Obama extends program for rare pediatric drugs | Chemical & Engineering News
Volume 94 Issue 41 | p. 17 | Concentrates
Issue Date: October 17, 2016

Obama extends program for rare pediatric drugs

By Glenn Hess, special to C&EN
Department: Government & Policy
Keywords: pharmaceuticals, FDA, rare pediatric disease, priority review, voucher, biotechnology

President Barack Obama has signed into law a bill (S. 1878) extending FDA’s rare pediatric disease priority review voucher program through the end of the year. The biotech industry, which strongly supports the program, is urging lawmakers to include a multiyear extension in the 21st Century Cures Act, a sweeping piece of health care legislation that is being negotiated by the House of Representatives and the Senate. The rare pediatric disease program awards a voucher to a drugmaker that wins approval of a treatment for an illness affecting 200,000 or fewer children. The company can later redeem the voucher when seeking approval for another medicine to treat any illness. FDA is obligated to review the other drug in six months instead of the standard 10 months. The Biotechnology Innovation Organization, an industry trade group, calls the voucher program “a critical incentive in promoting research into rare diseases affecting children.” But FDA has criticized the program, arguing the vouchers can delay reviews of more urgently needed medicines.

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