Jan 30, 2019

Generic drugs face quality, safety questions

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

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Japan to close schools through late March to control coronavirus outbreak

A couple takes photos in front of the Olympic rings in Tokyo. Photo: Tomohiro Ohsumi/Getty Images

Japanese Prime Minister Shinzo Abe announced Thursday that the government will ask elementary, middle and high schools around the country to close until late March as an attempt to contain its novel coronavirus outbreak, AP reports.

Why it matters: The government's decision — impacting 12.8 million students across 34,847 schools — comes as concerns mount about the spread of the virus in Japan, which has 189 confirmed cases and hundreds more abroad the quarantined Diamond Princess cruise ship.

Go deeper: The latest coronavirus updates

What the coronavirus means for Trump's presidency

Photo Illustration: Eniola Odetunde/Axios. Photo: Chris Graythen/Getty Images

A poor response to the coronavirus could be politically devastating for President Trump, and so far his administration has given the strong impression that it’s still scrambling as the risk of a pandemic mounts.

Why it matters: There’s only so much any president can do to stop a virus from spreading, and for now the coronavirus is still very much under control within the U.S. But if the disease get worse in the months ahead, and if the administration seems to be caught off guard, that spells trouble for public confidence in Trump.

Coronavirus updates: New global case numbers surpass China's

Data: The Center for Systems Science and Engineering at Johns Hopkins, the CDC, and China's Health Ministry. Note: China numbers are for the mainland only and U.S. numbers include repatriated citizens.

The novel coronavirus is now affecting every continent but Antarctica and the WHO said Wednesday the number of new cases reported outside China has exceeded those inside the country for the first time.

The big picture: COVID-19 has killed more than 2,800 people and infected over 82,000 others in some 50 countries and territories. As Denmark and Estonia reported their first cases Thursday, Scott Morrison, prime minister of Australia — which has 23 confirmed infections — told a news conference, "The risk of a global pandemic is very much upon us."

Go deeperArrowUpdated 4 hours ago - Health