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Thursday, May 30, 2013
May 30, 2013: Rep. Markey Introduces Bill to Support Compounding of Drug Products
WASHINGTON, May 30 -- Rep. Edward Markey, D-Mass., has introduced legislation (H.R. 2186) to amend the Federal Food, Drug, and Cosmetic Act to "provide for the compounding of drug products."
Contact: Eben Burnham-Snyder, Rep. Ed Markey, 202-225-2836
Follows Investigation Showing Lax Oversight of Compounding
WASHINGTON (May 23, 2013) – After his recent report showed that some states across the country are turning a blind eye to the risks of compounding pharmacies, Rep. Ed Markey (D-Mass.) today introduced new legislation to make compounding pharmacies safer for patients. The legislation will strengthen federal regulations for compounding pharmacies, especially high-risk sterile compounding and compounding pharmacies that ship drugs across state lines.
An investigation led by Rep. Markey and his Energy and Commerce Committee colleagues found last month that compounding pharmacies are going largely untracked, unregulated, and under-inspected by states across America, demonstrating the need for more federal oversight of the industry. Many of the risks from compounders were revealed following the 55 deaths and 741 illnesses in 20 states that originated from drugs created at the New England Compounding Center located in Rep. Markey’s Congressional District.
“We know some compounders are acting more like large drug manufacturers. We know that patients continue to be at risk for injury or death. And we know that some states are not doing their jobs to protect patients,” said Rep. Markey. “That’s why we need legislation that gives FDA more authority, while still allowing smaller mom-and-pop compounders to do their work for their patients.”
Massachusetts Governor Deval Patrick today praised Rep. Markey for his leadership on compounding pharmacy oversight. Governor Patrick has instituted a top-to-bottom review and proposed actions to increase the health and safety of compounding pharmacies in Massachusetts following the NECC tragedy.
“Congressman Markey’s legislation, coupled with the important steps we took at the state level, is critical to closing a regulatory gap created over the past several years for a variety of reasons,” said Governor Deval Patrick. “I commend Congressman Markey for his leadership. No one should live in fear that their medicine is unsafe.”
The legislation, the VALID Compounding Act, updates previous legislation introduced in 2012 by Rep. Markey. Original co-sponsors of the bill are Louise Slaughter (D-N.Y.), WM. Lacy Clay (D-Mo.), and Charles Rangel (D-N.Y.).
A one-pager on the VALID Act is available HERE, and the legislation includes the following main elements:
--Provides the FDA with sole regulatory authority over compounding pharmacies that engage in interstate commerce and high-risk sterile compounding without or in advance of a prescription.
--Preserves State regulatory authority for traditional small compounding pharmacies.
--Allows compounding pharmacies to compound drugs before receiving prescriptions for the drug provided that they register with the FDA and meet specified safety standards, and allows capable State regulators to oversee these pharmacies.
--Increases communication between the States and federal government.
--Increases transparency to patients and consumers.
A full copy of the legislation can be found HERE and a section-by-section document HERE.
“This bill will save lives because it improves safeguards for all types of important medications made by the largest compounding pharmacies,” said Diana Zuckerman, PhD, president of the Cancer Prevention and Treatment Fund and National Research Center for Women & Families. “At the same time, it protects the thousands of small 'Mom & Pop' traditional compounders that some patients need.”
The legislation has been endorsed by the National Consumers League, National Research Center for Women and Families, Cancer Prevention and Treatment Fund, National Women’s Health Network, Our Bodies Ourselves, Union of Concerned Scientists, U.S. PIRG, Community Catalyst, The TMJ Association, and WoodyMatters. A copy of the endorsement letter can be found HERE