Tuesday, November 12, 2019

Tuesday, November 12, 2019

Former FDA official responds – in part – to Taxpayers Protection Alliance's suggested reforms


Dr. David Gortler, former Food and Drug Administration (FDA) official, drug safety and FDA regulatory affairs expert and pharmacology professor, recently responded to the Taxpayers Protection Alliance's (TPA) list of recommendations to improve the FDA's business strategies, which was released Oct. 3.

The TPA’s Director of Policy Ross Marchand published Reforming the FDA: Saving Money, Saving Lives, a list of suggestions the group feels should be to be adopted by the FDA in order to best serve tax-paying citizens. Marchand selected each recommendation after he and the TPA analyzed which ones created the largest impact for consumers while receiving minimal attention from the media.

The suggestions include reevaluating medication safety and efficacy of statistical standards, tightening advisory committee (AC) standards, reclassifying electronic vaping products such as e-cigarettes as other than “tobacco products,” reaffirming the mandated time guidelines for the premarket tobacco product-application process, and revising nutritional guidelines.

Gortler only had objections to two of the recommendations: tightening advisory committee standards and the reclassification of vaping products.

"I think that the FDA should actually loosen its restrictions on AC appointees,” Gortler told FDA Reporter. “Today, AC appointees tend to be retirees and often less at the top of their game. As a former FDA medical officer who has attended many AC meetings, it is obvious to me whether or not AC members fully understand the science of what is being presented by the questions that they ask. This is one of the reasons that the FDA is not bound to the decisions made by AC members."

Gortler explained that the current process for one wishing to serve on an AC must have no prior conflicts of interest working previously in drug companies performing clinical trials, research grants or similar operations. This limits opportunities for prominent researchers to be appointed, as many have had to conduct clinical trials or use drug company grant money to fund research projects at least once before in their line of work.

Gortler also expressed his opinions about e-liquids, blaming foreign-produced, black-market products that lack “top-quality chemicals” as the cause for the surge in U.S. vaping-related illnesses and even some deaths.

"I don’t agree that e-liquids are necessarily safer than their tobacco alternatives at this point,” Gortler said. “Nobody, including the FDA, is prospectively or retrospectively testing the contents of these e-liquids, which tend to be produced overseas. The FDA needs to step in and test and regulate these e-liquids before they are released to the American public."

The Centers for Disease Control and Prevention (CDC) revealed that as of Oct. 8, there have been 26 confirmed deaths in 21 states from lung diseases caused by vaping products, with an additional 1,299 injured lung patients admitted to hospitals.

Gortler did not comment on whether there are any other areas within the FDA in need of improvement.

Organizations in this Story

Taxpayers Protection Alliance

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