#36 • A Healthy Dose of Healthcare News • July 9, 2021
Biden signs EO on antitrust, the Delta variant tops the charts, the FDA restricts the use of new Alzheimer's drug, OxyContin manufacturer reaches agreement with states, Dollar General's CMO, and more
Dr. Fauci affirmed that over 99% of the people who died from COVID-19 in June were unvaccinated. Thus, there seems to be a strong case for leaving the decision to get vaccinated up to each person. That did not discourage HHS Secretary Xavier Becerra from going on TV yesterday to tell Americans that because the federal government has spent trillions of (taxpayer) dollars on controlling the pandemic, people had better get the vaccine.
The big news of the week isn’t vaccine-related, however. Today, President Biden signed an executive order containing no less than 72 actions against anti-competitive behavior in various industries, including healthcare. More below.
In this edition, you will read about:
#36.1. President Biden’s latest EO on competition in healthcare,
#36.2. the Delta variant’s prevalence in the US,
#36.3. a narrower use for the new Alzheimer’s drug,
#36.4. a new settlement over OxyContin manufacturer’s bankruptcy plan,
#36.5. Dollar General’s new healthcare hire,
#36.6. a fertility app’s FDA approval for wearable-generated data, and
🍿 a quirky bonus read on Big Pharma, the Sierra Club, and Republicans pushing back against Big Paper.
Scroll to the bottom for job openings in health policy, and contact me if you want yours included in the next edition.
#36.1. FACT SHEET: Executive Order on Promoting Competition in the American Economy (The White House)
Today’s executive order contains a variety of actions on labor markets, agriculture, technology, banking, internet services, transportation, and — of course — healthcare. The order runs the gamut:
Drug importation: It “directs the Food and Drug Administration to work with states and tribes to safely import prescription drugs from Canada, pursuant to the Medicare Modernization Act of 2003.”
Biosimilars and generics: It “directs the Health and Human Services Administration (HHS) to increase support for generic and biosimilar drugs, which provide low-cost options for patients.”
Prescription drug prices: It “directs HHS to issue a comprehensive plan within 45 days to combat high prescription drug prices and price gouging.”
Ban “pay for delay”: "It “encourages the FTC to ban “pay for delay” and similar agreements by rule.”
OTC hearing aids: It “directs HHS to consider issuing proposed rules within 120 days for allowing hearing aids to be sold over the counter.”
Hospital consolidation: It “underscores that hospital mergers can be harmful to patients and encourages the Justice Department and FTC to review and revise their merger guidelines to ensure patients are not harmed by such mergers.”
Hospital price transparency: It “directs HHS to support existing hospital price transparency rules and to finish implementing bipartisan federal legislation to address surprise hospital billing.”
ACA marketplace plan standardization: It “directs HHS to standardize plan options in the National Health Insurance Marketplace so people can comparison shop more easily.”
Virtually all of these initiatives could either significantly help or hurt American patients depending on how they’re implemented. The devil will be in the details.
#36.2. CDC: Delta becomes dominant coronavirus variant in U.S. (Axios)
The Delta variant, succeeding to the Alpha variant and the “original” COVID virus, now accounts for 51.7% of COVID cases in the country. While it is more contagious than Alpha and far more contagious than the original virus, it seems to be just as powerless against people who are vaccinated. According to the CDC, 67% of U.S. adults have had at least one shot, and 58% are fully vaccinated.
#36.3. Amid criticism, FDA narrows use of $56K Alzheimer’s drug, calls for probe (Ars Technica)
Biogen’s Alzheimer drug Aducanumab (brand name Aduhelm) has been dominating health news headlines for weeks now following its controversial approval which sparked concerns over efficacy and spending and led three members of the FDA’s advisory committee to resign. The drug did not produce convincing evidence of efficacy in clinical trials, and its handsome price tag of $56,000 multiplied by six millions of Alzheimer patients, most of whom are enrolled in Medicare, has contributed to an intense debate about the limits of government-funded healthcare. This week, the FDA restricted its use to patients with mild disease like those tested in the trials. Still, a study by Boston University researchers estimates that half of America’s Alzheimer’s patients can be deemed to have mild disease. If just 10% of those patients were put on the new drug, it would cost Medicare almost $17 billion a year, of which more than $13 billion would be financed by taxpayers.
#36.4. 15 more U.S. states reach settlement in OxyContin maker Purdue bankruptcy (Nasdaq)
Fifteen more states just reached an agreement with Purdue Pharma on the company’s bankruptcy plan. Purdue, the large private company that manufactures OxyContin, has been the object of over 3,000 lawsuits due to its alleged role in the opioid crisis that has claimed about 500,000 lives since 1999. In the agreed-upon settlement plan, the Sackler family, which owns Purdue, will contribute around $4.5 billion. The plan would dissolve the corporation and put its assets into trusts run on behalf of plaintiffs who claim that the company and its owners downplayed the role of the product in the ongoing opioid crisis.
#36.5. Dollar General hires chief medical officer as it looks to become a health-care destination in rural areas (CNBC News)
Dollar General, which has 17,400 stores and counting across the country, identified a common complaint among its customers: affordable healthcare products are difficult to come by, especially in rural areas that may not have large grocery stores and pharmacies. That’s why the company just named a Chief Medical Officer, Dr. Albert Wu, who just did a five-year stint at McKinsey & Company, a top consulting firm. Dollar General has so far not expressed any intention to offer on-site clinical services. Rather, they plan to expand their offering of pharmaceutical products such as cough syrup and cold medication. Dollar General is also working on adding fresh produce and health products to its assortment.
#36.6. Natural Cycles snags FDA clearance to use wearable temperature data in its fertility algorithm (MobiHealthNews)
Natural Cycles is a Swedish company whose app allows women to track their fertility status using basal body temperature and other physiological data. Previously, users had to manually enter their body temperature into the app. Now, the FDA just authorized the app to collect temperature data directly from wearables. One small step for a startup, but one (potentially) giant leap for connected health and “femtech.”
🍿 A quirky bonus read…
… about a singular ritual among lobbyists on Capitol Hill: every year since 2015, the paper lobby has successfully placed a clause in the House Appropriation Committee’s legislation that mandates that drug manufacturers deliver information to pharmacists on paper (as opposed to a digital format). This fight pits unusual coalitions against one another:
The pro-paper team is headed by the Pharmaceutical Printed Literature Association, which is responsible for the legislative wins over the years and the associated literary bounty flowing from the mandate, with the support of legislators from counties and states with a significant paper mill presence.
The anti-paper team brings together the Alliance to Modernize Prescribing Information, i.e. the pharmaceutical industry’s lobbying group on the issue, as well as pro-innovation Republicans and none other than the Sierra Club, which bemoans the destruction of over 30 million trees attributable to the policy.
Dunder Mifflin is conspicuously absent from the pro-paper coalition. “I’m running away from my responsibilities,” Michael Scott stated, “and it feels good.”
Job openings:
Healthcare Program Manager @ a boutique consulting firm. 10 years of Program Management experience and 4 years of BPM and/or RPA implementation experience. Message me on LinkedIn for more information.