AAHP’s Pivotal Years of Advocacy: 2010-2015
This article is part of a series on the history of AAHP that expands on information originally presented in AAHP’s 100th Anniversary Report.
AAHP’s activities rose to a new level in the 2010s after paving the way for a market boom in the 1980s. For one, the association’s educational events jumped to 17 in-person and virtual events during this decade whereas just one annual seminar was held in the past. During one three-year period, AAHP educated more than 500 people, engaging more and more members of the industry.
During this era, the association and FDA together addressed challenges with the electronic drug listing process that were unique to homeopathic products. Behind the scenes, AAHP worked with the Consumer Healthcare Products Association, a reciprocal member and ally, to ensure homeopathic prescription drugs were exempt from new supply chain requirements. AAHP also successfully defended the industry against unintended consequences of OTC monograph reform by monitoring and advising lawmakers on provisions of the legislation that would have subjected homeopathic manufacturers to user fees.
These efforts were the result of a federal relations program AAHP launched in 2011. For almost 15 years now, AAHP has been working to educate Congressional members and their staffers on homeopathic drug products and appropriate regulations. These continual Congressional educational meetings help ensure a favorable regulatory climate for homeopathic products while maintaining public safety.
The association’s federal relations program has also included:
- A Congressional luncheon briefing at the U.S. Capitol Visitor Center for dozens of Capitol Hill staff.
- Honoring Senator Tom Harkin (D-Iowa) with AAHP’s Legislative Excellence Award in appreciation for introducing and supporting legislation that safeguards Americans’ right to choose complementary health care.
- Honoring Senator Barbara Ann Mikulski (D-Maryland) with AAHP’s Legislative Excellence Award for her support of policies that safeguard homeopathic manufacturers and medicines.
- Organizing an intimate luncheon with Senator Bob Casey (D-Pennsylvania) with prominent members of the homeopathic community in Pennsylvania, including local NCH and AIH representatives and homeopathic manufacturers with employees in the state.
AAHP members have also since benefited from this program by receiving regular and breaking news reports of legislative and regulatory activities that may affect their business.
Then in 2015, FDA held a public hearing on the regulatory framework of homeopathy due to its concerns about unexpected market growth and corresponding safety statistics. Within three weeks, AAHP identified a wide variety of experts, obtained speaker time slots, and hired a firm specializing in FDA communications to review presentations and prepare the speakers. AAHP financially supported these efforts as well as hiring a prominent toxicologist to analyze data maintained by the American Association of Poison Control Centers (AAPCC). Some of the funding for this intense analysis was contributed by the Consumer Healthcare Products Association to whom AAHP expresses much gratitude for this support. The analysis revealed the number of exposures to homeopathic medicines in any given year was less than 1 percent of all pharmaceutical reports to AAPCC, which is proportionally below their market share. Furthermore, 99 percent of all exposures were managed outside of a health care facility.
Two years afterwards, FDA published a guidance document on homeopathic product enforcement, which underwent subsequent revisions.
Later in 2015, AAHP rallied again for the Federal Trade Commission (FTC) “Workshop on Homeopathic Medicine & Advertising.” The workshop focused on clinical trials of homeopathic products or a disclaimer statement on labeling and advertising.
The association identified, nominated, and prepped half of the 20 panelists/subject experts in industry growth, scientific support for advertising claims, and legal/regulatory issues, including class action lawsuits. The workshop resulted in FTC publishing an enforcement policy a year later, which included lengthy and inaccurate concepts recommended to be conveyed by the agency. AAHP met with FTC, developed a research protocol leading to the creation and consumer-testing of disclaimer language. This was presented to FTC and achieves both of its goals: to inform consumers about the nature of the evidence supporting homeopathic product claims; and to protect the seller from claims of misrepresenting the product. AAHP underwrote the costs of this effort in the amount of $100,000 — a sum that would have been difficult, if not impossible, for most companies on their own.
For activities related to the FDA Guidance and the FTC enforcement policy, AAHP members raised around $450,000. “That was heroic by our standards at the time,” recalls Mark Land, AAHP President. “It is a strong measurement of how much coalescence could happen within the membership. And it led the entire industry and homeopathic community.”
Read about the association’s most recent accomplishments in the last of our History of AAHP series.
This article is part of a series on the history of AAHP that expands on information originally presented in AAHP’s 100th Anniversary Report. The full series of articles includes sections on: