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Photo: George Frey/Getty Images

The Food and Drug Administration has approved a record number of generic drugs, but at the same time it’s inspecting a lot fewer of the factories where those drugs are made.

Why it matters: Declining inspections are raising new concerns about their quality and safety, Bloomberg’s Anna Edney reports in the first part of a yearlong investigation.

  • And in addition to a drop in overall inspections, the FDA has in some cases been slow to crack down on the problems it does find, Edney reports.

By the numbers: Generics make up roughly 90% of all U.S. prescriptions.

  • FDA inspections of facilities inside the U.S. fell by 11% from 2017 to 2018 and have been falling since 2011, when the agency began shifting more resources overseas.
  • But international inspections, after rising steadily for years, have also been on the decline since 2016.
  • Companies from India and China alone account for almost half of all new generic drugs, and more than 80% of drugs' active ingredients are made abroad.

Between the lines: The story also includes 2 anecdotes in which FDA inspectors uncovered violations and began work on enforcement letters, but "higher-ups at the FDA … overrode the concerns of those on the ground."

The other side: "It’s not the number of inspections we do, it's whether we're targeting effectively," FDA Commissioner Scott Gottlieb told Bloomberg.

  • Janet Woodcock, who leads the agency’s center for drug reviews, also said the agency’s oversight is "better than it's ever been."

Go deeper: Why the spotlight on generic drug prices is getting brighter

Go deeper

Off the Rails

Episode 7: Trump turns on Pence

Photo illustration: Eniola Odetunde/Axios. Photos: Elijah Nouvelage, Alex Wong/Getty Images

Beginning on election night 2020 and continuing through his final days in office, Donald Trump unraveled and dragged America with him, to the point that his followers sacked the U.S. Capitol with two weeks left in his term. Axios takes you inside the collapse of a president with a special series.

Episode 7: Trump turns on Pence. Trump believes the vice president can solve all his problems by simply refusing to certify the Electoral College results. It's a simple test of loyalty: Trump or the U.S. Constitution.

"The end is coming, Donald."

The male voice in the TV ad boomed through the White House residence during "Fox & Friends" commercial breaks. Over and over and over. "The end is coming, Donald. ... On Jan. 6, Mike Pence will put the nail in your political coffin."

Big Tech's post-riot reckoning

Photo illustration: Sarah Grillo/Axios. Photo: Tasos Katopodis/Getty Images

The Capitol insurrection means the anti-tech talk in Washington is more likely to lead to action, since it's ever clearer that the attack was planned, at least in part, on social media.

Why it matters: The big platforms may have hoped they'd move to D.C.'s back burner, with the Hill focused on the Biden agenda and the pandemic out of control. But now, there'll be no escaping harsh scrutiny.

27 mins ago - Technology

Why domestic terrorists are so hard to police online

Illustration: Eniola Odetunde/Axios

Domestic terrorism has proven to be more difficult for Big Tech companies to police online than foreign terrorism.

The big picture: That's largely because the politics are harder. There's more unity around the need to go after foreign extremists than domestic ones — and less danger of overreaching and provoking a backlash.