Earlier this week, we broached the subject of pharmaceutical drug compliance, with some case studies on sales team education and the cost of not adhering to marketing regulations. Some more thoughts on the topic (and a link to the first post, in case you missed it):
FDA regulations and compliance
Pharma manufacturers spend a great deal of time and resources ensuring they adhere to regulations regarding promotion, and to ushering promotional materials through medical legal review. Although many of the regulations come from the FDA, state and local agencies may also have their own guidelines, which add another layer of compliance complexity. Pharma must enlist and depend on unbiased compliance experts to maintain awareness of new and changing regulations, and the implications to its marketing efforts. Often it is both wise and cost effective to engage outside expertise, rather than attempting to staff a robust compliance office.
Recently the FDA issued recommendations to pharma on the submission of records that will support its calculation of quality metrics, which it may update following review of the comments it received. The “Request for Quality Metrics” is intended to ensure clear expectations for industry on the submission of quality metrics data to support efficient regulatory review, compliance oversight and inspection policies. In addition to basic information (drug name, monograph, application number, etc.), the guidelines also request:
- The sum of product quality complaints received for product distributed in the US
- The number of lots attempted that are released for distribution or for the next stage of manufacturing for the finished drug product or active pharmaceutical ingredient (API)
- Whether the Annual Product Review (APR)/Product Quality Review (PQR) was performed within 30 days of the annual due date
- The number of specification-related lots rejected for the drug referenced
- The number of lots attempted pending disposition for more than 30 days on the last day of the time period within which the data being reported was collected.
- The number of test results that fall outside the specifications or acceptance criteria for the drug
- The number of lot release and stability tests conducted for the drug
- The number of invalidated out of specification (OOS) results for finished drug product or API and stability tests due to laboratory error for the drug
The FDA has also issued draft guidance on its approach to the benefits and risks for compliance and enforcement action that could affect medical device availability. The FDA recognizes that it must be careful when making these decisions, so it does not negatively impact patients. Its goal is to consider a multitude of data when considering a device’s benefits and risks, including such things as duration of effects, likelihood of patients experiencing one or more benefits, medical necessity, benefits for healthcare providers, medical device-related deaths or serious injuries, duration of harm, and false-positive or false-negative results.
Collecting, analyzing and submitting data to ensure adherence to federal, state and local regulations can be a burdensome responsibility for pharma, which can bury even the most robust compliance department. Ensuring there is close communication between compliance personnel and pharma’s marketing department and sales force is essential to maintain the integrity of a promotional campaign and to avoid the costly outcome of persuasive language that has turned to spin.
What are your biggest concerns when it comes to pharma sales/marketing compliance? Tweet @MMITnetwork to have a conversation and check back for more perspectives on trends affecting the payer, pharma and provider network.