PA Homeopathy - Dr. Bernardo A. Merizalde

PA Homeopathy Blog

Apr 8, 2015

It is not too late to comment


The FDA public hearing regarding homeopathic product regulation is scheduled for April 20-21, 2015. Written or electronic comments will be accepted until June 22, 2015.

It is important that you add your comments or testimony. This hearing will be extended or cut short depending on the level of public participation.

I explained what is happening in my post Act Now.

You can also read the government brief at http://1.usa.gov/1CnurTM.

Please take the time to leave a comment for the FDA at http://1.usa.gov/19xDY02. Click the Comment Now! button in the upper right corner and share how your experience with homeopathic products answers one or more of the following questions:
• What are consumer and health care provider attitudes towards human drug and biological products labeled as homeopathic?
• What data sources can be identified or shared with FDA so that the Agency can better assess the risks and benefits of drug and biological products labeled as homeopathic?
• Are the current enforcement policies under the CPG appropriate to protect and promote public health in light of the tremendous growth in the homeopathic drug market? Are there alternatives to the current enforcement policies of the CPG that would inform FDA’s regulatory oversight of drugs labeled as homeopathic? If so, please explain.
• Are there areas of the current CPG that could benefit from additional clarity? If so, please explain.
• Is there information regarding the regulation of homeopathic products in other countries that could inform FDA's thinking in this area?
• A large majority of human drug products labeled as homeopathic are marketed as OTC drugs. These products are available for a wide variety of indications, and many of these indications have never been considered for OTC use under a formal regulatory process. What would be an appropriate regulatory process for evaluating such indications for OTC use?
• Given the wide range of indications on drug products labeled as homeopathic and available OTC, what processes do companies currently use to evaluate whether such products, including their indications for use, are appropriate for marketing as an OTC drug?
• Do consumers and health care providers have adequate information to make informed decisions about drug products labeled as homeopathic? If not, what information, including, for example, information in labeling, would allow consumers and health care providers to be better informed about products labeled as homeopathic?
Thank you.


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