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# FDA Wants Authority to Require Superiority Data in NDAs
- URL: https://www.fdaweb.com/fda-wants-authority-to-require-superiority-data-in-ndas/
- Published: 2022-04-28T12:00:00.000Z
- Updated: 2026-09-14T17:42:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151705

FDA is considering asking Congress for additional authority to have the option of requiring drug sponsors in their NDAs to demonstrate their product’s superiority over drugs that are already on the market. During a 4/28 Senate [appropriations subcommittee hearing](https://www.appropriations.senate.gov/imo/media/doc/FDA%20FY%202023%20Senate%20Budget%20Hearing%20Written%20Testimony.pdf?ref=fdaweb.com) on FDA’s fiscal year 2023 budget request, commissioner **Robert Califf** said the agency would likely need Congress’ help to mandate such requests, which would be particularly helpful in approving new opioid pain killers. It was not clear whether the superiority option would be limited to new opioid approvals or whether it could extend to possibly other products, like me-too drugs, if the agency believed it would be necessary.

In addressing the opioid crisis, Califf said placebo-controlled trials are not the best option for approving new opioids. Having the option to request superiority in active comparator trials is “something I would like to see happen,” he said while directing the subcommittee members to a [speech](https://www.fda.gov/news-events/speeches-fda-officials/remarks-fda-commissioner-robert-califf-2022-rx-and-illicit-drug-summit-04202022?ref=fdaweb.com) he delivered a week ago at the 2022 Rx and Illicit Drug Summit in Atlanta to get a bigger picture of the actions FDA plans to take to address opioid crisis.

“For many years, the FDA has based decisions on whether to approve drugs, including opioids, on a framework for the assessment of the benefits and risks of a drug,” Califf said at the Summit. “That approach is the authority Congress mandated for us. When it comes to opioids, we take into account public health factors such as the impact on family and others when reaching the regulatory decision of whether to approve a drug.

“Through experience, however,” he continued, “we have learned that even this improvement in our framework isn’t suited to address the risks posed by opioids. To be clear, the FDA lacks the statutory authority to require that drug developers seeking approval for the marketing of new opioid products demonstrate that their products offer material safety advantages (such as a reduction in abuse liability or a reduction in respiratory depression) over existing approved opioids. I am committed to working to address this discontinuity, but, again, it will likely require Congressional action to give us the necessary authority.”

Califf told the subcommittee that during the course of the next year, FDA will be further implementing [recommendations](http://fdaweb.com/login.php?sa=v&aid=D5139135&searchWords=national%20academies%20opioids&cate=S&stid=%241%241o0..G2.%24ieoDiCb9rxcDplri8AkqO%2F&ref=fdaweb.com) made by the National Academies of Sciences, Engineering, and Medicine (NASEM) in 2017 to address prescription opioid abuse and misuse, as well as the evolving role that opioids play in pain management.

During the hearing, Califf was also asked to comment on advanced manufacturing and how to advance such technologies to produce and manufacture more products domestically to address supply chain concerns. “Resilience of the supply chain is a critical issue, and I think given the international strife right now and the things that we didn't think were possible, … we've got to move. We’ve got to have a resilient manufacturing base that Americans have access to, and that doesn't mean that everything needs to be made in America because there’s value in international trade… If we get ourselves in a situation where another country could, either due to a natural disaster or intention or the way markets work, cut off our supply then that’s a real problem.”

Califf said a lot of energy is being spent on upgrading FDA’s own capabilities in advanced manufacturing. “The reason the FDA needs to be so involved is twofold,” he explained. “There are areas where we think we can help industry quite a bit by creating prototypes and public/private partnerships. And the advanced manufacturing for a messenger RNA is one example that’s pretty far along that you will see come to fruition fairly soon. But the other part is as we get to the more advanced part of advanced manufacturing where you can, for example, make drugs locally in a small little shop…, future regulating that means we have got to be sure that we can tell the difference between a good job being done and not a good job.”