In a rare show of unity, healthcare professionals, patient groups and drug manufacturers are voicing concern over the growing list of drug-safety requirements issued under the Food and Drug Administration’s Risk Evaluation and Mitigation Strategies, or REMS, program.
Risky-drugs list in the spotlight
Healthcare groups, drugmakers push for changes to improve safety
During a recent FDA two-day public hearing, the groups agreed that the program is needed to allow some beneficial yet risky drugs to enter or remain on the market. But they also said the safety requirements are proving to be unnecessarily confusing and in some cases too burdensome to physicians, patients and manufacturers.
The groups are pushing the FDA to make significant changes to how REMS plans are developed.
“Evaluation of existing REMS is urgently needed to determine if they indeed improve patient safety without unduly burdening the healthcare system and impairing patient access,” said American Medical Association Chair Ardis Hoven in written statement to Modern Healthcare.
The roughly 3-year-old REMS program was established as a part of the 2007 Food and Drug Administration Amendments Act. The law requires the FDA to determine whether a risk-management plan is necessary to ensure safe use of a new drug or an already marketed drug when post-market surveillance or research identifies new safety concerns.
If a drug is determined to need a REMS plan, manufacturers are required to construct medication guides that detail the drug’s risks and in some cases produce and monitor an elements-to-ensure-safe-use plan. Those plans can include physician certification mandates, prescription limits, and patient counseling and registry requirements.
FDA officials have required REMS plans for 110 medications since March 2008. The list includes frequently prescribed medicines such as the anemia drug Procrit, the asthma drug Advair and the fibromyalgia drug Lyrica.
To date, 68% of REMS mandates have required only that manufacturers create new medication guides, while less than 10% have required development and implementation of the more resource-intense elements-to-ensure-safe-use plans. Both types of plans, however, have elicited concerns from stakeholders.
Manufacturers and pharmacists say the current medication-guide requirements result in duplicate development and distribution of the guides to patients, and that the process can cause confusion over a medication’s actual risks and care challenges for providers.
“Pharmacists and providers are saying that the proliferation of medication guides is a burden and that the guides aren’t easily pulled up” on electronic health-record systems, said Andrew Emmett, director of science and regulatory affairs for the Biotechnology Industry Organization, a drugmaker lobbying group.
Bill Vaughan, senior health policy analyst for Consumers Union, stopped short of calling REMS medication-guide requirements burdensome but agreed that the current system is problematic for patients.
“We definitely need a simplified, single-labeling system that people can understand,” Vaughan said. He noted that under the current system, a single medication with a REMS requirement can have multiple-user guides that are confusing to both patients and doctors. “The continued heavy prescription of certain black-box label drugs for which much safer alternatives are available raises questions as to whether even prescribers fully understand or appreciate such written warning materials.”
Providers said they too are unsatisfied with the current REMS system, chiefly because they have been excluded from lending advice on the design of manufacturers’ elements-to-ensure-safe-use plans, which can require that doctors receive drugmaker-designed certification to prescribe certain drugs and that patients undergo specific laboratory tests before receiving a prescription.
“Currently, the FDA consults with manufacturers but not physicians,” noted Michael Maves, executive vice president and CEO of the American Medical Association, in a May 2010 comment letter to the FDA. “Manufacturers develop proposed REMS but are not required to consult with physicians. The foregoing is deeply perplexing.”
Kaiser Permanente officials voiced similar concerns in comments to the FDA in December 2009. The group warned that the current REMS system has the effect of creating “a separate category of drugs” and that it will require “considerably more labor” from providers to deliver certain drugs to patients who need them. Kaiser officials also expressed concern that some drugmakers may be using REMS certification and monitoring requirements as an excuse to limit their distribution of specific drugs to contracted specialty pharmacies, thereby driving up prices.
Kaiser and other providers are encouraging the FDA to establish a stakeholder advisory committee, which would make REMS standards recommendations that would be used by drugmakers to mitigate risks when such actions are required.
No date has been set for the publication of proposed new draft guidance, but the FDA, according to a Federal Register notice, is accepting comments until Aug. 31 on suggested changes to its REMS program.
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