Trump and the Undermining of the FDA

President Trump has been making policy decisions that directly impact health care. Most of them are not good for patients.

Over the past week or so, health care has been on the mind of President Trump. Although news of his controversial executive order regarding immigration has dominated the headlines, you may have missed some actions he was involved in that directly relate to health care, medicine and even the FDA.

And none of it is good news for patients.

On Monday, Trump signed yet another executive order (EO), this one promising to significantly cut the number of federal regulations by promising to “knock out two regulations for every new regulation” adopted by federal agencies. While this may sound like a boon to small businesses and industries, it could be crushing to the FDA.

Legislation to Speed New Drugs to Market Impacted

Why? Take the recently approved, bipartisan 21st Century Cures Act. The legislation promises to speed new drugs to market (good idea, but the implementation could have issues) as well as boost dollars for government research.

Just one problem: The act spells out how the FDA should speed up the drug approval process. This will require a significant number of new regulations. Under Trump’s EO, which FDA regulations will be cut to make room for the new ones, and at what cost to patient safety?

Last week, President Trump also announced a hiring freeze in the federal government. This especially impacts the FDA, which has been understaffed for years. “A hiring freeze at the FDA would conflict with and do significant damage to these bipartisan efforts to fill vacant positions and expand the scientific and technical workforce needed for a robust review of drugs and medical devices,” several Democratic senators wrote in a Jan. 30 letter to FDA Acting Commissioner Dr. Stephen Ostroff.

Right-to-try laws sound like a win for patients, but they could be a back door for pharmaceutical companies to market drugs that have questionable efficacy and safety.

And on Jan. 31, Trump met with many of the CEOs of many pharmaceutical companies to discuss the high price of drugs as well as accelerate the drug approval process. Cutting the price of drugs was a major part of Trump’s platform during the campaign, and enjoys bipartisan support. He had said that the government should be able to negotiate prices for Medicare.

Pledge to Lower Drug Prices Seems Lost

However, during the meeting, Trump’s ideas for getting those low prices seemed flat. He instead boasted that he would ensure there would be greater competition in the pharmaceutical industry, by encouraging smaller drug companies to have a piece of the action, for example, to lower drug prices. This is a far cry from his pledge to make drugmakers negotiate prices for government health care programs.

Trump also likely put smiles on those CEOs’ faces by making clear he wants to streamline the drug approval process. Although the president and others who support this idea describe it as a win for patients, the bottom line is that it could allow for more drugs to get pushed through the FDA regulatory process with less scrutiny, potentially endangering patients’ health.

At the meeting, the president also mentioned his desire to get more drugs approved for people suffering from terminal illnesses. Again, while this sounds like a win for patients at face value, many observers believe it could just be a back door for pharmaceutical companies to get drugs that have questionable efficacy and safety to the public faster through so-called “right-to-try” laws.

All this, and Trump hasn’t even been in office for 2 weeks. Many employees at the FDA are worried, and rightly so. Here’s hoping more substantive discussion about Trump’s health care proposals will happen in the weeks and months to come.

Jonathan Block

Jonathan Block

Jonathan Block is a freelance writer and former MedShadow content editor. He has been an editor and writer for multiple pharmaceutical, health and medical publications, including BioCentury, The Pink Sheet, Modern Healthcare, Health Plan Week and Psychiatry Advisor. He holds a BA from Tufts University and is earning an MPH with a focus on health policy from the CUNY Graduate School of Public Health & Health Policy.

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