A. THE RESULT ACT SEEKS TO CHANGE how drugs are approved in the U.S. by allowing for reciprocal approval of drugs, devices, and biologics from foreign sponsors in European countries, Japan, Canada, Israel, and Australia. The bill would allow Congress to overrule FDA rejections of life-saving drugs with a majority vote via a joint resolution. While drug shortages are real, these shortages do not involve novel drugs but rather older generic drugs that are low profit, which manufacturers no longer are willing to produce. Passage of the RESULT Act would not solve this problem.
What this act would do is reduce the FDA’s authority and relax approval standards to the lowest common denominator. Furthermore, giving Congress the ability to overrule the FDA on drug approvals would make the process more political than scientific. The FDA’s role in adjudicating the risk-benefit for any new medicine should not be tampered with.
JOHN LAMATTINA, PH.D.
John is the former senior VP at Pfizer, Inc. and president of Pfizer Global Research and Development. In this role, he oversaw the drug discovery and development efforts of more than 12,000 colleagues in the United States, Europe, and Asia.