FDA’s promised menthol ban is about to face a critical test

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Senior Trump official spills the tea on Operation Warp Speed

Pfizer and the Operation Warp Speed ​​team really didn’t get along – and that impacted the early days of the Covid-19 rollout, according to a new book by Paul Mango, a senior official involved in the Warp Speed ​​effort.

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Mango’s book is peppered with a number of allegations against Pfizer, including that the company failed to meet some of the contractual obligations for its vaccines and that it refused to answer certain questions from the administration or let her observe its manufacturing processes. The book even alleges that Pfizer demanded he be paid extra after doctors realized they could extract a sixth dose of vaccine from vials early in the vaccination effort.

The allegations have already sparked a new war of words. A Pfizer spokesperson called the allegations “politically motivated, unfair and misleading.”

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For more drama, check out my new story for STAT here.

A SOTU dilemma: Biden went all-in on Covid-19, but voters are growing unimpressed

President Biden will deliver his first State of the Union address tonight. It would seem like a chance for him to highlight the massive efforts he has made to turn around the United States’ Covid-19 response. But the stark reality is this: Biden’s response to Covid-19 is a political handicap.

A new poll released today by the Kaiser Family Foundation finds that only 39% of voters would describe the president’s response to the pandemic as excellent or good. It’s the latest example in a long line of polls showing Biden’s Covid approval ratings.

The new poll underscores how the State of the Union is shaping up to be a messaging test for the White House, which will use the speech to drum up support for Biden’s agenda ahead of the tight midterm elections in November. Already, there are reports that the administration will take the cautious route and stop short of declaring victory over Covid. Instead, Biden will highlight the progress the country has made and the need to remain vigilant against the virus.

Already, experts doubt this approach will do much to reverse choppy odds.

“The president can’t really take advantage of this unless [Covid has] went away and people got back to normal,” said Bob Blendon, a health care and opinion polling expert at Harvard University. “You don’t get credit for effort, you get credit [if] the problem disappears.

Beyond the Covid, some specificities of the SOTU health policy: While Biden is expected to resume calls for lower health care costs for prescription drugs and premiums, the major new health policy initiative he will unveil is a major crackdown on the nursing home industry. – in particular, the 5% of nursing homes owned by individuals. equity companies.

The White House plans to:

  • institute mandatory staffing levels
  • ask Congress for more money to carry out inspections
  • toughen accountability programs for care homes that perform worst on quality measures
  • ask Congress to stop companies that own underperforming retirement homes from opening new facilities
  • examine the role of private equity and other investments in the care home sector

FDA’s promised menthol ban is about to face a critical test

The FDA is finally moving forward with long-promised regulations banning menthol cigarettes, according to a website run by the White House office that reviews regulations ahead of their release.

Even this small, early step is a major victory for public health groups, which have been locked in a years-long legal battle with the FDA trying to force the agency to ban menthol products.

But the settlement will still face a major test: escaping the White House Office of Management and Budget clearance process unscathed. After all, the OMB has sweeping power to kill or water down controversial regulations, and it has done so before on tobacco issues: Obama administration efforts to ban flavored vaping products have been thwarted. by the OMB amid a lobbying campaign by tobacco companies.

“In past administrations, the OMB is where regulations go to die,” said Matt Myers, president of the Campaign for Tobacco-Free Kids, which supports a ban on menthol. “This administration is committed to moving forward on this specific rule, and what OMB does will be a critical test of its commitment.”

The review process will also mark one of the first tests for Robert Califf, the new FDA commissioner, who will likely have to use political leverage to ensure the regulations are published quickly. Califf oversaw earlier efforts to ban flavored products during his last stint at the FDA under the Obama administration, and had previously proven unable to fight pressure from the tobacco industry. At the time, when Califf was asked why the Obama White House killed the flavor vaping ban, he told The New York Times he just didn’t know.

A major boost for NIH and FDA partnerships with the private sector

Congress is dramatically increasing the amount of money the NIH and FDA spend on research partnerships with the private sector, namely collaborations with drug and device companies.

A new bill by Sen. Ben Ray Lujan (DN.M.) allows each agency to allocate more of its own funding to nonprofit organizations authorized by Congress that facilitate partnerships: the Reagan Foundation- Udall for the FDA and the Foundation for the NIH. The legislation, which passed the House last night and is now heading to Biden’s office, raises the minimum annual funding for each organization to $1.25 million. The new maximum for each nonprofit is $5 million, a fourfold increase.

The legislation does not specify for which projects the new funds will be used. In the past, certain partnerships with the private sector have been the subject of controversy, such as abortive projects with the NFL and the alcohol industry. More recent ones, however, have had more success, such as a $215 million team on cancer immunotherapies and a number of efforts to develop Covid diagnostics, tests and vaccines.

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