Judicious Jane. Germane Janet. Bullish Bob. And other Gems on REMS
by: |
10/31/2008
Some memorable comments, questions, clarifications – and challenges from the recent Risk Management and Drug Safety Summit held at the National Press Club, October 28-29.
Janet Woodcock, MD, Director, CDER, FDA
“Safety means doing the right things for patients.”
“FDA must consider post-approval issues as part of a drug’s lifecycle.”
Dr. Woodcock also addressed the environment in which REMS exists. She pointed out that there is a real difference between “headlines and help.” In other words, REMS and other safety mechanisms can be viewed as either “headlines” about “unsafe” drugs or in a more appropriate context of “safe use.”
To this point she specifically discussed warfarin and abacavir – are these “dangerous drugs” or medicines that, with the appropriate diagnostic tools, can be used safely? Two sides of the same coin. Janet opts for “safe use,” while others (in the media and elsewhere) seem more predisposed to the other.
She also mentioned that the FDA’s Office of Surveillance and Epidemiology needs to hire “real experts” on “REMS issues” who can develop “predictable procedures and best practices.”
Per the agency’s forthcoming “safe use” program, Dr. Woodcock called for a public/private partnership to make the design and outreach of this important initiative more robust.
Laurent Auclert, MD, Head, Risk Management Plan Unit, Global Pharmacovigilance & Epidemiology, sanofi-aventis
Dr. Auclert began his talk by pointing out that “epidemiologists and statisticians must talk with each other.” Everyone seemed to agree that this is both a good idea and an interesting sociological experiment.
He also considered the difference between RMPs in EU (“risk assessment”) versus REMS in the US (“risk minimization”). A contentious proposition.
Jane Axelrad, JD, Associate Director for Policy, CDER, FDA
Jane pointed out that of the 15 post FDAAA REMS plans required by the agency, 12 were “MedGuide only.” Her point was that the agency is using its REMS authority “judiciously.”
They don’t call her “Judicious Jane” for nothing.
She also reinforced the point made by Janet Woodcock that the FDA is trying to provide clarity to the process by developing both templates and clarity (per FDAAA) of classifications – and that the agency is preparing official guidance.
Carmen Bozic, MD, Vice President, Drug Safety & Risk Management, Biogen Idec
Dr, Bozic presented the risk management plan for Tysabri (TOUCH -- TYSABRI Outreach: Unified Commitment to Health). Fascinating stuff. She called it “elaborate.” A more appropriate adjective is “elegant.”
Robert Goldberg, PhD, Vice President and Director of Programs, CMPI
CMPI’s very own Bob Goldberg opined that ‘REMS may very well be a way to revive applications that once looked dead.”
I hope so – and so do many others who look at the current “safety jihad (and jihadists) along with the current parched pipeline and wonder whatever became of the hoped-for miracles of the “biomedical century.”
Donald Therasse, MD, Vice President, Global Patient Safety, Lilly Research Laboratories
Don said what everyone was thinking, “The drug label must remain the central tool in risk minimization.” And considering the current and heated debate over preemption, this is not only a timely comment – but a core and crucial one. He also opined that, “REMS must complement rather than direct or impede the practice of medicine.”
John Ferguson, MD, Vice President & Global Head, Pharmacovigilance and Medical Safety, Novartis Vaccines & Diagnostics
John discussed REMS in the context of “string theory,” specifically outcomes, probability, and values (perceptions) – referring not to benefit and risk, but rather “composite benefit and composite risk.” He posed a disturbing question, “In an age of risk management – what happened to benefit.” Indeed.
Cherif began by saying that we must shift the conversation “from information to communication and information.” Sounds obvious – so why aren’t we doing it? He also asked a disturbing question:
“Who should manage drug safety? Lawyers? Doctors? The FDA? State legislators? Federal legislators?”
And that’s a good place to stop – but not for too long.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
