Representatives Mariannette Miller-Meeks (IA-02), Greg Murphy (NC-03), Nanette Barragán (CA-44), and Ann Kuster (D-NH) today introduced the Biologics Competition Act, legislation to direct the Secretary of Health and Human Services to evaluate the process by which interchangeable biological products are approved to be used in pharmaceuticals. In many cases, these products are more affordable, increase pharmaceutical drug competition, and the ability to use them interchangeably will lower drug prices. Text of the bill may be found here.
“As pharmaceutical prices continue to skyrocket, we must do everything in our power to make lifesaving drugs more affordable for those in need,” said Representative Miller-Meeks, M.D. “Our bill will encourage the Department of Health and Human Services to expedite the approval process for biosimilar products which may be used interchangeably in place of more expensive drugs.”
“As a physician of more than 30 years, I am deeply committed to advancing legislation which promotes access to affordable and accessible lifesaving cures,” said Representative Greg Murphy, M.D. “Our bill, the Biologics Competition Act, is an important bipartisan measure which will allow Congress to gain a better understanding of the barriers to interchangeable substitution to increase competition and lower costs.”
“At a time when Americans are struggling to afford the escalating prices for prescription drugs, bureaucracy can’t get in the way of Americans accessing life-saving medicines,” said Representative Barragán. “I am proud to join Reps. Miller-Meeks, Murphy, and Kuster in working to make biosimilars more accessible and affordable to the American people. Our bill will make HHS take a closer look at the unnecessary hurdles that delay access to innovative biosimilars and report back to Congress. Interchangeable biologics can reduce drug costs, and this bill takes an important step forward to ensure they are accessible to patients.”
“Too many Granite Staters are suffering because of the high costs of prescription drugs. We have taken action to bring costs down at the pharmacy counter, but we must do more to ensure Granite Staters can afford the medications they need,” said Representative Kuster. “Our bill aims to speed up the approval process for less expensive drugs, making them available more quickly and expanding access to affordable, life-saving medications.”
Background:
Currently, the process by which the Food and Drug Administration (FDA) approves generic drugs is different from that of biological products. When a generic drug is approved it is assigned a Therapeutic Equivalence (TE) rating, but biological products are instead designated as “interchangeable” which creates uncertainty among pharmacists. Because interchangeable products are new to the industry, there have been very few reports done to examine the efficiency of their approval process.
This legislation would require the Department of Health and Human Services to conduct a study on the approval process of interchangeable biological products to ensure these products are available to pharmacists in an efficient manner.
Original source can be found here
