While Congress ordered earlier this year that Medicare cover the cost of administering licensed vaccines, the requirement does not include prescription drugs under emergency-use designation. The possibility has also been raised that millions of people may be forced to pay out of pocket unless Congress takes a quick fix.
HHS in the last month. Officials thought they had reached a settlement with Charo The FDA should clarify that the emergency authorization of the Covid-19 vaccine is the same as “pre-licensing” and the result should be covered by Medicare, officials said.
But Hahn vehemently opposed the idea, amid concerns that failing to adhere to the FDA’s technical language would undermine the agency’s credibility and expose it to allegations that it could influence the Trump administration’s role in vaccinating victims.
A senior administration official said, “Han has a hell of a tendency to change the definitions, as it would be seen as the politics of science.” A senior administration official said Hahn has so far rejected the proposal, some believe. That White House may still be involved and demand changes.
This particular concern, the official said, is that talking about winning the Covid-19 vaccine “pre-licensed” would be confused with a shot that is fully licensed by the FDA – a level of regulatory approval that indicates the vaccine has received. Significantly higher standards for safety and efficacy, and one agency does not expect any vaccine candidates to be approved soon.
President Donald Trump has already spent months in conflict with his own health officials involved in the complex vaccine development process, and has repeatedly claimed that a viable vaccine is just around the corner and can be delivered faster than the year-end target agreed by officials.
A sudden change in how the FDA labeled accidental coronavirus vaccines could lead to a worsening of the situation, worrying FDA officials, spreading confusion and increasing distrust of its work toward authorizing the vaccine.
In a statement, an FDA spokesman pointed to “significant significant differences” between the authorization of emergency use and the more stringent procedure required to obtain a full vaccine license.
There is no such thing as ‘pre-licensing’ or ‘pre-approval’ under FDA-enacted law, the spokesman said.
An HHS spokesman said its Medicare and Medicaid services centers were still exploring coverage options for authorized vaccines under the Emergency Use Designation. And two executives denounced the “pre-licensed” concept as an “educational debate” about safety and effectiveness that never led HHS. Secretary Alex did not reach the level of Azar.
But in conversations with Han over the past few weeks, H.H.S. Officials introduced “pre-licensing” as the easiest and fastest way to close the loophole for Medicare coverage, officials familiar with the conversation said.
The move would also prevent the Trump administration from relying on Congress to pass a legislative fix – a path that could sink into the gridlock on Capitol Hill.
“They’re trying to be creative – Congress is in disarray and they want a compromise and they want it ready,” said a senior administration official. “So if and when a vaccine is authorized , [the question of Medicare coverage] There is a mot point. ”
H.H.S. It argued that the “pre-licensed” terminology does not recognize the misrepresentation of the procedure, as the FDA already requires coronavirus vaccination to meet more stringent requirements than the order for emergency authorization.
But Hahn has prioritized the FDA’s steering in light of circumstances that could raise questions about the agency’s independence, which is widely criticized by health experts and hampers the morale of FDA’s career civil servants.
Despite limited evidence supporting this decision, Trump played a central role in promoting hydroxychloroquine and chloroquine as coronavirus treatments. The FDA revoked that authorization just three months later following concerns about the safety and effectiveness of the treatment.
Most recently, Hahn misrepresented the effectiveness of convulsant plasma as Covid-19 therapy during a White House event for treatment – apologizing to her the day after the fire broke out in the public health community.
Since then, Hahn has sought to align itself closely with the agency’s career scientists – particularly in support of plans to publish strict new guidelines for authorizing vaccines in protest of the White House’s opposition.
The HHSA originally forced Hahn to include new “pre-licensed” terminology and explanations as part of that guideline, an official said. But when the FDA finally managed to make them public, that language was nowhere to be found.