It’s a question we’ve never had to ask with previous presidents, but it’s one we need to ask now. Could President-elect Donald Trump really dismantle America’s Food and Drug Administration?
It’s a growing concern among political analysts, including Sheila Kaplan of StatNews.com, who first brought the issue to the public’s attention.
Sheila claims that public health advocates “are bracing for a seismic shift”, as the FDA could surrender its rules for off-label promotion of drugs.
It’s also a possibility that the FDA will surrender restrictions on drug importation from other countries while also requiring fewer clinical trials before approving a drug. Today, clinical trials are required by the FDA to determine whether or not a drug is safe for the American public.
It’s part of a widespread deregulation movement across the pharmaceutical industry. Trump wants to deregulate the pharmaceutical industry to encourage innovation, while opponents warn that doing so would put public health at risk.
“Between a Trump presidency and a radically pro-business Congress, the next few years may see a removal of numerous consumer protections,” said Michael Jacobson, cofounder and president of the Center for Science in the Public Interest, as quoted in the StatNews.com piece.
Trump and his advisors, including Newt Gingrich, have previously stated that the agency has acted as a barrier for medical innovation.
Of course, the organization’s job isn’t to encourage medical innovation: it’s to protect the American public while ensuring medicines are safe and effective.
Nevertheless, Gingrich has previously described the FDA as the nation’s leading “job-killer”, and has called for it to be dismantled. He’s written things in the past like, “The FDA is a major prison guard stopping the breakout in health”.
Other people criticize the FDA from other directions. Last year, Dr. Robert Califf – a man with close ties to the pharmaceutical industry – was sworn in as the FDA’s chief. Dr. Califf himself has admitted that the FDA isn’t as stringent as it once was:
“Unfortunately, too many of the decisions made today about health and health care are not supported by high-quality evidence, because there is such a limited amount available,” he said in a speech last May to the Food and Drug Law Institute, as reported by the StatNews.com piece.
Dr. Califf went on to explain that the FDA has suffered a deficit in evidence in recent years, which then puts public safety at risk. Put simply, the FDA faces pressure to approve new foods and drugs, but doesn’t have the clinical evidence required to ensure they’re safe or effective.
Now, there’s a real threat that Trump could dismantle the FDA.
The Pharmaceutical Industry is Excited About Trump’s Deregulation Promises
The pharmaceutical industry was not excited for a Clinton presidency. They were reportedly prepared to fight the Clinton administration every step of the way for relaxed laws regarding drug testing.
Trump, on the other hand, is thought to be a supporter of the controversial “Right to Try” laws, which allow terminally ill patients to try unapproved drugs that have passed only basic safety testing.
The argument for those laws is that it gives patients one more chance to “beat the odds” on their deathbed. On the other hand, opponents argue that it turns dying people into guinea pigs.
With America facing a Trump presidency, the country is preparing for more pro-pharmaceutical laws. As Sheila explains in her article, “Trump’s presidency is likely to enable the industry to get much of what it wants in terms of deregulation.”
Could Trump Really Dismantle the FDA? Does He Have the Power?
Most people believe that Trump and his transition team do not support the FDA. That part is clear enough.
What isn’t clear is if he can actually do it. Congress could easily cut the FDA’s budget, for example, “crippling programs to prevent food-borne infections, prevent dishonest food labels, and keep unsafe additives out of the food supply”, explained one analyst.
However, if Trump wants to overhaul the FDA, he will inevitably run into checks and balances.
Said one senior public advisor, “You can be against regulation all you want, but the Food, Drug and Cosmetic Act is not something that is malleable within executive orders. There are laws, many laws, and it took a long time to get them.”
Like many other aspects of the Trump presidency, there’s a huge amount of uncertainty in regards to the future of the Food and Drug Administration. Stay tuned to see if any of this actually comes true.