Washington, D.C. — U.S. Senators Ted Budd (R-N.C.) and Maggie Hassan (D-N.H.) recently introduced the bipartisan Medication Competition Act, which would expedite the development of lower-cost alternatives to biologic medications, known as biosimilars. The legislation would require the FDA to publicly determine and list when brand-name drug exclusivity ends, allowing cheaper alternatives to come to market more quickly. Biologic drugs are a complex class of medications commonly used in cancer immunotherapy, autoimmune disease treatment, and certain insulin products. Biologic drugs tend to cost more than other medications, and very few biologic drugs face lower-cost competition.
“To lower the cost of prescription drugs, we need to enable low-cost biological drugs to reach consumers faster. Unclear policy on the exclusivity periods of biologics at the FDA is inhibiting competition, making it more challenging for the manufacturers of these lower-cost alternatives to develop new medicines. I am glad to join Senator Hassan in closing this loophole to help patients access the drugs they need at more affordable prices,” said Senator Budd.
“Big Pharma benefits from a loophole in federal law where it can keep the exclusivity dates on certain prescription drugs secret, making it harder for competitors to enter the market. This bipartisan bill requires the FDA to publicly determine and disclose when these exclusivity periods end, helping bring lower-cost alternatives to the market sooner. I urge my colleagues to support this commonsense effort to bring more transparency and competition to the market,” said Senator Hassan.
Read the full bill text HERE.
BACKGROUND
Federal law requires the Food and Drug Administration (FDA) to publicly specify the exclusivity period for biologic medications and list it. However, a loophole in federal law does not require the FDA to calculate the exclusivity period for all biologic drugs, meaning that of the more than 200 currently approved drugs in this category, only three have the exclusivity period publicly listed. Closing this loophole is critical to helping generic drug manufacturers plan for new, lower-priced products—increasing competition, lowering costs for families, and stopping monopolies from going on longer than necessary.
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