When looking forward, it is always important to first reflect on past trends, before making predictions about how the future might evolve. Regulations usually follow new business practices or emerging technology, sometimes as a result of unintended consequences (e.g. the deregulation of the financial sector). However hastily written legislation can sometimes create more problems than the situation it is trying to fix.
A relevant example of regulations lagging behind business practice is the emergence of social media as a mainstream communication channel post 2005 onwards. Pharmaceutical companies sought to leverage the opportunity to engage directly with patients and healthcare professionals using social media and user-generated content such as Twitter, Facebook and Wikipedia. Initially this was predominantly seen in the US where direct to consumer advertising is permitted. Companies could use Twitter to a broadcast tool to add to their corporate communications channel. There are some examples of companies using social media for medical information requests. Doctors could post patient care questions on the peer-to-peer site Sermo. For a time, Pfizer Medical Information was monitoring these questions and answering them, although this service is no longer available. AstraZeneca in the US responded to people tweeting about their medication costs, suggesting they phone their freephone number.
However, it was the promotion of medicines using sponsored ads in Google that brought about 14 Warning Letters from the FDA in 2008. In the absence of clear guidance about using social media, companies have to interpret the existing regulations and promotional codes and decide how they might apply. Inevitably there are unanswered questions about how companies can engage responsibly and compliantly with their customers over social media. In situations like this, companies develop business practices that will achieve their aims, whilst evaluating the risks involved. Sometimes the only way to find out what is unacceptable is to try something out, whilst ensuring that there is a risk mitigation plan in place.
Following the 2008 warnings, the FDA held 2 days of open hearings in November 2009 on “Promotion Of FDA-Regulated Medical Products Using The Internet And Social Media Tools”. They posed 5 questions;
Accountability of online communications
Fulfilling regulatory requirements for communications when space is limited (e.g. a 2 line sponsored Google ad)
Correcting third party information
Use of links
Reporting adverse events.
Various key stakeholders presented at the hearings including Google Health, patient associations, advocacy groups, medical communications agencies, market researchers and pharmaceutical companies. There was a Twitter storm of comments, blogs opining on the events and discussing the implications and numerous follow up communications from the wider medical communications community. It wasn’t until December 2011 that the FDA issued draft guidance: REF Guidance for Industry – Responding to Unsolicited Requests for Off-Label Information about Prescription Drugs and Medical Devices. However, it wasn’t about the wider aspects of social media but rather focused on handling unsolicited off-label questions.
The Near Future
So, what regulatory changes are likely to have impact on Medical Information over the next few years? There will always be on-going updates to the advertising and promotional regulations and codes. However, two areas in particular are worth consideration:
Clinical Trial Data Disclosure
Transparency and disclosure of payments to healthcare professionals and healthcare organisations
With the demand to open up clinical trial data to the public domain, or in controlled situations, to allow medical researchers to run their own analyses or meta-analyses, how will Medical Information respond to this trend? Many companies use pre-packaged standard response documents to answer requests, summarizing the salient points from the evidence base of published literature, ideally peer-reviewed. Medical Science Liaison or Medical Affairs personnel tend to own the responsibility for more in-depth discussions about the clinical data for the promoted or pipeline products. However Medical Information needs to stay aware of how this area develops.
The second development that has affected Medical Information practice is the transparency of payments and transfer of value to healthcare professionals and healthcare organizations in the US. The Centers for Medicare & Medicaid Services issued the final regulations implementing the Physician Payments Sunshine Act (also known as the Sunshine Act), a provision of the Affordable Care Act, on February 1, 2013. Under this regulation, reprints and publications have been swept into the transfer of value category. Therefore, if a publication is provided to a physician as part of the response to an unsolicited inquiry, that value needs to be calculated and declared.
The European Federation of Pharmaceutical Industries and Association (EFPIA) approved the EFPIA Code on Transfers of Value from Pharmaceutical Companies to Healthcare Professionals and Healthcare Organisation in June 2014. This Disclosure Code requires all member companies of EFPIA to disclose payments and other transfers of value made to Healthcare Practitioners and Healthcare Organisations (HCPs and HCOs) in certain categories. The transactions disclosed could consist of, for instance, a grant to an HCO, or a consultancy fee for an HCP speaking engagement. Unlike the US Sunshine Act, providing publications or reprints to answer customer questions has not been included.
The European Commission has now approved the General Data Protection Regulation which will harmonize the various data privacy laws that exist in the member states at the moment. This means that the current procedures and processes that MI currently adopt may have to change to one common process. This could include management of personal data within the Inquiry Management system, the wording of the Data Collection notice given to telephone callers and other relevant procedures.
Are Regulations Our Friend or Our Foe?
A frequent question that people with limited experience in Medical Information ask is “What are the regulations that tells me what Medical Information has to be provided? Rapidly followed by “What is the minimum service that we have to provide?”. As there is no one regulation or code for Medical Information that is legally binding gives us considerable latitude over how we operate our services, whilst recognizing that companies receive inquiries on their products. Companies can leverage a high quality Medical Information service to help differentiate themselves against their competitors. They also keep us on the right track ethically – answers to customers must be fair, balanced, substantiated, current and non-promotional. On the flip side, the actual wording in the regulations is open to interpretation. For example, many European regulations and promotional codes mention the scientific service. This is widely interpreted to include the Medical Information function. However, in some countries this section discusses approval of non-interventional studies and promotional review and approval with no inclusion of a Medical Information function.
So, does the existing regulatory framework protect the Medical Information function? Other Medical functions such as regulatory affairs, pharmacovigilance and clinical research have a very clear regulatory framework. Medical Affairs is covered by the promotional codes of practice as well as advertising laws. So, does Medical Information need to be more clearly included?
The UK industry organization Pharmaceutical Information and Pharmacovigilance Association (PIPA) has had guidance on Medical Information departments since 1995. Although they have no legal mandate, they help define standards and best practice. More recently, like-minded Medical Information managers and leaders from several companies have got together and created country specific MI position papers or guidelines. Although they have no legal status, they allow all companies in those countries to follow good business and ethical practice. More countries are likely to follow suit.
Sean Turbeville, Ph.D
Medical Affairs Consultancy
San Francisco, CA