drug costs
FDA analyzing importation
Like the August recess, the fall budget battles and all our other seasons, some things just always come back around. Yes, we're talking about drug importation again.
Monday marked the FDA's deadline for comment on its tracking of the impact that importing drugs from Canada could have on medications' prices and safety. While it's a relatively incremental change to FDA's information collection on this topic, it highlights the ongoing debate around importation — and the fact that the agency hasn't approved any state's plan to import from Canada, despite starting this process in 2020.
It also provides another outlet for the drug industry to vent its frustration about the possibility of state importation. PhRMA wrote in comments shared with STAT that the FDA's latest projection is "inconsistent" with earlier estimates and still underestimates the burden this puts on manufacturers or importers. The lobby urged the White House's budget office to nix the info collecting extension.
Elsewhere, during a rare in-person meeting of the White House's drug shortage task force Friday, temporary drug importation also came up. My colleague John Wilkerson has the scoop on that meeting, here.
straight to consumer
Will drug ads go the way of foreign flicks?
The Food and Drug Administration might soon decide whether to require subtitles about side effects during television drug commercials, which hopefully would be more helpful than that time the BBC subtitled comments by French President Emmanuel Macron as "speaks French."
Details of the final rule are not public, and my colleague John Wilkerson reports that it's difficult to predict what the FDA plans to do, given that the agency stopped accepting public comments on the rule in 2012.
Over the years, the FDA has said that research suggests viewers understand side effects better when subtitles are added to commercials. That same research did not show that images of happy, active patients distract attention from side effects, according to the FDA. Agency officials also have said they are considering shortening side effect information in ads because the risk of truly serious side effects might sink in better if less-serious side effects are left out. Read more.
emergency prep
Kidney doctors: Covid proves stockpile needs, again
When New York City hospitals ran out of dialysis machines in the early, shutdown days of the pandemic, the federal government had some. A fortuitous 2019 contract meant the strategic national stockpile had 50 user-friendly dialysis machines to ship to New York and surrounding areas as the virus wreaked havoc on kidneys and well as lungs and and other organs. Now, advocates are questioning why the stockpile isn't reinvesting.
Dialysis machines were part of the stockpile from 2019 to 2022 but were not renewed for this year, with no explanation, Carrie Arnold writes for STAT News. That's even after infrastructure-destroying hurricanes like Katrina made the need for emergency equipment clear, doctors say.
But as Congress hashes out the Pandemic and All-Hazards Preparedness Reauthorization Act — which funds the stockpile — some fear that the 550,000 people on dialysis in the U.S. will again be overlooked. More from Carrie.
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