FDA Revises Guidance on Postmarketing Studies to Reflect ARIA System, SUPPORT Act
The US Food and Drug Administration (FDA) on Thursday revised its draft guidance on postmarketing studies and clinical trials under Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).FDA says the draft guidance, first issued for comment in 2011, is being revised to detail the factors the agency considers when determining whether a postmarketing study or clinical trial will be required for a drug or biologic or whether postmarketing reports and the agency’s active postmarket risk identification and analysis (ARIA) system are sufficient to assess a product’s risks in the postmarket setting.
FDA explains that at the time the draft guidance was first issued, “the ARIA system was still in early development” and now that it is fully operational, it must be considered when determining if a postmarketing study or clinical trial is required.
The guidance is also being updated to reflect a provision of the 2018 Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act) that enables FDA to require postmarketing studies under section 505(o)(3) to assess the potential reduction in efficacy of a drug.
While the SUPPORT Act focuses on opioids and other controlled substances, FDA notes that “at this time, the agency does not intend to treat controlled substances differently than other prescription drugs.”
The revised draft guidance provides a list of four examples of clinical trials to assess risks related to reduced effectiveness; though, in line with the agency’s statement on not differentiating between controlled substances and other drugs, does not include any examples of trials involving opioids or other controlled substances.
FDA