House policymakers passed a user fee agreement this week between industry stakeholders and federal authorities for prescription drugs and medical devices.
This bipartisan pharmaceutical package streamlines the review process for new drug applications and acknowledges the gravity of shortages across the country. Notably, this legislation includes a provision extending market exclusivity for innovative drug developments that treat Fragile X Syndrome, Autism Spectrum Disorders and other neurodevelopmental disorders. Recent clinical studies dedicated to medicines for intellectual disabilities have presented promising findings in treatments that target the primary causes of these conditions. Maintaining market exclusivity for these novel therapeutics is crucial in guaranteeing that this research moves forward.
The bill, which also creates fee programs for generic drugs and biosimilars, is similar to an agreement advanced by the Senate last week. Both chambers are seeking to bring more therapies to the market, ultimately benefitting patients who are currently limited in their treatment options. Differences will be settled through conference negotiations.
I am committed to modernizing application programs for drug creators. This plan appropriately speeds up the review process and eliminates unnecessary steps delaying new treatments from reaching patients.
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Member of Congress