U.S. Senator Roger Marshall, M.D.’s Ensuring Innovation Act, introduced alongside Senators Bill Cassidy, M.D. (R-LA) and Tina Smith (D-MN) aimed at lowering prescription drug costs passed the U.S. House of Representatives April 14 and will be signed into law by President Joe Biden.
“As a physician, and now a U.S. Senator, I believe innovation and competition can have a profound impact on driving down the cost of health care,” said Dr. Marshall. “The current regulatory landscape unnecessarily delays patient access to FDA-approved generics. Our bipartisan legislation ensures affordable life-saving medicine while preserving innovation for cutting-edge medicine, and I’m pleased we are one step closer to this becoming law.”
Dr. Cassidy said, “We must lower prescription drug costs. We can do this by increasing competition and closing loopholes which prevent generics from reaching the marketplace. This bill does both.”
“We need to stand up for Americans who are struggling to afford life-saving prescription drugs. This is especially important as we navigate the public health and economic crisis of COVID-19,” said Senator Smith. “The House passage of our bipartisan Ensuring Innovation Act is important progress in the fight to make medications more effective and drive down costs for consumers. The next step is for President Biden to sign this into law.”
The Ensuring Innovation Act will provide clarity for drug exclusivity to prevent awarding market exclusivity to products that do not represent true innovation and unduly delay cheaper generic and “bio-similar” drugs from entering the market.
If a company invents an innovative new drug, they are rewarded with exclusive right to sell that drug for a period.
However, companies have found loopholes to claim new innovations on the same drug, that are not really innovations, to extend their exclusivity and prevent cheaper generics from coming to market.