Despite Trump's Deregulatory Drive, FDA Is An Island of Red Tape
President Trump has boldly pushed for deregulation across the economy since taking office. In fact, he slashed the total number of pages of regulation in the Federal Register from 95,894 to 61,308 in just his first year of office. The results speak for themselves. Unemployment remains near record-lows, and in October, workers saw their largest annual wage increase since 2009. There remains one weak spot, however, in the Trump administration’s otherwise stellar deregulatory effort.
Under the leadership of Commissioner Scott Gottlieb, the Food and Drug Administration (FDA) is paralyzing promising treatments, therapies, and devices in a sea of red tape and agonizingly lengthy deliberation. Millions of lives hang in the balance as cures to devastating diseases and dangerous treatments lie waiting on the sidelines. Now, amidst Gottlieb’s impending departure from the agency, President Trump has a real opportunity to push for a new direction at the FDA. By picking a new leader for the agency that understands the need for deregulation, President Trump can send a message that no area of the economy is off-limits to innovation.
It’s difficult to make sense of the regulatory zeal of the FDA, especially compared to the FCC or EPA’s market-friendly agenda. Consider, for instance, the FCC’s December 2017 repeal of onerous Title II rules on the internet. Studies have found that the implementation of Title II precipitated a massive, industry-wide drop in broadband investment. The FCC’s order restored certainty to broadband deployment, resulting in massive in access all over America and reiterated the ability of consumers to enjoy options such as free (“zero-rated”) internet apps.
But as the FCC expanded options for consumers and opened the door to innovation, the FDA was busy slamming the door shut. The agency has repeatedly used the issue of youth access to e-cigarettes to push for broad-based product restrictions, despite e-cigarettes’ proven role in transitioning smokers away from cigarettes and save countless lives.
This month, Axios reported that, “Food and Drug Administration Commissioner Scott Gottlieb has presented senior White House staff with his plan to effectively ban the sale of flavored e-cigarettes in convenience stores throughout the United States, according to two sources familiar with the meeting.” Never mind that a recent study published in the New England Journal of Medicine found that, "E-cigarettes were almost twice as effective as the 'gold standard' combination of nicotine replacement products," according to the study’s lead researcher Peter Hajek.
The FDA’s insistence on limiting choice and stymying harm reduction isn’t limited to vaping products. The agency has a byzantine examination and approval classification process for “medical devices,” ensuring that low-risk products that could simply be tested by consumers on the marketplace are instead subject to FDA dithering. The designation process has regulators claiming that fitness trackers that analyze “multiple physiological signals” are more similar to MRI scanners than a hand-held cholesterol checker.
And if consumers learn from the “medical devices” that they need to take medication, they may not have access to some of the newest, most promising drugs thanks to overregulation. Even the FDA’s designated fast-tracks for just drug approval (not even considering genetic linkages to medications) will take on average at least 6 months, and median times have been steadily increasing over the past couple of years.
Researchers from MIT and Boston College recently found that, even taking these necessary precautions into account, the FDA is far more conservative than it should be in assessing drugs for some of the deadliest diseases. Their results confirmed a long-held suspicion that bureaucrats are risk-averse, since being “too careful” draws far less attention than being too eager. If the FDA approves a drug that turns out to be unsafe and patients are harmed as a result, those in charge of the approval process may well be held accountable. But if the FDA stymies approval of a drug that would likely have saved thousands of lives, there’s no outrage from a foregone hypothetical.
But the FDA’s crusade against innovation may soon be reversed; Health and Human Services Secretary Azar confirmed yesterday that Commissioner Gottlieb is stepping down. President Trump can appoint a new leader ready to learn from other agencies’ regulatory approaches, instead of doubling down on red tape and onerous rules with devastating unintended consequences.
Taking a page from other agencies’ easing of rules, the FDA can resolve to further streamline the drug approval process and save “medical device” evaluations for products such as MRI machines and CT scanners. By embracing the deregulatory drive that has brought prosperity and innovation back to the United States over the past couple of years, the FDA can expand choices for consumers and save lives.
Ross Marchand is the director of policy for the Taxpayers Protection Alliance.