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Focus On COVID-19

FDA Uses Lessons Learned To Chart Ongoing COVID-19 Response

FDA is launching a Pandemic Recovery and Preparedness Plan (PREPP) that will apply best practices and lessons learned from the COVID-19 response so far to chart the agency’s response efforts going forward, FDA Commissioner Stephen Hahn said Monday (Aug. 10) during a webinar hosted by the Reagan-Udall Foundation for the FDA.

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President Donald Trump late Friday said that he plans to sign an executive order that will protect people with preexisting conditions, claiming that has never been done before, but the White House declined to elaborate on how the future order would be different from current law.

Seven major drug companies have launched an initiative to seek regulatory and legislative reforms that allow for expanded electronic drug labeling.

While President Donald Trump’s payroll tax holiday doesn’t appear to affect the Medicare portion of those taxes, one analyst said it’s a small step to go from not collecting the taxes that fund Social Security to not collecting the Medicare taxes and some lawmakers worry Trump is setting the stage to defund taxes supporting Medicare.

Hours after the House Energy & Commerce Committee launched a probe into health insurers’ business practices due to record-setting second quarter profits, the industry’s main lobby, America’s Health Insurance Plans (AHIP), issued a lengthy response highlighting plans’ efforts to assist throughout the pandemic and pointing to potentially large future costs due to the pandemic’s long-term effects.

A pair of former Obama-era health experts want FDA to embrace a European Pharmacopoeia-approved vaccine screening method that could cut back the time it takes to test a vaccine for endotoxins from two weeks to five days, but the U.S. Pharmacopeia urges caution, and FDA says the drug industry already has flexibility to use the novel method.

House Ways & Means rural health task force members on Thursday (Aug. 6) called for extending telehealth flexibilities beyond the pandemic, and some members stressed a need to add guardrails.

An industry expert expressed frustration with the lack of detail in FDA’s final guidance that lays out a pathway to expedite antimicrobial drugs that treat serious or life-threatening diseases in limited patient populations.

Hospitals in recent COVID-19 hotspots are concerned they won’t be getting the bulk of the funding aimed at places experiencing a flare up of coronavirus due to a data lag in HHS’ distribution system, but early hotspots say they still need that funding to help make up for their previous experiences – and all hospitals say more provider relief is needed overall.

The House Energy & Commerce Committee is launching an investigation into health and dental insurers’ business practices as company after company reported record-setting second quarter profits, largely driven by the steep decline in utilization amid the pandemic, Chairman Frank Pallone (D-NJ) said Thursday (Aug. 6).

Public health officials, including FDA chief Stephen Hahn, are trying to tamp down concerns that the agency will lower its drug approval standards in efforts to get a COVID-19 vaccine and potential therapies to the public as fast as possible.