Commerce, Justice, Science, and Related Agencies Appropriations Act, 2020

Floor Speech

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Mr. BIGGS. 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Chair, I rise in support of my amendment that prevents funds from being used to finalize, implement, or enforce the draft guidance issued by the Food and Drug Administration in December of 2017, titled, ``Drug Products Labeled as Homeopathic Guidance for FDA Staff and Industry.''

The 2017 draft guidance actually upends three decades of settled enforcement practice in homeopathy without a compelling reason or with no directive from Congress.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. The result is a poorly worded document that does not do what it purports to do.

Instead, this guidance covers all products labeled as homeopathic rather than distinguishing between those falsely labeled as homeopathic and those that are actually homeopathic medicines which have already been proven to be safe and effective. As written, the guidance threatens to limit access to safe and effective homeopathic medicines by subjecting them to new enforcement actions inconsistent with past practice and existing law.

The draft guidance purports to address improperly manufactured homeopathic products, and I support that, but the draft guidance drops the explicit manufacturing guidelines already contained in the existing guidance. Under the draft guidance, Americans would have fewer assurances that their homeopathic medicines are pure and properly manufactured.

The problems that FDA cites as reasons for introducing the draft guidance, falsely labeled products and improperly manufactured products, are actually better addressed under the current guidance, and the FDA has been effectively addressing these issues for the last 30 years.

This draft guidance is an unnecessary regulatory overreach, and I urge all Members to support this amendment.

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Mr. BIGGS. Madam Chair, I thank the gentleman for his comments and Ranking Member Fortenberry's assurances that we can get together with the FDA and see what we can do to resolve this very difficult issue. I look forward to working with him on this issue going forward.

Madam Chair, I yield back the balance of my time and withdraw my amendment.

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