Introduction
As the number of drug shortages increased rapidly since 2009, many studies and articles were presented to suggest different causes of the crises. The FDA has constantly been blamed for the whole process and has been denying responsibility.

Background
Every year the US healthcare system undergoes at least one drug shortage crisis a year. The general causes that have been reported include manufacturing difficulties, shortages of raw materials, voluntary recalls, natural disasters, as well as some economic and regulatory issues. As regulatory issues directly refers to the FDA’s role in the process, many have argued that the FDA is the one to blame for manufacturing difficulties, the major root of the whole crisis.

Issue

Is the FDA responsible for drug shortages in the United States?

Rule
The FDA is responsible for drug shortages if:

  1. FDA regulations cause manufacturers to stop production lines unnecessarily
  2. The FDA does not think about the consequences of their strict enforcement actions

Analysis
In June 2012, the US House Committee on Oversight and Government Reform published a congressional staff report, “FDA Contribution to the Drug Shortage Crisis,” making the case that the FDA’s overregulation was heavily responsible for the rapid increase in drug shortages since 2009. Since the agency has been an ongoing target for the public to blame when it comes to poor control of drug safety, Margaret Hamburg’s promise upon taking the FDA chief position in May 2009 was to aggressively enforce the FDA’s stringent manufacturing standards. The number of FDA-issued warning letters to drug makers and other companies increased 42% from 2009 to 2010 and another 156% from 2010 to 2011. As a result, four out of five of the largest manufacturers of generic drugs in the United States (Hospira, Teva, Bedford, and Sandoz) were forced to simultaneously halt some major production lines to deal with FDA warnings, explaining the 30% decline in generic injectable production. In short, the report alleges that the FDA has ordered costly general upgrades to plants rather than targeting the precise problems at hand, causing unnecessary production interruptions.

The findings and conclusions within the US House Committee on Oversight report mentioned above were supported by Scott Gottlieb, a former deputy commissioner of the FDA. He testified that the agency went overboard in its enforcement objectives, forcing major plant renovations, suspending facilities, and even stopping the shipment of goods from suspect production lines. That’s the main reason of the shortage. According to the Committee’s sources, the FDA’s field forces don’t believe that it’s within their scope of authority to worry about the implications of their actions, even when it concerns closing a facility or removing manufacturing lines. A former CEO of a generic drug company commented that the drug shortage situation could always be traced back to inspections initiated by some FDA compliance program. In the CEO’s opinion, the FDA has been insensitive in its timing of enforcing its warnings to all generic companies, resulting in a simultaneous almost shutdown of the whole industry.

Conclusion
The US House Committee on Oversight firmly holds the FDA responsible for the drug shortage crises happening every year while the FDA’s former deputy commissioner strongly supported the Committee in its findings and opinions. Additionally, the manufacturers also expressed their valid concerns regarding the FDA’s timing on its enforcements, causing the industry to suffer from production halts.

For more information on this issue, contact the Kulkarni Law Firm.