Regulatory 'enforcement discretion' can widen patient access but may erode evidence-based medicine. Critically examine with reference to recent U.S. policy on compounded peptides.

In October 2026, U.S. Health Secretary Robert F. Kennedy Jr. issued an "enforcement discretion policy" in the Federal Register. It lets licensed pharmacies and physicians compound six unapproved peptides, including BPC-157 and TB-500 (the "Wolverine stack"), without FDA action while a formal decision is pending [1]. The policy widens access, but it shifts the burden of proof away from the seller.

How it widens patient access

• It formalises an existing market. These peptides are already sold online, and routing them through licensed pharmacies puts a trained professional between buyer and product [1].
• It reduces harm. Licensed compounding improves purity checks. This matters because WHO estimates that 1 in 10 medical products in low- and middle-income countries is substandard or falsified [2].
• It respects patient autonomy. The policy follows "right to try" logic for patients who have run out of approved options.

How it erodes evidence-based medicine

• The burden of proof flips. The peptides stay unapproved [1] and need no prior human trials, so any harm is found only after people use them.
• Quality is not efficacy. A pharmacy can check what is in a vial, but only clinical trials show whether the molecule works.
• State backing signals legitimacy. It may draw healthy people into wellness, anti-ageing and sports-recovery use.
• The policy is fragile. A ministerial stopgap "pending" rule-making [1] can quietly become permanent permission, or be reversed overnight.
• Trial incentives weaken. Firms gain little from costly approval if they can sell without it.

Implications for India

• Higher U.S. demand may spill into India's unregulated online channel. The draft e-pharmacy rules (G.S.R. 817(E), 2018) are still not final because the matter is before the courts [3].
• The national drug survey tested 47,954 samples and found 3.16% not of standard quality [4]. It covered formal supply chains, not "recovery" peptides sold online.

Enforcement discretion addresses the purity problem but leaves the evidence problem open. A better approach would combine harm reduction with time-bound trials, mandatory adverse-event reporting and sunset clauses. India could finalise its e-pharmacy rules and enact the online-sale powers in the Drugs, Medical Devices and Cosmetics Bill, 2022 [5]. That would keep the burden of proof on sellers and support the right to health under Article 21 and SDG 3.8's goal of safe, effective medicines.