COL Congress must get answers about effectiveness of FDA

By Gil Gutknecht

In 1937, a "wonder drug" used to treat strep throat was marketed for use in children. But this drug's formula included a poisonous chemical, and the drug ultimately killed 107 people, mostly children. As a result, we created the U.S. Food and Drug Administration to help protect Americans from dangerous food and pharmaceuticals.

The FDA's mission is to promote and protect the public health by helping safe, effective and affordable products reach the market in a timely way, to monitor products for continued safety after they are in use, and to help the public get the accurate, science-based information needed to improve health.

On balance the FDA has done a pretty good job. But recent events have cast shadows of doubt on the FDA's abilities. The withdrawal of Vioxx, the discovery of side effects of antidepressants on children and the lack of flu vaccine weaken the public's confidence in the agency.

I believe it is imperative that the Congress -- Republicans especially -- get some answers about what is happening at the FDA.


Right now the FDA inspects less than 2 percent of the imported food supply -- yet food-borne diseases cause 76 million illnesses a year and an estimated 5,200 deaths. The FDA adamantly claims that importing prescription drugs is unsafe -- yet they are unable to identify a single American who has died from taking imported drugs. There is something seriously wrong with this picture.

Millions of American consumers are seeking access to more affordable markets in Canada and Europe. Instead of finding a way to help consumers do this safely, the FDA is doing everything in its power to stop them.

In September, the FDA peppered Oklahoma pharmacies with more than 50,000 pieces of "consumer education" materials outlining the so-called risks of prescription drug market access. This was the agency's response to the state's governor announcing that he would explore possibilities, such as opening prescription drugs markets, to reduce health care costs.

Last February, the FDA helped distribute to Illinois residents fliers touting the warning that prescription drugs from Canada might be "unsafe or ineffective." A representative from the FDA appeared at a press conference on the topic, but he could not cite a single case of a consumer being harmed by Canadian drugs.

Recently, the FDA sent inspectors to facilities in Germany and Canada in an attempt to secure extra flu vaccine dosages. Apparently the FDA can import vaccines when a critical shortage happens under their watch, but they can't find a way to import prescription drugs when prices are out of reach for too many Americans. Is it any wonder that they are losing the public's trust?

It's time for the FDA to redirect its efforts. The House of Representatives passed my prescription-drug-market access bill more than a year ago. For too long, my colleagues in the Senate have been hoodwinked by hundreds of pharmaceutical industry lobbyists. It would serve members of the Senate -- especially Republicans -- to remember that Harris polls suggest 84 percent of Americans support opening pharmaceutical markets. The FDA must stop obstructing the wishes of the American people and help devise a system to make market access work.

Nothing is more powerful than an idea whose time has come. The time has come to open pharmaceutical markets. I remain optimistic that the 109th Congress will be able to pass meaningful market access legislation.

If not, confidence in the FDA will continue to erode. Worse, angry taxpayers and disillusioned seniors will come looking for GOP defenders of an agency that looks like it's more interested in protecting pharmaceutical industry profits than our health.


That's not a good prescription for my party.

Gil Gutknecht represents Minnesota's 1st Congressional District in the U.S. House of Representatives.

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