Best of 2011: Pharmaceutical Supply Chain
It's the holidays, and we've got a special gift for you this year. Each day this week, Supply Chain Digital will select one top daily story from 2011 to feature here in our Best Of: 2011 section. Enjoy!
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.
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.