As Monica Kwarcinski, Purdue Pharma, reminded us, compliance wasn’t even on the Medical Communications landscape 15 years ago. Today, it’s a very different story. The whole area has become formalised into Medical Information practice and expanded to encompass all of our activities.
This was a 3 hour DIA US tutorial run by Monica, Joyce Martin from Genentech and Mark DeWynngaert from Huron Consulting Group. You may be already familiar with Joyce’s publications on quality in the Drug Information Journal. She now has a new role in Medical Affairs Compliance as well as years of experience in this area so gave us lots of real life examples. Mark regularly audits companies so shared his words of wisdom. Monica also gave us insights into staff training and essential documentation.
So what were the key learnings from this session? Inevitably this was a US perspective, although Joyce did briefly mention the EU directives.
- Compliance has made a dramatic entrance in Medical Information, driven by regulatory inspections but focused by Corporate Integrity Agreements (CIA).
- Although the 30+ delegates shared Best Practice, we all know there is not just one way of doing things. Although it’s good to know what most companies do (like making it mandatory to get a HCP signature for off-label requests), it’s equally valid to identify the outliers. Why do they go against the crowd? Hint – it’s all about risk assessment and business needs.
- CIAs are driving practice. They give us the clearest indications of HOW we should be doing things.
- You must keep up with the government and regulatory authorities thinking on compliance (which is why this tutorial and other US workshop sessions are vital information exchanges and thinking shops)
- The regulations don’t tell you what to do. For those of us in Med Info, the regulations usually tell us where we don’t fit in – like promotional activities.
- You need to look at the FDA Warning Letters to companies to find out what is not acceptable practice as these are real life examples. Hopefully this is not a lesson learnt because your company got one! In your own country, your industry body or regulatory authority probably publishes similar documents (like the PMCPA breach of code cases in the UK)
- Not all the necessary documents are available online. Joyce made us aware of the legendary FDA document, the Drug Company Supported Activities in Scientific or Education Contexts: Draft Concept Paper 1991. Like a family heirloom, it’s passed down like a precious scroll.
- As we know, it’s all about context, intent and perception. One activity on it’s own may be compliant (like providing off-label information) but when you put it together with another activity (like sales rep interactions with a HCP), it’s no longer OK. One of the first cases involving Med Info was discussed in depth. This was a DDMAC warning letter to AstraZeneca in 2008. If you look at the letter sent , many of us would have thought it acceptable but the sales rep activity affected the outcome.
- CIAs are additive: you need to read the latest cases to see what the FDA now expect for acceptable practice. There is always wide publicity about the latest company to be fined so you know when to look. But if you think living with a CIA is bad, a Deferred Prosecution Agreement (DPA) is worse! When a company is under a CIA, they have to submit to an annual audit of their activities for 5 years: are they now complying to the CIA? But with a DPA you have someone working in your organisation constantly monitoring what you are doing for a couple of years before you then work under a CIA for 5 years. Ouch!
All the main Med Info activities were then discussed in great detail:
- off-label (what you can and can’t use)
- query management systems and information to collect
- response documents
- booths at congresses
- out of office hour services
- call centre vendor practice
- social media
and lastly staff training. Monica gave a thorough review of the issues around staff training. One take home message is that we may have great induction programmes and thoroughly document training but the main area overlooked is on-going training. These ad-hoc or regular sessions can be more proactive than we might think. It’s easy to overlook documenting on-going-training and Monica gave us so ideas of how to track it and stay compliant.
Mark gave us insights and examples of some situations uncovered during his audits, along with a checklist of considerations.
This was a great session if you wanted an introduction to compliance; you would probably left with a huge To Do list. But at least you no longer had to worry about the infamous unknown unknowns!
For me, it gave me even more insight into current practice in the US. But I will leave you with a quotation from the legendary Lucy Rose;
If you’re not working under a CIA now, you need to act like your company already has one!