Drug Quality and Security Act Heads to President's Desk
The U.S. Senate has approved H.R. 3204, a bill introduced by U.S. House Energy and Commerce Committee Chairman Fred Upton, R-Mo., meant to improve oversight on compounding pharmacies.
President Obama will have the opportunity to sign into law H.R. 3204, the Drug Quality and Security Act, a bill prompted by the 2012 fungal meningitis outbreak, which killed 64 people and was linked to contaminated injectable steroids distributed by the New England Compounding Center. It was introduced by U.S. House Energy and Commerce Committee Chairman Fred Upton, R-Mo., who says Michigan families were hit hardest by that outbreak, with 264 cases and 19 deaths, including three people living in Upton's district who died.
The House passed the bill by voice vote Sept. 28, and the Senate did likewise Nov. 18, sending it on to President Obama's desk.
"To the dozens of families who have lost loved ones and to the hundreds who are still suffering today, with this bill we say 'never again.' I applaud the Senate's passage of this breakthrough bipartisan legislation and am pleased we are now just one step away from this bill being signed into law to prevent a future public health crisis like last year's deadly fungal meningitis outbreak," Upton said in a statement posted on his office's website. "Americans receiving medical treatments must have the peace of mind that their drugs are safe. With this bill, we are fortifying the drug supply chain while also cutting needless regulatory red tape that is harming Michigan businesses like Perrigo and Pfizer, creating an environment conducive to growth and job creation."
The bill clarifies FDA's authority over compounding pharmacies and requires the agency to coordinate with states to ensure the safety of compounded drugs.