The Blame Game

The NY Times recently reported on how Johnson & Johnson and other companies like it have been using the FDA to fight, and more importantly win, lawsuits. This legal argument, called pre-emption, follows likes so: the drug companies are claiming that because the FDA approved the drug, they are protected from any law suit. In the past, the courts have ruled against it, but lawyers and drug companies claim that they are on the verge of success.

Even though the argument itself goes against logic and ethics, the fundamental premise of the argument itself doesn’t hold. The drug companies would have you believe that it is the FDA that approves the drugs, but in essence, when the company sends the FDA the drug, they send their approval letter with it.

The FDA doesn’t actually conduct any of its own independent tests on these drugs, it gets tests results from the companies that make them and then compare those results to their own standards. In the case of Johnson & and Johnson, the test results for its Ortho Evra birth control patch had almost 30 more micrograms of estrogen than the limit that the FDA has banned in 1988. The FDA found this violation after consumption has already begun. A Johnson & and Johnson scientist concluded that they had forgotten to add a “correction factor” in their mathematical equation which reduced the amount of estrogen by 40%. Was the product changed? No, just the report. Did the FDA follow up with tests or penalize the FDA? No, the FDA, when they catch those who have broken the agency rules, does not penalize them. FDA supporter claim “These are scientists, not cops”. But how does the FDA regulate drugs if they aren't testing or penalizing companies who break the safety guidelines?

The drug companies of course know how understaffed and inefficient the FDA is and as one can see, takes full advantage of it. The FDA is an example of an institution that created an incentive for drug companies to not follow regulations. The result is then the production of dangerous drugs like Ortho Evra. But the reason we don’t have mass deaths due to dangerous drugs is because drug companies, though they are not afraid of the FDA, are afraid of lawsuits. After the first lawsuit against Johnson & Johnson for Ortho Evra, prescriptions went down 80% and its stock took a similar tumble. With such a structure, consumers were encouraged to file lawsuits against harmful drugs. If the pre-emption argument holds in court, the consumers won’t have any protection. But there is a silver lining. If consumer’s outcry is heard, maybe this change in the health care structure will create a new incentive for the FDA to be tougher on drug companies. Maybe the FDA will hold drug companies liable so we don’t have to; the result from the new institution and thus incentive, being the production of safer drugs.