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.”

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Gulf Coast braces for Zeta after storm strengthens into hurricane

Hurricane Zeta's forecast path. Photo: National Hurricane Center

Louisiana Gov. John Bel Edwards (D) declared a state of emergency Monday as Zeta strengthened into a hurricane and threatened Mexico's Yucatan Peninsula as it moved towards the U.S. Gulf Coast.

The state of play: Zeta was expected to make landfall on the northern part of the Yucatan Peninsula Monday night, bringing with it a "dangerous storm surge" and "heavy rainfall" as it moved into the Gulf of Mexico, the National Hurricane Service said.

Updated 58 mins ago - Politics & Policy

Coronavirus dashboard

Illustration: Sarah Grillo/Axios

  1. Politics: The swing states where the pandemic is raging — Pence no longer expected to attend Barrett confirmation vote after COVID exposure.
  2. Health: 13 states set single-day case records last week
  3. Business: Where stimulus is needed most.
  4. Education: The dangerous instability of school re-openings.
  5. World: Restrictions grow across Europe.
  6. Media: Fox News president and several hosts advised to quarantine.

Supreme Court rejects request to extend Wisconsin absentee ballot deadline

Photo: Saul Loeb/AFP via Getty Images

The Supreme Court in a 5-3 decision Monday rejected an effort by Wisconsin Democrats and civil rights groups to extend the state's deadline for counting absentee ballots to six days after Election Day, as long as they were postmarked by Nov. 3.

Why it matters: All ballots must now be received by 8 p.m. on Election Day in Wisconsin, a critical swing state in the presidential election.