Questions and Answers on FDA’s Postmarketing Safety Summaries of Recently Approved Drugs and Biologics
On June 15, 2010, the U.S. Food and Drug Administration (FDA) began posting summaries of Agency safety analyses of recently approved drug and biologic products. These summaries are intended to share what the FDA has learned about the safety of products 18 months after approval or after the medicine was used in 10,000 patients, whichever was later.
The safety summaries are for recently approved drugs with active ingredients that are new to the market or in some cases contain previously approved active ingredients. The website will also post safety data for certain biologic products, including vaccines.
The summaries describe any new, potentially important, safety information about each drug that has become known since it was first marketed. They also specify when analyses did not show evidence of a new safety concern and, as necessary, the steps FDA is taking to address any identified safety issue.
This activity satisfies FDA's obligation under Section 915 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) and affirms the Agency's commitment to proactively assess drug safety after marketing.
Q. What is the purpose of the postmarketing safety summaries and what information is included?
A. The purpose of the postmarketing safety summaries of recently approved drugs and biologics is for FDA to provide the public with new safety information on recently approved and marketed medicines. These safety analyses represent 18 months of data gathered after approval or after the medicine was used in 10,000 patients, whichever was later. Each entry will include:
- The name of the drug
- The number of the new drug or biologic licensing marketing application
- The date the product was approved
- The summary of findings and pending actions.
Q. How is this information different from other drug safety information from the FDA?
A. The postmarketing safety summaries of recently approved drugs and biologics information are summaries of comprehensive reviews of recently marketed medicines approved under certain new drug or biologics licensing applications. These new safety summaries are different from, but complement other important drug safety information already included in the product label or issued in a Drug Safety Communication.
This is a new approach to providing safety information to the public. Instead of focusing on one or two new toxicities or safety issues discovered, the postmarketing safety summaries of recently approved drugs and biologics reflect a comprehensive FDA look at the safety of individual products. A standard time period for conducting this assessment will be after the product has been on the market for 18 months or after it has been used by at least 10,000 patients, whichever comes later. This new safety information complements the safety data from clinical trials and other studies that were analyzed by companies and the FDA during product development, as well as from the routine monitoring of various sources of safety data by FDA after product marketing.
Although premarket safety information is sufficient to form the basis of approval for a medicine's benefits and risks in the clinical trial population, the clinical trial populations may not be entirely representative of the general public. Previously unknown side effects may become apparent when the medicine becomes available to a larger, more demographically and medically diverse population. Conducting systematic comprehensive safety reviews of recently approved drugs and biologics provides an early detection mechanism for potentially serious previously unidentified risks, or known adverse events that are occurring in greater than expected numbers based on safety data from clinical studies used for approval.
Q. How will the postmarketing safety summaries of recently approved drugs and biologics information help the public?
A. This information will inform healthcare providers and the general public of any newly identified, potentially serious adverse events that may be associated with a medicine, as well as the steps that FDA is taking to address or mitigate the potential risk.Information about drug risks, including newly identified concerns about potential risks, is an important tool for providers and patients.
As the Postmarketing Drug Safety Information website indicates, FDA's safety analyses of marketed medicines may not show a new safety issue. Even in these cases, FDA scientists will continue to routinely monitor safety data. People are encouraged to contact FDA at 1-888-INFO-FDA (1-888-463-6332) with any questions they may have about the medicines they take.
Q. Are all medicines listed on the postmarketing safety summaries of recently approved drugs and biologics information list?
A. No. The postmarketing safety summaries of recently approved drugs and biologics will only apply to recently approved drug and biologic products. Listed below are some additional resources that provide safety information for the public on FDA-approved drugs, including those not found on the Web page:
- FDA's MedWatch Web page
- FDA's Drug Safety Communications Web page
- FDA's Index to Drug Specific Information
- FDA's Information Hotline (1-888-463-6332)
- Postmarketing Drug Safety Evaluations
- FDA Fact Sheet: FDAAA 2007 Section 915 - Enhancing FDAâs Safety Reporting on Recently Approved Therapies