Senators Hassan, Budd Introduce Bipartisan Bill to Speed Up the Development of Generic Medications

WASHINGTON - U.S. Senators Maggie Hassan (D-NH) and Ted Budd (R-NC) introduced bipartisan legislation that would expedite the development of "generic" biologic medications. The Medication Competition Act would require the FDA to publicly determine and then list when brand-name drug exclusivity ends, allowing lower-cost alternatives to come to market more quickly. Biologic drugs are a complex kind of medication commonly used in cancer immunotherapy, autoimmune condition treatment, and certain insulin products. Biologic drugs tend to cost more than other medications, and very few biologic drugs have generic alternatives.

"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," said Senator Hassan. "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."

"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.

Federal law requires the FDA to publicly specify the exclusivity period for biologic medications when the agency already knows it. However, a loophole in the law does not require FDA to actually calculate the exclusivity period for all biologic drugs, meaning that of the more than 200 currently approved drugs in this category, only three currently 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 Big Pharma monopolies from going on longer than necessary.

This legislation is part of Senator Hassan's work to lower prescription drug costs for Americans. Earlier this year, two of Senator Hassan's bipartisan measures to lower prescription drug costs passed into law. The Increasing Transparency in Generic Drug Applications Act will speed the approval of generic drugs by ending the lengthy guessing game that manufacturers currently go through with the FDA, enabling generic drugs to get to market sooner, lowering prices for consumers, and saving taxpayer dollars. The Patients Before Middlemen (PBM) Act helps stop pharmacy benefit managers from driving up prescription drug pricing for seniors. Last month, Senator Hassan successfully forced a big pharmaceutical company to abandon its monopoly and egregious price hike strategy to allow a lower-cost generic inhaler for children to enter the market.

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