Advocates and critics of homeopathic therapies went head to head Monday and Tuesday over the value of these controversial products and whether they should be regulated by the Food and Drug Administration the same way conventional pharmaceutical products are.
The FDA held the two-day listening session in Silver Springs, Md., to consider whether to require that homeopathic remedies go through clinical trials to be proven safe and effective. Since 1988, the agency has allowed the sale of homeopathic products without such studies. The products are only required to meet standards for product strength, quality and purity as stated in the Homeopathic Pharmacopeia of the United States.
Homeopathy therapies are based on a concept originated in Germany during the 1700s that “like cures like,” in other words, that substances that cause disease symptoms in a healthy person can be used to cure that illness if the substances are greatly diluted.
The FDA said it called the session out of concern about the growth of the homeopathic industry and the fact that it has had to issue a series of warnings in recent years about individual products. Those products included a purported cold remedy, Zicam, associated with more than 130 reports of loss of the sense of smell, and Hyland's teething tablets marketed to alleviate babies' teething pain. Those tablets were found to contain toxic levels of belladonna.
On Tuesday, advocates of homeopathic remedies argued against tougher FDA regulation, saying the current framework has been effective. “We are confident that the majority of homeopathic drug products in the market are manufactured and labeled in substantial compliance with the Compliance Policy Guide (CPG) and the Food, Drug and Cosmetic Act, ensuring consumers have access to safe and clearly identified homeopathic products to choose from for their healthcare needs,” the American Association of Homeopathic Pharmacists said in a written statement.
But critics argued during the FDA sessions that homeopathic therapies are pseudoscience, and that such products should have to undergo the same type of clinical testing for safety and effectiveness that are required of other drugs before gaining approval to enter the market.
Homeopathic medicine sales reached nearly $3 billion in 2007, according to the Centers for Disease Control and Prevention. The FDA is reviewing its policy in light of the dramatic increase in the homeopathic product marketplace over the last 25 years, the agency said in a written statement.
Homeopathic products are often sold on pharmacy store shelves alongside over-the-counter drugs like aspirin and ibuprofen.
The FDA also cited the availability of more scientific data than it had back in 1988. Studies have found little evidence that homeopathic remedies are effective.
In March, the FDA issued a consumer safety warning recommending the public not rely on asthma products labeled as homeopathic that were sold over-the-counter since they had not been evaluated for safety or effectiveness. The agency noted that asthma can be fatal if not properly managed.
A report released in March by Australia's National Health and Medical Research Council (PDF) found no reliable evidence that homeopathic therapies are effective for treating any health condition. It concluded that these products “should not be used to treat health conditions that are chronic, serious or could become serious.”
An FDA official told the Washington Post that the agency has not made any decisions about whether to change its regulatory approach to homeopathic remedies and is simply gathering information.
