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Below, we provide a high-level summary of the Final Guidance, focusing on the legal and regulatory updates from the May 2023 draft guidance. Each phase-in policy allows eligible manufacturers to build up in a stepwise manner to the 10% and 20% applicable discounts by 2029 and 2031, respectively.
Although such designations are not typically a prerequisite for a voucher, the law is drafted so that once this first sunset date has passed, only designated programs may receive priority review vouchers for rare pediatric diseases until the program sunsets completely.
note : Please welcome Renee Knake Jefferson back to the pages of Above the Law. 2025 NYC Rule of Law Rally 2025 by David Lat is licensed under CC BY-NC-SA 4.0. The rally was held on May 1, established as Law Day by President Dwight Eisenhower May 1, 1958, as a day of national dedication to the principles of government under law.
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