Pitfalls of Announcing Regulatory Policy in Medical Journals

Under former Commissioner Marty Makary, the FDA increasingly announced major policy changes through medical journals rather than its normal public rulemaking process. This “policy by publication” approach can confuse patients, clinicians, insurers, and drug companies and limit their opportunity to weigh in before decisions appear final. Medical journals can help explain and debate FDA policy, but they should complement, not replace, transparent policymaking and public participation.