PDMA Compliance: What’s Your Retention Policy?

The PDMA Alliance Inc. is a non-profit corporation comprised of professionals who are dedicated to improving the pharmaceutical industry’s understanding of the PDMA, and meeting the intent and mandates of the law.  The organization is focused on strengthening the efficiency and effectiveness of prescription drug sample accountability programs.

Each year, the PDMA Alliance holds the PDMA Sharing Conference, a meeting of PDMA compliance professionals who benefit from the expertise of PDMA law enforcement and industry leaders, review new PDMA compliance products and services and exchange ideas with their colleagues and business partners.  At this year’s event, StayinFront was recognized for its active support of the PDMA Alliance over the past 10 years.  StayinFront’s continued participation in the PDMA Sharing Conference demonstrates StayinFront’s ongoing effort to assist the pharmaceutical industry in complying with the Prescription Drug Marketing Act and related regulations.

StayinFront’s extensive involvement with the PDMA Alliance includes the distinction of speaking at a recent annual conference.  StayinFront’s Director of Compliance, Rhonda Sobral O’Toole, Esq., delivered an informative presentation titled Untangling the Complexities of Record Retention, Retrieval and Destruction which identified a host of PDMA-focused document retention best practices and discussed FDA expectations.

In general, her recommendations included that pharmaceutical manufacturers consider the following factors when creating a record retention policy:

-          Applicable regulatory requirements;

-          Size of the business;

-          Cost/budget allocated for document retention;

-          Training/compliance considerations;

-          Exceptions to the retention policy;

-          The types of records to be retained;

-          The format of the record to be retained (i.e.,  paper, electronic or both);

-          How long a record should be retained; and

-          The destruction of records at the end of the retention period.

PDMA requirements add a number of additional factors and considerations to be managed, making this a complex and potentially hazardous area that pharmaceutical companies need to closely monitor and control.

Upcoming posts on this topic will delve further into specific PDMA requirements governing record retention, retrieval and destruction.