Pharmaceutical & Life Sciences News

Capsule: E-Cigarette Crusade, Generic Drug Bill, & Mixed Messages

Dec. 21, 2018, 11:20 AM

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.

Will they, won’t they—who’s to say whether lawmakers and President Trump will cave and pass a spending gap bill before the midnight deadline tonight? We’ve written extensively about what to expect if the government does shut down. Most of the Health and Human Services Department will be open, the Food and Drug Administration will be partially shut down, and National Institutes of Health employees can largely report to work as usual. Let’s take a look at what those health agencies had on their plates this week.

Here’s who ended the week on a high note:


  • E-cigarette use among teens is now officially considered an “epidemic” by the nation’s surgeon general. Regulatory agencies renewed their efforts this week to crack down on teen vaping, a good sign for parents whose kids are using popular e-cig products like Juul’s.
  • Head of the FDA, Scott Gottlieb, said the agency would use undercover agents to smoke out stores selling e-cigs to kids. The agency is also preparing advice on how to develop and prescribe smoking-cessation drugs for teens to help them quit.
  • Parents and agencies should expect an uphill battle though. The biggest player in the e-cigarette market, Juul Labs Inc., is stocking up on lobbyists to push back on any restrictive laws or regulations that come their way, Madison Alder reports.
  • Meanwhile, the FDA is asking for public input on what kind of warnings it can put on cigarette packaging that inform the public of health risks but don’t set the agency up for another court battle over First Amendment free-speech issues.

Device Development

  • Medical device makers have another option to get products on the market faster, Ayanna Alexander writes. New guidance from the FDA promotes the “least-burdensome approach,” according to the agency.
  • Device makers that must submit premarket approval applications (PMAs), premarket notifications for regulatory clearance, and novel medical device requests can participate in the breakthrough device program.
  • The change comes as device-specific records may become available to the public sooner, Alexander reports. The information includes the device’s expiration date, the maker’s information, and a code that tells what it’s used for. Broader access to device info is expected to improve patient safety, reduce medical identification errors, and help with device innovation once it’s integrated into the health-care delivery system.

Drug Stocks

  • GlaxoSmithKline Plc paved the way for a split into two companies, agreeing to create a consumer-health joint venture with Pfizer Inc. to be listed on the stock market, sending the U.K. company’s shares to their biggest gains in a decade, Bloomberg News’ James Paton writes.
  • Meanwhile drugmakers are getting ready to raise prices on Jan. 1, and on a broader swath of medicines than in prior years, according to Bernstein analyst Ronny Gal.
  • Novartis AG and Tilray Inc. are trying to cash in on medical marijuana, Kristine Owram from Bloomberg News reports. Tilray Inc. has signed a global partnership with a division of Swiss drug giant Novartis to develop and distribute its medical marijuana in legal jurisdictions around the world. More and more companies are trying to get in on the ground floor of legal pot, including Marlboro maker Altria Group and the producer of Corona beer.

It was a bleak week for others. Here’s whose Thursday closed on a downswing:

Generic Drugmakers

  • A new bill could massively cut into drugmakers’ coffers. The federal government could step in to make generic prescription drugs that have high prices or are in short supply under legislation offered by two Democrats in the Senate and House, Shira Stein reports.
  • Sen. Elizabeth Warren (D-Mass.) and Rep. Jan Schakowsky (D-Ill.) are backing the bill that would create a drug manufacturing unit within the HHS. Although the bill isn’t likely to pass the Republican-lead Senate, its a sign that lawmakers are willing to consider unorthodox routes to lower drug costs. A group of hospitals said last year they planned on making their own drugs as well.
  • Sen. Warren also called for hearings on allegations of price fixing by generic drug makers, Bloomberg News’ John Tozzi writes. She’s asking Republican committee leaders to investigate the industry alongside ongoing probes by state and federal authorities of more than a dozen companies.

Consistent Messages

  • When a Texas judge ruled the Affordable Care Act unconstitutional last Friday, health-care twitter exploded. The ruling doesn’t mean Obamacare is kaput—in fact we’re a long way away from that possibility. But while HHS officials were trying to reassure people who had signed up for or planned to buy Obamacare plans, President Trump tweeted a disparaging comment about the ACA, Madison Alder reports.
  • The HHS focused on making the distinction that the ACA was still in effect, whereas a statement from White House Press Secretary Sarah Sanders cheered the ruling, saying the “decision vindicates President Trump’s position that Obamacare is unconstitutional” and adding briefly that “the law remains in place.”
  • The mixed messaging continued into this week, Sahil Kapur from Bloomberg News reports. Congressional Republicans were handed the gift they said they wanted when a Texas judge invalidated Obamacare late last week. Yet few now seem willing to open it.
  • It’s a “lose-lose” situation for Republicans, a lobbyist and former health policy adviser to incoming Senate Finance Chairman Chuck Grassley (R-Iowa), told Kapur. He said the scope of the ruling “frankly caught a lot of people off guard.”

Compliance Costs

  • A pending federal proposal to free up the exchange of health-care data is likely to lead to costly hassles for hospitals, James Swann writes.
  • Hospitals and their electronic health record vendors sometimes restrict the electronic exchange of patient data with other institutions. They do this for a variety of reasons—fear of losing the patient, privacy concerns, or technology mismatches.
  • The proposed rule will flesh out the statutory definition of “information blocking,” which current law says should be kept to a minimum, and include details on the limited occasions when such blocking is allowed.

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 jlee1@bloomberglaw.com.

To contact the reporter on this story: Jacquie Lee in Washington at jlee1@bloomberglaw.com

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