How to stop the FDA from rolling back AMNEAL Pharmaceuticals

FDA Commissioner Scott Gottlieb on Thursday proposed a “public health solution” to a $3 billion market that he said was being driven by a “very well-funded lobby” that had successfully “magnified the perception that AMNEA is a drug for all.”

Gottlieb’s proposal comes after the Food and Drug Administration announced plans to rescind AMNEAA’s license in 2017, after an FDA advisory panel said it found “no evidence” that the drug was safe or effective.

The panel, led by former FDA Commissioner and Harvard Medical School professor Jonathan Gruber, concluded that the agency should review AMNEAB’s safety data and conclude that it “does not pose a significant risk to human health.”

Gottliebar also told reporters Thursday that he was “not convinced” that AMN was “a good product for a broad range of medical conditions.”

The FDA has not said whether it will follow up on the advisory panel’s recommendations and revoke AMNEAs license.

In an email, Gottlieber said that the FDA is not making a decision on AMNE, but “will not rule on whether to revoke the license until we have more information.”

“We will continue to review AMN for potential safety and efficacy,” Gottliebe said.

“We are in no way recommending to patients that we should discontinue their AMN products.”

The FDA, in a letter to AMNE’s backers, said that it will review its “assessments of the safety and effectiveness of AMNE” and will make a final decision in the “near future.”

In the meantime, the FDA said that AMNA could still be sold to other patients if they meet certain criteria.

“The FDA will be in contact with AMNE patients and health care professionals to ensure that they have all the information they need to make the informed decisions regarding their own health,” the FDA wrote.

“We are committed to making sure that our patients and healthcare professionals can make informed decisions about AMNE products,” Gottleib said in a statement Thursday.

Gretchen Fritz, CEO of the American Medical Association, said the proposal from GottlieB and other FDA officials was “very disappointing.”

“I’m disappointed that this proposal would make the FDA more of a bully, a tool of the pharmaceutical industry and a threat to patients and doctors,” she said.

Fritz also called the FDA’s proposed actions “very troubling” and “extremely dangerous.”

“It will only embolden the pharmaceutical companies to continue to fight for the FDA to make decisions that harm patients and put them at risk,” she added.

“The American Medical Group is very concerned by this proposed action, and we hope the Trump administration will take a stand against this dangerous move and reject the proposed FDA decision,” she continued.

The AMA said it was “surprised and disappointed” that Gottliebb’s proposal would threaten the lives of millions of patients and physicians.

“If FDA does not take action to ensure patients and the public can be confident in the safety of AMN, then patients and their doctors should not have to choose between their health and their choice to use a drug,” Fritz said.

“This is a troubling proposal and a bad decision for patients and our profession.”

Sponsorship Levels and Benefits

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