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Prescription Drug Marketing Act (PDMA)

Overview of PDMA regulations, data capture and reporting requirements and how MedPro Systems helps you validate every sample recipient.

MedPro Systems
Published
Updated
Jurisdiction

U.S. Federal, FDA

Who It Covers

Pharmaceutical manufacturers and wholesale distributors

License Validation

For each sample, at least once per calendar year

Reporting Deadline

April 1 each year

Overview

To protect U.S. consumers against the distribution and sale of improper or counterfeit pharmaceutical products, Congress passed the Prescription Drug Marketing Act (PDMA) of 1987. Specifically, the legislation was enacted to ensure pharmaceutical products purchased by consumers are safe and effective and safeguard the U.S. supply chain from counterfeit, adulterated, misbranded, subpotent or expired drugs.

Under this legislation and subsequent supporting guidance and regulations implemented by the U.S. Food and Drug Administration (FDA), pharmaceutical manufacturers and wholesale distributors are required to proactively validate and annually disclose key licensing and demographic data attributes for all Healthcare Professionals (HCPs) they distribute samples to.

PDMA Data Capture and Reporting Requirements

Accountability for manufacturers and distributors under PDMA is broken into two key requirements:

  • Each drug sample must be captured and tracked with its location, quantity and the validated recipient’s name and signature.
  • The recipient’s state license must be validated for each sample and no fewer than once per calendar year.

The wording of the PDMA leaves some room for interpretation so the ‘once per calendar year’ minimum is often interpreted to mean that if there is no change to a license, the manufacturer will at least record evidence of the validation step once in a given year. Practically speaking, in the time since the passing of the PDMA, technology has progressed to make a ‘once per calendar year’ validation the exception.

This information then must be annually reported to the FDA by April 1.

To learn more about PDMA regulations, visit the FDA’s PDMA page.

How MedPro Systems Can Help

We help Life Sciences and Healthcare companies drive better health outcomes by reducing complexity across their compliance and commercial operations.

Through MedProID®, we offer accurate, comprehensive and trusted HCP and HCO identifying data, accessible in real time through a centralized platform that integrates directly with your internal systems.

Use trusted MedProID data to meet PDMA’s ongoing commercial validation requirements through:

ProAccess

Real-time access to healthcare license verification straight from the source.

Explore ProAccess ›

ProSync

Continuous HCP and HCO license updates and status checks.

Explore ProSync ›

ProFocus

Nuanced first- and third-party data collection and validation.

Explore ProFocus ›

Explore MedProID

FAQ

Frequently Asked Questions

The Prescription Drug Marketing Act of 1987 protects U.S. consumers from improper or counterfeit pharmaceutical products and safeguards the supply chain from counterfeit, adulterated, misbranded, subpotent or expired drugs.

Each drug sample must be captured and tracked with its location, quantity and the validated recipient’s name and signature. The recipient’s state license must be validated for each sample.

For each sample and no fewer than once per calendar year.

Annually to the FDA by April 1.

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