May 31, 2018

FDA wants brand and generic drug makers to get along

The FDA issued new generic drug guidance. Photo: Saul Loeb/AFP via Getty Images

The Food and Drug Administration is rolling out official guidance on how it expects pharmaceutical companies to behave when generic drugs are ready to enter the market — namely by all parties using a shared safety protocol.

The bottom line: The guidance is not legally enforceable. But FDA Commissioner Scott Gottlieb said the policies should discourage companies that make brand-name drugs from using a drug safety system to "block generic entry and help end some of the tactics that can delay access."

Driving the news: The FDA put out two draft documents Thursday outlining how the agency can become an arbiter in the process.

  • The first document outlines how the FDA could prod brand and generic companies to sit down and develop a shared safety system.
  • The second document explains how generic drug makers could get an FDA waiver from the shared system requirement, especially in cases where drug approval is being inappropriately delayed.

Go deeper: Earlier this month, the FDA posted a list of manufacturers that have impeded generic access to their brand-name products.

Go deeper

Trump's big, empty beef with Twitter

Illustration: Aïda Amer/Axios

President Trump finally acted on his now year-old threat to take action against social media platforms for alleged bias against conservatives. But so far, according to experts in both government and the industry, the threat looks mostly empty.

Driving the news: Trump escalated his war on Twitter Friday morning, tweeting repeatedly that the company needs to be regulated after it overnight added a warning label to a tweet of his calling for the military to start shooting looters, which violated Twitter’s rules against glorifying violence.

In photos: Protests over George Floyd's death grip Minneapolis

The Third Police Precinct burns in Minneapolis on Thursday night. Photo: Stephen Maturen/Getty Images

Demonstrators demanding justice burned a Minneapolis police station and took control of the streets around it last night, heaving wood onto the flames, kicking down poles with surveillance cameras and torching surrounding stores.

What's happening: The crowd was protesting the death of George Floyd, an unarmed black man whose life was snuffed out Tuesday by a white Minneapolis police officer who kneeled on his neck for about eight minutes.

Minneapolis mayor to Trump: “Weakness is pointing your finger” during a crisis

Minneapolis Mayor Jacob Frey fired back at President Trump on Friday, after the president accused the mayor of weak leadership amid violence sparked by the killing of an unarmed black man by a white police officer.

Driving the news: Trump made his accusations in a pair of tweets early Friday, saying he would bring the national guard into Minneapolis if Frey couldn't “bring the City under control.”