A recent announcement from the U.S. Food and Drug Administration (FDA) reinforced some comments made in this blog last August.. The FDA announced a two-year pilot program aimed at improving drug safety. This program, which is termed Secure Supply Chain, seeks to voluntarily enlist 100 drugmakers that would help demonstrate the feasibility of guaranteeing the safety of foreign-produced drugs and active ingredients. It would require participants to document and maintain strict control over the production of up to five of their drugs from overseas manufacturing points to entry into the U.S. Drug makers who participate in this program must meet specific FDA-approved criteria, comply with Good Manufacturing Practices (GMP) and document that their products use a secure supply chain.
In a posting I penned in late August of 2008, I noted that the FDA and other regulatory bodies were ill-equipped to keep-up with the pace of current outsourcing within these supply chains, and risk mitigation must stem from internal and external controls. As an example, 15 FDA inspectors in China could hardly keep track of all present export volumes. Thus, you would think that I would be applauding this new program. Not really..
A lot has transpired in drug and food safety since August and I’m not totally convinced that a complete turn towards industry self-regulation is going to provide a secure supply chain. Do not mis-perceive, it is a step in the right direction. I tend to agree with an effort to determine the practicality of developing a secure supply chain. But, I would rather lean more toward higher regulation until the industry can prove it is ready and equipped for responsive self-regulation. That includes the ability to overcome some of today’s obvious challenges of oversight in many developing countries. Five products over two years may be too long a time to prove practicality.
What’s your view? Do you believe that either the drug or food industry is truly ready to assume self-control? Share your thoughts in the comments section below this post.