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

Updated 21 mins ago - Politics & Policy

Coronavirus dashboard

Illustration: Annelise Capossela/Axios

  1. Politics: Trump calls Fauci a "disaster" on campaign call.
  2. Health: Coronavirus hospitalizations are on the rise — 8 states set single-day coronavirus case records last week.
  3. States: California to independently review FDA-approved coronavirus vaccines
  4. Wisconsin judge reimposes capacity limit on indoor venues.
  5. Media: Trump attacks CNN as "dumb b*stards" for continuing to cover pandemic.
  6. Business: Consumer confidence surveys show Americans are getting nervousHow China's economy bounced back from coronavirus.
  7. Sports: We've entered the era of limited fan attendance.
  8. Education: Why education technology can’t save remote learning.
Dion Rabouin, author of Markets
47 mins ago - Economy & Business

The 2020 holiday season may just kill Main Street

Illustration: Eniola Odetunde/Axios

Online retail and e-commerce have been chipping away at brick-and-mortar businesses over the years but the combination of the coronavirus pandemic and the 2020 holiday season may prove to be a knockout blow.

State of play: Anxious consumers say financial concerns and health worries will push them to spend less money this year and to do more of their limited spending online.

California to independently review FDA-approved coronavirus vaccines

California Gov. Gavin Newsom. Photo: Justin Sullivan/Getty Images

California will "independently review" all coronavirus vaccines approved by the Food and Drug Administration before allowing their distribution, Gov. Gavin Newsom (D) announced at a news conference Monday.

Why it matters: The move that comes days after NAID director Anthony Fauci said he had "strong confidence" in FDA-approved vaccines could cast further public doubt that the federal government could release a vaccine based on political motives, rather than safety and efficacy.