| | | |   | Hello, D.C. Diagnosis readers. I’m excited to share that Rachel will be sitting down with Sen. Ron Wyden next week about the Senate’s recent efforts to pass drug pricing reforms. It’s a conversation you won’t want to miss, especially after Senate Dems unveiled a new version of their drug pricing bill just last week. You can sign up for that event here. I expect to see thousands of loyal D.C. Diagnosis readers on the attendee list … after all, if you’re reading this newsletter and you aren’t watching Rachel interview such a central player, what are you doing? Send Rachel the burning questions you want answered. She’s at rachel.cohrs@statnews.com. | | | A week of reckoning for Puff Bar … or is it? The FDA’s tobacco center — which has recently weathered a series of embarrassing missteps — will face a major test later this week. It’ll have to decide what to do about Puff Bar, the shadowy company run by two twenty-somethings with a penchant for luxurious living, that is now the most popular vaping product among youth, likely because of its marketing and fruity flavors like “mango,” “banana ice,” and “blue razz.”
The FDA is supposed to start cracking down on companies that make synthetic nicotine vapes, like Puff Bar, starting Thursday, after Congress closed the loophole they and others were using to sidestep scrutiny.
Puff Bar told me in a brief statement that it has filed an application with the FDA to stay on the market, and the company’s founders have insisted they’re trying to thwart youth use. But even tobacco industry attorneys tell me they expect the FDA to take some sort of action against the popular brand.
The FDA hasn’t said a thing about how it’ll approach Puff Bar, but there’s a few options the FDA could take, if it does want to order the company off the market: -
It could temporarily ban Puff Bar’s products while it finishes reviewing the application -
It could issue a so-called “refuse to file” determination, which would effectively deny Puff Bar’s application unless it was able to put together a more convincing one. -
It could fully deny Puff Bar’s application, effectively putting the company out of business for good. (Though attorneys said that seems unlikely given how little time the FDA has spent reviewing the company's application.) There’s also the possibility the FDA does nothing — a move that would prompt serious scorn from advocates and lawmakers. But it’s not out of the realm of possibilities: As I scooped on Friday, there’s already signs the FDA is falling behind on its responsibilities to regulate these synthetic nicotine products, leaving advocates and one top lawmaker concerned, and very angry.
Since my story published on Friday, Rep. Raja Krishnamoorthi (D-Ill.) and Sen. Patty Murray (D-Wash.), both of whom played a central role in giving FDA the authority to regulate these products, also weighed in.
Krishnamoorthi said in a statement that it is "disappointing and frustrating that the FDA, once again, finds itself unable to effectively regulate products that we know to be dangerous and addictive" and that "Congress and the American people deserve answers about why the FDA has failed to meet the deadline established by law."
Murray said the FDA "must do its job, use [its new] authority, and act without delay.”
Read more. | Speaking of FDA deadlines… The upcoming synthetic nicotine reckoning isn’t the only congressionally imposed deadline the FDA has to grapple with in the week ahead. The agency is supposed to allow the sale of hearing aids over the counter by next Monday, according to a 2017 law.
The FDA submitted the final regulation for White House review late last week, so it looks like the agency might meet Congress’ deadline. But the FDA has blown past these deadlines before. Under the 2017 law, the draft regulation was due in August 2020, but the agency didn’t finish that work until October 2021.
If the FDA doesn’t meet the deadline this time around, Congress will likely have something to say. Frustrated lawmakers tacked a provision onto the FDA funding bill set to pass later this summer that would require the agency to release the final hearing aid regulation within 30 days. | Addressing systemic issues to lower drug prices while maintaining innovation There is a lack of transparency in our healthcare system, complicating true drug pricing reform. More than 50% of the costs of medicines to patients are not associated with the medicines themselves. Mindful pricing decisions must strike the right balance between substantially lower costs for patients while preserving scientific innovation. Learn about Genentech’s commitments to pricing and payment reforms that will ensure patients in the US have affordable, equitable, and sustainable access to life-changing medicines. | Pfizer leads the pack for July price hikes It’s a tradition for drug makers to hike their prices on July 1, but one drug maker in particular stood out this year for its increases.
Pfizer and its subsidiary Hospira increased the price on more than 100 drugs this July, according to data reviewed by STAT. And some of the price hikes are pretty substantial: Pfizer raised the price of a number of drugs by roughly 10%. The only company that raised prices on a similar number of drugs was Avet Pharmaceuticals, which focuses on generics.
Consumers are unlikely, however, to feel the brunt of these price hikes at the pharmacy counter, because the majority of the drugs increasing in price are injectable products used in hospitals.
A Pfizer spokeswoman noted that the company is “investing $2 billion to upgrade the manufacturing network that supports these often life-saving medicines to ensure a network that can deliver high-quality, reliable supply.” She also noted that 15% of Pfizer's "hospital and sterile injectable portfolio" is sold for less than the drugs cost to make. | Two early 2024 hopefuls are already talking drug pricing Florida’s Republican Gov. Ron DeSantis and California’s Democratic Gov. Gavin Newsom have been trading barbs in recent days in what’s already being dubbed the “shadow 2024 race,” as both gear up for a potential presidential run in 2024. And, now, it seems, both are readying their drug pricing stump speeches and policy planks.
On Thursday, Newsom cut a minute-long video applauding his administration for moving forward on its plan to manufacture its own insulin. The video primarily plugged the legislature’s move to allocate $100 million to stand up the plan. If California succeeds in making its own insulin, it would be the first state to actually make its own drugs to lower prices — potentially setting up an entirely new chapter in the policy fight. However, it’s unclear when exactly California will have anything close to a proof of concept —and if it’ll be ready for Newsom to plug in his potential campaign.
The next day DeSantis held a press conference touting a new executive order enacting reforms to pharmacy middlemen that other states, like Ohio, have already implemented. But DeSantis spent most of his time criticizing the FDA for not yet approving his state’s plan to import drugs from Canada — another idea that has yet to actually be implemented in any state, despite interest from both Republican and Democratic administrations around the country.
Did the two governors know the other was planning a drug pricing speech? Was this a case of political one-upmanship? Probably not. But this health policy nerd really wouldn’t mind seeing these two debate drug pricing policy – especially if they keep pursuing these intriguing ideas. | What we're reading - In the label 'adult failure to thrive,' medicine reveals its own failures, STAT
- In America, cancer patients endure debt on top of disease, Kaiser Health News
- Drug companies will have to start refunding Medicare for certain drugs that get thrown out, STAT
- Two long weeks: Inside Biden’s struggle to respond to abortion ruling, Washington Post
- Remote technology could nudge patients to join cancer clinical trials, STAT
| Thanks for reading! More Thursday,  | | | |
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