The Senate approved bipartisan legislation on Friday that House Energy and Commerce Committee Chairman Rep. Fred Upton (R-Mich.) introduced to enhance drug safety and prevent fatal fungal meningitis outbreaks.
Upton authored the Drug Quality and Security Act in response to a nationwide fungal meningitis outbreak in 2012 that infected 751 people and killed 44. Michigan was one of the hardest hit states with 264 cases and 19 deaths reported there.
“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,'” Upton said. “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,”
The measure would clarify the FDA’s authority to oversee the compounding of human drugs and require the agency to work with states to ensure the safety of compounded drugs. It would also offer protections to traditional pharmacies and add clarity to the definition of compound drugs.
“Americans receiving medical treatments must have the peace of mind that their drugs are safe,” Upton said. “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 Drug Quality and Security Act also would bolster the supply chain of prescription drugs to prevent counterfeit drugs from entering the market. Those measures would help prevent drug price increases, drug shortages and cut hundreds of millions of dollars in redundant government regulations that impact pharmaceutical companies.
The measure will next advance to the president for consideration.