Federal court won't hear homeopathic drug suit, citing FDA's "extensive regulatory scheme"

Federal court won't hear homeopathic drug suit, citing FDA's "extensive regulatory scheme"

​There are plenty of reasons the FDA should begin regulating homeopathic drugs, a task Congress gave the FDA back in 1938.That's when Congress passed the Food, Drug & Cosmetic Act, which defines homeopathic remedies as drugs. In theory, at least, this meant the FDA should regulate homeopathic products just like any other prescription or OTC drug.  Because the FDA thought homeopathic drugs didn't present much of a safety issue, it blew Congress off for the next 75 years.

The FDA is now revisiting it's neglect of duty, a subject we've discussed several times over on SBM (also here and here). It held a two-day hearing and requested public comments on the subject. SFSBM submitted comments to the FDA, one among over 8,000 the FDA received. 

Because homeopathic drugs are based on a highly implausible "theory" and any number of studies have shown them to be ineffective for anything, the plaintiffs bar took note. Over the past few years, a number of class actions suits (also here) against homeopathic remedy manufacturers have been filed, alleging violation of various state consumer protection laws and common law fraud. It seemed like a no-brainer -- selling a product known to be ineffective for its intended use made these suits practically indefensible on the merits. Indeed, to my knowledge, all of these suits were settled.

The defendants, however, were not left wholly without a defense.  They regularly filed motions to dismiss based on preemption. That is, the defendants said that Congress had given the FDA the sole authority to determine the safety and efficacy of homeopathic drugs, as well as their labeling. These lawsuits, said the defendants, would interfere with that regulatory scheme and were therefore preempted by federal law. 

To which one federal district court basically said, "Ha! I don't think so." The court ruled that the FDA had essentially abandoned its authority to regulate homeopathic drugs. Instead, the FDA allows a private organization, the Homeopathic Pharmacopeia Congress of the U.S. (HPCUS), employing unknown standards, to decide what homeopathic substances can be used. (These substances include insects, diseased human and animal tissues, and poisons.) Whatever these standards are, according to the FDA, they do not mean that homeopathic products are safe, effective or not misbranded.  

The court didn't even mention the fact that the HPCUS is run solely by homeopathic industry insiders. It's hard to image a sweeter deal for any regulated industry. 

Now another federal court has decided the same issue and come to the opposite conclusion.  A class action was brought recently against Whole Foods in U.S. District Court for the Southern District of Florida, seeking both economic damages and injunctive relief, in the form of an order prohibiting further sale. The products at issue were Whole Foods house brand homeopathic remedies. 

Whole Foods was successful in its preemption defense, which knocked out the claims for injunctive relief.  Essentially the court ruled that the plaintiffs were trying to ban a product that the FDA allowed, something the court could not do. 

Whole Foods also won based on "primary jurisdiction."  This argument was based on the fact that Congress had determined the appropriate forum for deciding the issues raised by the plaintiffs -- the labeling of homeopathic drugs -- was the FDA, not the courts. Thus, this court must abstain from deciding those issues:

"The Food and Drug Administration has the necessary experience and expertise in regulating labeling of homeopathic medication and it is within the Agency's purview to decide whether the labels are compliant with federal law and the comprehensive regulatory scheme it has devised. . . . In this case, however, given the extensive regulatory scheme to oversee homeopathic drug marketing and the questions presented over the labels in this case, the Court finds abstention appropriate under the primary jurisdiction doctrine."

Both courts are right. There is, at least in theory, an "extensive regulatory scheme to oversee homeopathic drug marketing."  But, in fact, as the first court found, the FDA does virtually nothing to exercise the authority Congress gave it over homeopathic drugs.

Hopefully, the specter of leaving consumers with no possible remedy for the mendacity of homeopathic drug manufacturers will be one more reason the FDA is finally convinced to remedy the situation by regulating homeopathic drugs just like all other OTC and prescription drugs. Seventy-five years late is better than never. 

Points of Interest 08/18/2015
Points of Interest 08/14/2015