WASHINGTON — President Trump’s domestic policy chief on Friday suggested the regulation of tobacco and vape products — a critical function of the Food and Drug Administration — was a distraction and should be handled by another agency.

The remarks from Joe Grogan, the director of Trump’s Domestic Policy Council, came at a careening news conference at which he also slammed House Democrats’ marquee drug pricing bill and implied Medicaid expansions under President Barack Obama have furthered the opioid crisis.

Grogan’s comments on tobacco come as the administration has wavered on its attempts to ban some flavored vape products. They also follow two years in which Scott Gottlieb, Trump’s former FDA commissioner, made tobacco and nicotine product regulation a focus of his tenure at the agency.

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“I hate tobacco issues, I always have,” Grogan said. “And FDA shouldn’t be regulating this stuff in the first place.”

Tobacco products should be regulated, Grogan argued — just by a different agency, though he did not specify an alternative. But he drew a line between therapeutic medical products and vices like tobacco. Tobacco “shouldn’t be regulated by a health agency,” Grogan said, since it has “no redeeming qualities.” Grogan clarified that the remarks reflected his personal views, not formal administration stances.

“When I was in the Bush administration and this conversation started, I said, ‘This is a moronic idea,’” Grogan said. “FDA regulates drugs that help people, and you balance safety and effectiveness. It regulates devices, which help people, and you balance whether they’re safe and effectiveness.”

Yet tobacco, Grogan said, has “no redeeming qualities,” arguing “it shouldn’t be regulated by a health agency.”

Gottlieb responded in several Twitter posts as Grogan’s remarks circulated, calling tobacco regulation “one of the most productive uses of my time as FDA Commissioner.”

“It’s one of FDA’s most important public health missions … [and] must remain top priority for FDA,” he added in another post.

Grogan, who has repeatedly clashed with health secretary Alex Azar and helped to derail the administration’s May 2018 drug pricing “blueprint,” also slammed House Speaker Nancy Pelosi’s bill, which Democrats are expected to bring to a vote next month.

“Nancy Pelosi’s bill right now is unworkable, it’s impractical, and it’s hyperpartisan,” Grogan said. “And it’s not going to pass in its current form.”

The remarks appear to formally quash Pelosi’s aspirations that President Trump would support her bill, which is projected to massively lower drug prices but could cost the drug industry up to $1 trillion in the coming decade.

Grogan refrained from commenting in depth on the administration’s remaining drug pricing planks: an “international price index” to cap some U.S. prices based on foreign payment levels, and a plan to allow U.S. states to import cheaper medicines from Canada.

Grogan, who met last week with Canada’s acting ambassador to the U.S. to discuss the importation scheme, also acknowledged resistance both from Canada’s government and from industry groups. Canadian officials have repeatedly stressed that their market is too small to allow access for U.S. consumers, and drug manufacturers there could potentially write restrictions into business deals preventing the export of U.S. drugs.

“We’ll see,” Grogan said. “If it’s disruptive to the market and it forces companies to contract around it, so be it. The current situation is untenable.”

Grogan, lastly, pushed the largely baseless view that the Affordable Care Act’s expansion of Medicaid helped to further the opioid crisis.

“A lot of people who were addicted to opioids have been on government programs, whether it’s Medicare or Medicaid, and we had treatment guidelines and star ratings in Medicare that encourage aggressive pain management with opioids,” he said. “And frankly, somebody wasn’t minding the store.”

While casting blame on Obamacare for the opioid crisis has emerged as a conservative talking point, little research or academic work exists supporting the theory. One recent study showed that while Medicaid expansion states experienced a higher incidence of opioid addiction, the trends began prior to the Affordable Care Act’s enactment. Other studies have repeatedly shown that expansion-state populations enjoy broader access to addiction treatment.

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  • Since tobacco contains the drug nicotine, which has proven addiction potential, why should the FDA NOT regulate tobacco/nicotine-containing products? Doesn’t the letter D in FDA stand for the word drug? If Grogan hates tobacco issues, he should resign his position.

  • Grogan is bluntly dead-wrong in several aspects. Tobacco use causes serious, proven health disasters, and as the FDA regulates towards health merits, it IS in their realm to address tobacco use reduction / elimination. This guy’s plan to just milk a neighbouring country’s drug supplies totally disrespects the hard-fought for and lobbyist-free deals with drug suppliers accommplished by taxpayers moneys in that country. The lame “oh well” response to that country’s expressed concerns about ending up short-supplied is despicable. Ditch pharma lobbying in the US, and prices will drop. This guy needs to be kicked out swiftly, with background checks for tobacco company funding.

  • Did Mr Rogan give any sign that he was aware that Congress legislated this mission for the FDA? The agency did not volunteer for this mission, nor was it just another Executive Order from the prior administration.