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FDA Duplicity: Generic Promo Timely Insights on Laws, Issues and New Developements

The Cost of FDA Promotion

In a Feb. 21, 2013 web site article titled “Generic Drugs: Same Medicine, Lower Cost,” the FDA promotes the use of generic drugs; but the article also hides a dirty little secret: The FDA  fails to hold generic drug makers accountable when they are found to cause life-altering “side effects.”

The FDA fails utterly to protect consumers from dangerous generic drugs in the same manner in which the law protects consumers from brand-name drugs. You read that right. If you take a brand-name drug and suffer some horrible, life-altering “side effect,” such as, for example,  tardive dyskinesia (in the case of Reglan) – a debilitating nerve disorder for which there is no known cure – and you were given the brand-name drug by your pharmacist, you have a chance to face that drug’s maker in court and receive compensation for your injuries. If, on the other hand, you were given metoclopramide, the generic version of that same drug and you developed tardive dyskinesia as a result (as fully one in five people can), then you are likely to receive nothing. (See Pliva v. Mensing )

The FDA has the ability to do something about this miscarriage of justice, which occurred when the Supreme Court voted 5-4 in 2011 to insulate generic drug makers from liability when their drugs injure people. (see Alliance for Justice story). Writing for the majority, Clarence Thomas dispensed this pearl: “As always, Congress and the FDA retain the authority to change the laws and regulations if they so desire.”

So with the stroke of a pen, the FDA could hold generic drug makers liable for their dangerous drugs just as brand-name makers are held liable. And the agency needs to take that action if it expects citizens to trust it for advice when it shamelessly promotes generic drugs out in front of God and everybody on its web site while failing utterly to serve its main function as the nation’s police force for consumer safety. Promoting any of the 11,000 drugs the agency approves for the market without standing behind the people who take them as more of different drugs’ adverse events unfold over time, puts the agency in an untenable position, which only further tarnishes the FDA’s already ailing credibility.

FDA Priorities Skewed

If the agency has time to write promotions for generic drugs, why can’t it find the time to protect consumers from the very drugs (and by turn, the companies) which it promotes?

The cost of FDA promotion of generic drugs is precisely the further erosion of the agency’s  credibility. If the FDA sincerely wants consumers to save money by buying generic drugs (and 75 percent of drugs dispensed in the U.S. are generic), then it needs to change the law to protect citizens instead of multinational drug makers. Citizens deserve to have confidence in the safety of their FDA-approved drugs. The agency needs to step to the plate and bat for the citizens who fund it.


by Matthews & Associates

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