In late July, the U.S. Food and Drug Administration released a new draft guidance that outlines several proposed updates to the labeling of prescription drugs. Entitled “Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products – Content and Format Guidance for Industry,” the new set of requirements would apply to all prescription pharmaceuticals that are regulated under the Controlled Substances Act. The draft guidance also applies to any drugs (including those that fall outside the CSA’s jurisdiction) for which there is “important information to convey to health care providers related to abuse and dependence.”
Breaking Down the Proposed Updates
The FDA’s guidance is intended to help pharmaceutical companies draft the “Drug Abuse and Dependence” section of their product labels. In part, the agency hopes its new requirements will help combat the opioid abuse crisis sweeping across the nation. According to estimates from the Centers for Disease Control and Prevention, more than 46 people die each day from overdosing on prescription opioids, such as OxyContin, Vicodin, morphine and others. The FDA’s proposed changes fall into four key topic areas:
1. General principles: All prescription drugs must include detailed information on the “potential for abuse, addiction, physical dependence and tolerance.” Additionally, the “Drug Abuse and Dependence” section of product labels should “clearly and concisely” explain the symptoms of withdrawal to ensure patients’ can safely and effectively use the pharmaceutical as it was originally intended.
2. Information to be included: In addition to the abuse-potential summary, all prescription drug labels must feature specific subsections that describe which CSA schedule applies to the product. This information should also be supplemented with addiction data derived from clinical trials, nonclinical studies and any other relevant evidence that speaks to dependence and tolerance.
3. How to develop and format information: To help patients understand the associated risks of using prescribed substances, the “Drug Abuse and Dependence” section should be written using clear language. This includes removing technical terms, acronyms and any other wording that may reasonably cause confusion.
4. Providing relevant data outside the “Drug Abuse and Dependence” section: While redundancy should be avoided, the FDA believes that any information that is relevant to other labeling sections may be listed in duplicate. This includes adding information about abuse, misuse and addiction to the “Warnings and Precautions” section if applicable.
Most importantly, the FDA’s draft guidance makes it clear that pharmaceutical companies have a responsibility to ensure their product labels are accurate. Therefore, any new clinical information must be added to drug labels if it would render the original warnings “inaccurate, false or misleading.”