May 17, 2020

FDA calls for tighter pharmaceutical supply chain

Supply Chain Digital
Medical Supply Chain
Pharmaceutical S
Freddie Pierce
2 min
Deborah Autor of the FDA wants Congress to grant the FDA more power to regulate the medical supply chain
Help could be on the way for the pharmaceutical supply chain, as the United States Food and Drug Administration is calling on lawmakers to give the FDA...

Help could be on the way for the pharmaceutical supply chain, as the United States Food and Drug Administration is calling on lawmakers to give the FDA more power to that it can tighten its supply chain security.

The FDA is particularly concerned with competition from foreign manufacturers, who have certain advantages in the industry. FDA Deputy Commissioner for Global Regulatory Operations and Policy Deborah Autor wants to see Congress update its laws so that the agency can refuse admission of a product into the U.S. if the overseas manufacturer delays, limits or denies inspection to its facilities.

Right now, the FDA only has that authority on food imports into the United States.

According to Autor, the FDA doesn’t have the authority to require importers and product owners to ensure that an imported drug complies with U.S. standards before being imported into the country. By changing the FDA’s authority, foreign drugs would go through the same process as the domestic drug supply chain.

Undoubtedly, upping the visibility and inspection process would have a positive effect on foreign drug manufacturers, who would be held accountable for quality in their products.

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Among other issues concerning the medical supply chain and the FDA is product recall, as the FDA has no mandatory recall authority to drugs. According to Autor, this leaves the public in a precarious position.

The FDA is also seeking the authority to destroy harmful products at the border. Currently, the system stipulates that the process for destruction go through a time-intensive and costly hearing. Such a process is a deterrent to the FDA, as the agency is often forced to send back the potentially harmful drugs to the manufacturer, where there’s no guarantee that won’t be shipped out again.

The medical supply chain needs to be tightened, but Congress is walking a dangerous line when it comes to granting the FDA more power. More visibility is definitely needed, but how the federal government and the Food and Drug Administration go about adding that transparency will be the biggest question moving forward.

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Jun 8, 2021

DHL Claim Multi-Sector Collaboration Key to Fighting COVID

DHL
Supplychain
COVID19
Logistics
3 min
Global logistics leader DHL’s new white paper highlights what supply chain professionals have learned one year into the pandemic

Since January, global logistics leader DHL has distributed more than 200 million doses of the COVID vaccine to 120+ countries around the globe. While the US and UK recently rolled out immunisation plans to most citizens, countries with less developed infrastructure still desperately need more doses. In the United Arab Emirates (UAE), which currently has one of the highest per-capita immunisation rates, the government set up storage facilities to cover domestic and international demand. But storage, as we’ve learned, is little help if you can’t transport the goods.

 

This is where logistics leaders such as DHL make their impact. The company built over 50 new partnerships, bilateral and multilateral, to collaborate with pharmaceutical and private sector firms. With more than 350 DHL centres pressed into service, the group operated 9,000+ flights to ship the vaccine where it needed to go. 


 

Public-Private Partnerships

With new pandemic knowledge, DHL just released its “Revisiting Pandemic Resilience” white paper, which examined the role of logistics and supply chain companies in handling COVID-19. As Thomas Ellman, Head of Clinical Trials Logistics at DHL, said: “The past one year has highlighted the importance of logistics and supply chain management to manage the pandemic, ensure business continuity and protect public health. It has also shown us that together we are stronger”. 

 

Multisector partnerships, DHL said, enabled rapid, effective vaccine distribution. While international scientists developed a vaccine in record time—five times faster than any other vaccine in history—manufacturers ramped up production and logistics teams rolled out distribution three times faster than expected. When commercial routes faced backups, logistics operators worked with military officers to transport vaccines via helicopters and boats. 

 

In the UAE, the public-private HOPE Consortium distributed billions of COVID-19 doses to its civilians as well as other countries in need by partnering with commercial organisations such as DHL. For the first time, apropo for an unprecedented pandemic, logistics companies made strong connections with public health and government.

 

“While the race against the virus continues, leveraging the power of such collaborations and data analytics will be key”, said Katja Busch, Chief Commercial Officer DHL and Head of DHL Customer Solutions & Innovation. “We need to remain prepared for high patient and vaccine volumes, maintain logistics infrastructure and capacity, while planning for seasonal fluctuations by providing a stable and well-equipped platform for the years to come”. 


 

How Do We Sustain Immunisation? 

By the end of 2021, experts estimate that we need approximately 10 billion doses of vaccines—many of which will be shipped to areas of the world, such as India, South Africa, and Brazil, that lack significant infrastructure. This is perhaps the greatest divide between countries that have rolled out successful immunisation programmes and those that have not. As Busch noted, “the UAE’s significant investments in creating robust air, sea, and land infrastructure facilitated logistics and vaccine distribution, helping us keep supply chains resilient”. 

 

Neither is the novel coronavirus a one-time affair. If predictions hold, COVID will be similar to seasonal colds or the flu: here to stay. When fall comes around each year, governments will need to vaccinate the world as quickly as possible to ensure long-term immunisation against the virus. This time, logistics companies must be better prepared. 


Yet global immunisation, year after year, is no small order. To keep reinfection rates low and slow the spread of COVID, governments will likely need 7-9 billion annual doses of the vaccine to meet that mark. And if DHL’s white paper is any judge of success, multi-sector supply chain partnerships will set the gold standard.

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