I was pleased to chair the Fifth Annual Risk Management and Drug Safety Summit.
REMS is a tactic. Safe Use is a strategy and Safe Use is the new normal.
According to Greg Fiore, MD (Chief Medical Officer and Acting Head of Global Pharmacovigilance at The Medicines Company), we are now in a “new world order” where pharmacovigilance teams finally have a seat at the table. But, per Fiore, we are still spending too much time, talent, and treasure of process – and not nearly enough on insights development and use.
Good points. Could this be because ever-more process is a good excuse for actually doing something? Such action would require not just more dollars and FTEs for PV teams – but would also mean changing the cognitive mapping of the way many companies do business. It might actually mean that patient safety takes priority over marketing and sales.
Fiore also mentioned the need to consider what benefits a more aggressive use of social media might mean for pharmacovigilance.
Is it time to “friend” Gerald Del Pan?
Josephine Torrente, JD (a Director at Hyman, Phelps & McNamara), made the point that REMS is labeling (a view held by most at the conference) and that the implications for shared REMS must be taken into account – especially when it comes to biosimilars. Josephine also addressed the issue of possible FDA waivers from shared REMS programs. She doesn’t see it as likely.
Is this another possible point of political intrusion? As with Plan B, will the HHS Secretary decide to grant such a waiver if the FDA declines to do so? Ms. Torrente feels petitioning the Humphrey Building for such divine intervention would have little chance of success. Glad to hear that.
The class-wide Opioid REMS was much on everyone’s mind, and Stuart Kim, JD (Senior Regulatory Counsel, Covidien), made a strong case for a more active role by state-level stakeholders. The context for this was the crucial need to differentiate the desire to address abuse versus misuse. The failure to recognize the different nature of these issues will lead to negative and unintended consequences. He also asked, per the CME requirements, why we are not looking to a more thoughtful level of measurement. Just “ticking the box” on CME won’t solve any problems. Rather, Stuart pointed to a goal of a Moore’s Scale Level 7 achievement of actually improving patient outcomes.
For more on Moore’s Scale, see here.
Addressing abuse is one thing – but smartly dealing with misuse (while not as sexy or politically potent) is at least of equal import.
After Stuart’s presentation, I offered the following prediction:
FDA will not approve generic opioids minus the innovator-developed abuse-resistant technologies – unless they are forced to. IP issues? You bet. Watch this space for more on this issue as it rises to the top of the FDA agenda. (And don’t be thrown off-guard by what’s going on north of the border.)
Eleanor Segal, MD (Consultant, Segal PV Systems), discussed pharmacovigilance trends in the EU, with specific focus on how the EU is actually becomes less harmonized both between it’s own members – and with the FDA. And the new EU directive on Phase IV studies didn’t give anyone a warm and fuzzy feeling.
James Frame, MD (Medical Director, David Lee Cancer Center, Chair of ASCO REMS Working Group, and President, West Virginia Oncology Society) spoke about the “onerous” burdens that many REMS plans are placing on physicians. Not news, but he made the good point that such burdens impact patient access issues such as time spent with physician, availability of support staff to address patient needs – both of which could actually lead to less optimal care. Unintended consequences – but certainly not unpredictable when both sponsor and agency fail to take the weight of “practice burden” into account.
It’s the risk of risk mitigation.
Maybe its time for the FDA (and sponsors) to engage a “physician representative” when it comes to REMS design.
Day One ended with a thoughtful presentation by former FDAer Lynn Mehler, JD (Partner, Hogan Lovells). Lynn predicted that the FDA would be looking forward to more class-wide REMS.
We shall see.
Richard Hermann, MD (Safety Science Physician, Patient Safety, Global Regulatory Affairs, AstraZeneca) brought the issue of risk/benefit analysis via a validated grid into the conversation. His baby, the BRAT, is only one methodology under discussion – but it is an important one in the “date versus information” debate. He urged the audience not be prisoners of process and to fight cultures that are resistant to change be they in industry or at the FDA. He acknowledged that many firms are operating in a “change-weary environment.”
Well, if the Pope can start tweeting and off-label promotion is protected free speech, there is hope for us all.
What will tomorrow bring.