WASHINGTON, D.C. – Sen. Mike Lee (R-UT) has proposed bipartisan legislation to cut drug prices and bureaucratic red tape for American consumers.
Introduced into the 119th Congress on June 4, the Biosimilar Red Tape Elimination Act would reduce drug prices and increase competition in the pharmaceutical market by categorizing generic “biosimilar” drugs as interchangeable with their name brand counterparts.
“Many consumers would choose a cheaper generic-brand version of their medications,” Lee explained, “but technicalities from Congress have kept these out of reach.
“This legislation will cut red tape to bring drug prices down, break up the big pharma monopolies and let Americans make their own medication choices.”
Generic alternatives to name-brand medications – termed “biosimilars” – have the potential to significantly reduce the cost of biologic drugs through increased competition, according to members of Lee’s staff in Washington.
Biosimilar drugs must undergo extensive testing to prove they provide no meaningful difference from their name-brand versions. Lee’s staffers emphasize that bringing a biosimilar drug to market can cost as much as $300 million and can take as long as nine years.
After that process, however, Congress has stepped in to protect big pharma monopolies by adding another hurtle called “interchangeability.”
To also be classified as “interchangeable,” a biosimilar drug must undergo additional costly and time-consuming switching studies. Lee’s staffers say that added research has been proven to be unnecessary and medical experts agree.
“As the Food and Drug Administration (FDA) has made clear, there is no clinically meaningful difference between biosimilars and interchangeable biosimilars,” according to John Murphy, president and CEO of the Association for Accessible Medicines.
“We look forward to working with Congress to eliminate this outdated and unnecessary barrier to lower-priced biosimilar medicines.”
Lee’s staffers say that the Biosimilar Red Tape Elimination Act would remove these extra steps so that a generic drug will immediately be classified as interchangeable after being approved by the FDA. The proposed legislation would also streamline the regulatory pathway for biosimilar approval by aligning the law with current scientific reality.
Lee’s proposal is being co-sponsored by Senators Rand Paul (R-KY), Maggie Hassan (D-NH) and Ben Ray Lujan (D-NM).