| | | |   | Hello, D.C. Diagnosis readers. Special thanks to Lev for writing not one, but two, superb issues of this newsletter while I sat on the beach drinking wine and eating tinned fish. Since you all didn’t help him out with NBA Finals tickets, how about you send him a juicy scoop? He’s at Lev.facher@statnews.com. | | | The two unknown companies behind the abortion pill — and why they matter  (Alex Hogan/STAT) The fight over abortion access following the Supreme Court’s decision last week to overturn Roe v. Wade is increasingly becoming a fight over access to the abortion pill, mifepristone. President Biden brought it up in the wake of the decision, and Attorney General Merrick Garland says he wants to crack down on states that limit access to the FDA-approved treatment, but as I reported Friday, that’s easier said than done.
The new focus on mifepristone puts a big spotlight on two extremely opaque companies, Danco Labs and GenBioPro, which sell the medication in the U.S. Neither of the companies sells any other products, and neither has any sort of Washington presence. Neither even discloses much information publicly, which Danco confirmed is aimed at preventing attacks from anti-abortion groups. (Several other companies sell mifepristone globally but are not authorized to do so in the U.S.)
That’s relevant, I think, for two key reasons. First, these companies will play an outsized role in determining whether states can restrict access to abortion pills. As I reported Friday, most lawsuits challenging a state’s crackdown on an FDA-approved product don’t come from the FDA or the attorney general — they come from drug companies themselves. In fact, GenBioPro has already filed a lawsuit challenging a Mississippi law restricting access to its drug.
Second, the consolidation raises concerns about the stability of the drug supply chain. Policy wonks for years have sounded the alarm about supply chains that rely on one or two suppliers due to fears of shortages. There’s no signs of shortage for mifepristone yet, and Erin Fox, a drug shortage expert at University of Utah Health who has been tracking shortages since 2001, said she has no record of a mifepristone shortage during that 20-year period. But she said it’s impossible to say much about the reliability of the companies' supply chains, because they do not disclose much at all about where their drugs are made.
“In the US, drug suppliers are not required to disclose which companies actually make the drug products they sell,” Fox explained. “It really makes it impossible to know if these products are at risk of shortages — we have no way of knowing who the manufacturer really is and if they have a good or bad track record of quality.”
Both companies said in statements that they are prepared to meet increased demand. Danco also confirmed that it manufactures its mifepristone. | Unpacking the FDA’s Juul decision The FDA surprised some of the nation’s top tobacco experts last week when it disclosed that it was effectively shutting down Juul — not because of its role in getting young people addicted to nicotine, but out of concerns over its toxicology data.
In a new story for STAT, I unpack what we know and don’t know about the FDA’s decision — including analysis of a brand new legal filing from Juul, in which the company appears to claim that it did submit the data that the FDA wanted, but that the agency still pushed Juul off the market.
Check out the story here. | Collaboration is needed to build an ideal framework that defines the full value medicines provide When it comes to defining, measuring and communicating the value of our medicines, we need a framework that uses a more holistic set of attributes that are transparent and meaningful to patients, health care providers, payers and society. Learn about how Genentech is working to help all stakeholders fully understand a treatment’s total impact to ensure we get the right treatments to the right patients. | Amylyx Pharmaceuticals is bringing in the big guns Amylyx Pharmaceuticals, the company at the center of the debate over the future of treatments for ALS, has hired the lobbying firm Tarplin, Downs & Young, according to a new public filing.
The filing itself is vague — it says that the firm will lobby on “ALS and access to innovation.” And Amylyx declined to specify what exactly the firm will do. But we at D.C. Diagnosis are paying attention because the FDA is currently debating whether to approve Amylyx’s ALS drug AMX0035 after an expert panel narrowly voted down the drug this spring.
Tarplin, Downs & Young, which already represents drugmakers from AstraZeneca to Sarepta Therapeutics, is the second lobbying firm Amylyx has hired, despite having no products on the market. The drugmaker also hired Thorn Run Partners last November. | The rest of the Supreme Court’s health care decisions Besides Dobbs, the Supreme Court also wrapped up some loose ends on health care in the past few days that have gotten a bit buried amid all the other news.
It unanimously decided that prosecutors have to prove doctors knowingly prescribed drugs in aberrant ways to convict them of unlawful distribution. Patients with chronic pain were concerned that a crackdown on prosecutions could have had a chilling effect on prescribing needed medication.
The court also ruled against hospitals in a long-simmering case over the formulas used to calculate payments for safety-net hospitals. The ruling was 5-4, with an odd coalition of Justices Elena Kagan, Clarence Thomas, Stephen Breyer, Sonia Sotomayor, and Amy Coney Barrett in the majority. A key line: “The point of the statute is not to pay hospitals the most money possible; it is to compensate them for serving a disproportionate share of low-income patients.”
The justices also decided they won’t consider the following cases: -
A case where people with insurance tried to argue that pharmacy benefit managers have a financial duty to their clients when it comes to negotiating drug prices. Lower courts dismissed the case. -
A request by Amarin shareholders to overturn court decisions that invalidated patients for the blockbuster cardiovascular drug Vascepa. | What we're reading -
An FDA advisory panel meets today to advise on whether — and how — Covid vaccines should be updated, STAT -
This anti-abortion group shapes laws nationwide. Your state may be next, The 19th -
Cue Health rode Covid-19 to an NBA deal and a $3 billion valuation. Now it faces layoffs and a rocky future, STAT -
America is sliding into the long pandemic defeat, The Atlantic | Thanks for reading! More Thursday,  | | | |
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