FDA calls for tighter pharmaceutical supply chain

By Freddie Pierce
Share
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.

SEE OTHER TOP STORIES IN THE SUPPLY CHAIN DIGITAL CONTENT NETWORK

Libyan medical supply chain recovering from civil war

UPS releases medical supply chain report

Check out September’s issue of Supply Chain Digital here!

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.

Click here to download Supply Chain Digital’s iPad app!

Share

Featured Articles

Webinar: Coupa & Amazon Business on Streamlining Buying

In this upcoming webinar, leaders from Coupa and Amazon Business will shed light on how their partnership provides a streamlined purchasing experience

Interos: Building Trusted and Transparent Supply Chains

Interos, the supply chain risk intelligence company, has received a huge boost in the form of a US$40m investment from Blue Owl Capital

Kinaxis: The 'Customers' Choice' for Supply Chain Planning

Kinaxis has been recognised as a Customers’ Choice in the 2024 edition of Gartner’s ‘Voice of the Customer’ for Supply Chain Planning Solutions

Why Coupa has been Named a Supply Chain Leader by Forrester

Supplier Relationship Management (SRM)

Trick or Treat: Inside the $11.6bn US Halloween Supply Chain

Operations

Why Vanderlande has Agreed to Acquire Siemens Logistics

Logistics