FDA Blasts Shots Over the Bow to Four Homeopathic Firms for CGMP Violations

 

In the not-too-distant past (April 2015), the FDA held a public hearing on potential changes to the enforcement policies and the regulatory approach associated with the marketing of homeopathic drug products.  The FDA indicated that it has not had a comprehensive review of the enforcement policies related to these products to reflect changes in the homeopathic market in over twenty-five years (twenty‑seven years now).  The docket established for comments stemming from the public meeting received over 3,500 public comments; some were in favor of continuing current policy as it is (which is essentially to do nothing) and some were in favor of a more stringent approach to evaluating the safety and effectiveness of these products and monitoring firms more closely for proper adherence to good manufacturing practices.  Currently, homeopathic products are marketed without FDA approval as long as they appear in and meet the conditions outlined in the Homeopathic Pharmacopoeia Convention of the United States (HPCUS).

Today, the FDA announced it has warned four “homeopathic firms for putting patients at risk with significant violations of manufacturing quality standards” (see FDA news release here).  The Warning Letters include one to a repeat offender that the FDA has previously warned about significant cGMP violations.  Could this signal a change in the FDA priority given to monitoring homeopathic firms, just before Commissioner Gottlieb leaves the Agency?  If so, what is next after his departure?

Gottlieb noted in the new release that the Agency is “committed to continue taking appropriate actions when we believe patients are being put at risk by products that contain potentially harmful ingredients or have significant quality issues…  Today we’ve also posted warnings letters to three other homeopathic drug manufacturers for additional concerns we’ve observed – from the use of toxic substances like snake venom that has the potential to cause harm and does not have demonstrated benefit, to other firms whose products we’ve found to be contaminated.  These actions build on similar steps we’ve taken over the past year, as we continue to see products labeled as homeopathic that are being marketed without approval for a wide array of diseases and conditions, from chronic pain to cancer.”  The Agency goes on to discuss its update on the exercise of its enforcement discretion and the risk-based approach it has been taking for these products.

“Products labeled as homeopathic have not been approved by the FDA for any use and may not meet modern standards for safety, effectiveness and quality.  Products labeled as homeopathic can be made from a wide range of substances, including ingredients derived from plants, healthy or diseased animal or human sources, minerals and chemicals.  These products are often marketed as natural, safe and effective alternatives to approved prescription and nonprescription products and are widely available in the marketplace.”

The Agency has issued several other Warning Letters (described in the release) and implies that it continues to look at the current regulatory scheme for marketing homeopathic drugs and whether the Agency needs to change the current approach, which may take some help from Congress.