Pharmaceutical & Life Sciences News

Capsule: Shutdown Situations, a GOP Identity Crisis, & Right to Try

Jan. 11, 2019, 11:10 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.

We’re headed for the longest government shutdown in history if President Trump and Congress don’t reach a deal by Sunday. The FDA has shifted its concerns toward safety inspections rather than new drug development, but so far no drug companies have publicly said drug time lines have been affected. Here’s what has been affected by the shutdown, along with a rundown of this week’s health-care news.

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

Right to Try Advocates

  • A California man with a deadly form of brain cancer is receiving an experimental therapy under the so-called Right to Try law, the first publicly known use of the controversial legislation that was signed into law in May 2018 by President Donald Trump, Michelle Fay Cortez from Bloomberg News writes.
  • The treatment, called Gliovac, is a vaccine crafted from the patient’s own cells and tissue taken from other patients with glioblastoma. You might remember the disease because it’s the same type of tumor that killed John McCain a year after his diagnosis.
  • Advocates say it will give dying patients options, while critics say it will expose them to unknown side effects of little-studied therapies, without knowing if they have a reasonable chance of benefiting.

Maryland, Alaska, & Maine

  • Maryland, Alaska, and Maine are getting an unexpected surprise this year from the federal funding fairy. Funding for the Obamacare program that lowers premiums may vary widely from what was expected and these three states are flush with cash, Sara Hansard reports.
  • Maine got almost double what was expected in reinsurance payments from the federal government. Alaska saw a $10.2 million bump, and Maryland got an extra $69 million.
  • Reinsurance provides payments to health insurers to help pay claims for high-cost enrollees. That lowers premiums for Affordable Care Act plans, which in turn reduces premium subsidies for which the federal government is liable.

Unfinished Business

  • The outlook for a bill to reauthorize anti-pandemic and other health emergency programs looks good as lawmakers seek to clear unfinished health business from the last Congress, Alex Ruoff reports.
  • The House passed a bill (H.R. 269) Jan. 8 to renew $7 billion in emergency pandemic-prevention programs, modify the regulatory framework for nonprescription drugs, and establish user fees for drugmakers. The legislation is a new version of a bill (H.R. 7328) the House passed in December but the Senate never acted on.
  • Most of the emergency health programs covered by the bill expired Sept. 30 and were set to temporarily renew under a short-term spending bill that Congress never cleared because lawmakers are at odds over funding for a wall along the southern border.

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

Federal Lawyers

  • Legal questions about a Trump rule on short-term health plans, the constitutionality of Obamacare, and federal oversight of drug manufacturing plants likely won’t be settled until after the federal government reopens, Madison Alder reports. She helpfully lays out a list of the cases to keep an eye on.
  • In the absence of funding, Justice Department attorneys are barred from working on cases, even on a voluntary basis. DOJ attorneys almost always assist in cases where the government is a party. As a result, many government lawyers are requesting pauses on proceedings until appropriations to the DOJ are restored.
  • Judges and court leaders will make their own decisions as to whether to continue operations and what the priorities will be. That will likely create a patchwork situation, with each court treating things differently, legal analysts tell Alder.

The GOP’s Identity

  • Republicans—and the Trump administration in particular—are in a tough political spot thanks to the litany of drug price polices floating around. One policy analyst explained it to me this way: They’re damned if they do, and damned if they don’t tackle drug pricing because it will require a lot of regulatory lift. That’s hard to stomach for a party whose whole identity is based on less government interference.
  • Sen. Bernie Sanders (I-Vt.) and a handful of progressive Democrats have made the GOP position even more precarious. They introduced drug price bills Jan. 10, and a few of them mirror the Trump administration’s own policies. Will that give Republicans any incentive to throw in their support? Sanders thinks it should.
  • One of the progressive bills introduced Jan. 10 surrounds pegging U.S. drug prices to what other countries paid. The federal Medicare agency is already taking heat for a similar proposal. Some critics went as far as calling it a socialist move.

Data Hoarding Fixes

  • The ongoing government shutdown is delaying the release of two significant health information technology proposals—one to require hospitals and clinics to share patient data with one another and a second to create incentives for electronic health systems to talk to each other, James Swann reports.
  • The delay is keeping hospitals and health-care systems on pins and needles as they await more clarity on how patient data are shared among medical organizations and look to avoid potentially significant financial penalties. Those penalties can reach as high as $1 million per incident.
  • Both proposals were slated to drop in December and have a mid-January final deadline for when they’re supposed to be published. They’ll miss that deadline if the shutdown drags on.

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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