FDA establishes authorities to boost medical device supply chain

The FDA announced as part of its annual budget that it will include $21.6 million for a new Resilient Supply Chain and Shortages Prevention Program (RSCSPP).

Funding from the RSCSPP for the Center for Devices and Radiological Health (CDRH) will provide — the FDA says, for the first time — resources to establish a permanent program for U.S. supply chain resilience for medical devices.

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

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FDA establishes authorities to boost medical device supply chain

The FDA announced as part of its annual budget that it will include $21.6 million for a new Resilient Supply Chain and Shortages Prevention Program (RSCSPP).

Funding from the RSCSPP for the Center for Devices and Radiological Health (CDRH) will provide — the FDA says, for the first time — resources to establish a permanent program for U.S. supply chain resilience for medical devices.

Having implemented the Coronavirus Aid, Relief and Economic Security Act (CARES Act) in 2020, the FDA observed weaknesses in the medical device supply chain and the dependence on foreign medical devices. The implementation of the RSCSPP aims to take resources and expand authority to ensure that the U.S. is prepared to secure its medical device supply chain.

The focus of the funding as part of the FDA’s fiscal 2022 budget centers around strengthening the domestic supply chain through investments in preventive measures, identifying potential medical product supply shortf…

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Biden administration wants to boost funding for new pharma manufacturing processes

President Joe Biden [Image courtesy of the White House]The Biden administration today released findings from 100-day supply chain assessments, determining the need to boost pharmaceutical manufacturing.

According to a fact sheet, the administration plans to take immediate action to “address vulnerabilities and strengthen resilience” with its effort to take on near-term supply chain disruptions for four products: semiconductor manufacturing and advanced packaging; large capacity batteries, like those for electric vehicles; critical minerals and materials; and pharmaceuticals and active pharmaceutical ingredients (APIs).

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

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FDA shares guidance to protect the pharma supply chain

FDA has issued guidance documents to help pharmaceutical stakeholders identify illegitimate products and remove them from the supply chain. Two of the documents are final while another two are draft guidance. 

“Ensuring the quality of prescription drugs and safeguarding the integrity of pharmaceutical distribution are crucial roles the FDA plays in protecting the health of the American public. Illegitimate and unsafe products must be kept out of the U.S. drug supply chain,” said Donald D. Ashley, director of the Office of Compliance at FDA’s Center for Drug Evaluation and Research, in a statement. 

The FDA introduced the Drug Supply Chain Security Act (DSCSA) requirements to identify and weed out illegitimate products. 

The recent documents include recommendations for complying with DSCSA requirements and how to provide enhanced drug distribution security at the package level to comply with requirements that go into effect in November 2023. After that da…

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FDA seeks more money, authority in budget request

The FDA wants more money from Congress for the coming fiscal year, and more power, too.

Out of its $6.5 billion total budget, the agency is asking $676.55 million for its medical device program. That includes $571 million for the Center for Devices & Radiological Health (CDRH) and $105.4 million for the Office of Regulatory Affairs (ORA).

The request includes $452 million that would come from Congress— up nearly $44 million from FY 2021 — and $224.5 million from user fees, a $4.9 million increase.

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

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How end-to-end visibility and machine learning can safeguard the vaccine supply chain

Photo by Spencer Davis on Unsplash

For any vaccine, some degree of waste is expected. The problem is inspiring supply-chain companies to explore new technologies that can address a longstanding struggle.

“Before COVID-19, we often saw waste of about 8–10%,” said Ranjeet Banerjee, CEO of Cold Chain Technologies, which provides insulated packaging for drugs and biologics.

A 2019 World Health Organization report citing 2002 data concluded that between 5% and 50% of routine vaccines are wasted.

In some cases, entire pallets or freezers of vaccines are tossed out due to storage unit malfunctions that may have impacted only some vaccine vials.

In general, the biopharma industry loses roughly $35 billion each year as a result of cold-chain, according to a 2019 IQVIA report.

COVID-19 vaccines up the stakes. “COVID vaccine has ten times the complexity,” Banjree said. Not only are a variety of vaccines availabl…

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It’s time to rethink pharma supply chains

Image courtesy of Pixabay

Global supply chains have arguably seen more disruption in the past year than they have seen in decades.

Pharmaceutical supply chains were especially vulnerable in the early days of the COVID-19 pandemic, prompting a rethink of supply chain management for the industry.

Another wrinkle is a recent executive order from President Biden, which prompted a review of critical supply chains including for pharmaceuticals and related supplies.

To learn more about the quickly moving landscape, we reached out to William Wappler, the founder and CEO of supply chain specialist Surgere. In the following interview, Wappler shares his thoughts on broad advances in supply chain management including the challenges and possibilities of IoT technology in the sector. He also touches on inbound and outbound logistics considerations for pharmaceutical companies.

What are some of the mo…

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Medtronic hiring Walmart exec to run its supply chain

Image from Geoff Martha on LinkedIn

Medtronic (NYSE:MDT) CEO Geoff Martha announced that the company is appointing Greg Smith as EVP of global operations and supply chain.

In a LinkedIn post today, Martha wrote: “I’m pleased to share that Greg Smith, Executive Vice President of U.S. Supply Chain for Walmart, is joining Medtronic on April 5 as Executive Vice President of Global Operations and Supply Chain.”

The Medtronic CEO added that the Walmart executive currently heads one of the world’s “largest and most complex supply chains” for the massive retail company.

Smith developed and implemented a strategy to transform Walmart’s supply chain in an effort to drive sales and reduce costs while creating an engaging work environment. He also built Walmart’s sales and operations planning and quality organizations to improve forecast accuracy in pursuit of zer…

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FDA authorizes J&J’s single-dose COVID-19 vaccine

Americans will start receiving Johnson & Johnson‘s COVID-19 vaccine within the next 24 to 48 hours, J&J CEO Alex Gorsky told NBC’s Today this morning.

FDA issued an EUA for J&J’s Ad26.COV2-S vaccine on Feb. 27, a day after an advisory panel unanimously recommended that the agency authorize the vaccine for adults 18 and over. J&J’s vaccine is the third COVID-19 vaccine to receive authorization in the U.S. so far.

Get the full story from our sister publication, Drug Discovery & Development. 

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White House could promise states additional COVID-19 vaccines doses next week

Image from René DeAnda on Unsplash

Federal shipments of COVID-19 vaccines could increase roughly 16% next week, potentially reducing some states’ shortfalls as they have broadened access to adults 65 and older. 

The U.S. government plans to increase its weekly allocation to states from 8.6 million doses to approximately 10 million doses, according to The Washington Post.  

Government authorities ship COVID-19 vaccine doses to 64 jurisdictions spread across the country and eight U.S. territories. 

Moderna (NSDQ:MRNA) is likely to provide the supply boost. 

Pfizer (NYSE:PFE) has decided to send the U.S. fewer doses of its vaccine jointly developed with BioNTech (NSDQ:BNTX) after the surprise discovery that its vials contained an extra dose. It negotiated with the U.S. government to count the extra sixth dose in its vials toward its prior commitment to provide 200 million doses. 

Bot…

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AdvaMed wants input on Biden pandemic DPA use

AdvaMed reacted to President Joe Biden’s plan to use the Defense Production Act (DPA) to tackle the pandemic with some cautionary words.

In a letter responding to Biden’s 200-page COVID-19 plan, the medtech trade group asked for collaboration and urged the president to consider the industry’s experience with DPA orders issued by former President Trump.

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

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7 core strategies in Biden’s battle against COVID-19

[Photo by Fusion Medical Animation on Unsplash]

Included in President Joe Biden’s sprawling strategy document for dealing with the COVID-19 pandemic are an array of plans intended to ramp up vaccination efforts.

Also included are proposals for accelerating the development of therapies such as antiviral compounds effective against SARS-CoV-2 and other coronaviruses with pandemic potential.

The “full-scale, wartime” plans have considerable relevance for the pharmaceutical and medical device industries. (More information is available on the medical-device ramifications of the plan from our sister site, Medical Design & Outsourcing.)

While the plan stands out from the prior administration’s COVID-19 response in its detail and earnestness, several portions effectively represent a continuation of existing policy. The policy, for instance, says it will end the U.S. government’s practice of stockpil…

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