From Pharma & Life Sciences News on Bloomberg Law
March 22, 2019
By Jacquie Lee
Welcome to Capsule—your weekly dose of health-care news, where we give you a recap of this week’s highs and lows for key players in the health-care industry. You can expect us every Friday morning as a bookend for your week.
Amazon is 39-states-strong in its effort to launch its national online pharmacy, PillPack. Given that Amazon is moving to Crystal City, Va. (where Bloomberg Law’s office is located) I’m slowly accepting their eventual takeover of my entire life. Amazon isn’t the biggest player in the health-care market yet, though, so let’s take a look at what the other big shots are up to.
Here’s who ended the week on a high note:
- The chairman of the FDA’s advisory committee for opioid approvals is demanding the agency stop approving the painkillers until it steps up its regulatory game to ensure the drugs wouldn’t be a public nuisance.
- Meanwhile, Congressional pressure against opioid manufacturers is mounting. The House Oversight Committee asked Purdue Pharma for documents related to the Sackler family’s role in OxyContin’s marketing and consequential popularity. Raymond Sackler is credited with inventing pharmaceutical marketing as we know it today and his family still owns a controlling share of the company.
- Luckily one of the most popular and effective treatments used to fight the U.S. opioid epidemic is about to get much cheaper, Ari Altstedter reports for Bloomberg News. After a two-year legal battle, Dr. Reddy’s Laboratories has won the right to sell a cheaper version of Suboxone Film, the best-selling opioid addiction drug in the U.S.
Ukrainian Device Profits
- Ukraine recently moved to deregulate its medical device market, our international correspondent Sergei Blagov reports. A new decree will cancel the price ceiling applicable to medical devices originally instituted in 2008.
- As a result, retail prices of medical devices will no longer be regulated by the Ukrainian government. The measure is aimed at “removing excessive government interference” in device-market developments and will “optimize” price setting procedures, according to the government’s statement.
- The move runs counter to the U.S.'s health care environment, which is seeing a large push to get the government more involved in regulating health-care costs.
- For the roughly 15 percent of new moms who suffer from postpartum depression, a new drug might offer some relief. Sage Therapeutics got FDA approval this week for Zulresso, which is the first drug approved to treat the condition.
- Postpartum depression is “a major depressive episode that occurs following childbirth,” the FDA says, and “is a serious condition that, when severe, can be life-threatening.”
- There are major caveats to the drug that stand in the way of its effectiveness though: moms needs to check into a medical facility to get it through an IV, which can take 60 hours. It’s also expensive, with a price tag of $34,000 for a round of treatment.
It was a bleak week for others. Here’s whose Thursday closed on a downswing:
- Lawyers representing various drug middlemen—also referred to as pharmacy benefit managers—had their hands full this week. The Ohio Attorney General sued Optum Rx recently for $30 million for allegedly bilking the nation’s largest state-run workers comp program out of generic drug discounts, Alex Ebert reports.
- In Minnesota, middlemen negotiating drug prices for health insurers would be regulated in the state for the first time under a bill headed to a second state Senate committee in early April, Stephen Joyce writes.
- And Arkansas Attorney General Leslie Rutledge renewed her push this week to have the U.S. Supreme Court revive a state law regulating how companies like Express Scripts and CVS Health reimburse pharmacies for prescription drugs, Jacklyn Wille reports.
- Executives of drug middlemen will testify before Congress April 9 about their role in rising drug prices. The chairman of the committee where they’ll testify confirmed this week that executives from five major drug middlemen, including CVS and Optum Rx, will attend.
- Beware your sleep apnea machine, Ayanna Alexander reports. It’s collecting data on your heart rate, breathing, and sleeping patterns and the device’s manufacturer can share those data with third parties.
- It sounds sketchy but turns out it’s totally legal. Those companies aren’t covered by the Health Insurance Portability and Accountability Act of 1996, a major health privacy law that dictates what information doctors, insurers, and other health-care providers can share with other people.
- Patients may be unaware that they have authorized data sharing despite the privacy policies that are connected to the product and a company’s apps, one lawyer tells Alexander. “So, in most cases, when an individual hands over their health data to a device company, that company is not prohibited from disclosing the data to other entities,” another lawyer said. “This gives device companies a lot of leeway in terms of what they can do with health information they obtain.”
Litigious Nursing Home Residents
- The White House is reviewing a Health and Human Services regulation that would allow nursing homes that receive Medicaid and Medicare funding—which is nearly all of them—to enforce “pre-dispute” arbitration clauses, Tony Pugh reports.
- By requiring residents to resolve complaints through arbitration—even before a problem occurs—families that sign the agreements waive their right to sue if legitimate issues of abuse or neglect do arise. That would be a reversal from the Obama administration, which had sought to ban the practice.
- As 10,000 aging baby boomers become eligible for Medicare each day, nursing home care is poised to become a growth industry and an important issue for millions of families moving forward. Finding an equitable, safe, and cost-efficient way to provide that care is crucial to the financial stability of Medicare and Medicaid, which collectively paid $71.7 billion for nursing home care in 2017.
Thanks for joining us this week and have a great weekend. I’m all ears when it comes to your two cents, tips, critiques, or coordinating exclusive interviews. Send them my way at email@example.com.