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In a previous blog I discussed the Wyeth v. Levine case, soon to be argued in front of the United States Supreme Court, where the FDA takes the stance that federal drug-approval and warning-label standards should trump stricter state laws. In other words, the FDA wants the high court to preempt lawsuits in state courts over federally regulated drugs.

In an interesting turn of events an inter-office memo was discovered that directly contradicts the FDA’s current stance. The memo stated that "it is wrong to assume that FDA-approved drugs labels are completely reliable, or that they are based on full disclosure of safety risks by drug makers." A top official for the FDA, John Jenkins, wrote "[m]uch of the argument for why we are proposing pre-emption seems to be based on the false assumption that the FDA approved labeling is fully accurate and up-to-date in a real time basis." The associate director of the FDA’s drug evaluation and research division, Jane Axelrad, said the rule then under debate "is not, as it purports to be, consistent with the agency’s role in protecting human health." So that begs the question, what is the role of the FDA? The FDA’s stated purpose reads:

The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

In other words, the FDA exists to protect the people, so why is the FDA now attempting to limit recourse against wrongdoers? Coming from Michigan, I know what it is like for people who have been injured by a drug company’s negligence, but because they are in Michigan, they cannot hold the drug company responsible or accountable. Please don’t let the rest of the country go the way Michigan has. It is the FDA’s job to get the public "accurate, science-based information they need to use medications and foods to improve their health." In order to comply with that purpose, federal preemption cannot be allowed. Drug companies should be held accountable and the states should be able to increase the requirements on drug labels, because in the words of Jane Axelrad, "[w]e rarely find ourselves in situations where sponsors want to disclose more risk information than we think is necessary. To the contrary, we usually find ourselves dealing with situations where sponsors want to minimize the risk information." It’s time for the FDA to do their job and protect the people, not the pharmaceutical industry.

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