Recalls Lead FDA to Seek Greater Oversight of Foreign Supply Chain

By Howard Aughinbaugh

Many attractive business opportunities in today’s global marketplace also present new and complex challenges to consumer safety. As regulators reassess their role in overseeing manufacturers and retailers, they are paying greater attention to industries where the potential for product recalls and recall management is greater than previously expected. Not only are the final products under increased scrutiny, but components and ingredients, regardless of their origin, are quickly becoming targets for regulators looking to crack down on unsafe products.

While the global marketplace has, in many cases, outpaced regulators, there is now an increased regulatory focus on the areas where lapses in oversight have occurred and where areas of risk exist. Regulatory agencies today must do their work within an increasingly interwoven network of supply chains, where the resources, labor and manufacturing of a product can be derived from widely diverse regions and under equally diverse circumstances.

One such example was outlined in a recent Chemical & Engineering News cover story, which reported that drug makers are increasingly relying on the outsourced production of active pharmaceutical ingredients (APIs). The article notes that in the past several years, the Food and Drug Administration (FDA) has had to deal with several cases where gaps in supply chain oversight have led to substandard or criminally adulterated APIs. Recent recalls of products on a global scale illustrate how products developed in the global marketplace are constantly at risk of  contamination.

A recent report by the Government Accountability Office subsequently found that the FDA had inspected only 11 percent of the foreign establishments listed as suppliers of drug products sold in the U.S. in 2009, compared with 40 percent of domestic establishments inspected that same year. The FDA has since concentrated its efforts at being “prevention-focused and global,” as it seeks to strengthen its oversight. This, along with steps taken by the industry itself is contributing to improved consumer safety standards.

At the same time, drug companies and API suppliers have taken greater initiative in maintaining global quality standards by volunteering information through Rx360.com, a pharmaceutical supply chain consortium. The consortium serves as a valuable resource for both security and transparency.

Lawmakers in the U.S. are also taking an interest in the safety concerns traditionally associated with outsourced pharmaceutical drug production. Last year, Senator Michael F. Bennet (D-Colo.) introduced the Drug Safety & Accountability Act, which, among other provisions, would strengthen the FDA’s ability to track foreign manufacturing sites. Representative John. D. Dingell (D-Mich.) introduced the Drug Safety Enhancement Act, another bill that would increase the FDA’s oversight authority.

The risks posed by substandard or adulterated APIs illustrate the need for regulatory bodies to keep apace with the industries they oversee. As drug companies, politicians, and the FDA tighten their oversight of foreign supply chains, manufacturers should work to ensure that they are doing their part to ensure the safety of their products, and prepare for recalls.

Stericycle ExpertRECALL™ is the industry leader in recall logistics and regulatory compliance for consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. ExpertRECALL’s professionals are experts in recall management who can help you streamline the entire product recall process.

One Response to “Recalls Lead FDA to Seek Greater Oversight of Foreign Supply Chain”