FDA headquarters. Photo: Al Drago/CQ Roll Call

Many experts have questioned the FDA's drug approval standards over the past few years, as several controversial drugs have gotten the green light despite less rigorous testing.

What they're saying: Peter Stein, the head of the FDA's office that analyzes new drugs, sat down with Zachary Brennan of Regulatory Affairs Professionals Society and said the only thing that's changed with the FDA's approval process is a shift in the types of drugs the agency is reviewing.

  • "If you look in the last couple years, we still see some drugs for chronic diseases, but even there, it tends to be subgroups and populations that were undertreated with drugs previously available, and what we're seeing is a dramatic increase in drugs for rare diseases," he said.

The bottom line: There's no doubt biotech startups and drug companies have invested more time and money in treatments that go after cancers or conditions that treat a very small subset of people. Those kinds of medicines usually command the highest prices.

  • And the FDA is saying those types of drugs have more leeway in the approval process, even if they only have one trial or don’t have randomized test groups, because "patients and physicians are willing to accept a bit more uncertainty."

Go deeper: FDA allows states to test for coronavirus for faster results

Go deeper

Updated 6 mins ago - Politics & Policy

Coronavirus dashboard

Illustration: Sarah Grillo/Axios

  1. Global: Total confirmed cases as of 8:30 p.m. ET: 30,911,999 — Total deaths: 959,059— Total recoveries: 21,147,903Map.
  2. U.S.: Total confirmed cases as of 8:30p.m. ET: 6,796,384 — Total deaths: 199,474 — Total recoveries: 2,590,671 — Total tests: 95,108,559Map.
  3. Politics: Testing czar on Trump's CDC contradictions: "Everybody is right" Ex-FDA chief: Career scientists won't be "easily cowed" by political vaccine pressure.
  4. Education: What we overlooked in the switch to remote learning.
  5. Health: The dwindling chances of eliminating COVID-19 — 7 states set single-day coronavirus case records last week.
  6. World: England sets £10,000 fine for breaking self-isolation rules — The countries painting their pandemic recoveries green.

Arrest over letter to Trump containing poison ricin

President Trump returning to the White House from Minnesota on Sept. 18. Photo: Win McNamee/Getty Images

A suspect was arrested for allegedly "sending a suspicious letter" after law enforcement agents intercepted an envelope addressed to President Trump containing the poison ricin, the FBI confirmed in an emailed statement to Axios Sunday.

Details: The suspect, a woman, was arrested while trying to enter New York from Canada, law enforcement forces said.

Trump campaign goes all in on Pennsylvania

Trump poster in Scranton, Pennsylvania. Photo: Robert Nickelsberg/Getty Images

The president's campaign is placing more importance on Pennsylvania amid growing concern that his chances of clinching Wisconsin are slipping, Trump campaign sources tell Axios.

Driving the news: Pennsylvania, which has 20 electoral votes, twice Wisconsin's number, actually has been trending higher in recent public and internal polling, a welcome development for the campaign.