The new Trump administration is currently oscillating between two options for his head of the FDA. One is Scott Gottlieb, a right wing but accredited doctor, and a partner at one of the world's largest venture capital funds. The other is Jim O’Neill, the managing director at Peter Thiel’s tech investment firm Mithril, and a man who once said, without irony, that the FDA should prove the efficacy of drugs after they’ve been legalized. Here are some of the topics that a Trump FDA are likely to end up tackling.
FOOD SAFETY REGULATION
What Trump Could Do: Defund the FDA’s (already paltry) budget toward inspections, sanitation, and labeling.
Likelihood: Very likely. In September, Trump said, “My plan will embrace the truth that people flourish under a minimum government burden,” further calling the FDA the “Food Police.” At the least, we can expect the funding toward the FDA to return to the Bush years, where the many and various food controversies dubbed the administration “E. coli conservatism.” Despite the passage of the Food Safety Modernization Act in 2010, FDA is already gravely ineffective. We can expect a Trump administration to allocate it even less resources. “The Trump campaign website had a fact sheet (since removed) saying that one of the things that Mr. Trump wanted to do was reduce the number of inspections of food that were being required by the FDA,” says Jaydee Hansen, Senior Policy Analyst at the Center for Food Safety. “I would take that as a direct criticism of the Food Safety Modernization Act which FDA is now implementing.”
However, it must be noted that certain rules are already in place and were negotiated with the food industry, including a revised “nutrition facts” panel. The food industry has little desire to revisit those rules, as they will add even more confusion to their consumer base.
What Trump Could Do: Slash farm subsidies in the 2018 farm bill.
Likelihood: Trump has never put out a concrete plan for the farm bill, but he has surrounded himself with advisers who strongly oppose farming subsidies. Republicans wish to divorce the supplemental nutrition assistance program (SNAP) from the bill — a rider that provides millions of low-income Americans with food stamps to get their minimum nutrition. Separating them out makes the SNAP program more vulnerable to budget cuts, a long-time ambition of many Congressional Republicans.
SCHOOL LUNCH REFORM
What Trump Could Do: Roll back the Obama administration’s focus on healthy foods in school, which set stricter limits on fat, sugar, and sodium that can be served in the lunch line.
Likelihood: Trump himself is an avowed fan of fast food, and his Department of Agriculture head nominee is a Texas Agriculture Commissioner who repealed a state ban on deep fryers and soda machines at schools. Republicans have been looking for a way to cut what they see as unnecessary costs in schools, and with a fully Republican congress, the Trump administration hardly has to make it a top priority: They’re set to revisit the Child Nutrition Reauthorization next year, which provides healthy meals to children in and out of school.
MEDICAL QUALITY CONTROL
What Trump Could Do: Roll back the FDA’s current rulebook on quality control in healthcare.
Likelihood: The Affordable Care Act (ACA) is in the new administration’s crosshairs. Trump’s “contract with the American voter” calls for “[speeding] the approval of life-saving medications.” Since it’s hard to say what, if anything, Republicans will replace the ACA with, exactly what level of drop in quality control and efficacy testing remains unknown; the ACA contains guidelines for how drug companies may submit sampling information to the FDA. Separately, the passage of the 21st Century Cures Act, which seems imminent, would allow drugs and devices to get approved faster… at the detriment of quality control, by “allowing clinical trials to be designed with fewer patients and cheaper, easier-to-achieve goals.” Scott Gottlieb, one of Trump’s top picks for FDA head, is likely thrilled. “He has suggested that new genetic engineering techniques… should have new review processes developed to approve them, and we should not automatically consider them risky,” says Hansen.
THE OPIOID CRISIS
What Trump Could Do: Help slow the opioid-addiction crisis with more stringent law enforcement and stricter prescription guidelines.
Likelihood: Extremely likely. Trump said that he would “stop the flow of illegal drugs into the country,” and “close the shipping loopholes that China and others are exploiting to send dangerous drugs across our borders,” and “fix the misguided rules and regulations that have made this problem worse.” This will still likely be a tough battle: Trump has surrounded himself with Republicans who aren’t excited to turn their back on the pharmaceutical industry or provide the necessary funds for such an undertaking. For example, the Comprehensive Addiction and Recovery Act that passed this year to address the opioid crisis, Republicans failed to provide the necessary funding.
VAPOR AND E-CIGARETTES RULES
What Trump Could Do: Reverse the FDA’s rule that treats e-cigarettes as tobacco products, which allows the government to more thoroughly regulate them and set guidelines for product testing.
Likelihood: Very possible. There is a lot of interest in the vapor industry to get this done, and a recent letter from two congressmen to VPEOTUS Pence appealed to the cost to jobs and small businesses of such regulations. This is all amid the Surgeon General warning of a budding health crisis among the nation’s teenagers, who are vaping more and more.
PRESCRIPTION DRUG PRICES
What Trump Could Do: Bring down drug prices through cutting FDA red tape for generics and encouraging competition.
Likelihood: Possible. Trump wants to speed the green light for many cheaper, generic drugs — drugs that are similar to those out long enough that they've lost their patent protection. Making generic options more available is a distinct possibility to bring drug prices down generally, and would score a lot of political points. Trump could also have Medicare negotiate directly with lowering drug prices. With a fully Republican Congress surrounding him, pricing reform is doubtful, however — and investors aren’t betting on it.
DIRECT-TO-CONSUMER PHARMACEUTICAL MARKETING
What Trump Could Do: Slow down the practice.
Likelihood: Possible. The U.S. remains one of the two countries in the world that allows Direct-To-Consumer (DTC) drug marketing (along with New Zealand). If Trump makes lowering drug prices a priority, then pharma companies will likely pour less money in R&D and marketing, thereby curtailing it a little.
What Trump Could Do: If the proposed budget cuts take place, the FDA would lose more of its ability to (even passably) regulate the supplement industry.
Likelihood: The supplement industry is barely regulated by the FDA as is because of the 1994 passage of The Dietary Supplement Health and Education Act. The FDA has some say, mostly in terms of supplement marketing (products can’t over-promise or promise a medical solve) and in terms of contamination with pharmaceutical ingredients. “It isn’t as though, other than for reasons of contamination or misrepresenting the ingredients, that the FDA has really gone after dietary supplements,” says Sidney Wolfe, MD, Senior Advisor for the Health Research Group at Public Citizen. “For dietary supplements, the status quo is most likely.” Bringing down the FDA’s funding, and thus its ability to regulate even at a passable level, would likely end up flooding the market with even more bad-quality products.