WASHINGTON - There's a new player in the drug safety debate.
Mark McClellan, the administrator of the Centers for Medicare & Medicaid Services, recently offered Medicare's impending Part D prescription drug benefit as a new solution to the problems with drug safety surveillance. Speaking last week at the Pharmaceutical Care Management Association's drug safety symposium, he noted that CMS's initiatives to integrate data on drug use and the occurrence of adverse events would provide "a foundation for much more effective post-market surveillance of FDA-approved drugs."
Rather than relying solely on the current safety supervision system that includes spontaneous adverse event reporting and Phase IV studies, McClellan stressed that using de-identified data collected through the Medicare drug benefit process would allow all interested parties to learn more about the rates of side effects and get a better understanding of the types of patients who experience them. Using such data, he said, also would enable CMS to collect information on off-label use and to assess quality of care by comparing the effectiveness of different approaches to providing drug therapies.
But some observers aren't sure how those conclusions would be drawn from data collected under Part D, which becomes active on Jan. 1, or the clinical evidence that could be generated.
"We have not taken a full-blown position yet, because we need to see more detail about what's going on," said Jayson Slotnik, the director of Medicare reimbursement and economic policy at the Biotechnology Industry Organization. "We need to see how McClellan is going to use claims data for safety purposes, because claims data are not intended for adverse outcomes or quality measurements."
Instead, he said, claims data are collected for payment purposes. McClellan, on the other hand, said the system would prove effective because of its large-scale and automatic setup, based on the actual electronic data used to provide the Medicare drug benefit. He added that safety, off-label and comparison findings would be culled from among 36 data points to be collected for payment under Part D claims. Those elements include identifying characteristics for patients and their coverage plans, as well as prescription information on dosage, duration and cost.
Still, questions linger as to how CMS could apply claims data to make clinical decisions.
"We have some concerns on how it's going to be used," Slotnik told BioWorld Today. "We want to see how the data are going to be used, who is going to pay for data collection, how it's going to be disseminated, and how it's going to impact coverage."
That kind of wait-and-see attitude also has been adopted by the Pharmaceutical Research and Manufacturers of America.
"We have not reached a final conclusion yet," said Jeff Trewhitt, a spokesman at PhRMA. "It's one of many tools we are looking at to improve monitoring of drug safety."
Should McClellan's idea get off the ground, it would mean close collaboration with the FDA that could require a memorandum of understanding between the agencies, as well as with partners in private industry, such as insurance companies. In any case, he said CMS must do more than help seniors pay for their prescriptions and go several steps further to identify questions about drug safety and use through data that could build a large knowledge base.
Slotnik said BIO is interested in a response from the FDA, which this week held the first in a series of meetings of its drug safety and risk management advisory committee on its risk assessment program for marketed drugs. Already, there have been other proposals to reform the FDA's drug safety surveillance.
Recently, legislation has been introduced on Capitol Hill to create a drug safety division called the Center for Post-Market Drug Evaluation and Research that would still reside within the FDA, but independent of its Center for Drug Evaluation and Research division where the Office of Drug Safety currently exists. Consumer advocacy groups have backed that particular measure, the Grassley-Dodd bill, though BIO criticized the bill for failing to address the problem properly. (See BioWorld Today, May 10, 2005.)
"CMS involvement in addressing drug safety," Slotnik said, "is better than legislative involvement."
Earlier this year, the government's overarching health care agency, the Department of Health and Human Services, unveiled a plan that instituted the Drug Safety Oversight Board to improve its dialogue with the external medical community in an effort to better safety monitoring. And the FDA recently unveiled a new program to make drug safety information available to the public through a website, www.fda.gov/cder/drugSafety.htm.
For its part, PhRMA has not offered firm support for any single proposal that addresses the FDA's post-approval product surveillance.
"Our overall goal is to look at all tools to improve monitoring of drug safety," Trewhitt told BioWorld Today, adding that the pharmaceutical trade association met this week to "actively study Dr. McClellan's proposal."
McClellan said CMS would work to engage public discussion through meetings to consult with all interested stakeholders, including an initial open-door forum titled "Better Evidence on Using Drugs Through the Medicare Drug Benefit" scheduled for June 13.