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Shows & Panels
Prescription for Waxman
Tuesday - 11/4/2008, 7:07am EST
A recent report from the House Oversight and Government Reform Committee, chaired by Congressman Waxman, harshly criticizes the FDA for recent changes to FDA guidelines regarding the labeling of drugs.
Labeling pharmaceuticals is a critically important and complex issue. In fact, there is a high profile case before the Supreme Court on this very issue. But, underlying the illusion of concern for patients is another less palatable agenda. Trial lawyers want new opportunities to bring tort cases against drug makers.
The unintended consequence of Waxman's interference is that the tortuous FDA approval process that a new drug must successfully navigate could likely get a bit longer and a bit harder. The FDA would no longer represent a single national standard for drug approvals, and drug makers would need to seek similar labeling approvals from every state. The alternative is to risk potentially expensive litigation, in the event that unexpected side effects to the drug occur.
Difficulty in understanding the unintended consequences of legislative and executive mandates has long been a Washington weakness. But, no one has ever been quite so blissfully ignorant, or unconcerned, with the damage that his own actions have caused as Henry Waxman.
Let's consider what Waxman's unintended consequences have been to the FDA:
After a series of hostile hearings on drug safety conducted by Waxman's Committee, there has been (surprise, surprise) a sharp drop in the number of new drugs that are approved by the FDA. FDA officials, stung by the harsh criticism and the inquisitorial nature of Waxman's hearings, seem to have learned that the best way to avoid criticism for approving a new drug, is to approve fewer and fewer drugs.
Ten years ago, the FDA approved over 50 new drugs per year. Today, that rate has dropped to just about 10 new drugs a year. And, this surprising drop occurs at a time when pharmaceutical companies have dramatically increased their research and development efforts. So, the sharp reduction in drugs undergoing trials is certainly not because the drug companies are experimenting less. The reduction is a classic, bureaucratic response by the FDA. But, the costs of this more timid effort at the FDA are dire.
Terminally ill patients that need new drugs are denied access. Do you have a sick relative with a terrible disease that could benefit from a new drug? As a result of Henry Waxman's misguided efforts, they may not have access to those new medicines. Americans need to understand that, in the current climate, even fewer new medicines are going to reach the market.
Don't look for a "can-do" attitude at the FDA. Instead, it seems as if federal employees at FDA are afraid to act for fear of repercussions.
Congressman Waxman has helped to foster that "gotcha" environment by skillfully tapping "internal documents" that offer opposing views from within the FDA to any tough decision. Then, he bases his entire argument upon the dissenting view, while simultaneously ignoring the arguments that led senior management to make a different decision.
The reality is that every big decision comes with pluses and minuses and some risk. In any area of endeavor, management must balance the potential gains with the potential risks and make the wisest decision possible. What Congressman Waxman demands is a decision that is always perfect, that carries no risks, and that every agency employee involved agrees with.
Not everyone is unhappy with Congressmen's Waxman's castration of the FDA. Trial lawyers are licking their chops and eagerly look forward to this new opportunity to wring huge settlements from drug makers. That litigious zeal will certainly drive up the costs of drugs for the rest of us.
In addition, foreign hospitals and health care centers are now reporting a booming business. They offer Americans many of the high risk treatments, for terminally ill diseases, that remain unobtainable in the US. So, Americans are flying outside the country to receive treatments that might offer them a better chance for recovery and full health.
The FDA is charged with protecting the health of Americans by ensuring the safety and effectiveness of drugs and medical devices. And, most Americans, who are enjoying better health and longer life spans have reaped the benefits from FDA's protective vigilance.
But who is going to protect the FDA from Congressman Waxman?
Lurita Doan is the former Administrator of the U.S. General Services Administration.