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This op-ed was published in the Augusta Chronicle on July 4, Billings
Gazette on July 5, and other Knight Ridder / McClatchy newspapers,
July 5, 2006.
Guest Opinion: FDA needs help to heal itself as it turns 100
Like 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 rights
Last 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 underfunded
Should 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.
Diana Zuckerman is president of the National Research Center for Women &
Families, a Washington research and advocacy center, 1701 K Street NW, Suite
700, Washington, D.C. 20006; Web site: www.center4research.org.
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