New House bill aims to shore up US API production in response to pandemic shortages
Amidst heavy demand for drugs and vaccines throughout the world, a new House bill, dubbed the PREPARE ACT of 2021, would create a national stockpile of active pharmaceutical ingredients and prevent supply chain shortages.
The bill, introduced by Reps. Abigail Spanberger (D-VA), and David McKinley (R-WV), would ensure the country has a stockpile of APIs needed to manufacture generics for a list of essential medicines that would be determined by a group that includes the FDA commissioner, the assistant secretary for preparedness and response and the secretary of defense. The FDA commissioner has already identified a list as of Oct. 30, which would be updated at least once a year.
Routine threat assessments would also be established, with each taking into consideration the lack of existing capacity, the current supply of medicines or API, the potential for increased demand in a public health emergency and whether or not there are fewer than two manufacturers of the generic medicine or API.
The bill aims to curb a US overreliance on API from other countries. Generic drugs make up 90% of the prescriptions filled in the US, a press release from the Senate says, and 87% of API facilities are outside the US.
Spanberger spoke about the resolution in front of a crowd at Virginia Commonwealth University. The school’s engineering department has been recognized for leading efforts to improve generic drug manufacturing through its Medicines for All Institute.
“Our bill is a step forward toward fixing these issues by creating a list of essential medicines and ensuring that the supply chains for these drugs are based here in the United States, using the most up-to-date technology,” Spanberger said.
The representative from Virginia has been grilled in recent weeks about how she would find funding to lower the cost of prescription drugs and support caregivers.
The bill was introduced in the Senate by Bill Cassidy (R-LA) and Sherrod Brown (D-OH), in mid-September.
“COVID reminded us that we are too reliant on foreign countries for generic drugs and pharmaceutical products. This bill brings enough production back to the U.S. so America is better prepared,” Cassidy said in a press release.