Compounding Act of 2013. This bill would significantly strengthen FDA oversight of compounding pharmacies in several essential ways, and is clearly needed to prevent tragedies such as the contaminated steroid injections that have already resulted in 741 cases of fungal meningitis and 55 deaths.
The current laws and regulations regarding compounding pharmacies have resulted in giant loopholes that allow medical products that are not tested for safety or efficacy to be sold throughout the country, putting patients’ lives at risk. We are very grateful to you for your leadership on this very important, life-saving bill.
The VALID Act would protect the activities of traditional small compounding pharmacies while ensuring that compounding pharmacies that are essentially operating as drug manufacturers are solely regulated by the FDA. The VALID Act would give the FDA authority to define safety, testing, inspection, and reporting requirements for products compounded in advance of a prescription. It would require pharmacies that are engaged in interstate commerce or producing high-risk sterile products to register with the FDA. The bill would require compounded drugs to be labeled to ensure that patients and health care providers are aware that they are receiving compounded drugs, and how to report serious adverse events to the FDA. It would authorize the FDA to collect fees from pharmacies to offset the cost of inspection and oversight.
Contamination of compounded medications used in injections or intravenously have killed patients and undermined confidence in medical products. However, sterile products are not the only kinds of important medications that need to be regulated to ensure they are safe and effective. The VALID Compounding Act recognizes that lives depend on ensuring that cancer drugs, heart medications, and all other life-saving medical products are also made safely.
We look forward to working with you on the VALID Act, and thank you for your commitment to the health of patients and consumers.
National Consumers League
National Research Center for Women & Families / Cancer Prevention and Treatment Fund
National Women’s Health Network
Our Bodies Ourselves
The TMJ Association
Center for Science and Democracy, Union of Concerned Scientists