Op-Ed - A 100th birthday -- not quite celebration

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Kathynye@... wrote: From: Kathynye@...Date: Mon, 10 Jul 2006 09:38:49 EDTSubject: POST: Op-Ed - A 100th birthday -- not quite celebration Kathynye@...Thank you Dr. Z. KNSubj: A 100th birthday -- not quite celebration Date: 7/10/2006 9:25:29 AM Eastern Standard Time From: dz@... Dear Friends,This op-ed went out over the Knight Ridder/McClatchey newswire last week. It was published in the Billings (MT) Gazette and the Augusta Chronicle, and possibly other newspapers. I tried to convey the crisis at the FDA in a way that would interest the average reader, and was pleased that these 2 newspapers reached an audience that

we don't normally reach. Best wishes, Zuckerman, Ph.D.PresidentNational Research Center for Women & Families1701 K Street, NW, Suite 700Washington, DC 20006(202) 223-4000www.center4research.orgGuest Opinion: FDA needs help to heal itself as it turns 100By DIANA ZUCKERMANLike most Americans, I love to celebrate our country's birthday every July 4. My ancestors came to the United States nearly penniless about 100 years ago, and I can truly be amazed at the opportunities and blessings our family has enjoyed. But there is another important birthday milestone that came just before July 4,

and that one is harder to celebrate. The Food and Drug Administration just turned 100 and is the "oldest U.S. consumer protection office" providing "Americans with increasingly comprehensive, science-based protections that ensure the highest quality of products essential for health and survival." At least that's what the FDA's Web site says. I'm not so sure about that. After more than its share of well-publicized botched decisions and apparent cover-ups on several widely used drugs and other medical products, from painkillers to anti-depressants to heart valves, the FDA is in trouble. The FDA is responsible for the safety of food and medical products representing 25 cents of every dollar we spend. Meanwhile, it's funding is completely inadequate for that safety mission, and it is struggling to do its job while overcoming a lot of bad publicity. They are promising to do better. But the evidence isn't reassuring. Limiting patient rightsLast week the FDA issued a final rule designed to take away a patient's ability to sue a company for failing to warn patients adequately of potentially lethal side effects of its medication if that medication has been approved by the FDA. Last week a congressional report made it clear that the FDA has repeatedly failed to enforce the nation's food and drug laws, neglecting to seize drugs and medical devices it knew were dangerous or defective. These two developments contradict each other. How can the FDA on the one hand say that FDA-approved products are rigorously regulated and therefore companies that make them can't be sued, when the evidence shows that companies frequently don't comply with FDA safety

requirements and the FDA does nothing about it? These two developments tarnish FDA's 100th birthday. The question is: What should we -- as individuals or a country -- do about it?So far, we've done almost nothing. The funding situation at the FDA has become so worrisome that FDA officials admit that they can't always do their jobs. Essential services such as surveillance of approved prescription drugs or medical devices just can't get much FDA scrutiny because the law requires them to concentrate on other activities. That's why we should no longer be surprised when a contact lens solution causes eye infections or an extremely popular anti-depressant is found to cause an increase in suicide attempts. Congress is criticizing the FDA for its poor safety record, but Congress hasn't increased funding to prevent more of the same. The public is oblivious. More funding is absolutely necessary, but with FDA undermining consumers' rights and protections, it's

hard to drum up enthusiasm. Dangerously underfundedShould we make sure that FDA gets the money it needs to do its job, even if it means taking funding from other essential programs, many of which are slated for dire cuts? Of course, there are plenty of programs that I wouldn't mind taking funding from, if it were up to me, but those kinds of cuts -- eliminating bridges to nowhere and other pet projects, don't seem to be in the realm of possibility with the current Congress. If we don't do something to support better safeguards for medical products, the protections we have relied on will grow weaker day by day. We can't let pharmaceutical company lobbyists and their pals in government undermine the FDA, and we can't punish the FDA for its mistakes by ignoring its financial plight. We celebrate July 4 because our country has done so much we can be proud of. In its illustrious past, from keeping thalidomide away from pregnant women to requiring

some of the first clinical trials in the world for medical devices, the FDA has been part of that pride, a leader that set a golden standard that most other countries have not met. The FDA is not perfect, but we can't just complain and hope things will get better. As part of its 100th birthday, we need to fight to make sure it does get better -- for all our sakes. Zuckerman is president of the National Research Center for Women & Families, a Washington research and advocacy center, 1701 K Street NW, Suite 701, Washington, D.C. 20006; Web site: www.center4research.org.