Social Media, Regulatory Guidance and Patient Advocacy
Jonathan Richman, author of the Dose of Digital Blog, got it exactly right in today’s post entitled “Patients WILL Have the Final Say on Pharma Social Media” He was spot on with his conclusion that while social media pundits and patient advocacy groups can push FDA to attempt to provide guidance on the use of social media, in the end, it will be patients (customers) not regulators who determine whether or not pharma will incorporate social media into future business models. Recently, it has been pointed out (on Twitter of course) that patient advocacy groups were under represented at the recent public FDA hearings on social media. While this is true, it likely will have little bearing on the regulatory guidance ultimately issued by the agency. This is because public input is generally not used to fundamentally shape regulatory guidance or policies but to fine tune them! The agency generally has a regulatory framework in mind before it conducts public hearing to collect stakeholder input and comments.
As I mentioned in previous posts, FDA intentionally crafts regulations and guidelines that are subject to interpretation because they are meant to serve as the minimum regulatory requirements and standards that must be met to insure drug and device safety and efficacy. While this is not ideal for many corporate regulatory affairs professionals, it is necessary because the agency simply cannot provide specific or custom-designed guidance to the plethora of drug and device manufactures that it oversees. In other words, the regulations that FDA crafts are meant to serve as general regulatory frameworks not clearly defined, company-specific rules and regulations. Companies that struggle with interpretation of FDA regulations are encouraged to meet with FDA regulators for guidance and clarification. More importantly, while FDA is charged with insuring the safety and efficacy of drugs and devices, the agency has very little control over how companies choose to interact with patients, customers and stakeholders. For example, companies ARE NOT required to submit direct-to-consumer (DTC) ads, marketing and advertising campaigns or other promotional materials for FDA review. This means that drug and device manufacturers have enormous flexibility in choosing how to market, advertise and promote approved products. FDA regulators only get involved when the agency is alerted to the possibility that certain ads or promotional materials may contain inappropriate, misleading or inaccurate medical information or claims. When a company is “snagged” by FDA for suspect marketing practices, the agency generally imposes mandatory regulatory review (for a defined period of time) of all subsequent DTC and promotional campaigns developed by the transgressor. To that end, the lack of patient advocacy testimony at the recent FDA hearings on social media should have little or no impact on the guidance that FDA ultimately issues.
While the much anticipated guidance ought to provide a regulatory framework for companies that choose to use social media, it can not “force” drug and device manufacturers to adopt or use it. This will be a corporate decision that will likely be made by legal, regulatory and marketing pharmaceutical executives. Finally, as Jonathan rightly points out, the needs and demands of patients will ultimately determine whether or not a drug or device manufacturer implements a social media strategy. And, not surprisingly, this decision will likely be based on drug sales and business outcomes rather than a need for patient education or public safety. Because—at the end of the day—business is business!
Hat tip to Jonathan!
Until next time...
Good Luck and Good Tweeting!!!!!!!!!
