Consider ‘Net-Benefits’ In Product Lifecycles, CRO Urges Regulators

The FDA should stop thinking just about benefits and risks in a product’s lifecycle and adopt a “net-benefits” approach, a contract research organization has urged the agency.

Regulators are seeking public comment as they develop a draft guidance on benefit-risk assessments for medical products. The FDA held a public meeting on the issue last month and invited comments on the public docket by June 16.

In one submitted comment, Syneos Health Vice President Stephen Sun said the agency’s current thinking about benefits and risk can probably be repurposed for nearly every regulated product, but he urged the FDA to redefine the bottom line of benefit-risks conclusions as “net-benefit conclusions.”

For example, the questions after reviewing the benefit-risk framework would be: “[W]hat is the net-benefit that will define the regulatory decision? What is the net-benefit of having this product approved or keeping it on the market?”