FDA To Allow Manufacturers to Only Warn Of Most Serious Drug Side Effects

Federal regulators are looking to make major changes to how drugs will be advertised, requiring manufacturers to only warn about major side effects associated with their medications. 

The FDA issued a draft guidance (PDF) this month, on promotional and advertising labeling of drugs. If approved, the guidance would allow drug manufacturers to get rid of lengthy lists of all drug side effects in commercials and print ads. Instead, they would only be required to publish the most important potential side effects.

This would mean an end to long lists of adverse events, because the FDA believes that consumers are ignoring them and missing important risk information.

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“FDA believes these approaches are not optimal for consumer-directed prescription drug print advertisements and promotional labeling pieces because many consumers lack the technical background to understand some of the information as described in the PI (prescribing information),” the guidance notes. “To provide better and more actionable information for consumers, FDA believes that the brief summary should focus on the more important risk information rather than an exhaustive list of risks and that information should be presented in a way most likely to be understood by consumers. Thus, FDA strongly recommends against the use of the traditional approach to fulfill the brief summary requirement in consumer-directed advertisements, an approach in which risk-related sections of the PI are presented verbatim, often in small font.”

The FDA conducted a survey that found only a few respondents reported reading half or more of the brief summary that has been previously required. Of those who did read the summaries, 55% found them hard to read, and 40% of respondents said they did not read any of the brief summary in direct-to-consumer prescription drug print advertisements.

The revised guidance suggests that the inclusion of minor risks “detract from, and make it difficult for, consumers to comprehend and retain information about the more important risks.”

As a result, the FDA says it will not object if, in the future, drug manufacturers fail to include every specific side effect and contraindication in promotional print advertisements. However, these changes will not affect the requirements for the actual drug labels themselves.

The agency’s guidance will encourage manufacturers to use “consumer-friendly” language in all advertisements aimed at consumers. These should include clinically significant information on the most serious and most common risks in a conversational language. The advertisements would still be required to notify consumers of:

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

The FDA is accepting public comments for 90 days on the draft guidance. Comments can be submitted electronically to http://www.regulations.gov and written comments can be sent to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.


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