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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

Biden's Day 1 challenges: Systemic racism

Photo illustration: Sarah Grillo/Axios. Photo: Kirsty O'Connor (PA Images)/Getty Images

Advocates are pushing President-elect Biden to tackle systemic racism with a Day 1 agenda that includes ending the detention of migrant children and expanding DACA, announcing a Justice Department investigation of rogue police departments and returning some public lands to Indigenous tribes.

Why it matters: Biden has said the fight against systemic racism will be one of the top goals of his presidency — but the expectations may be so high that he won't be able to meet them.

Caitlin Owens, author of Vitals
2 hours ago - Health

Most Americans are still vulnerable to the coronavirus

Adapted from Bajema, et al., 2020, "Estimated SARS-CoV-2 Seroprevalence in the US as of September 2020"; Cartogram: Andrew Witherspoon/Axios

As of September, the vast majority of Americans did not have coronavirus antibodies, according to a new study published in JAMA Internal Medicine.

Why it matters: As the coronavirus spreads rapidly throughout most of the country, most people remain vulnerable to it.

Trump set to appear at Pennsylvania GOP hearing on voter fraud claims

President Trumpat the White House on Tuesday. Photo: Chip Somodevilla/Getty Images

President Trump is due to join his personal lawyer Rudy Giuliani in Gettysburg, Pennsylvania, Wednesday at a Republican-led state Senate Majority Policy Committee hearing to discuss alleged election irregularities.

Why it matters: This would be his first trip outside of the DMV since Election Day and comes shortly after GSA ascertained the results, formally signing off on a transition to President-elect Biden.