Nov 5, 2018

Why the FDA approved a powerful new opioid

Photo: Chip Somodevilla via Getty Images

The Food and Drug Administration (FDA) took some heat on Friday for approving Dsuvia, a new opioid painkiller that’s up to 10 times more powerful than therapeutic fentanyl.

What they’re saying: FDA Commissioner Scott Gottlieb acknowledged the criticism in a statement about the approval, and said it may be time for the agency to think differently about the standards for approving opioids.

  • “We generally consider each new drug approval — and each new opioid drug approval — largely on its own merits. As part of our review, we ask whether the individual drug meets the standard for safety and effectiveness, and whether additional controls are needed to ensure safe use of that specific drug.”
  • “Looking beyond this particular drug approval, I believe that we should consider whether we should be doing more to evaluate each candidate opioid, not just as an independent review decision, but rather also to consider each novel opioid drug in the context of the overall therapeutic armamentarium that’s available to patients and providers.”

Go deeper

Situational awareness

Photo: Brett Carlsen/Getty Images

Catch up on today's biggest news:

  1. Mike Bloomberg offers to release women from 3 NDAs
  2. Wells Fargo to pay $3 billion to settle consumer abuse charges
  3. Bloomberg campaign says Tennessee vandalism "echoes language" from Bernie supporters
  4. Scoop: New White House personnel chief tells Cabinet liaisons to target Never Trumpers
  5. Nearly half of Republicans support pardoning Roger Stone

Wells Fargo agrees to pay $3 billion to settle consumer abuse charges

Clients use an ATM at a Wells Fargo Bank in Los Angeles, Calif. Photo: Ronen Tivony/SOPA Images/LightRocket via Getty Images

Wells Fargo agreed to a pay a combined $3 billion to the Justice Department and the Securities and Exchange Commission on Friday for opening millions of fake customer accounts between 2002 and 2016, the SEC said in a press release.

The big picture: The fine "is among the largest corporate penalties reached during the Trump administration," the Washington Post reports.

Bloomberg offers to release women from 3 nondisclosure agreements

Mike Bloomberg. Photo: Brett Carlsen/Getty Images

Mike Bloomberg said Friday his company will release women identified to have signed three nondisclosure agreements so they can publicly discuss their allegations against him if they wish.

Why it matters, via Axios' Margaret Talev: Bloomberg’s shift in policy toward NDAs comes as he tries to stanch his loss of female support after the Las Vegas debate. It is an effort to separate the total number of harassment and culture complaints at the large company from those directed at him personally. That could reframe the criticism against him, but also protect the company from legal fallout if all past NDAs were placed in jeopardy.