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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 Two of the documents are final while another two are draft guidance.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…

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.

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…

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…

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…

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.

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.

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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.

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…

Biden leaning on Defense Production Act to bolster COVID-19 vaccine supplies

[Joe Biden photo from Wikipedia]

President Joe Biden has unveiled a series of anti-COVID-19 measures in his first full day in office, including signing an executive order instructing federal agencies to use the Defense Production Act (DPA) and other tools to speed the manufacture of COVID-19 vaccines and materials.

In total, the president has signed 10 executive orders intended to curb the spread of the novel coronavirus.

According to the “National Strategy for the COVID-19 Response and Pandemic Preparedness” document, the Biden administration will use the Defense Production Act to “fill any distribution gaps, including with respect to any needed refrigeration, transportation, or storage facilities.”

Biden has also moved to create a centralized federal approach to virus testing while ramping up the U.S. government’s involvement in vaccine distribution.

“President B…

Congressional leaders want more info on COVID supply chain

Millions of 3M N95 masks arrive at BWI airport in April. (Image courtesy of 3M)

Leaders in both houses of Congress want federal trade officials to further investigate the supply chain for COVID-19-related goods and devices, but don’t expect any answers before December.

Members of the House Ways and Means and Senate Finance committees wrote a letter to U.S. International Trade Commission (USITC) chairman Jason Kearns last week, asking for a more detailed look at industries that produce supplies for COVID-19 patients and frontline workers as well as key products within those sectors. The request is a follow-up to a report that USITC produced in April to identify imports of medical supplies and products relevant to the response to COVID-19.

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

COVID-19 lessons learned: 2 manufacturers, a healthcare system and a logistics company share their wisdom

The COVID-19 pandemic put medtech contract manufacturers, OEMs, distributors and healthcare providers in situations for which they were unprepared, particularly with their supply chains. What they learned will undoubtedly help them all going forward, especially if the world faces a second wave or another novel virus.

Here are some supply chain lessons learned by a small manufacturer of a critical device for COVID-19 patients, a major manufacturer of respirators for frontline workers, a health system administrator and a logistics company that recently entered the medical supply business. They participated in a webinar hosted Wednesday by Minnesota’s Medical Alley Association trade group.

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