US: The FDA’s CTP Review Uncovers Multiple Issues

The extensive review of the US Food and Drug Administration's (FDA) Center for Tobacco Products (CTP) found numerous problems and highlighted that the agency’s tobacco program should be proactive, not reactive.

It is no secret that the FDA has been under scrutiny for multiple reasons related to the authorization of safer nicotine alternative products. Last Summer the agency was heavily criticised by Senators Dick Durbin (D-Ill.) and Susan Collins (R-Maine). In a letter citing STAT’s reporting the agency’s lack of action with regards to a Synthetic Nicotine ban announced earlier this year, the Senators said that the FDA “appears to be on the brink of failing yet again at protecting our nation’s children.”

Similarly, president of the Campaign for Tobacco-Free Kids Matt Myers, highlighted that the FDA should exercise its authority to pull the products off the market. “All unauthorized synthetic nicotine products are now illegal and by law must be removed from the market now, not at some undetermined date in the future.”

Moreover, the agency has been consistently reprimanded for not sticking to the stipulated cut off point and complete the PMTA process on time. And to add insult to injury, the FDA was also forced to temporarily suspend the Marketing Denial Orders (MDOs) it had just issued Juul, saying that a more thorough review was required.

Certainly in a bid to appear like these missteps were being taking seriously, Commissioner Califf had an announced an audit on the CTP. “I have discussed this evaluation with the relevant leadership of these centers and offices, all of whom welcome the opportunity to work towards organizational excellence,” he said in a press release.

“Each of these areas are full of hardworking and talented individuals who have dedicated their careers to working across a variety of scientific, policy, legal and administrative activities. FDA employees deserve the best support possible so they can fulfill their strong commitment to public health—and the American public that we serve.”

A lack of organizational structure
The audit was conducted by partnering nonprofit, The Reagan-Udall Foundation, in collaboration with a number of unnamed experts with the aim of assessing the “processes and procedures, resourcing, and organizational structure” for the foods program and the CTP.

The review results were released last December and a report by a panel assembled by the Foundation says the Center for Tobacco Products “has a critical mission to protect the public health from tobacco-related disease and death and is regulating products that have no inherent benefit and huge societal costs, it is a government regulatory program with a duty to run efficiently, fairly, and transparent.”

The panel also reported a lack of clarity and transparency and also internal communication issues. Moreover they found that the CTP is not equipped to face the workload that comes with the PMTA process and other regulatory oversights they have been tasked with.