In response to questions from Congress, the FDA makes clear that it refuses to back down in its fight against homeopathy. Action Alert!
Earlier this year, ANH supported a sign-on letter from Congress calling on the FDA to clarify how the agency will ensure continued access to important homeopathic medicines. This was in response to a major assault by the FDA that threatens the entire homeopathic industry by declaring that all homeopathic drugs are being marketed illegally. In its response, the FDA showed no signs that it will relent on its misguided policy. We must oppose their efforts.
In essence, the FDA’s response to Congress restates the agency’s position that all homeopathic products are being marketed illegally in the United States since none have been FDA approved, and nothing is preventing homeopathic medicines from becoming FDA approved.
This is not true. FDA approval requires randomized controlled trials (RCTs), which are massively expensive. This generally isn’t an issue for drug manufacturers because their products are patentable, and the costs of FDA approval can be recouped once the drug hits the market. Homeopathic products, like other natural medicines, are not as strongly patentable, since many of these substances are natural and have been in use for decades; some even longer. Therefore, the costs of running RCTs to prove safety and efficacy for homeopathic products cannot be recouped, putting FDA approval out of reach for these products.
In our view, the FDA understands all of this, and it is the intention of its policy to substantially restrict or eliminate homeopathic products to remove competition for pharmaceutical drugs.
We know this attack isn’t about protecting consumer safety. A review of the evidence of adverse events related to homeopathy, which included data from 12 European countries, the US, Mexico, India, Israel and Brazil published between 1978 and 2010, found a total of just 1,159 adverse events. This equates to an average of just over 50 cases per annum across all 17 countries from which studies were conducted. Worldwide, an estimated 200 million people use homeopathy regularly, including 6 million in the United States. These data show that adverse events from homeopathic medicines occur at a very, very low rate.
Our friends at Americans for Homeopathy Choice outline other issues raised by the FDA’s response to the Congressional letter. They note that the FDA has not addressed the Citizens Petition that was submitted challenging the agency’s homeopathy policy, nor has the agency responded to multiple Freedom of Information Act (FOIA) requests asking the agency to produce evidence of harm from homeopathic products, suggesting that the FDA does not have compelling evidence that homeopathic products are a public health concern.
Given the safety record of homeopathic products discussed above, cronyism is, in our view, the only adequate explanation of the agency’s actions. It is another example of government health bureaucrats looking out for industry’s bottom line rather than the health of consumers, and it must stop.
Action Alert! Fill out the form below to write to the FDA and Congress, calling on the agency to stop the attack on homeopathy. Please send your message immediately.