- The oncology chief at the FDA, Dr. Richard Pazdur, long-criticized for obstructionism in approving new drugs, is facing new pushback after overseeing a speedup in drug approvals concurrent with the sickening and eventual death of his wife, Mary, from ovarian cancer.
- Dr. Richard Pazdur has long been the target of critics who say that the FDA has not approved drugs quickly enough, in part because of Pazdur's oversight of the process, according to reporting from the New York Times.
- However, within the last three years, the time-to-approval for new drugs has decreased to an average of five months from a previous six months. Pazdur is now being criticized by those who say that the agency is now compromising safety to expedite approvals—bringing scrutiny into how his experience with his wife's death affected his role as regulator.
While Dr. Pazdur concedes the death of his wife has made him determined to make decisions more quickly, he attributes the expedited approval timeline to several factors, including advances in genetic research which have made medications more effective, as well as easier to test. In addition, the Food and Drug Administration Safety and Innovation Act, passed in 2012, has spurred the approval process.
Under the law, drugs which receive a breakthrough designation are eligible for faster approvals. Breakthrough drugs are medications designed to "treat a serious or life-threatening disease or condition and for which preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.”
While faster approval timelines have mollified some, others are concerned that faster approvals could result in drugs coming to market that have not been properly vetted for safety and efficacy.
Public Citizen contends the FDA is more closely tied to industry, and overly focused on niche drugs which save few lives.
Dr. Pazdur is well aware of the controversy, and now has personal experience with the the plight of patients suffering from cancers with low survival rates. The five-year survival rate for ovarian cancer is 45%.
Speaking to the New York Times, Pazdur says he is focusing on addressing the scourge of adverse events associated with experimental treatments. He is promoting an initiative in which patients will help assess drug toxicities, instead of leaving it to physicians and researchers.