BARDA, J&J launch ‘reimagined’ emergency respiratory device challenge

The Dept. of Health and Human Services’ Biomedical Advanced Research and Development Authority and Johnson & Johnson‘s (NYSE:JNJ) Janssen R&D are launching a new crowdsourced tech development challenge looking to support innovative respiratory protection devices, according to a recently listed government posting.

The new contest, dubbed the QuickFire Challenge, will look to award up to $100,000 to developers of “reimagined, transformative respiratory protection” devices, according to the release.

Both J&J’s Janssen and BARDA will collaborate on the challenge, alongside J&J’s JLABS incubators, according to the release.

The aim of the challenge is to advance “reimagined” devices that would eliminate the issues associated with traditional respiratory devices, which are mainly designed for use in occupational settings and are often only available for adults.

“In an outbreak of a novel or newly emerging respiratory disease, respiratory protection may be the only countermeasure available to protect health care workers and the general public,” HHS wrote in the announcement.

BARDA said the challenge will directly benefit its mission of providing medical countermeasures to address health security threats, saying that respiratory protections are “often the first line of defense, and a radically improved approach to protect both health care workers and the general public, including children, would truly improve our ability to respond to public health emergencies.”

Neither J&J or Barda have released any further details on the project, which has a performance period ending on June 30, 2019.

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HHS secretary calls on drug companies to ‘stop the price hikes’

After President Donald Trump’s drug pricing speech last week was deemed a “non-event” by analysts, all eyes turned to the secretary of the U.S. Dept. of Health & Human Services, Alex Azar, to see what the former pharma executive viewed as the administration’s top concerns.

Azar called on the industry to “stop the price hikes” and cautioned that Trump would not hold back from calling out drug manufacturers by name – an effort echoed by FDA chief Dr. Scott Gottlieb who told STAT that the agency would publish the names of companies that are hindering generic drugs from reaching the market.

Get the full story at our sister site, Drug Delivery Business News.

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House committee urges HHS to improve med device cybersecurity


The US House Energy and Commerce committee is looking to the Department of Health and Human Services to shore up medical device cybersecurity, according to a report from The Hill.

Committee Chair Greg Walden (R-Ore.) sent a letter to the HHS asking it to require device makers to provide a listed bill of materials, including third-party software components, used in each of its products, according to the report.

“Stakeholders do not know, and often have no way of knowing, exactly what software or hardware exist within the technologies on which they rely to provide vital medical care. This lack of visibility directly affects the ability of these stakeholders to assess their levels of risk and adjust their strategies appropriately,” Walden wrote in the letter, according to The Hill.

Due to the modular nature of electronic development, both software and hardware components often feature modular designs that require updates and support from third parties outside the company that assembles devices, according to the report.

Security exploits and vulnerabilities are normally patched by manufacturers and not the original component developers. Due to the oft-long periods between manufacturing and sales of devices, problems can manifest themselves quickly upon release, according to The Hill.

In the letter, Walden references bills of materials as an important recommendation of the Health Care Industry Cybersecurity Task Force established by the HHS last year, according to the report.

“It helps solve two questions: Am I affected and where am I affected,”task force member and I Am The Cavalry device security advocacy group co-founder Josh Corman told The Hill. “This is a problem we know how to solve.”

The letter requests the HHS begin developing a plan to form a framework which would allow coordination between stakeholders in medical devices by December 15.

Tom Price is out as HHS secretary

Rep. Tom Price HHSTom Price has resigned from his post as U.S. health and human services secretary after days of fending off criticism over chartered flights he took on the public dime.

The announcement today out of the White House said Don J. Wright – presently assistant secretary for health and director of the Office of Disease Prevention and Health Promotion – will take over as acting secretary.

The announcement came soon after President Donald Trump, at his Bedminster, N.J. gold course, told reporters that he didn’t like the “optics” around the hundreds of thousands of taxpayer dollars spent on Price’s flights – and that he was “not happy,” according to media reports in the Washington Post, Associated Press and elsewhere. Trump had publicly expressed similar unhappiness earlier this week.

Price yesterday tried to defuse the scandal by offering to personally pay for the cost of his seat on the planes. The distances of some flights had been as short at Washington, D.C. to Philadelphia.

“All of my political career I’ve fought for the taxpayers,” Price said in an HHS news release. “It is clear to me that in this case, I was not sensitive enough to my concern for the taxpayer.”

Price’s statement was apparently not enough. His departure throws another wrench into Trump and congressional Republicans’ efforts to repeal and replace the Affordable Care Act.

Price – a longtime ACA critic when he was a U.S. representative from Georgia – had been a point person for rolling back executive branch efforts to promote Obamacare while his former GOP colleagues in Congress tried to kill and replace the program for good. The future of both efforts is now unclear.

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