FDA Proposes New Reporting Rules For Investigational Drugs

Federal regulators are proposing a new rule which would require investigational drug manufacturers to give an annual report on the progress of patients who have chosen to take the risk of trying their new, unapproved medications.

The FDA published a proposed rule, the Annual Summary Reporting Requirements Under The Right to Try Act, on July 23, which the agency says will provide more oversight on experimental drugs which address serious illnesses.

The Right to Try Act was passed in 2017, and allows patients facing life-threatening diseases or conditions who have no other options to volunteer to take experimental drugs, which have not yet been approved by the FDA. It is separate from those patients who participate in investigational clinical trials, since they do not need to be part of any trial to take the drug.

However, with clinical trial subjects, the data is supposedly available to federal regulators, who can call for a halt to a clinical trial if too many patients are being seriously injured or dying. With Right to Try patients, there is no such reporting mechanism since they are not part of any clinical trial.

The new rule, if finalized, would create a statutory requirement that sponsors and manufacturers of investigational drugs submit an annual report which includes data on the progress of patients trying their unapproved drugs; much in the way that a clinical trial would provide that information.

According to the proposed rule, as published in the Federal Register this morning:

“The manufacturer or sponsor of an eligible investigational drug shall submit to FDA an annual summary of any use of such drug supplied under section 561B of the FD&C Act. Per the statute, the summary shall include the number of doses supplied, the number of patients treated, the use for which the drug was made available, and any known serious adverse events from use of the drug.”

“The FDA is dedicated to achieving the goals that Congress set forth in the Right to Try Act, so that patients facing terminal conditions have another avenue to access investigational medicines,” Dr. Anand Shah, Deputy Commissioner for Medical and Scientific Affairs, said in an FDA press release. “Today’s proposed rule builds on the FDA’s long-standing dedication to enhancing access for patients who are facing life-threatening diseases or conditions and our continued commitment to transparency.”

The FDA is taking public comment on the proposed rule until September 22, 2020. Comments can be submitted electronically at

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