End of Week Update

David Ermer–Congress, FDA, U.S. Healthcare–
Photo by Dane Deaner on Unsplash

From Washington, DC

  • Roll Call offers the history of the August Congressional recess, which began on Thursday. The recess gives the staff time to prepare for the big September legislative push.
  • Roll Call adds
    • “Days after it was passed by the House, the Senate cleared legislation Thursday evening that aims to overhaul the organ transplant system in the United States.
    • “The bill now goes to President Joe Biden’s desk for his signature.
    • “The bill would give the Department of Health and Human Services the authority to expand competition for contracts related to the operation of the Organ Procurement and Transplantation Network, which matches donor organs with patients waiting for transplants.
    • “The legislation comes as the Biden administration moves to open up the contracting process that has allowed one company to manage the system for nearly 40 years, despite claims of mismanagement that has allowed patients to die on waiting lists.
    • “The management of the U.S. organ transplant system needs serious reform,” said Sen. Bill Cassidy, R-La., a co-sponsor of the Senate companion version of the bill and the ranking member of the Senate Health, Education, Labor and Pensions Committee. “Breaking up this monopoly will increase competition, save lives and improve the system. Glad to see our legislation pass Congress and look forward to it becoming law.”
  • NBC News and STAT News let us know that both Houses of Congress are preparing legislation to hopefully solve the Nation’s widespread drug shortage.
  • AHA News adds,
    • “In the wake of tornado damage last week to a large Pfizer sterile injectables plant in North Carolina, the Food and Drug Administration July 28 posted a list of products made at the facility that have less than three months of inventory in the supply chain. According to Pfizer, there does not appear to be any major damage to production areas at the 250-acre site, but about 40,000 pallets of supplies and finished goods stored in the facility’s high-rise warehouse were damaged. The company said it is working to restart production and explore alternative manufacturing locations and will update the information as it learns more. Meanwhile, the company said it is allocating products in its hospital portfolio.”
  • Also, per AHA News
    • “The Centers for Medicare & Medicaid Services July 28 issued its final rule updating hospice payments for fiscal year 2024. CMS finalized a 3.1% ($780 million) net increase to FY 2024 payments as compared with FY 2023. This update includes a 3.3% market basket, reduced by a 0.2% productivity adjustment.”
  • The Food and Drug Administration approved
    • “RiVive, 3 milligrams (mg) naloxone hydrochloride nasal spray for over-the-counter (OTC), nonprescription use for the emergency treatment of known or suspected opioid overdose. This is the second nonprescription naloxone product the agency has approved, helping increase consumer access to naloxone without a prescription. The timeline for availability and the price of this nonprescription product will be determined by the manufacturer.”

From the U.S. healthcare business front —

  • Beckers Payer Issues informs us that health insurer “Centene recorded $1.06 billion in net income in the second quarter of 2023 after recording a $172 million loss over the same period last year, according to the company’s earnings report released July 28.”
  • BioPharma Dive reports
    • “Biogen is making one of the biggest business bets in its 45-year history, announcing Friday a deal to buy Reata Pharmaceuticals and its newly approved rare disease drug for approximately $7.3 billion.
    • “The Cambridge, Massachusetts-based biotechnology company will pay $172.50 per Reata share, which represents a premium of about 59% over the stock’s closing price Thursday. Biogen expects to fund the deal with cash on hand as well as additional debt.
    • “Acquiring Reata gives Biogen access to Skyclarys, a drug for the neuromuscular condition Friedreich’s ataxia that gained U.S. approval in March. The disease is uncommon, affecting an estimated 5,000 people in the U.S. And its clearance was controversial, following years of back-and-forth with the Food and Drug Administration.”
  • and
    • “AstraZeneca has reached a deal to acquire a group of early-stage gene therapy programs and related technologies from Pfizer, the British drugmaker’s most significant move to date in the field of genetic medicine.
    • “Per deal terms, AstraZeneca’s rare disease division Alexion will pay up to $1 billion to acquire the programs and novel “capsids,” the protein shells that protect gene therapies as they’re delivered into the body. AstraZeneca intends to use those capsids to develop genetic therapies with “improved safety and efficacy profiles,” the company said Friday.
    • “AstraZeneca will pay royalties on sales of any commercial products that arise from the deal. Alexion also intends to “welcome talent from Pfizer” who were working on the research, an area the drugmaker has cut back on in favor of more advanced gene therapy programs.”
  • Per BNA News,
    • “Employer-sponsored health plans are investigating the possibility of organizing risk pools to help finance the high cost of prescription drugs.
    • “They are eyeing asking for government help in setting up risk pools that would help cover costs for so-called orphan drugs that treat rare diseases, as well as for high-cost gene and cell therapies. Risk pools are funds collected from groups of employers that would be used to pay for high-cost drugs.
    • “Employers are particularly worried about high-cost drugs that can run more than $1 million. Even with stop-loss insurance, which covers high claims costs, employers can end up footing the bill after a drug is covered the first year.”