Date: 2005-03-01
Speaker: GENE GREEN (democrat)
Chamber: H
State: Texas

Mr. Speaker. I rise today to address the problematic FDA approval process. In recent weeks. we have learned that the Federal Drug Administration has established an independent board to review postmarket drug safety issues. We have also learned that the FDA committee issued a recommendation to return Vioxx to the market and keep Bextra and Celebrex on the market. On the surface. it Would seem the FDA has taken measures to address drug safety issues. However. we know all too well the devil is always in the details. and by looking at these details. it is clear that it is just business as usual at the FDA.. Take the committee that issued the recent recommendations on the COX2 inhibitors. Ten of the 32 drug advisers had ties to the pharmaceutical industry and. in fact. had received consulting fees in the past from the drug manufacturers. I wonder how they voted? Nine to one to keep the drugs on the market. Without the votes of these industry consultants. the committee would have recommended withdrawal of Bextra from the market and keep Vioxx off the market. We will never know if their votes are the result of an actual conflict of interest. Yet to stay above the ethical fray. there should not even be an appearance of conflict of interest at the FDA. Their job is too important. With nearly a third of the panel receiving consulting fees from the industry. the appearance of conflict of interest is undeniable. Unfortunately. the newlyestablished Drug Safety Oversight Board will suffer from similar problems. Despite the claims that the board will be independent. all but two members of the board will be FDA employees. What is more. the board will include FDA employees from the Office of New Drugs. the entity that approved the drugs in the first place. What incentive would board members truly have to conclude the decisions made by the FDA were mistakes in judgment and should be reversed? Even less likely is the chance that the board members from the Office of New Drugs would vote to reverse their own decisions or those of their closest colleagues when it comes to drug safety. Mr. Speaker. the makeup of this board is more incestuous than independent. and. unfortunately. this problem pervades the entire FDA approval process. not just approval of pharmaceuticals. We have experienced it in our own efforts to keep silicone breast implants off the market. When the implant manufacturers came before the FDA. 40 percent of the advisory panel was made up of plastic surgeons. Needless to say. each of the plastic surgeons voted to approve silicone breast implants. There is a conflict of interest if I ever saw one. since plastic surgeons are virtually guaranteed more business if the FDA approves again the use of silicone breast implants. Despite the panels recommendation to approve the device. the FDA. thank. goodness. recognized the need for additional clinical trials. and rejected that H816 Co application. Now. with. another advisory panel in the works. we face another uphill battle to ensure that decisions are based on science alone. rather than tainted by conflicts of interest. Like device approval. the FDA approval process for pharmaceuticals no longer reflects publics use of these products. Whereas the FDA approval process is based on clinical trials with small samples and short durations. the drug industry is now geared to treating. chronic conditions. such as high cholesterol and arthritis. that affect millions of Americans for decades at a time. In a rush to get these drugs to market. the FDA relies on preliminary studies with little insight into longterm risk.. telling manufacturers they will get conditional approval as long as they conduct postmarket studies. The problem is. the FDA has no enforcement authority to mandate these studies. With the drugs on the market and the profits rolling in. the manufacturers have nothing to gain from conducting the postmarket studies. The statistics paint a crystal clear picture. As of September 2003. drug manufacturers agreed to perform 1.338 postmarket studies. The FDA has reported. however. that twothirds of them have not even begun that agreement from September of 2003. All the while. manufacturers can either market these products to physicians or directly to the -public. .who equate the FDA stamp of approval with safety. Mr. Speaker. we need to give the FDA the tools to hold drug manufacturers to their agreement to do the postmarket studies. If they are fined for noncompliance or barred from direct advertising until the studies are completed. maybe the manufacturers would have an incentive to get moving on these studies. The FDAs regulatory authority. needs some teeth. Creating this Drug Safety Oversight Board takes us in the opposite direction by simply rearranging the deck chairs on a sinking ship. If this is how the FDA intends to get back* to business. then business as usual is simply not good enough.