Aug 3, 2017

The internal FDA discord over a controversial drug approval

Janet Woodcock, a top FDA director (Jose Luis Magana / AP)

The Food and Drug Administration's controversial decision last year to approve a drug for Duchenne muscular dystrophy sparked divisions within the agency — with one former-high ranking official alleging that another top official ignored the FDA's normal scientific review, according to emails obtained by journalist Charles Seife and published at Undark.

The big email: John Jenkins, who used to be the head of the FDA's Office of New Drugs, sent a memo to former FDA Commissioner Robert Califf this past September. Jenkins alleged Janet Woodcock, the director of the FDA's Center for Drug Evaluation and Research, undercut the expert team that questioned the benefits of the drug — eteplirsen, branded as Exondys 51 by Sarepta Therapeutics.

Jenkins' memo also said Woodcock was in close contact with Sarepta and the patient advocacy groups who desperately wanted the drug to get the green light, and she approved the drug before vital outcomes data was published.

Why it matters: The approval process for Exondys 51 appears to have been just as controversial behind the scenes as it was in the public eye.

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Trump and Zuckerberg share phone call amid social media furor

Photo: Alex Wong/Getty Images

In the week that President Trump took on social media, Axios has learned that he had a call Friday with Facebook CEO Mark Zuckerberg that was described by both sides as productive.

Why it matters: With the White House and Twitter at war, Facebook has managed to keep diplomatic relations with the world's most powerful social-media devotee.

Twitter, Google lead chorus of brands backing George Floyd protests

Illustration: Lazaro Gamio/Axios

Twitter and Google are among the dozens of brands over the past 24 hours that have taken public stances in favor of Americans protesting racial equality. Some companies have changed their logos in solidarity with the movement, while others have pledged money in support of efforts to address social injustice.

Why it matters: The pressure that companies feel to speak out on issues has increased during the Trump era, as businesses have sought to fill a trust void left by the government. Now, some of the biggest companies are quickly taking a public stand on the protests, pressuring all other brands to do the same.

NYPD commissioner: "I'm extremely proud" of officers' response to protests

New York City Police Commissioner Dermot Shea in February. Photo: Yana Paskova/Getty Images

New York City Police Commissioner Dermot Shea said in a public statement Sunday that he is "extremely proud" of the New York City Police Department's response to protests over the death of George Floyd Saturday night, writing: "What we saw in New York City last night and the night before was not about peaceful protest of any kind."

Why it matters: New York City residents captured several instances of police officers using excessive force against demonstrators. In one video, two NYPD SUVs are seen ramming into protesters who were blocking a road and throwing traffic cones at the vehicles.