So far this year the U.S. Food and Drug Administration (FDA) reports that drug companies have "voluntarily" recalled more than 30 prescription drugs. I know this because I am a class action lawyer who spends his professional days and nights suing drug companies. But how are average American consumers supposed to know when their medicines may be killing them?
Prescription drug recalls in the United States are almost always voluntary -- occurring only if and when a company discovers some kind of problem and recalls the product on its own. Occasionally, a drug company will recall a product after the FDA raises concerns, but rarely if ever does the FDA actually request or order a recall. According to the FDA, it views its role as simply to oversee the company's recall strategy and determine if the recall notice is adequate.
FDA recalls are classified as Class I, Class II, Class III, or Market Withdrawals:
Class I Recall: Evidence shows "a reasonable probability" that the drug will cause "serious adverse health consequences or death."
Class II Recall: Use "may cause temporary or medically reversible adverse health consequences."
Class III Recall: Use "not likely" to cause adverse health consequences.
Market Withdrawal: Drug has a "minor violation" such as a risk for tampering.
For the last two years the FDA has been unsuccessfully experimenting with a weekly "enforcement report" -- a pilot program for how to best notify Americans that the drugs they may be taking have been recalled.
The notification is a confusing and ambiguous list of drugs that are posted every Wednesday on an obscure FDA website. Last week's report listed dozens of Class I recalls -- ranging from veterinary products to pistachios, and two prescription drugs, Mitosol made by Mobius Therapeutics LLC, and Magnesium Sulfate made by Med Prep Consulting, Inc.
One of the obvious problems with the FDA's weekly reporting scheme occurs when a manufacturer recalls a drug a day after the report is released. For example, a third drug was recalled last week when Nexus Pharmaceuticals Inc. issued a voluntary nationwide recall of benztropine mesylate injections after the FDA's weekly report was issued, so it did not make the list, even though the manufacturer stated that it has been associated with life-threatening thromboembolisms. Probably nobody knows.
On a separate website, the FDA names dozens of drugs as "pending classification," as apparently an overwhelmed and understaffed FDA is unable to keep up with the increasing number of recalled drugs and cannot classify them fast enough.
For some reason, the FDA chooses not to announce or even issue press releases for every recall. It actually seems as though the FDA avoids publicity about recalls -- stating on its website that it chooses to notify the media only when it believes that a recalled drug has been "widely distributed" to a "large number of people." I guess the FDA is just hoping that consumers are still reading newspapers, watching the evening news or following it on Twitter.
Solving the Recall Notification Problem
One obvious solution to the FDA's ineffective recall notification system is simply to mandate that all manufacturers of drugs that have been recalled contact all consumers via email and direct mail through the pharmacy, Medicare, and Medicaid. According to the United States Bureau of Labor and Statistics, the total value of U.S. consumption of pharmaceutical drugs is over $300 billion and growing. One would imagine that with financial firepower of that kind a more sophisticated method of alerting consumers about potentially fatal defective drugs could be employed, rather than hoping that one's grandmother will be able to navigate the complex date data buried deep in the FDA's website to learn that her diabetes drug has been recalled.
Perhaps the prescription drug industry's plan is to whisper bad news while screaming the praise of the latest and greatest new drug. Once the FDA forces drug manufacturers to directly contact consumers who have been prescribed or are taking recalled medicine, it will send a strong message that patient safety is more important than corporate profit.
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