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FDA Statement

Statement on steps to make health care professional and patient labeling information for prescription medications consistent and clear

For Immediate Release:
Statement From:
Statement Author
Leadership Role
Acting Commissioner of Food and Drugs - Food and Drug Administration
Norman E. "Ned" Sharpless MD
Leadership Role
Director - Center for Drug Evaluation and Research
Janet Woodcock M.D.

The FDA is committed to making sure that health care professionals and patients have up-to-date, accurate and actionable information about prescription medications so that informed treatment decisions can be made. We recognize that the choice of which medication to use, if any, for a particular patient is often a complex decision. These decisions involve a number of factors, such as assessing the progression of the disease or condition; looking at the other medications being taken; evaluating the ability of the patient to follow treatment regimens and instructions to help ensure safe use of a medication; and sometimes, assessing the risk of abuse and dependence of a medication for a particular patient. 

As such, we continually work to help ensure that FDA-approved medication and biological product labeling (often referred to as the “package insert” or Prescribing Information) provides clear, complete information so that health care professionals have the essential information needed to make informed decisions and to facilitate safe and effective use of a medication.

One area of patient counseling that is incredibly important within a discussion about a product’s benefits and risks is the potential for abuse and the development of a physical dependence to a prescription drug. This is relevant in the context of prescription opioids for treating pain, but it’s important for patients to understand that other drugs can be habit-forming as well – for example, certain medications used to treat insomnia and some medications used to treat attention deficit hyperactivity disorder. We’ve taken many steps to ensure that patients and health care professionals have clear information on a drug’s abuse and dependence potential, so they can make informed treatment decisions. This is one of the key factors in our evaluation of a drug’s benefits and risks when we’re considering approval and remains part of our ongoing monitoring once a drug is approved. In fact, we’ve taken steps when evidence makes the FDA concerned that the abuse of a drug may result in its benefits no longer outweighing its risks – like when the agency requested removal of the prescription opioid, Opana ER, based on postmarketing data that demonstrated a significant shift in the route of abuse of Opana ER from nasal to injection following the product’s reformulation, in addition to evidence that injection of the product had been associated with a serious outbreak of HIV and hepatitis C, as well as cases of a serious blood disorder (thrombotic microangiopathy).

Today, we’re taking another step in this area and announcing new draft guidance, Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products - Content and Format. The recommendations in this draft guidance, when finalized, will represent our current thinking on the content and format of this section for prescription medications that are scheduled under the Controlled Substances Act (CSA) as well as for prescription medications not scheduled under the CSA for which there is important information to convey to health care professionals related to abuse and dependence.

Our goal is that this guidance will help ensure that information in product labeling on abuse, misuse, addiction, physical dependence and tolerance is clear, concise, useful and informative. Details about a product’s abuse-deterrent properties should also be presented in this section, when applicable. Additionally, the draft guidance provides recommendations on how to present information about applicable drug products in a consistent manner where possible within, and across, drug and therapeutic classes to inform decisions and facilitate the safe and effective use of medications.

This draft guidance reinforces these principles by recommending, for example, that terminology used in the Drug Abuse and Dependence section – such as abuse, misuse, addiction, physical dependence and tolerance – be defined in labeling to ensure common understanding. Because these terms are commonly confused or misinterpreted, the FDA has included recommended definitions for the purposes of labeling. The draft guidance clarifies, for example, that a person who takes a friend’s prescription opioid medication to relieve tooth pain is misusing the medication; if that person takes a friend’s opioid to get a euphoric high, that use represents abuse of the medication. 

In another example of our work specific to opioid medication labeling and dependence, recently the FDA announced required changes to the prescribing information for all opioid analgesics to provide additional information to health care professionals on how to safely decrease the treatment dose in patients who are physically dependent on opioids. The FDA remains focused on striking the right balance between reducing the rate of opioid use disorder by decreasing excessive exposure to opioids through rational prescribing, while still enabling appropriate access to treatment for patients living with pain. We are also committed to making sure that patients who use opioids take them correctly, and, if opioid treatment is no longer needed, that patients and their health care providers know how to discontinue the medication safely.

We’re also issuing a second draft guidance today, Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products — Content and Format, which relates to how the drug or biologic is used. The Instructions for Use (IFU) is a type of labeling for patients who use products that have complicated or detailed patient-use instructions. Importantly, an IFU provides detailed, action-oriented, step-by-step written and visual instructions in a patient-friendly manner to guide the patient on how to use a prescription medication product. It typically includes instructions on preparation, administration, handling, storage and disposal. The recommendations in this draft guidance are intended to promote development of consistent content and format across IFUs to help ensure that patients receive clear, concise information that is easily understood to facilitate the safe and effective use of such products.

Additionally, as part of our ongoing efforts in labeling development, the FDA recently issued other draft guidances that provide clarity and recommendations on how best to draft specific sections of labeling. For example, we issued a draft guidance to assist applicants in developing the Indications and Usage section of product labeling for products approved under the accelerated approval pathway. We also issued a final guidance to assist applicants in determining the appropriate placement and content of pediatric labeling information to help ensure that information on use of prescription medications in pediatric populations - whether positive, negative or inconclusive - is consistently written and appropriately placed in labeling so that the information is clear and accessible. 

These actions aim to enhance the safe and effective use of prescription medication and biological products to optimize patient care and keep Americans healthy. We hope the two draft guidances being announced today will assist companies in creating labeling that is clear, concise, useful and informative, and, to the extent possible, consistent in content and format within and across drug and therapeutic classes. We encourage the public to comment on these draft guidances and will consider all comments as the agency works to finalize them. 

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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