FDA re-emphasizes Trump administration


While Congress said earlier this year that Medicare covered the cost of a licensed vaccine, the requirement did not include drugs authorized under emergency-use designations. There has been an increased possibility that millions may be forced to pay out of pocket until the Congress recovers soon.

Last month HHS officials thought they found a solution with Charo Officials said the FDA should clarify that the emergency authorization of the Kovid-19 vaccine is equivalent to “pre-licensure” and should be covered by Medicare.

But Hahn strongly opposed the idea, that by failing to stick to the FDA’s technical language, the agency’s credibility would be destroyed and open accusations that it would play its role in the Trump administration’s vaccine hunt Allowing politics to influence

A senior administration official said, “Hahn is in hell against the revision of any definition, as it would be seen as politicizing science,” said a senior administration official, while Hahan has so far rejected the proposal Granted, some believe the White House may still be involved and demand changes.

Of particular concern is the fact that it is officially said that referring to the Kovid-19 vaccine would win a “pre-licensure” if a fully licensed shot is forfeited by the FDA – a level of regulatory approval Which refers to the vaccine. High standards for safety and effectiveness, and an agency does not expect to grant any vaccine candidates any time soon.

President Donald Trump has already spent months contradicting his own health officials involved in the complex vaccine development process, who repeatedly claim that a viable vaccine is just around the corner and compared to the year’s target agreed upon by officials Can be delivered rapidly.

Suddenly changing how an FDA label can ultimately worsen the coronovirus vaccine situation, FDA officials are concerned, sparking confusion and deepening mistrust of their work toward authorizing a vaccine.

In a statement, an FDA spokeswoman pointed to “significant significant differences” between an emergency use authority and the more rigorous process required to obtain a full license of a vaccine.

“There is no such thing as ‘pre-licensure’ or ‘pre-approval’ under FDA administrations,” the spokesperson said.

A spokesperson for HHS said its Centers for Medicare and Medicaid Services is still exploring coverage options for vaccines authorized under the Emergency Medicine designation. And two administration officials removed the “pre-licensure” concept as an “academic discussion” about safety and effectiveness, which never rose to the level of HHS Secretary Alex Azar.

In conversations with Hain for the past several weeks, HHS officials presented “pre-licensure” as the simplest and quickest way to close Medicare coverage loopholes, with officials said to be familiar with the conversation .

The move would also prevent the Trump administration from relying on Congress to pass a legislative determination – a path that could get stuck in a gridlock on Capitol Hill.

A senior administrative official said, “They are trying to be creative – the Congress is in disarray and they want a solution and they want to prepare it.” [the question of Medicare coverage] There is a loot point. ”

HHS also argued that “pre-licensure” would not amount to a misrepresentation of the terminology process, because the FDA already required the coronovirus vaccine to meet more hazardous requirements as it would normal for an emergency authorization. Will be related to form.

But Hahn has prioritized clarifying the FDA well over any situation that might question the agency’s independence, after a pair of damaging episodes in the first pandemic followed by widespread criticism from public health experts and the FDA’s Career boosts morale among civil servants.

The agency played a central role in promoting Trump’s hydrocarbonquin and chloroquine as coronavirus treatments, issuing a March emergency authorization for the drugs despite limited evidence supporting the ruling. The FDA terminated that authorization only three months after concerns about the safety and effectiveness of the treatment.

Recently, Hahn misrepresented the effectiveness of coniduscent plasma as a COVID-19 therapy in the White House, stating that the next day of forgiveness caused an arson within the public health community during treatment Got a demand.

Since then, Hahn has sought to align himself closely with the agency’s career scientists – most notably supporting plans to publish strict new guidelines to authorize the vaccine in the wake of opposition from the White House.

HHS originally pressed Hahn to include the new “pre-licensure” terminology and explanation, an official said. But when the FDA finally succeeded in making them public, that language was nowhere to be found.

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