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# FDA Required Post-Market Studies ‘Empty Threat’: Professor
- URL: https://www.fdaweb.com/fda-required-post-market-studies-empty-threat-professor/
- Published: 2019-09-04T12:00:00.000Z
- Updated: 2026-09-15T01:47:35.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144923

Dalhousie University Health Law Institute director **Matthew Herder** says that so far FDA’s power to withdraw approval of a drug if its manufacturer fails to produce useful post-approval required clinical studies on time is an “empty threat.” Herder interviewed senior FDA officials involved in the approval of Sarepta’s Exondys 51 muscular dystrophy drug and rejection of the same company’s Vyondys 53 to learn how such decisions are made within the agency. In a *Stat* opinion [column](https://www.statnews.com/2019/09/03/fda-sarepta-real-world-drug-regulation/?ref=fdaweb.com), he says he wanted to learn why FDA appears increasingly open to approving drugs like Exondys 51 despite weak evidence that it works. And why the agency would be willing to trust a company to study a drug after approval, when the results might undercut the drug’s sales.

While most postmarketing studies mandated for accelerated approval drugs are completed within four years, Herder writes, delays are common. “In the meantime,” he says, “patients are exposed to unforeseen safety risks or, in some cases, forego other care options while taking new drugs that ultimately do not serve their intended purposes. In addition, when these studies are finally completed, they often fail to yield clinically meaningful information. Yet, FDA seldom takes action in response to these delays.”

Herder writes that in the real world of drug regulation, where making companies do the work beforehand would be the safer move, decisions to approve or reject drugs are driven not just by evidence but also by resources, relationships, and politics. He asserts that when CDER director **Janet Woodcock** was pushing for approval of Exondys 51 in 2016, she expressed concern that Sarepta would go out of business if the drug was not approved, even though that had nothing to do with the drug’s safety or effectiveness.

While FDA is not unaware of the challenges of assuring company compliance with required post-approval studies, Herder writes, his conversations with senior officials suggest that “the agency is engaged in a deeper political calculus that is embedded in its interactions with key stakeholders, including industry and increasingly patient groups.

“FDA no longer organizes itself in the service of public health,” Herder concludes. “If it was genuinely committed to generating and acting upon rigorous evidence, it would be distributing its resources and decision-making authority across the regulatory lifecycle. Instead, those resources remain heavily allocated toward pre-approval review, and the power to issue a safety warning, alter a drug’s label, or withdraw an indication from the market is still held exclusively by those who decided to approve the drug in the first place. In other words, FDA’s increasing reliance on real-world evidence in recent years has yet to be inscribed into the institution and its practices. The promise of lifecycle drug regulation is that regulatory decisions will evolve along with the evidence. If a company fails to conduct a post-market study in a timely manner, or a drug’s effectiveness is not confirmed through clinical use, FDA can withdraw its approval. The reality is that’s an empty threat.”