The Food and Drug Administration (FDA) has recently issued draft guidance with regard to obtaining postmarketing data on populations who are typically underrepresented in drug clinical trials. The guidance, titled “Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products” is intended to help clarify the agency’s current stance on requirements and considerations for obtaining safety and effectiveness information on drugs and biological products in the postmarketing setting amidst underrepresented patient populations. Read the full article here.
This new draft guidance by the FDA is part of an ongoing effort to encompass a wider breadth of patients in clinical data, addressing the historical inequality within these drug trials. This move stands to impact not only healthcare providers and patients, but also corporations and law firms involved in the pharmaceutical industry. Furthermore, those companies producing drugs and biological products will need to ensure that their postmarketing studies and surveillance are constructed in ways that will gather veritable data from a more diverse demographic.
From a legal standpoint, this new draft signifies changes in the FDA’s requirements to pharmaceutical companies. Understanding the specifics of these changes, and how they affect ongoing and future clinical trials, is crucial for legal departments in these corporations. This could involve adapting legal strategies to ensure compliance with the new directions, reprioritization of resources, and possible revisions of contracts with clinical trial organizations.
The draft guidance document has been brought into existence by the FDA as a consultative paper, open for public commentary and input. It’s important for legal professionals working in the pharmaceutical industry to familiarize themselves with its contents, and to consider contributing to the ongoing dialogue if they have expert perspectives or data which could assist in the refinement of the guidance.