Public comments to help shape FDA approach to significant issues
From approval through post-marketing, FDA’s Center for Drug Evaluation and Research provides information about drug risks and benefits to health care professionals and patients, especially when that information has generated a specific concern. Recent guidance from the Agency outlines how CDER develops and disseminates drug safety information, and classifies drug safety issues.
These draft guidance reflect the Agency’s current thinking about reviewing and communicating potential post-marketing drug safety issues. CDER is asking for public comments and feedback on these documents.
In recent years, CDER has begun making information on potential drug risks available to the public earlier — often while the Center is evaluating safety data and determining whether any regulatory action is warranted.
The guidance entitled, Drug Safety Information -- FDA's Communication to the Public, describes how CDER develops and disseminates messages about important drug safety issues, including emerging drug safety information. An important drug safety issue has the potential to alter the benefit–risk analysis for a drug that can affect decisions about prescribing or taking the drug. Examples include serious adverse drug reactions identified after the drug is approved and medication errors that can cause confusion between drug names or with drug labeling.
FDA has developed effective and ongoing relationships with a wide array of trade and professional associations, patient advocacy and consumer groups, safety organizations, the media, and other entities. When drug safety issues arise, the Agency reaches out to these groups. In addition to written communications, FDA uses webinars, broadcasts, conference calls and its web site to get out the news.
Before developing and communicating information, CDER must classify significant post-market safety issues.
After a drug is approved, FDA may learn of new, more serious, or more frequent adverse drug reactions. CDER integrates what is learned from sponsor reports and its own evaluations into a system of postmarketing surveillance and risk assessment.
The Center uses this information to take appropriate action when the risks indicate a need to provide additional safety information to the public, update drug labeling, require postmarketing studies or trials, require additional risk management interventions, or, on rare occasions, to remove a drug from the market.
Significant postmarketing safety issues include serious adverse events, product quality issues, and medication errors. To be considered significant, the problem or adverse event must meet certain criteria. In general, postmarketing safety issues are significant and will be tracked by the Center if they have the potential to lead to:
- withdrawal of FDA approval of a drug
- withdrawal of an approved indication
- limitations on a use in a specific population or subpopulation
- additions or modifications to the Warnings and Precautions, or Contraindications sections of the labeling, or the Medication Guide or other required patient package insert
- establishment of or changes to the proprietary name/container label/labeling/packaging to reduce the likelihood of medication errors
- establishment or modification of a risk evaluation and mitigation strategy
- a requirement that a sponsor conduct a safety-related postmarketing trial or study the conduct of a safety-related observational epidemiological study by FDA