Homeopathic Divide: FDA Talks Pre-Market Approval As Industry Floats Label Changes

FDA officials point out label changes would not resolve their concerns that homeopathics, unlike other Rx and OTC drug categories, are available without pre-market approval. Stakeholders emphasize the products’ safety while suggesting changes such as more information on labels to better identify ingredients.

Homeopathic industry stakeholders’ concessions on potential label changes or other relatively small adjustments to FDA’s regulation of their products might not be enough to convince the agency to continue giving the category a pass on pre-market approval.

Representatives of manufacturers, research and professional organizations and trade groups speaking at an April 20-21 public hearing for comment on FDA’s homeopathy market oversight emphasized the safety of Rx and OTC homeopathic drugs while allowing some changes could help, such as more information on product labels to better identify ingredients.

However, FDA officials participating in the hearing consistently pointed out that label changes would not resolve their concerns that homeopathics, unlike other Rx and OTC drug categories, are available without pre-market evaluation and approval by the agency.

“That’s the big difference there,” said Brad Pace, supervisory regulatory counsel in the Center for Drug Evaluation and Research’s Office of Compliance.

As Pace and the other panel members asked questions following the speakers’ presentations during the hearing, they acknowledged industry stakeholders’ exhortation that consumers should have a choice to use homeopathics.

“At the risk of sounding like a broken record, I know a lot of people have discussed consumer choice,” Pace said during the hearing’s second day.

But without FDA’s pre-market approval required for homeopathics, the agency is concerned whether consumers know what they are using. “That’s why I think we’re so concerned about consumers having an informed choice,” Pace said.

And while homeopathic product indications are based on “provings” – showing through observance how a substance affects healthy subjects, without comparisons to placebo groups – FDA approval of other Rx and OTC drugs rely on clinical trials, a point panel members made clear.

“Obviously, we do things pretty differently in the FDA,” said Elaine Lippmann, regulatory counsel in CDER’s Office of Regulatory Policy.

Following homeopathy physician Karl Robinson’s presentation, Lippmann asked whether CDER’s process of evaluating and approving conventional Rx and OTC drugs will work for homeopathics.

“It’s a totally different paradigm,” said Robinson, who practices in the Houston area. Randomized, clinical trials are “an option” for homeopathic ingredients, he added. “It has been done … but it’s difficult. In general, homeopathy is very much of an observational science.”

He said while other drug ingredients initially are tested on animals before trials with people with certain disease or health conditions, homeopathics “are only treated on healthy human beings.”

“It’s like comparing apples and eggs. It just doesn’t compare very well,” Robinson said.

Confusion An Issue Of Perspective

However, FDA is making comparisons in its consideration of ending its regulatory policy from a 1988 Compliance Policy Guide that recognizes an ingredient’s inclusion in the Homeopathic Pharmacopeia of the United States’ monograph as pre-market approval. The CPG does not exempt homeopathics from quality standards or from good manufacturing practices requirements, but shifts oversight of those to HPUS.

While speakers assured the panel members that few consumers are confused about homeopathics and practitioners easily help others understand the products, panel members asked for data to support their perception.

Lippmann and others pointed out that particularly with homeopathics stocked on retail shelves and listed on websites adjacent to allopathic OTCs, they are not convinced about the relative lack of confusion.

“What about the confusion the consumer might have in just an OTC environment, going into a pharmacy and seeing homeopathic remedies comingled or right next to allopathic OTC products, often in packaging that is made to appear very similar?” Lippmann asked after attorney Will Woodlee, representing the American Herbal Products Association, said AHPA is not aware of data showing confusion over whether homeopathics are replacements for Rx drugs for all conditions.

“I’m guessing that you probably don’t have that data, but I’m asking is that a concern you have?” she said.

“Generally speaking AHPA is concerned about consumer confusion and interested in ensuring that consumers understand what products are and what the risks, limitations and benefits of products are,” said Woodlee, with Kleinfeld, Kaplan & Becker LLP in Washington.

Although FDA officials questioned where retailers stock OTC homeopathics, the agency has little oversight of how a drug is available to consumers beyond determining whether a product requires a prescription. Requiring segregation of allopathic and homeopathic OTCs on retail shelves likely would come only from legislation and not an agency rulemaking.

Pseudoephedrine-containing nonprescription products currently are available only behind the counter due to federal law; the initial Plan B emergency contraceptive switch NDA was approved with the sponsor’s voluntary BTC condition; and some retailers sell hair-growth treatments, nicotine replacement therapies and other higher-cost products from locked displays to prevent losses to theft.

Look It Up Online?

Woodlee’s presentation also noted FDA can determine from online searches whether firms are marketing unregistered homeopathic or other drugs and conduct enforcement against those products.

But Theresa Michele, director of CDER’s Division of Nonprescription Drug Products, questioned whether online searches are an adequate regulatory tool.

“The internet is really a remarkable data source for everyone including FDA, but we all know that a whole variety of information can be posted on the internet … some of which may or may not be of complete veracity,” Michele said.

How should FDA “use that data source to ensure that we are getting the full information on each product?” she asked.

Woodlee explained that while FDA “is very experienced in processing what’s on the internet and understanding the limitations and the benefits of the information,” the agency would also need to gather material from trade shows, retailers and practitioners among other additional sources “to inform its regulatory decision-making.”

‘Complicated’ Label Questions

Michele and other panel members also questioned whether OTC homeopathic labels states sufficient and effective information. She questioned Robinson’s suggestion to remove indications from all OTC homeopathic labels.

“How would the consumer choose amongst the different medications that are on the market?” she said.

Robinson allowed that determining effective labeling for homeopathics is “a very complicated issue” and the solution could be FDA working with homeopathy professionals to write approved labels for the products.

“By the very nature of homeopathic medicines they have so many uses that how to label without causing confusion I simply don’t know,” he said.

In addition to removing indications, Robinson suggested that labels state that a product should not be used indefinitely and is not a substitute for conventional pharmaceutical treatment.

J.P. Borneman, the president of the Homeopathic Pharmacopoeia Convention of the United States, which compiles the monograph FDA recognizes as the standard for approved ingredients, also commented on potential labeling requirements.

Borneman, also CEO of homeopathics firms Hylands Inc., cautioned, though, that homeopathic labels “can be enhanced” without substantive changes to the current regulatory framework for the products.

Similarly, listing homeopathic ingredients in monographs under certain indications would be “particularly difficult,” he said. It is an “area of the CPG that might require future thought, but it may not require changes” to the CPG.

[Editor’s note: Each week, "The Pink Sheet" DAILY includes a story contributed by "The Tan Sheet," highlighting a current topic in the consumer medicines or dietary supplements sectors. Look for additional coverage from the two-day hearing in the May 11 issue of “The Tan Sheet."]