The guidance calls for a median two months' worth of follow-up safety data from well-designed Phase III studies as a precondition for a vaccine receiving an EUA. The Wall Street Journal reported that the White House had backed down in its opposition to the guidance, which pushes the date of an EUA past Election Day.
The FDA commissioner took to Twitter Monday night to defend his performance at the agency, which came under sharp criticism amid accusations that the authorization of a plasma treatment for Covid-19 was politically motivated and that he stood by while President Trump unfairly maligned FDA staffers, prompting calls for his resignation.
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Amid fears of a premature emergency use authorization for a Covid-19 vaccine granted for political reasons, the guidance that the FDA released at the beginning of the month sets much tougher standards. But trial enrollment, anti-vaccine sentiment and other potential problems persist.
The agency issued a guidance for industry laying out its various recommendations for vaccine development. The announcement preceded the release of data from Pfizer and BioNTech's Phase I/II clinical trial of their messenger RNA vaccine.
While not necessarily faulting the FDA for granting a limited emergency use authorization to hydroxychloroquine and chloroquine despite little data to support their use in the pandemic disease, some interviewed experts said it risked politicizing the agency.
The agency said it had redeployed some staff and streamlined processes to enable it to review clinical trial protocols faster and respond faster to companies and scientists developing new drugs for the disease.
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The researchers wrote that RWE could complement trials, but that observational methods are unlikely to take away the need for traditional clinical studies.
A market research report issued at the beginning of the year forecast that the market for ALS drugs in several key countries would exceed $1 billion over a 10-year period.
In a guidance issued Wednesday, the agency said randomized, controlled trials of cancer drugs should only use placebo in cases like when surveillance is standard of care. A bioethics expert said such principles have long existed, but it was good to see them in an official guidance.
The agency warned against use of AbbVie's Mavyret, Gilead Sciences' Vesovi and Merck's Zepatier in patients with moderate to severe liver disease amid reports of 63 patients with liver decompensation, with some cases being fatal.
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The Wall Street Journal reported that the agency was focusing on the two-month delay between the March 14 discovery of data manipulation by Novartis' AveXis unit regarding the therapy Zolgensma and its May 15 launch of a formal inquiry into the matter.
Several FDA approvals - including ones going against AdCom votes - have attracted controversy and a perception of lowered standards at the agency. However, some see a long-standing institutional tension between patient protection and speedy approval, with the latter having a net positive effect.
In a statement Tuesday, an FDA official wrote that subsidiary AveXis disclosed manipulation of mouse data for the gene therapy Zolgensma, which the agency approved in May for spinal muscular atrophy. The official wrote that civil or criminal penalties were possible.
The administration proposed two pathways, one that would allow importation of some drugs from Canada via pilot projects, and another that would allow manufacturers to import from other countries and sidestep distribution contracts. PhRMA's president criticized the proposal as "dangerous."
Although the agency goes against about one-fifth of AdCom recommendations, a study published Sunday only found one reliable variable predicting when that would happen.