WASHINGTON, D.C. — Today, Congresswoman Nikki Budzinski (IL-13) introduced the Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act, which would discourage pharmaceutical companies from parking their exclusivity on a generic drug application.
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“Too many Americans are burdened by high drug prices, and Congress must act. Current policies are failing to foster competition and are hindering affordable options,” said Congresswoman Budzinski. “This bill aims to right this wrong by reducing exclusivity, enabling generics to enter the market sooner and lower prices for people.”
Under current law, drug manufacturers are granted 180 days of market exclusivity when they are the first to file a generic drug application for a drug that does not yet have a generic. Unfortunately, some companies "park" or "hold" their exclusivity, blocking other companies from producing generics and keeping prices inflated.
The BLOCKING Act seeks to discourage this practice, enabling more generics to enter the market more quickly. The bill specifies that if a company delays a second generic by holding its tentative approval, the 180-day exclusivity will start once specific conditions are met.
The legislation also includes protections to ensure fair competition and provide ample protection to first generic drug submissions. It does this by 1) clarifying that any generic drug applications go to the earliest applicant; 2) providing for first filer protection from secondary applications if the first filer can present issues that are preventing the company from marketing the drug; and 3) clarifying that this legislation is only forward-looking and does not apply retroactively to previous applications.
The BLOCKING Act is endorsed by the American Academy of Family Physicians.
Since coming to Congress, Congresswoman Budzinski has been committed to lowering drug prices, driving competition, and advocating for rural pharmacies. In the 118th Congress, she was a cosponsor of the bipartisan Pharmacists Fight Back Act, Drug Price Transparency in Medicaid Act, and voted to pass the Lower Costs, More Transparency Act.
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