Viewpoint: FDA Should Release CRLs and Clinical Study Reports

Regulatory NewsRegulatory News
| 03 July 2018 | By Zachary Brennan 

The US Food and Drug Administration (FDA) has a chance to improve its transparency by releasing clinical study reports (CSRs) and complete response letters (CRLs), a viewpoint published Monday in JAMA Internal Medicine said.

Matthew Herder of the Health Law Institute, Department of Pharmacology, Faculties of Medicine & Law at Dalhousie University in Halifax, Canada explains how there’s a public health rationale for not keeping CRLs and clinical study reports confidential.

“The key issue legally is whether the rejection is ‘final,’” Herder told Focus. “Officials will say that they hardly ever are. Ideally FDA would release them all, not just a subset.”

Jim Miller, JD, MPH, senior associate in the Department of Health Policy and Management at the Johns Hopkins Bloomberg School of Public Health, previously explained to Focus that FDA could, without congressional action, change its regulations via a proposed rulemaking to allow for at least portions of CRLs to be released.

Transparency is Coming

Back in January, FDA said it would release portions of CSRs and CRLs. FDA Commissioner Scott Gottlieb said in a statement: “We intend to post the parts of the CSRs that were most important to the FDA’s assessment of the safety and efficacy of the drug. Specifically, we’ll include the study report body, the protocol and amendments, and the statistical analysis plan for each of the participating product’s pivotal studies."

Gottlieb also said he would release certain redacted CRLs to help inform the public about how a drug was rejected by the agency.

Herder wrote: “Legislation, and regulatory changes in particular, to clarify when a drug has been finally rejected, abandoned, or withdrawn, may bolster the FDA’s authority to disclose clinical study reports and complete response letters in a timely fashion. But the agency already has the flexibility under its governing laws to make the reasons for its regulatory decisions to approve, and in some cases to reject, drugs clear to the public. It is time for the agency to act, for the benefit of patients and public health.”

But he also notes that for disclosures of CRLs to occur, FDA’s decision denying market approval “must be final, either because all legal appeals have been exhausted or the company takes no further action on the file within 1 year of the date of the letter.”

Reviving the FDA’s Authority to Publicly Explain Why New Drug Applications Are Approved or Rejected


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