Compliance Watch: Cracking Down on the Pharmaceutical Supply Chain and Suppliers

There are certain times even ardent libertarians would agree that a bit of government intervention is probably not such a bad thing. Such is the case when it comes to maintaining the integrity of the pharmaceutical supply chain. Unlike SarbOx, it's hard to disagree with the premise behind a recent Senate Bill that seeks to ensure greater transparency and accountability in the pharmaceutical supply chain. According to sources quoted in the above-linked Industry Week news analysis, the goal of the Drug Safety and Accountability Act, introduced last week, is to make sure that "pharmaceutical drugs meet the highest standards for safety and quality" because "for too long, the FDA has lacked the proper authority to adequately safeguard our drug supply."

Consider the growing problem, compounding on a yearly basis: "One of the reasons for the increased scrutiny of the quality of the medicine is due to the record 1,742 drug recalls in 2009 which is a 400% increase from the prior year." Global sourcing is paying into the heightened awareness afforded the issue as well, given that in many cases, the majority of active ingredients in U.S. drugs are now made overseas in countries "where regulatory oversight" may not meet US standards. Doing the 80/20 analysis shows the problem here -- and the need for realignment of FDA resources. As one source in the article points out, "about 80% of active drug ingredients come from overseas -- the majority from India and China -- yet receive less than 5% of FDA's resources."

Just what does the bill aim to accomplish? If you have time, you can read the proposed legislation in its entirety here. But in short, it seeks to address many of the quality assurance shortcomings that led to, among other catastrophes, the 2007 and 2008 scandal involving contaminated imported Herapin, where "up to 149 Americans died," according to the proposed legislation. These new requirements will include quality management programs which required the registration, tacking and active management of all "materials used in the manufacture of APIS based on a risk assessment that gives additional consideration to materials extracted or derived from plants, microbes, animal tissue, or other biological sources."

What is the expert take on this legislation? I've asked our resident pharmaceutical procurement expert, Gregg Brandyberry, to chime in with his take in a guest column later this week.

Jason Busch

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