FDA Streamlines Drug Approvals, Offers Reviewer Bonuses Under New Policies
The FDA announced major policy changes including requiring only one study for drug approvals instead of two, and offering performance bonuses to reviewers who complete work ahead of schedule while maintaining thoroughness.
The Food and Drug Administration announced it will require only one study for drug approvals, reducing the longstanding review process that required two rigorous studies. The FDA says reducing the study count will speed up the availability of medicines. Additionally, agency reviewers who complete their work on specific drugs ahead of schedule could receive performance bonuses, provided their review is also thorough.
The FDA Commissioner said he wants more drugs available over the counter, stating he believes "everything should be over the counter" unless a drug is unsafe, addictive or requires monitoring. In announcing the reviewer bonus pilot program, the Commissioner said to agency staffers, "If you don't like [the program], we can get rid of it, but usually everybody loves money."
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