AVM Wants HHS to Probe Congressional Pressure on FDA

American Vapor Manufacturers (AVM) president Amanda Wheeler is asking the U.S. Department of Health and Human Services Inspector General (OIG) to launch an inquiry into whether “political pressure” is driving U.S. Food and Drug Administration Commissioner Robert Califf’s marketing denials for vaping products.

AVM wants the OIG to help the public learn about the commissioner’s coordination with elected officials, allied activists, and reporters as his agency continues its review of premarket tobacco product applications (PMTA), according to a press note. 

“I am asking the Inspector General to intervene,” said Wheeler. “The PMTA process is rigged. Arbitrary standards rewritten behind closed doors corrupt any effective review. It’s embarrassing for the commissioner, but one U.S. senator’s call for his resignation was enough for Dr. Califf to override the standards set for the PMTA process. We are confident that OIG intervention will reveal what we have feared all along, ideology, not science, is driving decisions at the FDA.”  

In a letter sent to HHS Inspector General Christi A. Grimm requesting an inquiry into “improper political pressure,” Wheeler contends that “interference has corrupted FDA’s statutory obligation to properly implement its premarket tobacco product application (PMTA) review process based solely on scientific, empirically-based judgment.”

A timeline of suspect events shows Califf’s decision to deny a marketing order for Juul Labs, Inc. came within hours of a U.S. senator calling for the commissioner’s resignation. Within days, a federal judge blocked the FDA from implementing its order, forcing the agency to re-open its review of the JUUL application.

The FDA backtracked on its decision, claiming there were “scientific issues unique to the Juul application that warrant additional review.” An OIG inquiry can show the public how the commissioner and his staff were forced into their decision by political pressure while ignoring salient facts.

“Manufacturers are routinely meeting the PMTA requirements to scientifically demonstrate how their products are appropriate for the protection of public health,” Wheeler said. “Despite compliance, the agency isn’t approving the vape products sought by adults who want to quit smoking. The OIG should open the door and hold the FDA accountable to its standards.” 

Wheeler is requesting a full review to affirm the FDA’s assertion that the administrative stay was based on incomplete information. The agency is also thwarting Freedom of Information Act requests, so the OIG has an opportunity to create a new level of transparency.

Wheeler is requesting the OIG make public communication between the commissioner and members of Congress, the media, and ideologically aligned advocacy organizations.