Botanical Drugs in the U.S. vs. Traditional Herbal Medicinal Products in Europe

In the U.S., the existing pathway for botanical drugs has, so far, only yielded a total of four authorized products since the system was established in 2006. Clearly, this is a sign that the category is not very attractive for pharmaceutical or nutraceutical companies.

At the end of August, Congress introduced a new bill (the Advancing Botanical Drug Development Act), which would amend the Federal Food, Drug, and Cosmetic Act to grant 12 years of market exclusivity to FDA-approved botanical drugs. During that window, the FDA would be barred from approving any generic (ANDA) or hybrid (505(b)(2)) application that references or relies on the approved botanical product. For comparison, a new chemical entity drug currently gets only 5 years; 12 years matches the exclusivity period Congress set for biologics in 2010.

The bill does not create a new category, nor does it lower FDA standards. Botanical drugs must still complete full clinical trials and meet the same safety and efficacy requirements as any other drug.

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A Different Strategy in the E.U.

In the E.U., the category of herbal medicinal products (HMP) faces a similar problem. The category is underdeveloped with little to no innovation. The E.U.’s solution though was fundamentally different from the U.S. approach: create the traditional herbal medicinal products (THMP) category with a simplified authorization procedure that does not require proof of efficacy or safety.

The reasoning behind this approach is that tradition (i.e., 30 years of market presence, of which 15 must be in the E.U.) is all the proof that is needed for the product to be considered safe and effective.

“The E.U. trades exclusivity for accessibility. THMPs get no data or market protection at all, but the barrier to entry is much lower. The U.S. offers the opposite: high barrier (clinical trials) in exchange for standard exclusivity, and the new bill would further raise the reward to 12 years.”

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The differences are clear: The E.U. created a separate category; the US did not. THMPs are a legally distinct registration scheme with reduced evidence requirements. The U.S. “botanical drug” pathway is simply the standard new drug application (NDA) process applied to plant-derived products without any shortcuts.

The E.U. trades exclusivity for accessibility. THMPs get no data or market protection at all, but the barrier to entry is much lower. The U.S. offers the opposite: high barrier (clinical trials) in exchange for standard exclusivity, and the new bill would further raise the reward to 12 years.

The E.U.’s geographic restriction is a known weakness. The 15-years-in-the-E.U. requirement effectively blocks most non-European traditional medicines (e.g., Traditional Chinese Medicine (TCM) and Ayurveda). Only one TCM product has been registered as a THMP. The U.S. has no such restriction.

Limitations on Innovation

The E.U.’s indication scope is narrow. THMPs must be suitable for use without medical supervision. A botanical drug targeting cancer or a serious chronic condition cannot use the THMP route and must go through full marketing authorization with clinical data, the same as any other medicine.

These limitations on innovation in botanical drugs in E.U. markets have resulted in growth of the food supplement category, which seems to have absorbed most of the would-be botanical drugs after slight reformulation.

However, the food-drug demarcation in Europe means that food products, of which food supplements are a part, cannot have a pharmacological action or a therapeutic effect. Also, it is hard to make health claims on botanicals in the food supplement category, which is a long-lamented and often criticized state of affairs. Disease-related claims, of course, are impossible, as they are within the purview of medicinal products.

Companies in the E.U. have long criticized how legislators are dealing with the botanicals issue. The THMP solution has proved underwhelming. One way out would be to, at long last, resolve the health claims issue for botanicals. Right now though, all that companies can do in the way of innovation is pursue the full new drug registration route, or make the most of the on-hold health claim situation — possibly with the help of experienced consultancies such as analyze & realize GmbH.