FDA's New System to Track Approved Drugs' Effectiveness
The New York Times reported on the Food and Drug Administration's announcement last week of a new system to track already-released drugs' effectiveness. Called the Sentinel Initiative, many bodies such as the Institute of Medicine have recommended such a system for years. Additionally, the Sentinel Initiative is supported by recently-released research showing fast-tracked approval of new drugs leads to problems down the road. However, there are also many criticisms regarding the system's method of collecting data and its accuracy.
The need for a monitoring system has been corroborated by many sources. In studies recently released by Harvard Medical School reported in Science Daily, researchers found "fast-tracked" drugs, those approved within months of the FDA's deadline to act, had higher probabilities of problems later. The "deadline" is one imposed by the Prescription Drug User Fee Act (PDUFA) of 1992 requiring the FDA take action within twelve months with regard to at least ninety percent of all drug candidates or face decreased funding. The deadline was recently decreased to ten months by the renewal in 2007 of the 1997 Food and Drug Administration Modernization Act.
Lead researcher Daniel Carpenter, professor of government in Harvard's Faculty of Arts and Sciences, found approval of drugs near FDA deadlines leads to "unintended consequences" regarding drug safety down the road. Such safety concerns include likelihood of being withdrawn for safety reasons, manufacturing revisions, and labeling changes. Broadly, the Study found fast-tracked drugs are more likely to require later FDA intervention.
Due to these deficiencies in the FDA's operations, the need for a solution such as the Sentinel Initiative to monitor drug effectiveness is clear. The system functions through doctors reporting claims on services for Medicare patients. Excluding personal data about the Medicare beneficiary, the system then gathers information regarding the drugs used for a specific patient and their effect.
Criticisms of the system are two-fold, the method of data collection is either inaccurate or inapplicable. The Wall Street Journal reports, "The pharmaceutical industry is concerned that the new system, called Sentinel, will trigger unnecessary alarms because it isn't as reliable as rigorous clinical trials."
Additionally, the New York Times cites other deficiencies, such as the system relying solely on "claims data" from Medicare. The data is collected only when a medical provider seeks payment, as differentiated from actual patient health records. Thus, the data could be outdated.
A second criticism is "sometimes patients suffer problems after receiving drugs because they are sick, not because the drug is to blame." Lastly, data collected from such a small segment of the population is unrepresentative of the total population. This is so especially in light of the fact that Medicare beneficiaries use an average of 15 more prescriptions in a year than the average American, according to the New York Times.
Acknowledging these criticisms, FDA Director Janet Woodcock vows the "agency will work with public- and private-sector partners to create methodologies" for examining data. In summary, it seems the Sentinel Initiative is an evolving answer to cries for FDA action, albeit an imperfect one.