New HHS initiatives put spotlight on long COVID

The U.S. Department of Health and Human Services (HHS) recently announced two major initiatives to shed light on long COVID, a condition affecting millions. First, the agency plans to establish the Office of Long COVID Research and Practice. HHS is also set to launch new long COVID-19 clinical trials through its RECOVER initiative. Jointly, the long COVID drug development efforts highlight the need for therapies and create openings for pharmaceutical companies to drive research and drug development related to the condition.

HHS has earmarked $1.15 billion for the RECOVER Initiative to explore novel therapies for the condition estimated to have affected between 7.7 and 23 million Americans. To date, the RECOVER Initiative has enrolled more than 24,000 participants in observational studies on long COVID. New clinical trials, beginning enrollment in summer 2023, will test experimental therapies across five focus areas to identify therapies that can alleviate symptoms and…

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FDA’s mandatory medical device shortage reporting ends

This colorized scanning electron microscope image shows SARS-CoV-2 (round blue objects), the virus that causes COVID-19, emerging from the surface of cells cultured in the lab. [Image courtesy of National Institute of Allergy and Infectious Diseases]

Reporting of medical device shortages to the FDA is no longer mandatory with last week’s expiration of the COVID-19 public health emergency.

Manufacturers can still voluntarily report device production interruptions or permanent discontinuations to the FDA. Patients, healthcare providers, healthcare systems and other stakeholders can also notify the FDA of any supply chain disruptions they’re experiencing by emailing patients, healthcare providers, healthcare systems, distributors, group purchasing organizations) experiencing supply chain disruptions may also notify the FDA by emailing deviceshortages@fda.hhs.gov.

“The FDA encourages device…

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HHS to offer Tamiflu doses from national stockpile

[Image courtesy of Wikimedia Commons]

The U.S. Department of Health and Human Services (HHS) has announced that it would provide the prescription flu treatment Tamiflu (oseltamivir phosphate) to jurisdictions with an elevated demand for the antiviral during the flu season.

The move would make millions of treatment courses available.

Roche is the developer of Tamiflu. Several generics are also available for the drug.

The U.S. government stores the antiviral in its Strategic National Stockpile (SNS), containing antibiotics, life-support medications, airway maintenance supplies and other medical items.

HHS notes that jurisdictions will work with the Administration for Strategic Preparedness and Response (ASPR) regional teams, who will evaluate requests for the antiviral.

The news comes as supplies of Tamiflu have dwindled. In addition, the U.S. has also encountered shortages of the AD…

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U.S. government earmarks $1.6 billion to battle opioid crisis and overdose epidemic

[Photo by Karolina Grabowska from Pexels]

The U.S. Department of Health and Human Services (HHS) has awarded more than $1.6 billion as a part of an initiative to battle the drug overdose epidemic.

SAMHSA’s State Opioid Response (SOR), Tribal Opioid Response (TOR) grant programs and Health Resources and Services Administration (HRSA)’s rural communities opioid response programs will lead the new initiative.

The government plan will expand access to the opioid mu receptor antagonist naloxone, and improve access to opioid treatment programs. It also includes provisions to reduce abuse of stimulants such as cocaine and methamphetamine that contribute to the overdose epidemic.

The government initiative will also provide funding for law enforcement in high-intensity drug trafficking areas.

Drug-involved overdose deaths have surged in recent years, according to federal statistics.

In 2020…

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HHS and DOD order 3 million doses of Novavax COVID-19 vaccine

Novavax (Nasdaq:NVAX) announced that its protein-based NVX-CoV2373 COVID-19 vaccine could be the first of its type to be available in the U.S., assuming it wins backing from the FDA and CDC.

The U.S. Department of Health and Human Services (HHS) and the Department of Defense (DOD) have secured 3.2 million doses of Novavax’s COVID-19 vaccine.

There are currently two FDA-approved mRNA vaccines and an authorized adenovirus vector vaccine.

The protein-based Novavax vaccine is built using a more traditional technique than rivals and is adjuvanted to enhance the immune response. Hepatitis B and shingles vaccines are also protein-based and adjuvanted.

The vaccine includes a small amount of the SARS-CoV-2 spike protein.

In June, an FDA advisory committee recommended authorization of the Novavax vaccine.

Typically, FDA grants authorization soon after hearing from its advisors but has not yet authorized the Novavax vaccine.

Novavax note…

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HHS makes 144,000 more doses of Jynneos monkeypox vaccine available 

The U.S. Department of Health and Human Services (HHS) has said it would make available an additional 144,000 doses of the Jynneos vaccine doses available to states and jurisdictions.

Bavarian Nordic A/S (OMX:BAVA) is the manufacturer of the vaccine.

Jynneos won FDA approval for both smallpox and monkeypox in 2019.

There have been approximately 700 confirmed monkeypox cases in the U.S., according to the CDC.

HHS said it would begin shipping the most recent doses from the Strategic National Stockpile (SNS) on July 11.

“We are using every tool we have to increase and accelerate Jynneos vaccine availability in jurisdictions that need them the most,” said Steve Adams, Director of the Strategic National Stockpile, in a statement. “In less than ten days, we’ve made available 200,000 Jynneos vaccine doses in communities where transmission has been the highest and with high-risk populations, and significantly scaled testing availability and conveni…

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HHS offers guidance for HIPAA-compliant audio telehealth

The HIPAA Security Rule does not apply to audio-only telehealth services provided via landline, but does apply to calls over cellular and internet connections. (Imagy by Frederik Lipfert on Unsplash)

The Office for Civil Rights at the U.S. Department of Health and Human Services today issued guidance on providing audio-only telehealth services in compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA).

“Audio telehealth is an important tool to reach patients in rural communities, individuals with disabilities, and others seeking the convenience of remote options,” Office for Civil Rights Director Lisa Pino said in a news release. “This guidance explains how the HIPAA rules permit health care providers and plans to offer audio telehealth while protecting the privacy and security of individuals’ health information.”

HHS said the guidance is meant to ens…

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U of Maryland scientist to set up NIH’s new Advanced Research Projects Agency for Health

U.S. Dept. of Health and Human Services (HHS) announced that it formed a new research project agency for health.

HHS Secretary Xavier Becerra announced the formal establishment of the Advanced Research Project Agency for Health (ARPA-H) as an independent entity within the National Institutes of Health (NIH). Adam H. Russell was appointed as acting deputy director, effective next month.

Russell currently serves as chief scientist at the University of Maryland’s Applied Research Laboratory for Intelligence and Security (ARLIS). He previously spent more than 10 years as a program manager, first at the Intelligence Advanced Research Projects Activity (IARPA) and then at the Defense Advanced Research Projects Agency (DARPA).

At Darpa, Russell focused on new experimental platforms and tools to facilitate discovery, quantification and “big validation” of fundamental measures in social science, behavioral science and human performance, accordin…

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HHS to support more healthcare products manufacturing

HHS will fully establish a program to provide loans, grants and other types of funding to expand the U.S. health resources industrial base, the White House announced today.

The news was part of a package of actions the Biden administration is taking to support American manufacturing and boost supply chains.

During the COVID-19 pandemic, HHS created a Defense Production Act office to use the Korean War–era law to break through bottlenecks in the supply chain and spend funds to combat shortages of needed medical supplies. Now, HHS will fully establish a DPA Title III Program.

Today’s announcement out of the White House also included news that the Treasury Department will deploy $10 billion of American Rescue Act funds under a new and improved State Small Business Credit Initiative (SSBCI). The move will leverage the funds into more than $70 billion in additional lending and investment for small businesses, including small manufacturers.

Get th…

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HHS to support more manufacturing of APIs, other healthcare products

HHS will fully establish a program to provide loans, grants and other types of funding to expand the U.S. health resources industrial base, the White House announced today.

The news was part of a package of actions the Biden administration is taking to support American manufacturing and boost supply chains.

The White House briefing statement said: “The United States remains critically dependent on imports for a range of key pharmaceutical products and active pharmaceutical ingredients—the primary ingredients of generic drugs.”

During the COVID-19 pandemic, HHS created a Defense Production Act office to use the Korean War–era law to break through bottlenecks in the supply chain and spend funds to combat shortages of needed medical supplies. Now, HHS will fully establish a DPA Title III Program.

“This program will ensure timely availability of essential domestic industrial resources; establish the necessary authorities and mechanis…

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HHS OIG will review FDA’s approval of Biogen’s aducanumab

The HHS Office of Inspector General will review FDA’s accelerated approval pathway following the controversy surrounding the agency’s approval of the Alzheimer’s drug Aduhelm (aducanumab) from Biogen (NSDQ:BIIB) and Eisai (TYO:4523).

Among the controversies surrounding the drug’s approval is the use of the accelerated approval pathway, which led the agency to use a surrogate endpoint to approve aducanumab conditionally. 

The HHS watchdog will investigate how the agency implements the accelerated pathway and will review “interactions between the FDA and outside parties as well as other aspects of the process, such as deciding on this pathway and scientific disputes,” HHS OIG said in a statement. In addition, the OIG will study FDA policies and procedures and the agency’s compliance with them. It will later make “appropriate findings and recommendations based on a sample of drugs approved using the accelerated approval pathway, which will include Aduhelm.”

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HHS OIG will review FDA’s approval of Biogen’s aducanumab

The HHS Office of Inspector General will review FDA’s accelerated approval pathway following the controversy surrounding the agency’s approval of the Alzheimer’s drug Aduhelm (aducanumab) from Biogen (NSDQ:BIIB) and Eisai (TYO:4523).

Among the controversies surrounding the drug’s approval is the use of the accelerated approval pathway, which led the agency to use a surrogate endpoint to approve aducanumab conditionally. 

The HHS watchdog will investigate how the agency implements the accelerated pathway and will review “interactions between the FDA and outside parties as well as other aspects of the process, such as deciding on this pathway and scientific disputes,” HHS OIG said in a statement. In addition, the OIG will study FDA policies and procedures and the agency’s compliance with them. It will later make “appropriate findings and recommendations based on a sample of drugs approved using the accelerated approval pathway, which will include Aduhelm.”

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