U.S. Food and Drug Administration Regulations Lack Rigorous Analysis

March 21, 2014

The U.S. Food and Drug Administration (FDA) employs rigorous standards when granting drug approvals, but the agency does not craft its regulations with the same precision, say Jerry Ellig, senior research fellow, and James Broughel, program manager of the Regulatory Studies Program, at the Mercatus Center.

Americans expect regulations to increase safety, but regulations that are intended to reduce certain risks can actually increase risks elsewhere. Every time the FDA considers granting approval to a drug that can combat AIDS, for example, it has to consider both the side effects of the drug as well as the potential deaths of patients who cannot get access to it. All regulatory analyses should assess these "risk-risk tradeoffs." Unfortunately, this rarely happens.

According to research from the Mercatus Center, the FDA often fails to provide strong evidence to back up its claims that a problem in the marketplace requires regulatory intervention. Frequently, it also fails to show that its proposed regulations are likely to produce actual benefits to the public. The agency is adept at naming a desired outcome but often does not provide credible evidence to back up its regulatory scheme.

  • For example, when the agency issued a proposal on Risk-Based Preventive Controls for Food for Animals, it claimed that consumers and purchasers lack information on the safety attributes of foods. However, it provided no information on the actual state of customer information, despite that a lack of sufficient information was the supposed market failure that it was trying to correct.
  • Additionally, the FDA claimed that it was reducing risks to animals and to humans by making contamination less likely, yet it provided no empirical evidence for such a claim.

For an agency that added more than 1,000 new restrictions to the Code of Federal Regulations between 2008 and 2012, these analytical inadequacies are incredibly troubling. If the FDA is going to hold drug makers to rigorous standards, it should assess its own regulations with the same level of exactitude.

Source: Jerry Ellig and James Broughel, "FDA Regulations Should Be Safe and Effective," Mercatus Center, March 12, 2014.

 

Browse more articles on Government Issues