Regulation

What is a REMS program?

A Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program that the FDA can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. REMS are designed to reinforce medication use behaviors and actions that support the safe use of that medication.1

The products mentioned are part of a class-wide FDA-approved REMS program for opioids. REMS resources for these products include a medication guide for patients, prescriber notification letters, a patient counseling guide, and prescriber training materials.

What are Drug Schedules?

Drug schedules are the classification system created by Congress under the Controlled Substances Act and used by the FDA and U.S. Drug Enforcement Administration (DEA) to group drugs and other substances into distinct categories based on whether they have a currently accepted medical use in the United States, their relative abuse potential, and likelihood of causing dependence when abused.3 Schedule I is reserved for drugs with no currently acceptable medical uses and high potential for abuse. Examples include illegal opioid drugs like heroin. Classifications for prescription opioid medications range from Schedule II (highest potential for abuse) to Schedule V (lowest potential for abuse). DURAGESIC® (fentanyl transdermal system), CII, NUCYNTA®, and NUCYNTA® ER (tapentadol) tablets, CII are classified as Schedule II controlled substances.

How does the FDA regulate prescription product labeling and marketing materials?

FDA-approved drug product labeling (commonly referred to as “prescribing information”) summarizes essential scientific information needed for the safe and effective use of the medicine. This prescribing information is the primary source of information for physicians and patients about a drug’s safety and effectiveness. When seeking approval for a medication, a manufacturer submits a New Drug Application (NDA) to the FDA, which includes a clinical data package and all of the scientific data that support the medicine’s use.2 The submission must include proposed prescribing information for the new medication, including dosage information. As part of the evaluation, the FDA ensures the prescribing information clearly describes the medication's benefits and risks, and how the risks can be detected and managed. The prescribing information must also include, among other things:

(1) the approved usage information (referred to as indications);
(2) information on appropriate dosing for the medicine;
(3) a summary of essential scientific information needed for the safe and effective use of the medicine;
(4) statements regarding the medicine’s contraindications, warnings and precautions;
(5) a description of clinically significant adverse reactions (including any that are potentially fatal, are serious even if infrequent, or can be prevented or mitigated through appropriate use of the medicine).

Marketing materials created by manufacturers must be consistent with the FDA-approved prescribing information. Once a medication has undergone the rigorous approval process, both the FDA and the manufacturer continue to monitor its safety. This safety monitoring, called post-market surveillance, may lead to changes in the prescribing information.

References

  1. Risk Evaluation and Mitigation Strategies. U.S. Food and Drug Administration. https://www.fda.gov/drugs/drug-safety-and-availability/risk-evaluation-and-mitigation-strategies-rems
  2. The Drug Development Process, Step 4: FDA Drug Review. U.S. Food and Drug Administration. https://www.fda.gov/patients/drug-development-process/step-4-fda-drug-review
  3. Controlled Substance Schedules. U.S. Department of Justice, Drug Enforcement Administration. https://www.deadiversion.usdoj.gov/schedules/
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