The rapid growth of the pharmaceutical and biotechnology industries has been accompanied by an escalation in the complexity of drug-safety regulations -- particularly when it comes to data integrity. What seems like an almost daily onslaught of regulatory requirements for these organizations can be overwhelming, and it is especially so for emerging and mid-sized drug companies. Drug regulators in the United States, Europe, and the United Kingdom have responded to this growth and complexity by stepping up inspections in order to stay ahead of potential product recalls.
Over the past two years, the U.S. Food and Drug Administration (FDA) and the European Union Drug Regulatory Authorities (Eudra) have issued a plethora of warnings, recalls, and product bans across the globe. Almost 80% of the warning letters issued by the FDA in 2015 and 2016 cited: good manufacturing practices (GMPs), data-integrity failures in computer-system validation, laboratory audit trails, and maintaining electronic records and systems to track lost records. According to the FDA the number of warning letters specifically associated with data integrity jumped to 41 in 2016 from just 15 the prior year.
The profits of companies that receive warning letters are directly impacted as a result of lost productivity, increased downtime at manufacturing plants, product import bans and—in some cases—drug shortages. Despite the growing number of regulations, the number of Adverse Drug Reports (ADRs) continues to climb. Since 2000, the FDA has had more than 14 million ADRs, of which 1.4 million resulted in death. ADRs have surpassed 1 million since 2013 and have been nearing 2 million each year since 2015. The increase in ADRs and calls both inside the agency and from consumer advocacy groups have resulted in more determined and detailed government monitoring of production and efficacy.