Feb 19, 2019

FDA head is open to orphan drug law changes

FDA Commissioner Scott Gottlieb. Photo: Drew Angerer/Getty Images

FDA Commissioner Scott Gottlieb told Axios that while he thinks the orphan drug market is too small to seriously dampen competition, he's open to changes in the law.

Details: Gottlieb's top priority is giving drugmakers an incentive to develop treatments for the rarest of diseases, or diseases that aren't getting much pharma attention.

Where it stands: Right now, part of the definition of an orphan drug is that it's intended for a patient population of less than 200,000 people. One idea would be to lower that number, meaning orphan designation goes to treatments for even rarer conditions.

  • In turn, there could be a "richer incentive" for drug companies to go after orphan approvals.
  • "For a drug that's already on the market, maybe you don't need as much incentive to study a subsequent indication," Gottlieb said. "Maybe we make the designation harder to get."
  • "I see a lot of things not getting studied or not getting into drug labels that should be. I'd like to have that clinical discussion," he added.

Go deeper: Blockbuster drugs are stacking up orphan approvals

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Pro-Trump warrior takes the helm of U.S. intelligence

Richard Grenell in Berlin. Photo: Sean Gallup/Getty Images

By picking Ambassador Richard Grenell to be acting director of national intelligence, President Trump has slotted a pro-Trump warrior into the ultimate apolitical role.

What they're saying: James Clapper, the longest-serving DNI (2010-2017), tells Axios it's "very worrisome installing a partisan with no real intelligence experience in this position."

Coronavirus kills 2 Diamond Princess passengers as Israel confirms first case

Data: The Center for Systems Science and Engineering at Johns Hopkins, the CDC, and China's Health Ministry. U.S. numbers include Americans extracted from Princess Cruise ship.

Two elderly Diamond Princess passengers have been killed by the novel coronavirus — the first deaths confirmed among the more than 600 infected aboard the cruise ship — as Israel confirmed its first case among evacuees from the ship.

The big picture: COVID-19 has now killed more than 2,200 people and infected over 76,000 others, mostly in mainland China, where the National Health Commission announced 118 new deaths since Thursday.

Go deeperArrowUpdated 53 mins ago - Health

California's "woman quota" law seems to be working

Illustration: Eniola Odetunde/Axios

When California passed its boardroom law requiring public companies based there to have at least one female director, there were concerns it would spark a gold rush for the same handful of well-known women — but that hasn’t happened.

Why it matters: Of the 138 women who joined all-male California boards last year, 62% are serving on their first company board, per a study by accounting firm KPMG. That means a majority of companies aren't contributing to so-called overboarding in corporate America.