One of the more popular sessions at this year's American College of Cardiology 62nd Annual Scientific Session and Expo featured a discussion on regulatory oversight and the need for better protection of patients' interests.
One of the more popular sessions at this year’s American College of Cardiology 62nd Annual Scientific Session and Expo featured a discussion on regulatory oversight and the need for better protection of patients’ interests. Among the speakers in this discussion was Robert G. Hauser, MD, FACC, who spoke about how the US Food and Drug Administration (FDA) and Congress are not doing enough to protect patients, as well as what he believes can and should be done to do so.
Dr Hauser began his presentation by rattling off 3 essential components to protecting patients:
Unfortunately, the FDA and Congress have both failed to deliver the types of approval processes, post-marketing surveillance, and recall management that Dr Hauser described. Major problems still exist in the area of post-marketing surveillance, according to Dr Hauser. While this process is supposed to enhance public health by reducing the amount of adverse events due to drugs or medical devices, the fact is that, despite multiple recalls in recent years (and some tragic events), patients in the United States continue to be exposed to hazardous drugs and defective or underperforming devices after they have been approved by the FDA. Dr Hauser illustrated this point by featuring a slide of drugs and devices—including rofecoxib (Vioxx), Sprint Fidelis (ICD lead), rosiglitazone (Avandia), and others—that were FDA approved at one point but then removed from the market (often times 5 or more years later) due to adverse events, such as strokes and fractures. Why does this happen? “Because the FDA is a passive regulator,” says Dr Hauser, who also points out that none of the 3510 medical device recalls from 2005 to 2009 were mandated by the FDA. In some cases, recalls took place after a product had been removed from the market, meaning that manufacturers set the patient safety agenda.
Dr Hauser believes that the FDA can learn a thing or two from the airline industry, and he points out that, since the last airline crash on September 11, 2001, there have been no fatal major US airlines crashes, and this includes 93 million flights with more than 6.5 billion passengers. The reason for this success rate, says Dr Hauser, is that the Federal Aviation Administration (FAA) and the National Transportation Safety Board (NTSB) not only have a passion for safety, but also separate but complementary roles. The FAA is responsible for regulation and operating the aviation system, whereas the NTSB investigates accidents and makes safety recommendations. And, even though the NTSB has no regulatory authority, they do report directly to Congress and operate independently of both the FAA and Department of Transportation. The NTSB operates independently because Congress established the organization in 1974 specifically because “no federal agency can properly perform investigatory functions unless it is totally separate and independent.”
Dr Hauser would like to see this model adopted by the FDA. There is a great need for an independent national drug and device safety board to identify safety issues, investigate adverse events, provide recommendations based on findings, and share information with all stakeholders. Until this occurs, patients will continue to believe that drugs and devices that are “FDA Approved” are, in fact, safe and effective, when this is not true. Dr Hauser believes that there is much work to be done in order to make that belief a reality.