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The Trump administration delivered a double whammy to the pharmaceutical industry on Tuesday morning — releasing updates to policies related to COVID-19 vaccines and the “Most Favored Nation” executive order.

First, the Food and Drug Administration announced it will limit access to COVID vaccine boosters to those 65 years of age and older or those at higher risk of becoming seriously ill if infected.

For healthy people between the ages of 6 months and 64 years old, the agency will require randomized, controlled trial data evaluating clinical outcomes before Biologics License Applications can be granted.

FDA Commissioner Dr. Martin Makary and Dr. Vinay Prasad, who was recently tapped to serve as the director of the Center for Biologics Evaluation and Research, detailed the policy shift in a commentary published in the New England Journal of Medicine,

The pair wrote that this updated stance reflects the agency’s “balance of regulatory flexibility” as well as a “commitment to gold-standard science.” 

In the piece, the two leaders wrote that while the rapid development of multiple COVID vaccines represented “a major scientific, medical, and regulatory accomplishment,” the benefit of repeat dosing remains “uncertain.”

Makary previously indicated a coming shift in approvals for vaccines, publicly delineating that COVID booster shots are new products and would thus require additional testing before receiving regulatory approvals.

“The FDA will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at low risk,” they wrote. “These clinical trials will inform future directions for the FDA, but more important, they will provide information that is desperately craved by health care providers and the American people.”

Stock prices of vaccine manufacturers welcomed the news. Moderna’s stock jumped more than 9% by early afternoon trading, while share prices for Novavax and Pfizer increased by 3% and 1.5%, respectively. 

The guidance was also unveiled one day after the FDA granted full approval to Novavax’s COVID shot, but with a narrower range and more than a month after it was expected to be released.

Meanwhile, on Thursday, advisers to the agency will discuss if the upcoming immunization campaign will target the LP.8.1 subvariant — which is spreading at a faster rate than other variants and is dominant in the U.S.

Additionally, the Department of Health and Human Services unveiled the framework for the Most Favored Nation drug pricing plan announced last week by President Donald Trump. 

The department stated that it expects each drugmaker to align its domestic pricing for all branded products across all markets where there isn’t a generic or biosimilar competition with the lowest set price of the peer nations.

The target price, the administration stated, is the lowest price in an OECD country with a GDP per capita of at least 60 percent of the U.S. GDP per capita.

In practice, the U.S. Trade Representative and Secretary of Commerce will be tasked with taking action to ensure foreign countries don’t intentionally undercut market prices and drive price hikes in the U.S. 

The administration added that HHS Secretary Robert F. Kennedy Jr. will establish a mechanism for American patients to buy prescription drugs directly from manufacturers who sell to them at a Most Favored Nation price.

“For too long, Americans have been forced to pay exorbitant prices for the same drugs that are sold overseas for far less,” Kennedy said in a statement. “That ends today. We expect pharmaceutical manufacturers to fulfill their commitment to lower prices for American patients, or we will take action to ensure they do.”

The fact sheet explaining the order reiterated that pharma companies are expected to recognize America as the largest purchaser and funder of prescription drugs in the world — therefore entitling it to receive “the best deal.”

Should they fail to do so, Trump’s order empowers Kennedy to “take other aggressive measures” to significantly reduce the cost of prescription drugs to the American consumer and end anticompetitive practices.