Supreme Court Upholds ACA
The Supreme Court decided (7-2) that the entire ACA stands. The reason is that the plaintiffs lacked standing to bring the suit because they could not show harm. The important issues, such as the severability with respect to the tax (penalty) provision, were not addressed by the majority. It leaves urther challenges open.
About pharma
US plays catch-up with Europe over biosimilar patents: “Europe’s more liberal approach to biosimilar drug patents is continuing to give it an edge over the US in producing lower cost medicines — despite moves by Washington to ease market access for generic manufacturers…
In Europe, the European Medicines Agency (EMA) will not approve a biosimilar in the first 10 years after approving the original drug. But, in the US, the Food and Drug Administration (FDA) will hold off for 12 years.
That difference in timing can be seen in the case of the drug bevacizumab — a treatment for colon and lung cancer and renal-cell carcinoma, sold as Avastin. This year, Europe approved a fifth Avastin biosimilar, whereas the US has approved just two biosimilars for bevacizumab overall, in 2017 and 2019…
Iqvia estimates that expanding the use of biosimilars could reduce the costs of medications in the US by $100bn over five years.”
New Alzheimer’s Drug is Projected to Increase National Health Expenditures [NHE]by More Than One Percent: “The contribution of Aduhelm to prescription drug spending and to NHE grows to more than $73 billion by 2028.”
AstraZeneca's lawsuit over 340B contract pharmacies survives after judge dismisses challenge from HHS: “A federal judge has dismissed the Department of Health and Human Services’ (HHS') bid to toss a lawsuit from drugmaker AstraZeneca over the 340B drug discount program.
The decision by Judge Leonard Stark, delivered Wednesday, ensures the lawsuit over AstraZeneca’s restriction of sales to 340B contract pharmacies will continue.
AstraZeneca and several other drug companies over the past year have restricted sales of 340B-discounted products to contract pharmacies, which are third-party entities that dispense the discounted drugs on behalf of covered entities.”
FDA launches global Generic Drug Cluster: “Described as ‘the first forum established for the world’s leading regulatory agencies to address generic drug development globally,’ the new cluster, wrote FDA, is meant to help harmonize approaches global regulators take to generic drug development through a variety of approaches. FDA announced the launch of the new body in a 14 June tweet from its FDA Drug Information Twitter account.”
GlaxoSmithKline awarded no restitution in high-profile trade-secrets theft case: This decision is odd and may have implications for other, similar, cases.
“The legal filing comes in the case of the U.S. vs. Yu Xue and Tao Li, Chinese nationals who previously pleaded guilty to trade secrets theft to benefit a company they founded, Renopharma…
In August 2018, Xue pleaded guilty to conspiracy to steal GSK’s trade secrets. And the following month, federal prosecutors secured a guilty plea from Li.
While the government agreed to limit Li’s sentence to no more than seven years and drop other charges, the sides did not agree on any amount of financial loss, leaving the issue up to the court, the judge wrote this week.
Now, despite arguments from the government that GSK lost more than $1 billion in the ‘fair market value’ of the trade secrets, the court is not awarding any restitution. In doing so, the court found that GSK ‘suffered no pecuniary loss.’”
About health insurance
Colorado becomes 2nd state to create own public insurance option: “The legislation, signed by Democratic Gov. Jared Polis Wednesday, would create individual and small group health plans starting in 2023. It became the second state after Washington to pass a public insurance option, and several more could come after it.
The standardized plan must offer healthcare coverage on the bronze, silver and gold levels and offer all pediatric and other essential benefits.
Colorado’s insurance commission must also create rules regarding network adequacy for the public option plan.”
Feds sue to block Aon's $30 billion Willis Towers deal: “The U.S. Justice Department sued to block Aon’s proposed $30 billion acquisition of Willis Towers Watson, saying the deal to create the world’s largest insurance brokerage is anticompetitive.
The department’s antitrust division filed a lawsuit in federal court in Washington asking a judge to stop the deal, arguing that it would create too much concentration in the market and hurt businesses, their employees and retirees.”
Democrats devise a way to finally expand Medicaid in resistant states: This morning, Rep. Lloyd Doggett (D-Tex.) introduced “legislation, co-signed by more than 40 House Democrats, that would let cities and counties bypass the states still refusing to expand their Medicaid programs…
Cities, counties or even hospital districts could get special permission from the Centers for Medicare and Medicaid Services to expand Medicaid within their own jurisdiction. The permission, granted through what are known as ‘demonstration projects,’ would last for five years, with an option to extend for an additional five years. It would provide the same federal assistance provided to states; localities would have all of their expansion costs covered for the first three years, with the federal subsidies phased down to 90 percent of costs by the seventh year.”
UnitedHealth Group Releases 2020 Sustainability Report: “The report includes three long-term commitments UnitedHealth Group is making to expand access to care, improve health care affordability and achieve better health outcomes. These commitments are to:
Ensure that 85% of members receive preventive care services annually by 2030.
Ensure more than 55% of outpatient surgeries and radiology services among members are delivered at high-quality, cost-efficient sites of care by 2030.
Close 600 million gaps in care for members by the end of 2025.”
About Covid-19
Despite progress in this country, the virus continues to spread globally. Below are a few articles examining this problem.
WHO says delta Covid variant has now spread to 80 countries and it keeps mutating: “The variant now makes up 10% of all new cases in the United States, up from 6% last week. Studies have shown the variant is even more transmissible than other variants. WHO officials said some reports have found that it also causes more severe symptoms, but more research is needed to confirm those conclusions.”
The good news is that current vaccines are very effective against infection by this variant.
Coronavirus infections rising exponentially in England - REACT study: “The number of people infected with the coronavirus is increasing rapidly in England, doubling every 11 days…
Most infections are happening in children and young adults, but they are rising in older people too, increasing at a similar rate in the over 50s and the under 50s.
Africa sees 44% spike in new Covid infections, 20% increase in deaths: “Weekly cases jumped 44% while fatalities rose 20% over the previous week across Africa, according to the World Health Organization.
African countries currently have the lowest share of vaccines in the world.”
U.S. buys 200 mln more Moderna COVID-19 vaccine doses: “The additional Moderna doses, which brings total U.S. orders to 500 million, could be used for primary inoculation, including of children, or as a possible booster shot, the company said.”
Pfizer’s arthritis drug Xeljanz shows lifesaving benefits in hospitalized COVID-19 patients: “Xeljanz reduced the risk of death or respiratory failure among hospitalized patients with COVID-19 pneumonia who didn’t require ventilation, according to data published in the New England Journal of Medicine.”
About healthcare IT
CVS Health database leak left 1B user records exposed online: “More than 1 billion search records belonging to CVS Health were accidentally posted online and accessible to the public earlier this year.
The database belonging to the healthcare and retail giant, which was not password protected, was discovered at the end of March by independent cybersecurity researcher Jeremiah Fowler, according to a report published by Website Planet, which conducts research into unsecured internet data.
The database, which was approximately 204 gigabytes in size and totaled 1.1 billion records, had no form of authentication in place to prevent unauthorized entry, the researchers said.
The data exposed online included customer email addresses, user IDs and customer searches on CVS Pharmacy websites for COVID-19 vaccines and other medications, according to the report.”
Penn Medicine releases bedside Epic tool to share EHR data with patients: “Philadelphia-based Penn Medicine has released a digital tool, MyChart Bedside, to share scheduling and updated health information with patients…
The Epic-hosted tool gives patients access to educational materials, descriptions of hospital staff assisting with their treatment, their medications, and other information through hospital iPads.”
About the public’s health
A randomized controlled trial to isolate the effects of fasting and energy restriction on weight loss and metabolic health in lean adults: “Even with net energy intake restricted to that of daily dieters, alternate-day fasting less effectively reduced body fat content and offered no additional short-term improvements in metabolic or cardiovascular health compared to daily energy restriction.”