FDA making a stand on supply chain security
Seems like this time, FDA is not going to let the problem of counterfeit products slip by again. It has been announced that FDA has submitted a formal application to start a supply chain security pilot programme for overseas manufacturers of finished pharmaceuticals and active substances. Surprised? You should not be if you have been following the news which will tell you that FDA has been planning on this scheme since 2009. This supply chain security programme was first introduced as a voluntary scheme in the wake of the heparin scandal and was tagged as a practice to help FDA resolve the import of fake drugs “by allowing the agency to focus its resources on imported drugs that fall outside the programme and that may pose such risks”.
This two-year programme would involve 100 selected applicants who believe that they can "maintain tight control over their products from the time of manufacture through to entry into the US." You may question why any pharmaceutical company would want to partake in this programme. Here's the catch to passing the programme: after stringent examination by the FDA’s Center for Drug Evaluation and Research (CDER) and Office of Regulatory Affairs (ORA), these companies can enjoy an expedited entry into the US for their medicines or active pharmaceutical ingredients (APIs). It has been said that the success of this pilot will mean implementation of the programme on a much larger scale.
FDA's step towards legitimizing such a programme will improve the quality of pharmaceutical products greatly. Nonetheless, such an act also poses a new challenge for pharmaceutical companies to streamline and better their supply chain so as to meet the stringent requirements set by FDA.
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Article adopted from InPharm