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Addressing vulnerabilities in the medical product supply chain

Image courtesy of Pexels

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 disruptions magnified these pain points, resulting in the ongoing problems that have persisted for the past two years.

Although the root causes are complex and the possible solutions numerous, important developments at the U.S. Food and Drug Administration (FDA) have led to increased transparency about drug and medical device shortages. Although this transparency is a promising starting point for formulating short- and long-term supply chain solutions, strong policy development, planning and …

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 in November 2020, had procedural issues. Namely, the agency provided less time for involved parties to comment on the rule than the Administrative Procedures Act prescribes.

HHS predicted the rule would save the federal government $85 billion over the next seven years.

Now, the Biden administration is moving to revoke the interim final rule that would have enacted the rule.

It remains unclear, however, what scheme to reduce drug pricing might follow. The Biden administration has stated that it is eyeing ways to reduce spending on Medicare Part B drugs.

The ‘most favored nation’ rule was not ju…

Supreme Court upholds Affordable Care Act again

The front of U.S. Supreme Court in Washington, D.C. (Adobe stock photo)

The U.S. Supreme Court has turned back a third Republican challenge to the Affordable Care Act (ACA), this time by a 7-2 vote.

The latest challenge to the law popularly known as Obamacare came from Texas and other states, backed by the administration of former President Donald Trump. The justices ruled that the challengers lacked legal standing for their case. They did not address part of the law known as the “individual mandate,” which requires Americans to have health insurance and which the complainants sought to overturn as unconstitutional.

Get the full story on our sister site, Medical Design & Outsourcing.

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 had quarantined doses it had in reserve. The FDA will subject those vaccines to further testing before clearing the way for their distribution, explained two head FDA officials, Peter Marks and Janet Woodcock, in a statement.

It is possible that other batches of vaccine need to be discarded. “There is no assurance that other batches have not been subject to cross-contamination,” the FDA concluded.

“The issuance of findings by the FDA is normal following a facility inspection and provides direction on the necessary steps to improve operations. Emergent is committed to workin…

Trump advisor urged PPE push, drug scale-up early in pandemic

[Image from Unsplash]A top advisor to former President Donald Trump urged his pandemic response team in February 2020 to respond swiftly to the spread of COVID-19, but told Trump that his recommendations had been largely ignored.

Then-assistant to the president Peter Navarro wrote an impassioned memo to Trump on March 1, 2020, recommending that the federal government boost the supply of protective gear for healthcare workers, rapidly develop diagnostic tests and vaccines, and bring manufacturing back to the United States. Navarro said he had urged the White House Coronavirus Task Force to move in “Trump time” to stay ahead of the virus, but said movement had been too slow.

Get the full story on our sister site, Medical Design & Outsourcing.

Pandemic Emergency Manufacturing Act would supplement DPA

(Photo by Louis Velazquez on Unsplash)

A rewritten pandemic manufacturing bill was introduced to both houses of Congress yesterday to enable the federal government to manufacture or contract with existing manufacturers to make products to fight COVID-19.

The bill, introduced by Sen. Elizabeth Warren (D-Mass.) and Rep. Jan Schakowsky (D-Ill.), builds off the COVID-19 Emergency Manufacturing Act, introduced in 2020 to enable the federal government to manufacture or contract with existing companies to manufacture personal protective equipment, prescription drugs and other medical supplies necessary for the pandemic.

Get the full story on our sister site, Medical Design & Outsourcing.

U.S. government stockpile of COVID-19 vaccines already drained

Pfizer-BioNTech vaccine image courtesy of Wikipedia

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 officials had already drained vaccine reserves before the HHS vowed to open up a vaccine stockpile, according to state officials who had been expecting more doses.

Local government officials expecting vaccine supplies to roughly double starting next week are now forced to contend with the status quo.

Critics of Operation Warp Speed, a public-private partnership established by the Trump administration to support COVID-19 vaccine distribution, have been frustrated with the speed …

What’s next for the FDA and for Stephen Hahn?

FDA Commissioner Dr. Stephen Hahn

Outgoing FDA commissioner Stephen Hahn says he needs some time to reflect on his future after leading the FDA for a little over a year.

It’s hard to blame him.

Hahn’s brief tenure at FA has been rocky, to say the least.

Get the full story on our sister site, Medical Design & Outsourcing.

Medtech takes a stand on D.C. rioting

The medtech industry has joined other business and industry groups in condemning Tuesday’s siege of the Capitol in Washington, D.C. by supporters of President Donald Trump.

The National Manufacturers Association called for Vice President Mike Pence to invoke the 25th Amendment to remove President Donald Trump from office. The Business Roundtable tweeted a call for an end to the violence and for a peaceful transition of power to President-elect Joe Biden’s administration.

Get the full story on our sister site, Medical Design & Outsourcing.

Report: AstraZeneca Phase III COVID-19 vaccine remains on hold in U.S.

AstraZeneca (NYSE:AZN) is reportedly keeping its COVID-19 vaccine trial in the U.S. on hold as questions remain over patient safety.

U.S. Health and Human Services Dept. Secretary Alex Azar told CNBC yesterday that federal investigators are looking for “answers to important questions,” regarding the safety of patients involved in the trial operated by the United Kingdom-based company in collaboration with Oxford University.

Earlier this month, AstraZeneca voluntarily paused its trial after a standard review process was triggered so an independent committee could review safety data surrounding a single event of an unexplained illness that occurred in the UK Phase III trial for the AZD1222 vaccine candidate. The UK trial has since resumed, but the U.S. study remains paused.

“Look at the AstraZeneca program, Phase 3 clinical trial, a lot of hope. Single serious adverse event report in the United Kingdom, global shutdown and hold of the clinical …

Ambu, Boston Sci execs see domination for single-use scopes

Hospital closures connected to COVID-19 have cut into the sales of many medical device companies, but executives at rival makers of single-use scopes say pandemic has only heightened existing concerns about contamination, exposure and cost.

In interviews in this week’s DeviceTalks Weekly Podcast, executives from Ambu A/S and Boston Scientific (NYSE:BSX) said improved technology make single-use scopes as effective as reusable scopes without carrying the price tag or risk of infection traditional scopes require.

Steve Block, president of Ambu US, projected that over the next decade disposable scopes will account for a majority of devices sold, saying they’ll perform better than traditional devices, cost less, and eliminate the risk of infection. “There is just no reason to use a reusable product,” he said. He said Ambu has sold single-use scopes into 96% of the Top 500 hospitals in the US performing bronchoscopies.

Block appeared on the podcast alongside…

The top 5 MassDevice stories of the week — September 11, 2020

From the Theranos case to wearable medical devices, it’s been another busy news week for the medical device industry.

Want to hear more about the week’s top news? Executive editor Chris Newmarker and Tom Salemi will discuss the week’s “Newmarker’s Newsmakers” during our DeviceTalks Weekly podcast. Without further ado, here’s this week’s MassDevice Top Five:

5. Bardy Diagnostics names new CEO

Kevin Hykes— who over the years has led companies including Relievant Medical Systems, Metavention and Cameron Health — will take over the corner office at Bardy Diagnostics. Bardy has developed the CAM (Carnation ambulatory monitor) for monitoring cardiac rhythms. Read the full story.

4. Drug companies say they won’t release COVID-19 vaccine until it’s ready

Executives from nine different drug companies announced a pledge to ensure safety with a potential COVID-19 vaccine. “We believe this pledge will help ensure public confidence in the rigorous scienti…