There has been recent discussion around modifying FDA requirements for substantial support of both safety and efficacy in marketing applications. GZP examines the potential fallout on FDA review of drugs, biologics, vaccines, and combination products.
The issues as we see them, revolve around several major aspects of such changes:
- Congressional approval of one of more laws that would modify or void the 1962 amendments to the Food. Drug. And Cosmetic Act and the Public Health Service Act
- Effects on FDA morale and the potential for en masse resignations of that Agency’s Reviewers
- Major pushback from physicians, who receive guidance on patient treatment from labels that contain summaries of evidence of both safety and effectiveness
- Uncertainty in many patient communities with regard to selection of therapies
- Resistance by insurers, who direct reimbursement
- Competitive confusion and major effects on the marketplace worldwide, along with the investment community
In upcoming blogs we will examine each of the above topics of concern.