Successes, Serious Concerns, and No More Eye Drops!

Summary of Today’s Report:

Success in the Senate!

Our most important recent achievement is getting supportive language in the report accompanying the Senate Appropriations bill directing the FDA to work with the homeopathy community to develop a suitable regulatory framework for homeopathic medicines. The language recognizes that there should be “a legal pathway [for homeopathic medicines] that includes homeopathic specific standards for the regulation of these medicines.”

We are exceedingly grateful to the committee members for including this report language in the coming year’s appropriation. Report language tells agencies about concerns and policy positions of legislators on a variety of topics.

Here is the full report language regarding homeopathic medicines:

The Committee understands the importance of homeopathic medicines for millions of users. Consumers access and safety to these products are best ensured by implementing a legal pathway that includes homeopathic specific standards for the regulation of these medicines. The Committee understands FDA is limited to enforcing pharmaceutical specific standards when taking enforcement action against products labeled as homeopathic. The FDA’s interpretation of the law that all homeopathic medicines are unapproved new drugs that are illegally marketed has created confusion both for the homeopathic community and enforcement officials. The Committee directs the FDA to work with the homeopathic community with regards to the regulation of these medicines.

Action in the U.S. House of Representatives Falls Short

Several members of the U.S. House of Representatives attempted to get language into the Agriculture/FDA appropriations bill that would protect homeopathic medicines from arbitrary removals as a result of the FDA’s new interpretation of the law that all homeopathic drug products “may not be legally marketed.” Although there were over 87,000 messages from constituents sent to members requesting support for this language, the language was not included in the bill.

While we would have loved to move this interim remedy forward, we also viewed this effort as an opportunity to move one more step down the road to building the coalition we will need to pass legislation that will protect access to homeopathic medicines in the long run. It has allowed us to identify more supporters in the House and begin to work with them more closely.

We are, of course, exceedingly grateful to those members and staffers who supported these efforts for this much-needed stopgap measure. 

The FDA Strikes Again: No More Homeopathic Eye Drops

As we mentioned in an email earlier this month, the FDA has struck again with enforcement actions that could lead to the end of homeopathic eye drops in America. Six suppliers of homeopathic eye products have received warning letters with the all-too-familiar claims that the companies are illegally marketing unapproved new drugs. Among the companies targeted is the maker of the widely used Similasan brand of eye drops. The FDA has placed what is called an Import Alert on virtually all of Switzerland-based Similisan’s eye-related products. That means that those products are no longer allowed to enter the United States. And, Similasan is not the only company affected. US-based companies have also been targeted.

Given the FDA’s actions, we have a reasonable expectation that many of your favorite homeopathic eye drops will become unavailable in a very short time. While we cannot speak to any specific manufacturing violations cited by the FDA, we do know that CGMP violations don’t always equate to safety issues, the FDA cites no actual harm or adverse event reports, and many of you have been using some of these products without issue for decades. The intention of the FDA is clear, as the agency is now in the process of eliminating entire classes of homeopathic medicines—even though many of the products cited have been used safely and effectively for decades.

This is yet another example of why we need legislation to protect homeopathic medicines from the arbitrary actions of an agency that lacks expertise in homeopathic medicines and which has engaged in an abrupt about-face after previously allowing the legal marketing of homeopathic medicines for more than 80 years.

That’s it for our insider report this month, and we’ll be back next month with more updates.