Article
What We're Reading: Public Transit Mask Mandate; BLA Decision on Alzheimer Drug Extended; Drug Pricing Rule Delayed
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CDC mandate requiring masks on most forms of public transportation to go into effect today; FDA will extend its review period on a possible new Alzheimer disease drug; HHS will delay the start date of a Trump administration drug pricing rebate rule.
CDC Now Requiring Masks on Public Transportation
Reported by Reuters, the CDC has issued a mandate requiring that face masks be worn on most forms of public transportation, including airplanes, trains, buses, and taxis. The mask mandate will go into effect today at 11:59 pm EST. A similar measure was initially blocked by former President Donald Trump, who rejected efforts by Congress to implement a national mask requirement. Although airlines and most forms of transportation already require masks, the new mandate will make it a violation of federal law for those who do not wear a mask.
FDA Seeks More Evidence on Biogen’s AD Drug
The FDA announced it will be extending the review period for Biogen and Eisai Inc’s Biologic License Application (BLA) for aducanumab, an antibody targeting beta-amyloid for the treatment of Alzheimer disease (AD) whose efficacy has drawn skepticism. Reported by BioSpace, the decision on the BLA, originally expected on March 7, will now be delayed until July 7, 2021. The delay is related to the FDA's request for additional information on analyses and clinical data from the companies. The FDA considered the new information as a major amendment to the application, requiring additional review time.
HHS Delays Trump’s Drug Pricing Rebate Rule by 1 Year
Reported by Fierce Healthcare, HHS announced it will be delaying the start date of a drug pricing policy designed by the former Trump administration that would prevent drug makers and middlemen from negotiating rebates on prescription drugs. Set to take effect on January 29, 2021, the rule will now be delayed until March 22, although the rule’s elimination of safe harbors for drug rebates will be delayed by 1 year to January 1, 2023. The move comes as the Pharmaceutical Care Management Association has sued the Trump administration over the rebate rule that some believe may lead to higher premiums for Medicare Part D beneficiaries.
