Change Considered in FDA Side Effects Regulation

The U.S. Food and Drug Administration (FDA) is considering a change in how medications can be advertised, which would only require drug makers to warn about major side effects associated with their products. In draft guidance issued in February 2015, the FDA proposed allowing manufacturers to abolish lengthy lists of all side effects in print ads and commercials. Instead, drug makers would only be required to publish and publicize the most important potential side effects.

If you or a loved one has suffered a severe side effect or life-threatening complication from a medication, contact Attorney Group to learn more about your options. We can provide you with a comprehensive case evaluation at no out-of-pocket cost to you, and we can connect you with an affiliated attorney who can assist you in seeking the compensation to which you may be entitled.

Consumers Ignoring Warning FDA Side Effects Regulation
Labels, FDA Believes

The proposed change is based on the FDA’s conclusion that consumers are not thoroughly reading warning labels and are subsequently missing important risk information. According to the guidance notes, the FDA maintains that long lists of side effects are not optimal for promotional labeling pieces and drug print advertisements, as many consumers lack the technical or medical background to understand the prescription information.

Instead, the FDA believes a brief summary focusing on the more important risk information would provide better information for consumers than an exhaustive list of all possible side effects. Additionally, the FDA proposes that information should be adequately presented in a way that most consumers can understand.

The proposed change comes after the agency conducted a survey in which it found only a handful of respondents reported reading even half of the summary information previously required. Of those who read the labels, 55 percent found them difficult to understand, and 40 percent admitted they did not read any of the summaries in drug print advertisements. The revised guidance suggests that including minor risks makes it more difficult for consumers to understand and remember information about the more important side effects.

The agency’s guidance will encourage drug makers to use consumer-friendly language in all consumer-directed commercials and advertisements, requiring them to inform consumers of:

  • The most frequently occurring adverse reactions
  • Measures that consumers can take to lessen or prevent harmful drug side effects
  • Special precautions
  • Required monitoring and laboratory tests
  • Information that could affect the decision to take a drug
  • The most clinically-significant precautions and warnings
  • Contraindications
  • Boxed warnings

Contact Attorney Group to Learn More

If you have questions or concerns regarding the most recent FDA side effects regulation, or if you or a loved one has suffered complications caused by a medication, call Attorney Group today. There is no out-of-pocket cost to speak to us, and we can connect you with an affiliated attorney who can assist you in seeking the compensation to which you may be entitled.