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Illustration: Aïda Amer/Axios

The Institute for Clinical and Economic Review and the pharmaceutical industry don’t even agree on what should be considered relevant evidence when deciding if a drug is safe and effective.

Why it matters: "This debate on what constitutes high-quality, 'real-world' evidence is not going away," said Walid Gellad, a pharmaceutical expert at the University of Pittsburgh.

Driving the news: Pharmaceutical companies that were singled out in ICER’s report yesterday on "unjustified" price hikes sent along hundreds of studies for ICER to consider in its analysis. ICER rejected almost all of them.

  • Many of the drug company studies were observational and funded by the companies, and ICER made it clear from the outset that it would only consider observational studies "that were high quality and comparative."

What we're watching: The FDA wants to use more simple trials and observational data in drug evaluations, similar to what drug companies submitted to ICER. 

  • But as Joseph Ross, a professor of medicine at Yale, wrote several years ago, it’s important to assess "the methodological rigor of observational studies before interpreting real-world effects."

Our thought bubble, via Bob: ICER's report is transparent, telling readers that none of the funding for its report came from any part of the industry and outlining clearly what it considered to be acceptable research.

Go deeper: Concerns rise about generic drugs from over

Go deeper

58 mins ago - Politics & Policy

Jen Psaki: "With that I’d love to take your questions”

In her inaugural briefing as White House press secretary, Jen Psaki said she has a “deep respect for the role of a free and independent press in our democracy,” and pledged to hold daily briefings.

Why it matters: Conferences with the press secretary in the James S. Brady Press Briefing Room became almost non-existent under the Trump administration. By sending Psaki to the podium hours after President Biden took the oath of office, the White House signaled a return to pre-Trump norms.

Avril Haines confirmed as director of national intelligence

Haines. Photo: Joe Raedle/Getty Image

Avril Haines was quickly confirmed by the Senate on Wednesday as the director of national intelligence (DNI) in a vote of 84-10.

Why it matters: Haines is the first of President Biden's nominees to receive a full Senate confirmation and she will be the first woman to serve as DNI. She's previously served as CIA deputy director from 2013 to 2015 and deputy national security adviser from 2015 to 2017.

Updated 2 hours ago - Politics & Policy

Inauguration Day dashboard

Biden delivers his inaugural address on the West Front of the Capitol. Photo by Tasos Katopodis/Getty Images

President Biden has delivered his inaugural address at the Capitol, calling for an end to the politics as total war but warning that "we have far to go" to heal the country.

What's next: The Celebrate America event, with remarks by Biden and Harris.