FDA Foot-Dragging Keeps Americans in the Dark

July 24, 2020
By Naomi Lopez

After more than two years of delay, the U.S. Food and Drug Administration (FDA) has finally issued a proposed rule for how general information about the use of the federal Right to Try Act must be reported to the government. The pandemic isn’t the reason for the lag—after all, the instructions for reporting and publicly sharing this information was already late well before anyone had ever heard of COVID. This sluggishness is just business as usual at the FDA —even when lives hang in the balance.

The federal Right to Try law allows patients facing life-threatening or terminal illness to seek treatments that are considered safe enough to test on humans but have not received FDA approval, under their doctor’s care and recommendation and when the manufacturer is able and willing to make the treatment available. We know patients have used and benefitted from the law, but we won’t have complete information until it is reported to the government and posted publicly. And that’s because the FDA has been lax about fulfilling its obligation to set up that reporting system: Under the law, the government is required to annually post summary information about the use of Right to Try.

The FDA has been inhospitable to Right to Try in other ways, too. For example, the government’s clinicaltrials.gov website, which lists important information about ongoing clinical trials in the U.S., is blocking manufacturers from sharing important information about the use of Right to Try. Today, the federal agencies that have jurisdiction over the management of this site have chosen—despite manufacturers’ requests to be listed—to not include information about medicines they are making available under the Right to Try law, even though there is no legal reason why the information couldn’t be included.

This means that the same drug makers whose medicines are currently being used to save lives—and have already received safety approval from the FDA—cannot share crucial information with doctors and patients via the government’s online registry. This is where patients and doctors seek treatment information. Meanwhile, that same registry does include studies for non-approved, potentially dangerous treatments that are not under FDA review and are being administered in places such as Azerbaijan and Togo.

There is no reason why the federal government should exclude information that might make it simpler and faster for doctors and patients to learn about promising treatments that they have agreed to make available under Right to Try. This is especially true given the fact that unvetted, possibly dangerous treatments are being listed.

Right to Try is moving us closer to the important goal of bringing the right treatment to the right patient at the right time. But much work remains, and the slow, foot-dragging pace that the FDA too often takes should remind us that much work remains especially when red tape and bureaucratic hurdles continue to stand in the way when lives hang in the balance.

Naomi Lopez is the Director of Healthcare Policy at the Goldwater Institute.