Homeopathic Regulation Critics Will Swing For Change Against Industry Stalwarts At FDA Hearing

In addition to marketers and trade groups, Gary Yingling, a former FDA counsel involved in the agency’s decision to omit homeopathics from the OTC drug review, will make a presentation at a public hearing April 20-21. FDA’s current approach as “a rational framework,” CHPA says.

FDA will hear arguments at a public hearing to continue its current homeopathics regulatory framework from a former agency counsel involved in its decision to separate its review of the product category from conventional OTCs.

In addition to presentations by trade and professional groups for the industry during the April 20-21 hearing at FDA’s White Oak headquarters campus in Silver Spring, Md., making the case for maintaining the existing regulatory policy will be trade groups not directly linked to the homeopathic market, the Consumer Healthcare Products Association and the American Herbal Products Association.

While the hearing agenda is heavily weighted toward supporters of the current regulatory framework, arguments or suggestions for changes in homeopathic industry regulation will come from speakers including Adriane Fugh‐Berman, a Georgetown University Medical Center professor of pharmacology and physiology who also worked for National Institutes of Health’s alternative medicine office and consulted with the Federal Trade Commission on dietary supplements.

Also recommending changes will be the Center for Inquiry, which asked FDA in a 2012 citizen petition to initiate a rulemaking to require the products meet standards of effectiveness set for nonprescription pharmaceuticals, or bear a label disclaimer that the agency has not evaluated the quality, safety or efficacy on products that fail to meet those standards (Also see "Science-Based Evaluation Advocates Want Tighter Homeopathic Oversight" - Pink Sheet, 3 Oct, 2011.).

Michael De Dora, director of the center’s Office of Public Policy and its representative to the United Nations, will make the center’s presentation in the first group of speakers in the hearing’s first day.

Yingling Presents For HPCUS

FDA’s Center for Drug Evaluation and Research said in a March 27 Federal Register notice that the hearing – “Homeopathic Product Regulation: Evaluating FDA’s Regulatory Framework After a Quarter-Century” – will start a review of homeopathic drug regulations separate from the agency’s OTC drug review (Also see "GNC, Rite Aid expansion plans" - Pink Sheet, 13 Aug, 2007.).

Gary Yingling, a former FDA assistant counsel who was part of the agency’s 1972 decision to defer a separate review of homeopathic drug regulations, will represent the Homeopathic Pharmacopoeia Convention of the United States, which compiles a monograph that FDA recognizes as the standard for approved ingredients. J.P. Borneman, HPCUS president and CEO of homeopathics firms Hylands Inc., and former convention board member Todd Hoover, a physician, will present with Yingling.

FDA’s Compliance Policy Guide on homeopathy “provides a sufficiently substantial regulatory platform for homeopathic drug product oversight.” – attorney Will Woodlee for AHPA

Yingling, senior counsel at Morgan Lewis & Bockius LLP in Washington, managed the initial OTC drug review for establishing monographs in 1972 and 1973 during his work as an assistant counsel at FDA. According to records of FDA officials’ meetings with members of the public, Yingling and other agency staff in February 1972 discussed with homeopathic industry stakeholders whether FDA would include homeopathic ingredients in the drug review, which created the OTC monograph system.

In describing how and by whom homeopathic drugs were tested, the industry representatives explained that because the majority of testing was done in the 19th century and had not been repeated, only limited recent documented research reports would be available. They said homeopathic "proving" differs from pharmacologic testing because the practice of homeopathy is based on using a drug with a pathogenicity matching a patient’s symptoms and matching the medications to the "totality" of the patient without attempting a statistical determination of efficacy, according to the FDA record of the meeting.

Agency officials recommended the industry submit comments on the January 1972 OTC drug review proposal and FDA would consider those and other comments in determining whether homeopathic ingredients would be part of the review.

FDA later that year deferred its consideration of a regulatory framework for homeopathic ingredients, and in 1988 published the Compliance Policy Guide, which recognizes an ingredient’s inclusion in the HPCUS monograph as approval to be marketed in the U.S.

While traditional pharmaceuticals must meet standards set by the U.S. Pharmacopeia, FDA’s pre-market approval is required for Rx and nonprescription drugs, with some OTC products allowed for sale through compliance with monographs rather than through applications to the agency.

Another attorney influential in FDA’s approach to homeopathics oversight, Alvin Lorman, also will speak at the hearing. Lorman, of Washington, represented the industry in discussions with FDA that led to publication of the agency’s homeopathy CPG.

According to Lorman’s website, the CPG on homeopathy led “to a dramatic increase in the availability of homeopathic products.” The website also notes Lorman has represented the homeopathic industry in a series of unfair competition and false advertising cases brought in the California state courts.

Sufficient, Rational Regulation

According to AHPA’s presentation prepared for the hearing posted April 17 on FDA’s website, the trade group says the agency’s Compliance Policy Guide on homeopathy “provides a sufficiently substantial regulatory platform for homeopathic drug product oversight.”

AHPA’s representative, Will Woodlee, an attorney with Kleinfeld, Kaplan & Becker LLP in Washington, explains in the presentation that homeopathic manufacturers, like all firms marketing drugs in the U.S., must submit to FDA annual establishment registrations that identify products not listed on a firm’s previous registration.

“The various types of information required to be submitted for each drug listing is substantial,” as required in FDA’s May 2009 Guidance for Industry: Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing, Woodlee said. “The requirements for drug listing are the same for prescription and OTC drugs,” he said.

FDA can determine from online searches whether firms are marketing unregistered homeopathic or other drugs and conduct enforcement against those products. With this capability, FDA does not need to conduct review homeopathics in the same way it reviews other OTCs, Woodlee said.

The internet “may have obviated the need for a formal regulatory process to gather information about this product category and provides a means of identifying manufacturers, marketers, and products as candidates for education, administrative, or enforcement action,” according to Woodlee’s presentation for AHPA.

Additionally, as OTC drugs, homepathics are subject to FDA’s requirement that firms marketing the products submit reports on serious adverse events to the agency and maintain records of AERs made by consumers or other parties.

The “additional mechanisms in place in the United States, including reporting of adverse events to FDA by poison control centers, healthcare professionals, and the general public, augment mandatory industry reporting and FDA’s acquisition of other ‘signals’ of possible safety issues associated with such products,” Woodlee said.

He added that AHPA is not aware of any data indicating consumers perceive OTC homeopathics as substitutes for Rx drugs approved for treating serious medical conditions.

CHPA’s presentation says the organization supports FDA’s current approach as “a rational framework.”

In addition to annual registration, product listing and AER requirements, homeopathic manufacturers are subject to FDA’s good manufacturing practices for drugs and labeling regulations and to the standards set in the HPCUS, according to CHPA’s presentation.

Consumers ‘Greatly Appreciate’ Choice

The industry’s interests also will be represented by the American Association of Homeopathic Pharmacists and other academic, research centers, institutes and trade associations; naturopathic and homeopathic practitioners and physicians groups; and product marketers including M’lou Arnett, CEO of Zicam cold remedy brand manufacturer [Matrixx Initiatives Inc.]

Additionally, Wayne Jonas, a physician who during 1995-1998 was the National Institutes of Health’s alternative medicine research director, will offer information supporting homeopathy.

Jonas is president and CEO of Samueli Institute for research on healing, wellbeing and resilience aimed at “fostering wellness through self-care to create a flourishing society,” according to its website. He has conducted research on homeopathy, electro-acupuncture, and nutritional supplements in addition to his operating his conventional medical practice.

The National Center for Homeopathy’s executive director, Alison Teitelbaum, prepared a presentation that addresses two questions CDER suggested for comments, and points out FDA’s notice for the hearing provides part of an answer to one.

On the question, “What are consumer and health care provider attitudes towards human drug and biological products labeled as homeopathic?” Teitelbaum noted FDA’s notice states that “the homeopathic drug industry has continued on an upward growth trajectory since” the CPG was issued in 1988.

“Most consumers have no idea what homeopathy is and may assume that these products are dietary supplements or even conventional drugs. Consumers (and, probably, most health professionals) are unaware that FDA does not review homeopathic drugs for safety or efficacy.” – Adriane Fugh‐Berman, Georgetown University Medical Center professor of pharmacology and physiology

She also stated that the center’s “interactions with consumers indicate that consumer attitudes about homeopathic products are very positive” and consumers “greatly appreciate the opportunity for choice when selecting over-the-counter remedies.”

Addressing FDA’s question on whether consumers and health care providers have adequate information to make informed decisions about homeopathics, Teitelbaum said “as the homeopathic organization most visible to the public, we receive calls and inquiries from consumers every week about homeopathy. We do not receive inquiries from consumers expressing confusion about these over the counter products or requesting additional information to assist them in making a decision about using a product labeled as homeopathic.”

“If consumers routinely experienced confusion about homeopathic drug products when making purchase decisions about over the counter products, we would receive inquiries about this issue,” she added.

OTC Homeopathics Confuse Consumers

Georgetown’s Fugh‐Berman does not agree on consumers’ understanding of OTC homepathics.

In her presentation, she said the majority of currently OTC homeopathics today represent ingredient mixtures, such as a remedy for attention deficit disorder with “no fewer than 22” Homeopathic Pharmacopoeia of the U.S. ingredients.

And selling homeopathic remedies labeled for specific symptoms or conditions alongside conventional OTCs on stores shelves “is innately misleading,” Fugh-Berman said.

“Most consumers have no idea what homeopathy is and may assume that these products are dietary supplements or even conventional drugs. Consumers (and, probably, most health professionals) are unaware that FDA does not review homeopathic drugs for safety or efficacy,” according to her presentation.

Fugh‐Berman also pointed out that “classical homeopathy,” by targeting “a precise match between a patient’s symptoms and temperament and a single remedy,” could be called “an early form of personalized medicine.”

But OTC access to the products does not provide the same precision for consumers as Rx homeopathy.

Fugh‐Berman said “sequestered racks of individual homeopathic remedies, ordered or compounded by prescription, and administered by those with specialized knowledge, have not and should not be a regulatory concern.”

The hearing will start at 9 a.m. both days, with CDER Director Janet Woodcock making opening remarks on the first day. The panel of FDA officials who will consider the speakers’ comments and ask questions following their presentations includes Theresa Michele, director of CDER’s Division of Nonprescription Drug Products, and Brad Pace, supervisory regulatory counsel in the center’s Office of Compliance.