The final regulation enables the FDA to open a Medicare Part D prescription benefit claims database to federal agencies, states and academic researchers.
The Centers for Medicare and Medicaid Services cleared the way Thursday for a collaboration with FDA that is the first step in helping the drug regulating agency catch deadly medication side effects before the numbers of cases reach more ominous levels typically required to raise red flags.
Comment on this article in The Forum.Legislation passed into law in September that reauthorized user fee programs at FDA and gave the agency additional powers to oversee drug safety directed FDA to partner with federal and private organizations to mine healthcare databases. CMS issued a final regulation Thursday that will enable the agency to open a Medicare Part D prescription benefit claims database to federal agencies, states and academic researchers. The Part D information will be linked to claims for hospitalizations and physician services, according to CMS.
Once the Part D data can be accessed, in about a month, FDA will be able to query the database and identify adverse event patterns and more accurately connect side effects with specific drugs, FDA Commissioner Andrew von Eschenbach said.
HHS Secretary Leavitt called the new system, dubbed the Sentinel System, a "quantum leap forward." Anything before Sentinel "was like looking at the stars in your backyard with the naked eye. You could only see what was [over] your head from far way."
FDA relies on a voluntary reporting system called MedWatch to amass adverse event reports.
The information mined from the claims database will not identify patients to protect privacy.
The Pharmaceutical Research and Manufacturers of America is on board with the new surveillance system. "Clearly, this program should improve the efficiency of post-market surveillance of medicines and, in the end, the beneficiaries will be the many patients using these products," PhRMA Senior Vice President Ken Johnson said.
CMS Acting Administrator Kerry Weems said the Sentinel information could eventually be used to compare the effectiveness of drugs. "And then, I think, moving on in conjunction with the Food and Drug Administration, we'll start looking at specific drugs to determine how they work with multiple drugs. Do they work in people who are well beyond 65? You know, start answering questions like that," Weems said.
FDA plans to partner with private organizations such as health insurers that operate claims databases of their own. Janet Woodcock, head of FDA's drug center, said the agency is talking to many groups, but would not name names.
Woodcock predicted results from Sentinel would not lead to more blanket drug warnings, but rather FDA conveying to healthcare providers what sections of the population should not take a specific medication. The agency plans to craft standards for evaluating results.