The U.S. Food and Drug Administration (FDA) holds primary responsibility for approving and regulating various human and animal prescription drugs, medical and tobacco products and the nation’s food supply. However, the Taxpayers Protection Alliance (TPA) believes the government agency sometimes falls behind on their responsibilities, which is why Director of Policy Ross Marchand published a list of improvement recommendations for the FDA to adopt.
“This report was absolutely a labor of love,” Marchand told FDA Reporter. “It was really just sort of a prolonged, systematic effort to understand the inner workings within the FDA, and make sure that we as an organization understood the ins and outs, how this organization works and how it serves, and sometimes it unfortunately fails to serve taxpayers and customers.”
“Reforming the FDA: Saving Money, Saving Lives” is a new TPA publication that includes suggestions such as reevaluating medication safety and efficacy statistical standards, tightening advisory committee standards, not classifying electronic vaping products such as e-cigarettes as “tobacco products,” reaffirming the mandated time guidelines for the premarket tobacco product application process, and revising nutritional guidelines.
Once the TPA gained a thorough understanding of the FDA’s business practices and work ethic in terms of pharmaceutical, food and tobacco product regulation, Marchand believed they had all the information needed to think critically on how the FDA can improve for the future and offered the TPA's list of recommendations. The TPA has provided strong governance reforms for nearly 10 years.
Taxpayers Protection Alliance Director of Policy Ross Marchand
In determining each individual recommendation the FDA should implement, Marchand analyzed which FDA regulations affect the most people but still do not receive substantial media attention or discussion. Marchand specifically pointed to a “very onerous, complicated and too strict” drug-approval process costing more than $2 billion to introduce drugs to the market, which gets passed onto taxpayers and customers in the form of Medicare reimbursements.
“We’re trying to figure out which regulations impact the most lives and which sort of regulatory processes are just not figuring prominently in the conversation that we’re having in terms of not getting too much play in the media,” Marchand said.
Marchand always remains “cautiously optimistic” on whether government agencies read and actually adapt some of the strategies suggested, including the FDA. He said he just hopes the FDA can change some of their business policies in order to make some major improvements.
“I think that a lot of the folks who work at the FDA are good people and they do want to deliver for customers and taxpayers and help bring life-saving medications and products to market,” Marchand said. “Unfortunately, there’s a lot of status-quo bias, and there’s a lot of foot-dragging that just goes on at the agency, and it’s not questioned because it’s just the way it’s always been done there.”
Marchand stresses to the FDA that their current business system just simply does not work efficiently anymore.
“It’s leaving too many patients behind, and it’s leaving too many life-saving medications and products just sitting on the table," he said. "If we streamline processes and we embrace comprehensive reform, we can save millions of lives to guarantee a better quality of life for patients and we can save taxpayers hundreds of billions of dollars.”