Managed Care - August 2012 - (Page 10)
M E D I C AT I o N M A N A G E M E N T
IoM outlines Framework For Postmarket Safety
The Food & Drug Administration’s approach to this stage of a drug’s life cycle is inadequate
By Tom Reinke
“We welcome studies that incorporate active comparators,” says Brian Solow, MD, chief medical officer of OptumRX.
hen health plans and PBMs evaluate new medications for efficacy, safety, and cost, safety is the thing they know the least about. Safety data are limited by the vagaries of the new-drug approval process and by several factors internal to the FDA, including insufficient staff and infighting between departments responsible for drug safety. The FDA Amendments Act of 2007 gave the agency added responsibility and authority for postmarket safety and in 2010 the FDA asked the IOM to report on ethical, scientific, and practical concerns about postmarket studies and drug safety actions. The Institute of Medicine’s report “Ethical and Scientific Issues in Studying the Safety of Approved Drugs,” released in May, finds that the FDA’s approach to postmarket safety does not ensure a systematic review of drug safety or consistent decisions and action when risks are found. It said the use of a standardized threestage safety framework could make the FDA’s decision-making process more predictable, transparent, and proactive. The first stage involves clearly defining safety problems. Stage II covers assessing the drug’s benefits and risks, and Stage III is deciding the appropriate regulatory action. While these steps seem incredibly basic, they are intended to prevent breakdowns in how safety problems are handled — breakdowns that have occurred in the past. The report recounts high-profile medications that were withdrawn from the market and it provides a detailed analysis of the protracted bungling of Avandia’s cardiovascular risks. The report recommends a life-cycle approach to managing drugs with safety risks. It calls for the creation of a benefit and risk assessment and management plan (a BRAMP) that is reviewed
and updated at specified times and whenever the FDA reevaluates the drug’s benefit-risk profile. But the FDA is not planning to implement the program. “A BRAMP is more than a document: It is a commitment to create a one-stop resource that has all of the information from multiple sources on the performance, benefits, and risks of medications that have safety issues,” says Ruth Faden, PhD, director of the Johns Hopkins Berman Institute of Bioethics and cochairperson of the IOM report committee. “The BRAMP approach would demonstrate that the FDA is totally committed to postmarket safety,” says Faden. Brian Solow, MD, chief medical officer of OptumRX, says, “A constantly updated document that tracks risk-to-benefit profiles would be particularly valuable. Now, we get breaking information from FDA alerts or other sources, and that forces us to be reactionary. It would be nice to be proactive with safety information from the BRAMP that we could use to supplement our own claims data to help us discern safety signals early in the life cycle.” A key advantage of BRAMPs for insurers is that these plans would include safety information not usually available — a list of potential safety risks.
Red flags While adverse events that occurred in preapproval trials may be included on drug labels, there is no formal mechanism for identifying safety risks, yet these risks are a key consideration when P&T committees review new medications. Health plans have identified their own red flags for safety in the absence of information on potential risks. “Our P&T committee is always cautious about new medications with
MANAGED CARE / AUGUST 2012
Table of Contents for the Digital Edition of Managed Care - August 2012
Managed Care - August 2012
Legislation & Regulation
News & Commentary
Private Exchanges: Practice Makes Perfect
Hospitals and Providers Ganging Up on Plans?
Q&A: Kaiser Permanente’s Sharon Levine, MD
God Save the Health Care System!
Future Points to Greater PBM/Plan Cooperation
Managed Care - August 2012