ICYMI: Biden Signs Sen. Marshall’s Bill to Lower Prescription Drug Prices into Law
(Washington, D.C., April 26, 2021) – On Friday, President Joe Biden signed into law U.S. Senator Roger Marshall, M.D.’s bipartisan bill to lower prescription drug prices. This bill is one of just 11 bills that the President has signed into law since being sworn-in on January 20th and is Marshall’s first bill to be signed into law since becoming a Senator. Marshall is the only Freshman Senate Republican to have a bill signed into law so far. Following the signing, Senator Marshall issued this statement:
“As a physician, I believe innovation and competition can have a profound impact on driving down the cost of health care. The current regulatory landscape unnecessarily delays patient access to FDA-approved generics. I’m pleased my first bill as a U.S. Senator to be signed into law ensures affordable life-saving medicine while preserving innovation for cutting-edge medicine.”
In case you missed it, here is some of what they are saying:
Senator Roger Marshall (R-Kan.) says on Friday, President Joe Biden signed into law his bipartisan legislation to lower prescription drug costs. He said the Ensuring Innovation Act will provide clarity for drug exclusivity to prevent awarding market exclusivity to products that do not represent true innovation and delay cheaper generic brands from entering the market.
Kansas Senator Roger Marshall announced the Ensuring Innovation Act, which is designed to lower prescription drug prices, has been signed by President Joe Biden. Marshall says the goal here is to close loopholes that award “market exclusivity” to drugs that don’t represent true innovation for prescriptions, thus delaying cheaper generic drugs from reaching consumers. Currently, the Food and Drug Administration gives so-called New Chemical Entities five years of exclusivity before generics can get to the market.
Currently, the FDA grants five years of exclusivity to drug products that are determined to be a New Chemical Entity (NCE). In order to be an NCE, a drug product must contain an “active moiety” that has not been used in a product previously approved by the FDA. This legislation will codify the FDA’s current “active moiety” approach to granting NCE exclusivity.
If a company invents an innovative new drug, they are rewarded with exclusive right to sell that drug for a period of time. However, companies have found loopholes to claim new innovations on the same drug, that aren’t really innovations, to extend their exclusivity and prevent cheaper generics from coming to market. The Ensuring Innovation Act would close loopholes to prevent awarding market exclusivity to products that do not represent true innovation and unduly delay cheaper generics from entering the market.
Introduced in February, the Ensuring Innovation Act passed the Senate on March 10, 2021 by unanimous consent. It passed the House of Representatives on April 14, 2021 by voice vote.