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FDA Likely Headed for Big Changes Under Trump Administration

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fda-logoPresident Trump and a Republican majority in Congress will undoubtedly spell major changes for the U.S. Food and Drug Administration (FDA) in terms of leadership, enforcement, and perhaps rules will be scaled back or scrapped entirely.

Dr. Robert Califf became the chief of the FDA just one year ago, but the next few years might bring about major changes in the form of deregulation, and with it, numerous consumer protections may disappear. “We’re going to be cutting regulations at a level that nobody’s ever seen before,” Trump said in a recent Business Insider report, stating that he estimates 75-80 percent of regulations will be cut.

The Pharmaceutical Industry

The FDA has long balanced the need for patient protection with intense pressure from the pharmaceutical industry for quicker approvals of drugs and medical devices. Over the past several years, lawmakers have fought over a myriad of bills that would clear the way for major changes in the way the U.S. regulates prescription drugs and medical devices, and Trump is expected to give the pharmaceutical industry much of what it wants in terms of deregulation.

Tobacco Regulation

In 2016, long-awaited federal rules to put the regulation of all tobacco products, including e-cigarettes, under the authority of the U.S. Food and Drug Administration (FDA) finally became official. Prior to the rules, e-cigarettes, a popular product with unknown long-term health effects, have been virtually unsupervised by the government.

During his first week in office, President Trump received a letter from Rep. Duncan Hunter (R-Calif.), asking that he consider repealing or suspending the rules or at a minimum move the filing deadline for new products back two years, from August 8, 2018 to August 8, 2020.

Farm and Food Production

Trump has previously expressed intent to overhaul FDA programs that govern farm and food production, and Congress could potentially move to cut the agency’s budget, making it difficult or impossible to fund programs to prevent food-borne infections, prevent misleading food labels, and keep unsafe additives out of the food supply. However, Trump’s power is limited – the Food, Drug, and Cosmetic Act cannot be altered with an executive order.

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