- The Food and Drug Administration (FDA) released guidelines for complying with suspect and illegitimate product notifications last week, according to the Regulatory Affairs Professionals Society.
- Noting the threat of illegitimate sourcing and counterfeit products in the pharmaceutical supply chain, the FDA passed the Drug Supply Chain Security Act in 2013, which makes manufacturers responsible for reporting suspicious goods to the FDA.
- The guidelines released last week outline procedures for this responsibility, for which the FDA is seeking comment. The guidelines also include a section on sample scenarios that would elicit notification.
As pharmaceutical supply chains expand into India, China and other emerging economies, safety protocols become increasingly difficult to enforce. A recent Financial Times report shows, for example, governments are at times complicit with stonewalling audits that would threaten suppliers within the profitable industry.
Major vendors like Johnson & Johnson or Pfizer may themselves be fully complicit, supply chains stretch far beyond the first supplier. Quality problems may emerge not just at contractor-level producing final pharmaceutical goods, but also at the Active Pharmaceutical Ingredient (API) level which are often less scrutinized.
As a result, danger signs increase whenever a manufacturer finds itself dealing with a new or unknown trading partner, or one with a suspect or poor reputation within the industry. Significantly lower prices, especially when found on the Internet, are also reason to question the legitimacy of a drug's ingredients or production. Further, cargo theft of pharmaceuticals is not uncommon, so ensuring inbound quality control is key.
To improve tracking of such violations, the FDA sought to create a process for suspicious or illegitimate good notifications. Pharmaceutical companies, meanwhile, can address the issue by ensuring multi-tier visibility and doubling down on quality control at the cargo level. In addition, new technologies such as blockchain and serialization regulations will help ensure the entire industry is participating in visibility efforts.