Ethics And The FDA: Is It Time For A `Priority` Review?

   Is objectivity much of a priority in studies of new medications? Granted, pharmaceutical companies have the wherewithal to support funding of these studies. Without that funding, some of the leading advances in new medications may not be possible. However, the companies also have a vested interest in the results of these studies and you have to wonder if that vested interest casts an imposing shadow at times on those doing the research.    One DPM says he has “rarely felt any pressure” in the research studies he has participated in over the years. He says he has actually been “impressed with the objectivity” displayed by the sponsoring companies of these studies. However, another doctor recently discussed his experience evaluating the functional and financial outcomes of an antibiotic in the diabetic population. He notes he was instructed to “delete certain adverse outcomes from the study or (his) funding would be pulled.” The doctor stopped doing the study and returned the initial funding of the project back to the sponsoring company.    In light of the ongoing controversy over COX-2 inhibitors, questions are also being raised about the influence of pharmaceutical companies on the Food And Drug Administration (FDA).    In a particularly revealing article, “What Ails The FDA?,” in a recent edition of The New England Journal Of Medicine, Susan Okie, MD, discusses the Prescription Drug User Fee Act (PDUFA), which Congress passed in 1992. This legislation allowed pharmaceutical companies to pay fees to the FDA to help facilitate a more efficient and timely review process for new medications. The legislation worked well in some respects. In the subsequent 10-year period, these fees enabled the FDA to have “77 percent” increase in the hiring of personnel to review new drug applications, according to the NEJM article. During that same time period, the FDA was able to shave four months off the “standard” review given to drugs as the median time for the “standard” review dropped from 27.2 months to 23.1 months.    However, the flipside of this is a bit troubling. According to the article, “user fees from pharmaceutical companies now account for more than half the money the FDA spends on the review process.” There is also the troubling specter of the “priority” review, which, according to the article, is given to drugs because they were deemed to offer “a therapeutic advantage over existing medications.” In 2003, the median “priority” review took approximately 6.7 months.    That does not seem like enough time to gauge long-term results, does it? It also seems kind of arbitrary. Who really judges which drugs get a “priority” review and which ones get the “standard” review? It makes sense to strive for improved efficiency in the approval process but a six-month review period hardly seems adequate and may actually be harmful in the long-term. Keep in mind that Vioxx (rofecoxib) was given a “priority” review.    While the aforementioned doctors have had different experiences in regard to pharmaceutical company influence on research studies, they both note that one may not get a full picture of harmful side effects with the initial study of a medication.    To that end, the FDA has stated its intentions to improve monitoring of medications after they have been put on the market. One of the initiatives will be the undertaking of a study of the FDA’s Drug Safety System by the Institute of Medicine.    Still, if the FDA is to re-establish itself as an agency for the public good, eliminating the notion of the “priority” review is an essential first step toward promoting long-term outcomes and re-emphasizing patient safety as a true priority.