While the medical product supply chain has always been subject to vulnerabilities, those weaknesses were laid bare early in the COVID-19 pandemic. Drug and medical device supply chains have historically been susceptible to factors such as a lack of supplier redundancy, components, active pharmaceutical ingredient (API) or finished product manufacturers. But pandemic-driven sourcing and workplace…
CMS retreats from ‘most favored nation’ drug pricing scheme
Former President Trump’s plan to peg the price of some drugs to those paid in other developed nations was always controversial. Not long after Trump unveiled an executive order supporting the idea on Sept. 13, 2020, organizations, including PhRMA and Regeneron, filed lawsuits to block the rule. Several courts agreed that the policy, which CMS codified…
FDA releases scathing inspection report regarding Emergent BioSolutions plant
An FDA report cites multiple failures in an Emergent BioSolutions plant tapped to produce vaccines for Johnson & Johnson and AstraZeneca. The vaccine plant had been forced to discard up to 15 million doses of Johnson & Johnson’s COVID-19 vaccine in a single manufacturing batch. Emergent BioSolutions recently paused production of the vaccine during the FDA inspection and…
U.S. government stockpile of COVID-19 vaccines already drained
Last week, President-elect Joe Biden vowed to release COVID-19 vaccine doses from a government stockpile. On Jan. 13, the U.S. Department of Health and Human Services (HHS) echoed that sentiment, stating it would “no longer stockpile millions of COVID-19 vaccine doses held to ensure Americans receive their second shot,” according to a brief notice. But federal…
Trump’s ‘most-favored nation’ drug-pricing plan hits a snag
A federal judge in Maryland has temporarily blocked a Trump executive order that tied Medicare reimbursement for several drugs to lower rates in other countries. The executive order was facing a flurry of lawsuits. U.S. District Judge Catherine C. Blake sided with the plaintiffs’ argument that the Department of Health and Human Services (HHS) did not…
Biden to bolster COVID-19 vaccine production with Defense Production Act
Joe Biden is reportedly planning on invoking the Defense Production Act to shore up the production of COVID-19 vaccines in the U.S. While FDA has authorized the distribution of vaccines from Moderna Moderna (NSDQ:MRNA) and Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX), distribution has been patchy thus far. The news came from Dr. Celine Gounder, a Biden…
Trump’s ‘most-favored nation’ drug pricing scheme faces lawsuits
Almost immediately after President Trump indicated he planned on tying Medicare reimbursement for dozens of drugs to lower rates in other countries, it seemed certain that legal action was inevitable. Now, Trump’s executive orders related to drug pricing are attracting a growing number of lawsuits. Earlier this month, the Pharmaceutical Research and Manufacturers of America (PhRMA),…
HHS chief assures smooth transition to Biden administration, COVID-19 vaccine availability
Health and Human Services Secretary Alex Azar stated on CNN that he has met with President-elect Joe Biden’s transition team. “I have already met with the Biden transition team. We want to make sure they get everything that they need,” Azar said in an interview with CNN’s Alisyn Camerota. Azar also noted that he would…
Trump’s latest drug pricing plan will likely face legal challenges
President Trump recently unveiled his latest initiative to standardize drug pricing, tying government drug payments to lower prices abroad. Trump also signaled his intent to eliminate pharmaceutical industry middlemen — pharmacy-benefit managers — who are “ripping off Medicare patients with high prescription prices,” he said. The policies, the president claimed, are the “the biggest ever…
5 takeaways from the latest White House Coronavirus Task Force meeting
The White House Coronavirus Task Force promised a swift rollout of COVID-19 vaccines — but one of a number of takeaways from its first briefing since July. The briefing yesterday gave the task force a chance to once again urge Americans to heed COVID-19 guidance while also providing an update on vaccines and therapeutics. The…