Imported Drugs: FDA Suddenly Gets 'Concerned'

Rosa L. DeLauro is a member of the House of Representatives from Connecticut

If you ever needed evidence of a government agency in the pocket of the industry it is supposed to regulate, you need look no further than the U.S. Food and Drug Administration and its relationships with the pharmaceutical and food industries.

Under the law, the FDA is responsible for ensuring the safety of almost 80% of the food we consume, including fruits and vegetables. (The Department of Agriculture is responsible for the other 20%.) Given that, you might be surprised to learn that the FDA inspects only a little over 1% of the food imported into the U.S.

The agency's official policy is that imported foods pose "no additional risk," even though we have clear evidence that food-borne pathogens affect huge numbers of Americans -- 76 million illnesses, 325,000 hospitalizations and 5,000 deaths annually -- and that imported food causes some of that suffering. The agency has not requested, nor does it want, the authority to inspect foreign food processors. And the FDA has never suggested that we ban any of the imported food under its purview -- it insists that we have the safest supply of food in the world.

Contrast that with the FDA's newfound concern about the safety of imported drugs. The skyrocketing cost of prescription drugs in this country has forced millions of citizens to cross the border into Canada to buy their prescriptions at much lower prices.

Although technically illegal, for years the FDA has looked the other way, recognizing that for many in the U.S., especially seniors living on fixed incomes, going to Canada was the only feasible way they could afford the drugs they needed.

Two months ago, the House of Representatives passed legislation to legalize drug importation, in effect opening the door to a more organized and concerted effort to bring in cheaper drugs from Canada and other countries.

Cities like Springfield, Mass., have already moved to set up local prescription-drug programs to bring in drugs from Canada.

The drug companies view such programs as a serious threat to their bottom line and are doing everything they can to make sure the bill doesn't become law.

The companies' strategy has been to scare people into believing that imported drugs are not safe. They have found, through focus groups, that fear "moves the needle" of consumer perceptions, so now they are spending millions of dollars on scare ads paid for by organizations meant to look like senior advocacy groups.

It is to be expected that an industry will fight back when it sees its profitability endangered. What is unacceptable is that an industry is able to co-opt the FDA for its own selfish purposes.

It is curious that at exactly the time that the pharmaceutical industry is spending heavily to defeat legislation that overwhelmingly passed in the House, the FDA has suddenly become concerned about the "dangers" of imported drugs -- going so far as to recently conduct a series of "blitz exams" of drug shipments in an attempt to uncover unsafe medicines. In fact, the FDA cannot cite a single case in which an American became ill from using Canadian drugs, as William Hubbard, a senior associate commissioner at the FDA, told the House earlier this year.

The FDA is now telling us that bringing in drugs from other countries is not safe -- that the government cannot certify that those drugs pose no additional risk to Americans.

In reality, the safety issue is a red herring. The bill passed by the House in July would allow the importation of only FDA- approved drugs manufactured in FDA-approved facilities from 25 designated countries. It also would require that all prescription drugs use counterfeit- resistant packaging similar to the technology used for U.S. currency.

The FDA can't have it both ways. It loses all credibility by arguing that imported drugs made in facilities it has approved pose a serious danger to the public while assuring us that uninspected imported food is perfectly safe.

The FDA has lost track of its original mission of ensuring the safety of our food and drug supply and substituted a new agenda focused on protecting the profits of the pharmaceutical industry.

It needs to get back to the business of safety and its responsibility to protect the consumers of this nation.


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