Trump: Drug Importation Coming Soon

Regulatory NewsRegulatory News | 03 October 2019 |  By 

In remarks related to an executive order on Medicare, President Donald Trump on Thursday gave a speech filled with falsehoods about the Right-to-Try law, claims that drugmakers would lower their prices once importation begins and a suggestion that the pharmaceutical industry is aiding his impeachment.

Trump also read from the teleprompter to explain a proposal that’s coming soon to lower drug prices by importing drugs from Canada and other countries. First revealed in July, HHS still needs to publish a Notice of Proposed Rulemaking (NPRM).

The NPRM is expected to propose several limitations (i.e. only facilities that also manufacture active pharmaceutical ingredient for the FDA-approved version would be allowed) and exclusions (no costly biologics, drugs with a REMS or infused or injected drugs) that may raise further questions about what drugs would actually be imported and how much could be saved.

While lamenting that drug prices in other countries are “60% lower” in some cases, Trump told Florida Gov. Ron DeSantis (R), who was in attendance, that he will be able to “negotiate til his heart's content,” and will be able to go to Canada and European countries to find lower prices, "and I have a feeling that when that happens, the drug companies are just going to drop their prices, I think. Now they’re very smart, they may go the other way. And when they do, don’t blame me."

Meanwhile, Trump also praised FDA’s work in approving a record number of generic drugs over the last two years. He said: “And every time I see the folks over at FDA, I say c’mon fellas, let’s go, faster, faster.” Then he falsely claimed that the drug approval process takes 12 years, “but we brought it way down,” even though the standard FDA review for a pharmaceutical is 10 months and priority review is six months (neither have changed since Trump was elected).

Then he discussed Right-to-Try, which he signed into law in May 2018 and is meant to help terminal patients access investigational products. And although Trump said “miracles are happening” because of the law, in reality, just two patients have publicly declared that they’ve used the law to access an investigational drug and it’s unclear if either one has benefited.

Another surprising moment came when Trump suggested that the pharmaceutical industry might be helping his impeachment.

"I wouldn't be surprised if the hoax didn't come a little bit from some of the people we’re taking on” and “I wouldn’t be surprised if some of the nonsense we have to go through” is from industries "that we take on, like pharmaceuticals," he said, and then sort of whispered into the microphone about how “they’ve got this system wired” no matter what he does, pharmaceutical stocks seem to keep going up.

Trump Remarks


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