The US Food and Drug Administration (“FDA”) released a draft document, entitled Best Practices in Drug and Biological Product Postmarket Safety Surveillance for FDA Staff, describing the FDA’s best practices for safety surveillance activities for drugs and biologics.
The 21st Century Cures Act requires the FDA to make publicly available its best practices for product safety surveillance. Previously, the FDA was required to conduct a safety analysis of a drug 18 months after approval, or when 10,000 patients had used the drug, whichever occurred later. However, the FDA noted that this 18-month/10,000 patient analysis was “largely redundant,” inefficient, and “did not provide sufficient flexibility to take a risk-based approach based on various factors.” The Cures Act eliminated this patient analysis approach.
The best practices document sets forth the risk-based principles the FDA uses to conduct ongoing safety surveillance. It includes sections for different types of products and specific patient populations. It also discusses safety signal identification, evaluation and documentation. The FDA groups products into the following three categories to determine the frequency and type of monitoring:
Category A: Generally, on a weekly basis, reviewers screen newly received individual case safety reports (“ICSRs”) for products in the first 3 years following approval, including new molecular entities, originator biological products, and biosimilars, as well as products with newly approved dosage forms, newly approved indications, extension into new patient populations, as well as several other situations. In addition, reviewers perform periodic screening of cumulative data in the FDA adverse event (“AE”) databases.
Category B: Reviewers generally screen on a weekly basis newly received ICSRs and the medical literature for homeopathic and compounded products.
Category C: Reviewers generally screen the database weekly for newly received ICSRs that report adverse events (AE’s) of interest for any product in category A that is beyond 3 years postapproval, OTC products, and any product not in category A or B. In addition, reviewers generally perform data mining at least yearly for category C products.
The best practices document identifies the following as factors that may signal the need for enhanced safety and monitoring:
- Reports involving death or other types of serious or unexpected safety issues that may impact public health.
- Safety issues that historically are known to be likely related to a product, such as hypersensitivity reactions including anaphylaxis.
- Important potential risks of the product recognized at the time of or after approval.
- Safety issues that are biologically plausible based on a product’s known pharmacological actions.
When a safety signal is detected, the FDA can take a variety of actions, including product labeling changes, safety communications, postmarketing studies and trials, enhanced pharmacovigilance, posting safety signals online and risk evaluation and mitigation strategies (“REMS”).
Comments on the draft are due January 6, 2020.