A controversial program created by Congress to spur development of new drugs for neglected tropical diseases has failed to achieve its goals, according to a new analysis.
Known as priority review vouchers, these are awarded to drug makers that win regulatory approval of a tropical disease treatment and can later be redeemed when the company seeks approval for yet another medicine for treating any illness. Moreover, the Food and Drug Administration must review the other drug in six months, instead of the standard 10 months.
There is very little traction for a bill that would seek to deprive Americans of gold standard therapies simply because they have been approved in other countries. There is no fundamental biological property dictating that novelty equates to better safety or efficacy. I am sure we can argue about whether a PRV should be awarded for bringing an already approved drug to the U.S. but the intent of the legislation and the FDA is clear. The FDA Guidance for Industry, Question 16, page 7 states that products that have been approved and used in other countries but not previously submitted for FDA reviewed would be eligible for a tropical disease PRV (http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0530-gdl.pdf). This is not a “loophole” as some others have suggested but exactly what the legislation and the FDA encouraged. The PRV program is designed to encourage bringing both novel drugs to the world and existing drugs to the U.S. if they have never been approved for the U.S. population. In our ever more global society, I don’t see Congress changing this legislation to harm U.S. citizens who might happen to suffer from a rare tropical disease, forcing them to wait for a more novel (but not necessarily better) treatment to get approved.
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