| | | | | | | | | | | Axios Vitals | | By Tina Reed · May 22, 2023 | | Good morning, Vitals readers. Today's newsletter is 998 words or a 3½-minute read. | | | | | | 1 big thing: America's drug shortages worsen again |  | | | Illustration: Aïda Amer/Axios | | | | Shortages of cancer drugs and other life-saving medications are reaching their worst point in a decade, forcing physicians to develop workarounds and the Biden administration to mount an all-of-government response. Why it matters: The shortfalls are surfacing deeply entrenched problems in America's drug supply chain, particularly around commonly-used generic drugs. What they're saying: "This generic business, particularly for these complex drugs, these complex formulations, is not a healthy business right now," Scott Gottlieb, former FDA commissioner and a Pfizer board member, told CBS News on Sunday. - "There are things the government can do but most of them are going to cost money. We're going to have to look for ways to provide more reimbursement for these hard-to-manufacture drugs," he said.
Driving the news: There are more than 300 drugs in shortage, the highest since 2014, per the American Society for Health-System Pharmacists. - The American Cancer Society warned earlier this month about potentially "life-threatening" supply problems of chemotherapy drugs which "don't have an effective alternative."
- The Society of Gynecologic Oncology this month outlined strategies for allocating limited supplies of drugs for gynecologic cancers and warned that without planning, disparities in care could worsen.
- Heart drugs like adenosine, administered intravenously for emergency treatment of an irregular or a rapid heartbeat as well as cardiac stress tests, are also in short supply and may require hospitals to limit use to emergencies, the health-system pharmacists say.
Between the lines: Experts are quick to point to the challenges faced by generics makers in a low-margin business that has driven much of the manufacturing to consolidate to just a few players or move overseas. - Gottlieb, who was FDA commissioner during the Trump administration, pointed to efforts to curb drug costs, including caps on drug price increases, in the Inflation Reduction Act as contributing to underinvestment in safe and sustainable generic supplies.
What to watch: The Biden administration and Congress are both examining ways to address what has been dubbed a national security issue — including via a reauthorization of the Pandemics and All-Hazards Preparedness Act, or PAHPA. - But solutions could be expensive and disruptive. The FDA can identify problems and work with manufacturers, but lacks the expertise and, in some cases, authority to address bigger economic issues around the industry.
Go deeper. |     | | | | | | 2. Sparks fly over Illumina this week |  | | | Illustration: Gabriella Turrisi/Axios | | | | Activist investor Carl Icahn is expected to make a play this week to shake up the leadership of the $36 billion gene-sequencing giant Illumina, including ousting CEO Francis deSouza. Driving the news: Illumina's annual shareholder meeting is scheduled for Thursday and all eyes are on Icahn. The big picture: Illumina has been embroiled in a proxy fight with Icahn, who owns 1.4% of Illumina, and has been pushing the company to unwind its acquisition of cancer detection test maker Grail. The Federal Trade Commission blocked the deal in April and EU authorities objected to the takeover, forcing Illumina to run the business as a subsidiary. Zoom in: Icahn proposed replacing three Illumina board members with directors from his firm. He's received support from proxy firm Glass Lewis to replace deSouza and chairman John Thompson, the Financial Times reported. - Glass Lewis said the pair have failed to take responsibility for the "value crimping" acquisition of Grail, per FT.
- Corporate governance adviser ISS, threw support behind Andrew Teno, Icahn's proposed candidate to replace Thompson, but said replacing the CEO as well would be too disruptive, the Wall Street Journal reported.
The other side: Illumina urged shareholders to "protect their investment" and reject all three of Carl Icahn's "unqualified nominees." | | | | | | | | 3. Heat is coming |  | | | Map showing seasonal temperature trends likely during summer 2023 across the U.S. Image: NOAA | | | | The climate outlook for June through August shows a broad swath of the Lower 48 states and Alaska are likely to see a hotter than average summer, Axios' Andrew Freedman writes. Why it matters: Heat is one of the most common natural contributors to injury or death and as Axios' Arielle Dreher previously reported, summers are becoming deadlier as climate change blankets millions in hotter, more frequent heat waves. Zoom in: The NOAA outlook shows the highest probability of above-average temperatures is across the Southwestern U.S. It's centered over New Mexico and Arizona, where there is a 60% to 70% chance of a warmer-than-average summer. - The odds are slightly lower, at about 50% to 60%, for warmer-than-average temperatures from Texas to New England.
- A tilt toward drier conditions is projected for the Pacific Northwest and the Southwest, with drought hanging on in eastern New Mexico and west Texas.
Read the rest. | | | | | | | | A message from Axios | | Goldman Sachs' Tony Fratto on revising your comms strategy | | |  | | | | It's time for leaders to take a hard look at how they're operating and find new, innovative, and strategic ways to lead their teams to success. - Join us May 24 when Fratto and Axios Co-founder Roy Schwartz dig in on how to get it done — and communicate it well.
Register here. | | | | | | 4. FTC targets drug industry | | The Federal Trade Commission is getting more aggressive in targeting the drug industry, KFF Health News writes. Case in point: Last week's agency challenge of Amgen's $28 billion Horizon takeover marked the first time in more than a decade that the FTC has sued to stop a big pharma merger, and reflects the Biden administration's expansive view of antitrust law, Axios' Dan Primack reported. - The FTC also announced last week an expansion of a yearlong investigation of PBMs, saying it was looking at two giant drug-purchasing companies, Ascent Health Services and Zinc Health Services.
What they're saying: The FTC's action is a "shot across the bow for the pharmaceutical industry," Robin Feldman, a professor and drug industry expert at the University of California College of the Law-San Francisco, told KFF Health News. Yes, but: Experts have expressed skepticism the FTC will prevail. - The case is being heard in U.S. District Court in Illinois by Trump appointee John Kness, who is a former member of the Federalist Society whose membership tends to be skeptical of antitrust efforts, KFF Health News points out.
Related: FTC signals tougher rules for health companies' use of data | | | | | | | | 5. While you were weekending |  | | | Illustration: Annelise Capossela/Axios | | | | ☠️ Medical AI's weaponization is another risk to consider, experts say. (Axios) 🏠 As residential care homes expand in Maine, seniors don't always get the care they need. (ProPublica) 👉 Nebraska rolls abortion restrictions into a measure curbing gender-affirming care for trans minors. (Axios) 💊 Did scientists accidentally invent an anti-addiction drug? (The Atlantic) | | | | | | | | A message from Axios | | Goldman Sachs' Tony Fratto on revising your comms strategy | | | | | | | | It's time for leaders to take a hard look at how they're operating and find new, innovative, and strategic ways to lead their teams to success. - Join us May 24 when Fratto and Axios Co-founder Roy Schwartz dig in on how to get it done — and communicate it well.
Register here. | | | | Thanks for reading Axios Vitals, and to senior editor Adriel Bettelheim and senior copy editor Bryan McBournie. Please ask your friends and colleagues to sign up. |  | | Dive deeper into the future of health care | | | | | | Axios thanks our partners for supporting our newsletters.
Sponsorship has no influence on editorial content. Axios, 3100 Clarendon Blvd, Arlington VA 22201 | | | You received this email because you signed up for newsletters from Axios.
To stop receiving this newsletter, unsubscribe or manage your email preferences. | | | Was this email forwarded to you?
Sign up now to get Axios in your inbox. | | | | Follow Axios on social media:    | | | | | |
No comments