By Susan F. Wood, PhD
In an article in the New England Journal of Medicine today, Sheila Weiss Smith points out that the FDA has not been responsive to the Institute of Medicine (IOM) report on Drug Safety. That study and its recommendations took on the question of how to improve our nation’s drug safety system, specifically through regulation by FDA. In her Perspective article, Dr. Smith writes:
In general, the IOM implored the agency to “embrace a culture of safety” by increasing the priority accorded to the safety of patients. Such an emphasis could have ramifications for medical care that would be as broad and positive as those that the 1999 IOM report on medical error, To Err Is Human,2 has had for the health care system. Sadly, the FDA’s official response falls far short of what the American public expects and deserves.
She also identifies the connection between the Prescription Drug User Fee Act (PDUFA) and it’s impact on safety:
Under the 1992 Prescription Drug User Fee Act, resources were provided to accelerate access to new drugs, and the FDA shortened review times and began to approve certain drugs earlier in the clinical development process.4 Safety was affected in several ways. First, some drugs were approved on the basis of surrogate end points and fewer safety data than had previously been required. Second, user-fee funds could not be used for postmarketing safety assessments; this restriction changed in 2002, but even now such use is permitted only in limited circumstances. Third, mechanisms intended to speed access to potentially lifesaving medicines were broadly interpreted.
Congress is in the midst of reauthorizing PDUFA, along with user fees for medical devices, and including provisions on drug safety, reporting on results of clinical trials, reducing financial conflicts of interest of FDA advisory committee members and strengthening the science and transparency of the agency. As of yet, we don’t know what the final legislation will look like. It is “in conference” between the House and the Senate - and the two versions of the bill have some significant differences. Some critical improvements, such as requiring industry to report the results of clinical research studies to the public and reducing conflicts of interest, may be included in the final bill – or may not.
The user fees, which I’ve written about before, here , here, and in the Boston Globe, and with David Michaels here , will be continued for at least 5 more years, but the other provisions have the potential to increase the transparency of FDA and to help change the agency toward a “culture of safety” as recommended by the IOM.
It’s in the hands of Congress.
Susan F. Wood, PhD is Research Professor at George Washington University School of Public Health and Health Services, where she is part of the Project on Scientific Knowledge and Public Policy (SKAPP). She also served as Director of the FDA Office of Women’s Health from 2000-2005.