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How the presidential election could affect medtech

No matter who ends up in the White House, there will need to be a reckoning over how the government’s relationship with medtech has changed, according to industry insiders.

(Image by Markus Winkler on Unsplash)

It’s been a tumultuous few years for the medical device industry, with highs and lows that no one could have foreseen.

President Donald Trump’s administration streamlined some FDA processes. The medical device excise tax, enacted during the Obama-Biden administration, was permanently repealed.

But any normal state of affairs in the industry was upended by the coronavirus pandemic. COVID-19 disrupted supply chains, brought elective surgeries to a halt and attracted all sorts of businesses to jump into an industry that they knew nothing about. The pandemic also brought about unprecedented cooperation within medtech and betw…

Drug companies agree not to release COVID-19 vaccine until it’s ready

[Photo by Fusion Medical Animation on Unsplash]

Executives from nine different drug companies today announced a pledge to ensure safety with a potential COVID-19 vaccine.

The CEOs of AstraZeneca (NYSE:AZN), BioNTech (NSDQ:BNTX), GlaxoSmithKline (NYSE:GSK), Johnson & Johnson (NYSE:JNJ), Merck (NYSE:MRK), Moderna (NSDQ:MRNA), Novavax (NSDQ:NVAX), Pfizer (NYSE:PFE) and Sanofi (NYSE:SNY), all of whom are developing vaccine candidates, all signed the pledge, which vows to “uphold the integrity of the scientific process” as they pursue regulatory approvals of the first vaccines for the novel coronavirus.

“FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorization or approval in the US,” the pledge states. “FDA’s guidance and criteria are based on the scientific and medical principles necessary to clearly dem…

Biden is getting the most money from medtech employees

Medtech company employees and their families have donated $289,533 to former Vice President Joe Biden, versus $190,570 for President Donald Trump, according to OpenSecrets.org. Check out our breakdown covering 25 of the largest companies.

[Image courtesy of Biden for President]

Medical device company employees’ preference in the U.S. presidential election appears to be clear: They’re providing more money to the Democratic presidential nominee Joe Biden, according to campaign contribution data compiled by the nonpartisan, nonprofit Center for Responsive Politics’ Opensecrets.org.

The difference is even starker when adding donations to other Democrats who failed to secure the nomination.

As of June 30, employees and their families at 25 major medtech companies had donated nearly $1.1 million. Biden received 26.6%, Bernie Sanders received 21.6%, Trump received 17.5%, Elizabeth Warren received 11%, Pet…

BREAKING: U.S. to reportedly pay Abbott $750M for new COVID-19 tests

Multiple reports have said President Trump will announce a $750 million deal with Abbott (NYSE:ABT) for 150 million of its rapid COVID-19 antigen tests.

As first reported by Politico before being confirmed by other outlets, a White House official said that Trump will announce the deal tonight, using his speech at the Republican National Convention to confirm the news.

The U.S. Department of Health and Human Services confirmed the reports in a news release late Thursday. Trump spoke for more than an hour at the RNC but did not make an announcement related to the deal with Abbott.

“This is a major development that will help our country to remain open, get Americans back to work, and kids back to school,” White House communications director Alyssa Farah said in a statement to CNBC. “The Trump Administration is proud to partner with Abbott Labs to make this purchase possible to help the American people.”

“The introduction of Abbott’s antigen test is a…

Hahn apologizes for convalescent plasma claim

FDA commissioner Stephen Hahn

Under intense criticism for his statement that convalescent plasma donated by former coronavirus patients could reduce COVID-19 deaths by 35%, FDA commissioner Stephen Hahn apologized on Twitter late Monday.

The agency announced on Sunday that it had granted an emergency use authorization (EUA) for plasma donated by coronavirus survivors as a treatment for new patients. President Trump, Hahn and U.S. Health and Human Services secretary Alex Azar all touted the 35% figure based on a small subgroup of hospitalized COVID-19 participants in a Mayo Clinic study — patients who were younger than 80 years old, not on ventilators and who received plasma that contained high levels of antibodies within 3 days of diagnosis, according to a report by the New York Times.

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

Feds’ convalescent plasma claim questioned

[Coronavirus image courtesy of World Health Organization]

Scientists are questioning the Trump administration’s claim for the effectiveness of convalescent plasma in preventing deaths from COVID-19, according to published reports.

President Trump and the heads of the FDA and the Department of Health and Human Services all said on Sunday that plasma donated by former coronavirus patients has reduced deaths by 35%. Their calculation appears to be based on a small subgroup of hospitalized COVID-19 participants in a Mayo Clinic study — patients who were younger than 80 years old, not on ventilators and who received plasma that contained high levels of antibodies within 3 days of diagnosis, according to a report by the New York Times.

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

Report: Top FDA official vows to quit if vaccine approved prematurely

A top FDA official has threatened to resign if the Trump administration moves too quickly to approve a vaccine for COVID-19, according to a published report.

Peter Marks, director of the agency’s Center for Biologics Evaluation and Research (CBER), made the threat over concerns a vaccine would be approved without being proven safe and effective, according to a report by Reuters. The news agency quoted Marks as saying that he is not under political pressure to speed a vaccine to market but that he would quit if that changed.

Get the full story on our sister site, Pharmaceutical Processing World.

Report: Top FDA official vows to quit if vaccine approved prematurely

A top FDA official has threatened to resign if the Trump administration moves too quickly to approve a vaccine for COVID-19, according to a published report.

Peter Marks, director of the agency’s Center for Biologics Evaluation and Research (CBER), made the threat over concerns a vaccine would be approved without being proven safe and effective, according to a report by Reuters. The news agency quoted Marks as saying that he is not under political pressure to speed a vaccine to market but that he would quit if that changed.

Get the full story on our sister site, Pharmaceutical Processing World.

Report: Top FDA official vows to quit if vaccine approved prematurely

A top FDA official has threatened to resign if the Trump administration moves too quickly to approve a vaccine for COVID-19, according to a published report.

Peter Marks, director of the agency’s Center for Biologics Evaluation and Research (CBER), made the threat over concerns a vaccine would be approved without being proven safe and effective, according to a report by Reuters. The news agency quoted Marks as saying that he is not under political pressure to speed a vaccine to market but that he would quit if that changed.

“I could not stand by and see something that was unsafe or ineffective that was being put through,” Marks told Reuters. “You have to decide where your red line is, and that’s my red line. I would feel obligated (to resign) because in doing so, I would indicate to the American public that there’s something wrong.”

Public health officials have expressed concern that the administration might move too quickly on a COVID-19 vaccine a…

Report: Will Dr. Hahn crack under political pressure?

Many jobs have come with increased stress levels during the coronavirus pandemic, from ICU staff to Walmart greeters. Now officials who’ve been keeping tabs on FDA commissioner Dr. Stephen Hahn are wondering whether he can weather the strain of defending science while working for the Trump administration, according to a New York Times report.

Hahn has been squeezed between expressing his professional opinions and toeing the administration line on topics such as hydroxychloroquine and COVID-19 vaccines. (Hydroxychloroquine may cause a heart rhythm disorder or drug-induced sudden cardiac death, according to the Centers for Disease Control and Prevention (CDC).) He has gamely fielded questions raised about statements made by President Trump — including on whether the coronavirus is deadly and the possibility of a vaccine being will be ready by Election Day, November 3, 2020.

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

More than $500m wasted on Philips ventilator contract, House report says

Philips Trilogy EVO portable ventilator (Image courtesy of Philips)

A Congressional report today accused the Trump administration of bungling plans to obtain ventilators early in the coronavirus pandemic and claimed that federal officials squandered more than $500 million in a contract with Philips (NYSE:PHG).

The House Subcommittee on Economic and Consumer Policy began an investigation in April into a federal contract with Philips to determine why the country lacked enough ventilators during the initial months of the coronavirus pandemic. According to the report:

The Obama administration contracted with Philips in 2014 to supply the nation’s stockpile with 10,000 ventilators by June 2019. That administration later gave Philips an extension through October 2019. Philips delayed delivery through 2017 and 2018, and the Trump administration mismanaged Philips’ repeated failures to meet contractual require…

Report: Trump fundraiser tried to cash in on N95 masks

N95 respirator [Image from the FDA]

The co-founder of a political action committee that has raised funds for President Donald Trump may have attempted to profit from N95 respirators made by 3M (NYSE:MMM), according to a report by CBS News.

The report said that, shortly after Trump invoked the Defense Production Act to obtain 3M’s respirators, Great America PAC (which raised more than $40 million in support of Trump) co-founder Eric Beach formed Colt International, touting connections with 3M despite having no known experience in supplying medical goods.

CBS News cited a letter sent to prospective customers and signed by Beach that claimed Colt International would work directly with 3M and its distributors and offering Beach’s contact information. Another letter claimed that Colt’s ties to 3M would provide local governments, hospitals and first responders access to a stock of “sever…