To protect US 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 US supply chain from counterfeit, adulterated, misbranded, subpotent, or expired drugs.
Under this legislation, and subsequent supporting guidance and regulations implemented by the US Food and Drug Administration (FDA), pharmaceutical manufacturers and whole distributors are required to proactively validate and annual 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. First, each drug sample must be captured and tracked with the location, quantity, validate healthcare recipient name, and signature. Second, the state license of the recipient 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 1st.
To learn more about PDMA regulations, please visit the FDA website: www.fda.gov.
How MedPro Systems Can Help
Powered by MedProID, MedPro’s suite of license validation solutions offer a centralized directory of all required data attributes for PDMA compliance, streamlining sample distribution efforts and eliminating the need for manual state licensing board lookups.
- WebID – Real-time HCP & HCO license verification
- BulkID – Automated healthcare license data verification and enrichment
- WebServicesID – Integrated healthcare license database and data capture
- Sampleability Updates – Configurable, ongoing license status verification
The Sharing Alliance™
The Sharing Alliance, formerly known as The PDMA Alliance, is a not-for-profit organization dedicated to the ongoing education of its members on pharmaceutical sample compliance best practices. Since its founding in 1989, the focus has been improving the industry’s understanding the Prescription Drug Marketing Act of 1987 (PDMA) and related sample compliance regulations. Since then, the Alliance’s focus has also expanded to include other areas critical to a strong regulatory compliance program such as OIG Guidelines, Corporate Integrity Agreements, Open Payments, Aggregate Spend, the Drug Supply Chain Security Act, 340B Drug Pricing Program, and more.
MedPro Systems has been an active member of The Sharing Alliance since the earliest days of MedProID and looks forward to many future years of participation and mutual shared benefits with the organization.
To learn more about The Sharing Alliance, please visit their website: sharingalliance.org.
Please contact us to learn more about MedPro’s PDMA license validation solutions.