Madam Chair, I yield myself such time as I may consume. Madam Chair, I rise in support of my amendment that prevents funds from being used to finalize, implement, or enforce the draft guidance issued by the Food and Drug Administration in December of 2017, titled, ``Drug Products Labeled as Homeopathic Guidance for FDA Staff and Industry.'' The 2017 draft guidance actually upends three decades of settled enforcement practice in homeopathy without a compelling reason or with no directive from Congress. My amendment would prevent that overreach and maintain the safe and effective guidance that has been in place since 1987. For decades, homeopathy has thrived as the fastest growing alternative to pharmaceuticals, and FDA estimates more than 3 million Americans use it. The products can be a natural alternative to addictive opioids in the management of pain and other conditions. The current guidance provides a precise definition of a homeopathic product and clear manufacturing standards. Violations of these standards are already subject to FDA enforcement. The proposed change in guidance goes too far by restricting access to safe homeopathic medicines, while also being less effective at regulating the safety and quality of homeopathic products. The new guidance replaces clear definitions with a vague, risk-based approach. By its own admission, the FDA failed to consult with consumers and those in the homeopathic community before they drafted this guidance.…
On the recordJune 20, 2019
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