Supreme Court ruling could put FDA in the crosshairs of critics
The Food and Drug Administration, which oversees many of the products people use every day, is expected to see a surge (perhaps even a flood) of lawsuits following Friday’s Supreme Court ruling.
“This is disastrous for public health. This is disastrous for the critical role of science-based regulators,” said Mitch Zeller, former associate commissioner of the FDA and director of the Tobacco Division. “Chevron has worked well for half a century and makes a lot of sense.”
Challenges can range from whether contaminated spinach can be traced back to a farm to the heart of the FDA’s decisions about whether drugs are safe and effective enough to be sold in the United States.
“The FDA has always been referred to as the gold standard for product approval around the world,” said Perham Gorji, a partner at law firm DLA Piper and former deputy chief counsel at the FDA. “The FDA has a strict set of requirements for the approval of products that are available here in the United States.”
The agency employs approximately 18,000 people, many of whom are physicians or have advanced degrees in biostatistics, chemistry and toxicology. Given the complexity of some of the scientific decisions the agency makes, attorneys targeting the FDA said initial challenges could focus on areas where the FDA exercises policy power, including some involving drug pricing.
Chad Landmon, an attorney at Axinn and head of the FDA practice group, predicted that the first lawsuits could be the result of a combination of issues facing companies.
“I think companies will be much more aggressive and generally look for opportunities to challenge the FDA,” Mr. Landmon said.
Others expect a broad attack from tobacco companies that are overseen by the agency. “I would expect the tobacco industry to target every aspect of the FDA’s regulatory infrastructure,” said Desmond Jensen of the Public Health Law Center. The agency decides which e-cigarettes can be sold and can reject new cigarettes that might attract new smokers.
Chevron restrictions are widely perceived as beneficial to the industry, but the reality could be more complex as advocacy groups gear up, said Nick Shipley, a former lobbyist for BIO and PhRMA and the founder of Cronus Consulting. He cited the group that challenged the FDA’s approval of abortion drugs.
“The industry,” he said, “could be caught in the crossfire.”
