Pharma Compliance & Field Rules

01PDMA Sample Rules

The Prescription Drug Marketing Act requires that free samples go only to licensed practitioners who make a signed written (or electronic) request before or at the time of delivery. Samples can never be sold, purchased, or traded, standing orders aren't allowed, and a signed receipt is required at delivery.

02Sample Inventory & Accountability

Reps must securely store any samples in their possession and reconcile their sample inventory against distribution records at least annually, with companies auditing sales forces to prevent diversion or loss.

03Sunshine Act / Open Payments

Manufacturers must report payments and transfers of value to physicians and teaching hospitals — meals, speaking fees, travel, consulting — to CMS annually. Physicians get roughly 45 days to review and dispute the data before it's published on the public Open Payments website.

04On-Label vs. Off-Label Promotion & Fair Balance

Sales reps may only proactively discuss FDA-approved (on-label) uses; unsolicited off-label questions get routed to Medical Affairs/MSLs rather than answered by the rep. Fair balance requires that risk information (side effects, contraindications, warnings) be given comparable prominence to benefit/efficacy claims.

05HIPAA in the Field

Reps have no right to access, request, or use patient-identifiable health information beyond what's incidental and unavoidable, and should never view, note, or act on protected health information they happen to encounter in an office setting.

06Formulary Pull-Through Basics

After a product wins favorable formulary placement, 'pull-through' means educating provider offices on the plan's coverage, prior authorization, and step therapy requirements plus available access support — so eligible patients prescribed the on-label product can actually get it covered and filled.