The Prescription Drug Marketing Act (PDMA) sets forth federal requirements for drug sample distribution. Among other things, companies are required to obtain a signed written request from a licensed practitioner prior to distributing drug samples to that practitioner.
Companies must also confirm that the requesting practitioner is authorized by state law to prescribe the product for which samples have been requested.
For many practitioners, the authority to prescribe and sample prescription drugs is inherent in the license to practice. Some practitioners, however, must take additional steps to obtain prescriptive and sampling ability and may also have their authority delegated and/or restricted by a state-imposed formulary. As state laws can widely vary on prescriptive and sampling authority for HCPs, companies should proactively monitor legislative changes and trends so they are compliant with both federal and state laws.
To maintain a compliant sampling program, your company needs to know which practitioners are authorized to prescribe your product. Laws and regulations governing prescriptive and sampling authority vary from state to state and sometimes even within practitioner categories. For example, a nurse practitioner in West Virginia does not have the same prescriptive authority as a nurse practitioner in Colorado. Staying current with ever-changing laws and regulations can be burdensome, and the PDMA has both criminal and civil penalties for violations.
The regulatory landscape is constantly shifting, posing many challenges to life sciences companies. Recent legislative updates illustrate a general broadening of prescriptive authority, especially for advanced practice registered nurses (APRNs). There has also been an increase in the number of states that recognize naturopathic doctors and their authority to prescribe and sample medications. While such trends are generally good for business, ensuring samples are appropriately provided to authorized prescribers, so as not to run afoul of federal and state law, is challenging.
How We Can Help
PorzioLS has a team of compliance and medical professionals to assist you in understanding and appropriately applying various regulatory requirements with regard to practitioner prescribing and sampling. Changes that may have a potential impact on your business rules are communicated via email using our Information Center Updates. Tell us what you need and we will customize a compliance solution to your specifications.