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Renewal Proposed for Pediatric Disease Drug Approval Program

The U.S. Senate is considering a proposal to extend a program that offers vouchers for fast-tracking FDA approval of drugs for rare pediatric diseases. Initially introduced in 2012, the program is set to expire soon, but Senators Bob Casey (D-PA) and Markwayne Mullin (R-OK) are advocating for a decade-long renewal. This extension is intended to provide more stability for pharmaceutical companies, encouraging them to develop new treatments for these diseases, which often have limited options.

Currently, only 5% of rare pediatric diseases, defined as serious conditions affecting under 200,000 U.S. patients, have approved treatments. The voucher system reduces the FDA approval process from 10 months to six, facilitating quicker patient access to new drugs. This accelerated approval has proven financially beneficial for drug companies, with most vouchers sold averaging $100 million each. Despite these benefits, the Government Accountability Office reports no increase in drug development due to the program, though it does help advance more drugs through clinical trials.

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