Washington Post Examines FDA Actions on Drug Regulation in Recent Years
FDA in the past four years has taken a "noticeably less-aggressive approach toward policing drugs that cause harmful side effects," leading some observers to "complain that the agency is focusing more on bolstering the pharmaceutical industry than protecting public health," the Washington Post reports. According to the Post, a review of agency actions shows that in recent years, fewer medications have been taken off the market and fewer warning letters have been sent to pharmaceutical companies challenging "misleading or dishonest drug advertising." From 1996 to 2001, 10 medications were taken off the market, compared with the recall of three "important" medications from 2001 to 2004 -- even as the annual number of adverse events reports doubled between 1996 and 2004, according to the Post.
In addition, FDA sent about 130 "cease-and-desist" letters concerning medication marketing practices in the past four years, compared with 480 between 1996 and 2001, the Post reports. Some lawmakers, scientists and consumer advocates have expressed concern that FDA has "tilted from its public health mandate toward a focus on industry needs." Such critics note that FDA lawyers under the Bush administration have worked to block product liability lawsuits by arguing that only FDA has the authority to determine when and how pharmaceutical companies should issue product warnings and that state court decisions could undermine the agency's authority over product labels. Another concern stems from the passage of a 1992 law that requires the pharmaceutical industry to "assume a significant share of the costs of evaluating new drugs," prompting questions of conflicts of interest. Under that law, pharmaceutical companies fund more than half of the FDA Center for Drug Evaluation and Research's annual budget of close to $500 million.
Sen. Chuck Grassley (R-Iowa) has proposed FDA reform measures, such as "beef[ing] up" the agency's Office of Drug Safety and making it more independent from the Office of New Drugs, which reviews and approves drug applications, according to the Post. He says the move would allow the safety office to more readily acknowledge when treatments were approved in error. Grassley said, "The kind of mismanagement we've seen this year by the Food and Drug Administration demands tough scrutiny," adding, "One of my concerns is that the FDA has a relationship with drug companies that is too cozy. That's exactly the opposite of what it should be. The health and safety of the public must be the FDA's first and only concern."
Curt Furberg -- a drug safety expert at Vanderbilt University who was removed from an FDA advisory panel set to review the safety of COX-2 inhibitors next year after he publicly questioned the safety of Pfizer's Bextra -- also supports boosting the safety office's independence. Furberg said, "I think what we've seen in the United States is that the FDA and industry have gotten very successful at getting drugs to the market based on their efficacy. But that has come at a cost: We are discovering the safety problems here after the drug has been on the market and widely used. ... This is why I say safety has become a stepchild to the agency and the process." Jerry Avorn, a Harvard University drug safety specialist, said recent events "pretty clearly indicate the safety surveillance system isn't working. It's a little like driving drunk. You can go for a number of trips inebriated and not get in an accident, but the risk is there and eventually you'll have a crash."
CDER Acting Director Steven Galson said FDA has "learned some important lessons in the past year and will make some changes," adding that the agency has "taken the criticism to heart." However, he added there is no reason to create an independent safety office and suggested that the decline in recalls could be attributed to a drop in new drug approvals. He also said the decline in enforcement letters about prescription drug marketing resulted from providing better guidance from FDA to pharmaceutical companies before they launch promotional campaigns. Galson added that while he saw no significance in the decrease of recalled medications, the rise in adverse-event reports "was of some concern."
Alan Goldhammer, associate vice president of the Pharmaceutical Research and Manufacturers of America, said that fewer drugs have been submitted and approved since 2001 and noted that FDA increasingly has sought out signs of liver- and heart-damaging side effects before approving new drugs, so some potentially dangerous drugs have never reached the market. "Drugs are approved based on an evaluation of both the benefits and the risks," Goldhammer said, adding, "There is no drug on the market without some risk" (Kaufman/Masters, Washington Post, 11/18).
The fact that FDA this week strengthened the warning on mifepristone -- a drug taken to induce a medical abortion -- three months after it caused a death by blood poisoning was "surprising," considering Merck's arthritis drug Vioxx "stayed on the market for four years after FDA officials first learned it increased the risk of heart attack and stroke," a St. Louis Post-Dispatch editorial states.
The editorial questions whether "the agency's quick reaction results from concerns about safety, or from the Bush administration's opposition to abortion in general and the easy access to the drug in particular." The "speed" with which FDA made the mifepristone decision "certainly makes it look like red meat tossed to the pro-life voters who returned Mr. Bush to the White House," and "if that's the case, it does not bode well for the integrity of the FDA or the future of reproductive choice in America," the editorial concludes (St. Louis Post-Dispatch, 11/18).