FDA Launches Secure Supply Chain Pilot Program
February 24th, 2014
The United States Food and Drug Administration — the FDA — has recently approved an initiative to speed specific imported drugs through their approval process. This action enables a much hastier process for these pharmaceuticals than what was previously in place. This in turn enables the FDA to spend less effort overseeing all steps of the process.
The FDA’s new initiative, called the Secure Supply Chain Pilot Program, was first proposed in August 2013. In this proposal, the FDA asked for voluntary participation from pharmaceutical companies. Companies that wanted to be involved could submit an application for the program’s two-year test window.
On February 18, 2014, the FDA announced the companies selected in this process and revealed how the program will work. A selected 13 pharmaceutical companies will be able to submit up to 5 imported drugs through a different system that is quicker and requires less investigation and formal approval by FDA. This lets the companies get their products to market faster, and allows the FDA to spend more time on other, higher priorities.
The Supply Chain Pilot allows participation if several conditions are met. First, a company has to oversee every step of the drug’s production and distribution, including a secure supply chain. Companies must also have a very effective recall system in place to compensate for the more lenient drug testing and comply if the FDA decides changes need to be made to the drug.
Companies involved in this greenlighting process are required to commit to levels of quality and control standards applicable to all other drugs the FDA approves. The FDA is expediting the entry of these drugs into the U.S. because of the increasing toll upon the FDA’s services as more and more drugs and pharmaceutical companies spring up.
Acting director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research Carol Bennett had this to say on the initiative: “By creating incentives for manufacturers to adopt best practices for supply chain integrity, we can enhance the quality and safety of imported drugs.”
-Nate Stevens, Editorial Intern
