FDA Hearing on Homeopathic Medicines: What Is the Role of the Compounding Pharmacist?
This week, the FDA held a public hearing to evaluate the regulatory framework surrounding homeopathic drugs, including prescription drugs and biological and over-the-counter (OTC) products labeled as homeopathic. Homeopathy is an alternative form of medicine that operates under the notion that minute amounts of what ails a person can be used to cure him. The current FDA enforcement policies were issued in a 1988 guide, and state that homeopathic remedies need not undergo the efficacy and safety trials that pharmaceutical drugs must pass. However, as U.S. sales of homeopathic products top $1 billion annually, the FDA decided it is time to take another look at how homeopathic drugs really affect patient health.
Frankly, it’s due time. Many individuals who take prescription drugs also take homeopathic OTC remedies, such as pollen for allergy relief or flower essence for nerves. While patients taking these homeopathic treatments often tell their doctors what they are taking, without FDA guidance it’s difficult to have detailed, accurate information on drug effects and interactions. The arguments for and against homeopathic treatment are detailed and passionate — this week’s FDA hearing gave both camps the opportunity to discuss their concerns and advise the agency on how to care for patients best.
In a statement submitted to the panelists at the hearing, Dr. Adriane Fugh‐Berman, of Georgetown University Medical Center, wrote: “I am concerned about the current state of labeling for homeopathic remedies, particularly OTC preparations. Although the FDA has increased its focus on the safety, quality, and claims of dietary supplements (products that are not permitted to make “disease” claims), the agency has continued to defer its regulatory oversight of homeopathic drugs.” Considering how much effort the FDA goes through to ensure that pharmaceutical treatments and food are safe for people to consume, it’s troubling that the agency doesn’t take more precautions with homeopathic remedies.
The concern is one shared by many compounding pharmacists. As experts in drugs and how they interact, pharmacists are often the first resource patients turn to when they have questions about their medications. Pharmacists undergo rigorous education and training to understand the science behind the drugs they dispense and stay updated as new medicines become available. However, since homeopathic drugs are often sold side by side with regulated pharmaceuticals, it can be difficult to advise patients if their treatment profile is safe and what adverse symptoms to look out for. At best, compounding pharmacists can look to personal experience from their patients, or worse, from the same source many patients resort to — the Internet.
The American Association of Homeopathic Pharmacists does not necessarily share this concern. In their own presentation submitted to the FDA, Mr. Mark T. Land, president of the association, stated that the framework in the current policy guide gives ample counsel for proper labeling and how to act swiftly on issues of misbranding. “Consumers most likely to buy homeopathic medicines are committed to their health and devote considerable research effort in evaluating healthcare choices.” The same patients, then, should welcome the added information FDA oversight and labeling will provide.
Experts who have submitted opinions to the FDA include conventional physicians, alternative medicine practitioners, drug specialists and at least one compounding pharmacy. Panelists communicated with them, and others in attendance, on issues such as consumer and health care provider attitudes towards homeopathic products, how the current policy guide is effective and where it is lacking, and what information providers and consumers need to make informed decisions about these products.
Said Dr. Robert C. Dumont, of Raby Institute for Integrative Medicine at Northwestern, “Homeopathy has come to play a major role in my treatment regimens particularly as I have gained experience in its use. It has proved to be exceptionally versatile and efficacious for many medical problems both simple and more complex.” He believes that homeopathic medicines are invaluable but that lack of drug safety and interaction information can still be improved.
It is too soon to predict what the final outcome of the process will be, but judging from early response, homeopathy skeptics are making a strong case. If they have their way, compounding pharmacists should expect to see products like zinc sprays and lozenges, and belladonna-based teething tablets, yanked pending further trials. This may seem limiting in the short term; however, it may prove that safety and efficacy trials with these remedies can only help us do our job — helping our patients stay safe and healthy.
Whether you are preparing conventional or alternative treatments, Pharmaceutica North America would like to be your resource for safe, effective ingredients. Contact us today to see how we can help meet all of your pharmaceutical needs.