FDA chief spokesperson removed after convalescent plasma debacle

It remains unclear whether Emily Miller, who was assistant commissioner for media affairs, will remain at the agency in some capacity, said a senior administration official, who spoke on the condition of anonymity because he was not authorized to speak publicly. Miller formerly worked for One America News, a conservative cable news network and for Sen. Ted Cruz, R-Texas. She does not have a health or science background and has been a strong advocate for gun rights.

Also Friday, Wayne Pines, a longtime communications consultant, confirmed his contract to advise FDA Commissioner Stephen Hahn on communications strategy has been terminated.

"Effectively immediately, Emily Miller will no longer serve the FDA as the assistant commissioner for media affairs and will no longer be the official spokesperson for the agency," Hahn wrote in an email to senior managers on Friday. "I will appoint someone to an acting role in that position in the interim." The email was obtained by Politico.

Hahn, Trump and Health and Human Services Secretary Alex Azar have been sharply criticized for the way they exaggerated data on plasma's potential benefits during a news conference Sunday. The president announced the FDA was granting emergency authorization to plasma as a treatment for covid-19.

The administration officials suggested it could reduce mortality by 35 percent - but that number referred to a subgroup of patients who were treated early in their disease, were under 80 and not on ventilators. It was also incorrect to say, as Hahn did, that the data meant that of 100 people who are sick with covid-19, 35 would have been saved because of the administration of plasma.

Scientists say convalescent plasma might offer a modest benefit but is far from a breakthrough.

Much of the data for the emergency authorization came from an observational study - a type of study that scientists said cannot be used to determine whether a treatment causes a decline in mortality. Such a conclusion can only be reached through a randomized clinical trial, in which patients are prospectively assigned to either a group that receives a treatment and or one that doesn't.

Earlier this week, Hahn apologized repeatedly for misrepresenting the findings. Pines said in an interview that he had urged Hahn to correct the erroneous statements.

"I advised the commissioner, as I would do so again, to correct the record to clarify points about the efficacy of plasma," Pines said in an interview. "I'm an advocate, as I always have been, for transparency at the agency. The public needs to have confidence in the FDA."

Other parts of the botched rollout drew attention to Miller. In announcing the emergency authorization on Sunday, the FDA issued a statement with a headline that was in stark contrast to the agency's usually staid releases, calling it "another achievement in administration's fight against pandemic." It is not clear who wrote the headline.

Miller was criticized on Twitter by scientists for retweeting the claimed 35-percent reduction in mortality and then had to backtrack to correct it.

The job Miller held usually, but not always, is filled by a career official with public health knowledge.

Miller, also a former Washington Times opinion editor, has stated in the past that she was a "victim of a home invasion." In her book "Emily Gets Her Gun" she writes about her difficulties in obtaining a gun, saying it was a sign of unnecessary gun control laws.

The Sunday briefing came on the eve of the Republican National Convention where Trump hopes to resurrect his flagging popularity, which has nosedived over his handling of the pandemic. He has put extraordinary pressure on federal agencies to test and approve treatments and a vaccine against the novel coronavirus, which has killed more than 170,000 Americans.

A spokeswoman for HHS declined to comment on Miller, saying the department doesn't comment on personnel matters.