Week in Review

Electronic cigarettes

  • The number of vaping-related illnesses reported to the Centers for Disease Control and Prevention grew by 275 last week, sending the total number of cases to 1,080 across 48 states and the Virgin Islands, as the death toll rose to 19. Sales growth for electronic cigarettes slowed during the past month, according to new Nielsen data, as reports of the health risks of vaping sparked a reduction in demand.
  • Contrary to earlier reports, vitamin E oil and other thickeners are likely not to blame in the spate of lung illnesses, according to researchers at the Mayo Clinic tasked with investigating the cause of the illnesses. Lung-biopsy tissue from 17 patients examined indicates injury from inhaling a caustic chemical fume and appears similar to toxic-fume exposure.
  • The Federal Trade Commission is demanding six e-cigarette manufacturers — Juul Labs Inc., RJ Reynolds Vapor Co., Fontem US Inc., Logic Technology Development LLC, Altria Group Inc.-owned Nu Mark LLC and NJOY LLC — share sales and advertising data with the agency, signaling an investigation into the companies’ marketing practices may be on the horizon. 
  • New York’s ban on flavored electronic cigarette products did not take effect Friday as planned, after a state appellate court granted a temporary stay on the regulation. The temporary restraining order is a victory for vaping advocates who filed a lawsuit against New York Gov. Andrew Cuomo (D) and the state health department, arguing executive overreach, and the appellate court plans to rule on a preliminary injunction Oct. 18. 

Opioid epidemic

  • In a court filing concerning Purdue Pharma LP’s decision to file for bankruptcy in the face of massive opioid litigation, 24 state attorneys general said Purdue must be blocked from distributing $38 million in bonuses for its employees. However, the five drugmakers that are the target of the lawsuits are reportedly considering settling the case and avoiding liability by participating in Purdue’s bankruptcy filing.
  • Johnson & Johnson agreed to pay $20.4 million — $10 million in cash, $5 million in reimbursements for legal fees and $5.4 million for donation — to resolve opioid-related litigation brought by the two Ohio counties taking several drugmakers to federal trial this month. 
  • The federal judge overseeing a Justice Department lawsuit, which claims that a plan to build the nation’s first supervised drug injection site was unlawful, ruled in favor of the Philadelphia nonprofit creating the facility. U.S. District Judge Gerald McHugh said the site, which aims to reduce drug overdoses by allowing people to use illegal opioids under medical supervision, is compliant with the Controlled Substances Act, and McHugh’s ruling is now the first legal decision on the issue.
  • Despite a nationwide surge in the number of deaths from opioid overdoses, the Drug Enforcement Administration permitted drug manufacturers to produce even more narcotic painkillers between 2002 and 2013, according to a report from the Justice Department’s inspector general. 

Food and Drug Administration

  • President Donald Trump has selected a nominee to serve as the commissioner of the Food and Drug Administration, according to two people familiar with the selection process: Stephen Hahn, the chief medical executive at Houston’s MD Anderson Cancer Center and a Republican donor who supported the presidential campaigns of Mitt Romney, John McCain and George W. Bush, plus many GOP lawmakers. 
  • The FDA and DEA sent letters to four companies — Divyata, Euphoria Healthcare Pvt Ltd., JCM Dropship and Meds4U — accusing them of operating websites that illegally market unapproved and misbranded opioid products. 

Health technology

  • United Parcel Service Inc. said it has received historic federal approval to use drones for the delivery of health supplies and eventually ship consumer goods. The decision from the Federal Aviation Administration will allow UPS’ Flight Forward unit to deliver medical products and specimens in North Carolina to hospital sites immediately.

Abortion

  • The Supreme Court will take up a case on the legality of an abortion law in Louisiana and expects to release a decision by the end of June. The law requires that doctors who perform abortions have admitting privileges at a hospital within 30 miles of the abortion clinic, and when the justices oversaw a similar case in 2016, they struck down the law.

Pharmaceutical industry

  • Some heartburn drugs tested by federal health officials, such as Zantac, contain “unacceptable levels” of a carcinogenic contaminant, according to early tests conducted by the FDA. The impurity is the same one found in the blood pressure and heart failure medicines that have recently been recalled by the FDA, and retail chains including CVS Health Corp. and Walgreens Boots Alliance Inc. halted the sale of Zantac.

Trump administration

  • In a speech at a Florida retirement community, Trump issued an executive order to expand Medicare Advantage plans, while also criticizing Democrats’ “Medicare for All” proposals and promising to preserve the private insurance industry. 
  • Idaho state officials are asking the Trump administration for approval to implement work requirements for Medicaid expansion, which would mandate that able-bodied beneficiaries between 19 and 59 years old work 20 hours per week or risk losing coverage. 

Providers

  • The Centers for Medicare and Medicaid Services hit 2,583 hospitals with Medicare payment cuts as penalty for failing to adequately reduce the number of patients readmitted within a month of their first visit. The penalties affect 83 percent of the facilities evaluated by the Hospital Readmission Reduction Program and will cost hospitals an estimated $563 million over a year.
  • The Trump administration’s plan to improve health cost transparency could hit a snag, as hospitals and patient advocates are sparring over a White House proposal to require that hospitals publicly disclose the prices they have negotiated with insurers.

What’s Ahead

  • The House and Senate are both on recess, and return to session Oct. 15.
  • On Wednesday at 12 p.m., the American Enterprise Institute for Public Policy Research will hold a discussion titled “Who Benefits? The Winners and Losers of Medicare for All, Obamacare, and Other Health Care Proposals.”
  • Jury selection for the landmark opioid trial in Cleveland is set to begin Oct. 16. The trial is scheduled to start the following week.

Events Calendar (All Times Local)

10/07/2019
AdvaMed workshop: FDA perspective on 510(k) Submissions 8:30 am
Science Board to the FDA Meeting 8:30 am
10/08/2019
AdvaMed workshop: FDA perspective on 510(k) Submissions 8:30 am
10/09/2019
Becker’s Hospital Review 5th Annual Health IT + Revenue Cycle Conference
FDA Vaccines and Related Biological Products Advisory Committee Meeting 8:30 am
AdvaMed workshop: IDE Submissions 8:30 am
AEI hosts a panel discussion on health policy proposals such as “Medicare for All” 12:00 pm
View full calendar

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