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Threading the Needle on Pharmaceuticals, Supplements, and Nutrition Products

How Dr. Sherry Wang Facilitates Collaboration in the Hectic Global Market

2018-09-25 10:32 Tuesday

As consumers, we're accustomed to viewing the market as a clear dichotomy:companies that make products and regulatory agencies in charge of overseeing the market. But that's not the full picture. In the pharmaceutical and supplement industries, which are reliant on scientific claims and consumer goodwill, intermediary organizations that disseminate product standards without the blunt force of the state, serve a crucial function.

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Dr.Sherry Wang works for the United States Pharmacopeial Convention (USP), which occupies this middle ground between the public and private sectors. As an independent, non-profit and internationally recognized pharmacopeial organization that is self-funded, its advice has heavy weight with drug, supplement and food regulators. With USP's unique positioning, their volunteer experts from around the world play a large role in this independent governance, documenting and providing scientifically-based standards that determine the acceptable quality in pharmaceuticals and consumer health products.

Dr.Wang is the Associate Director of Public Policy and Regulatory Affairs for USP – Singapore, and is responsible for many of USP's functions in Southeast Asia, studying the safety, quality, and effectiveness of products on the market. She grew up in Singapore, and has worked in healthcare-related professions for more than a decade, previously as an academic researcher in the field of molecular and cell biology. Her work with USP is a shift in focus, from pure science to resolving the practical challenges associated with shaping and approving scientifically-sound products. Dr.Wang works closely with food and drug authorities from around the world, as well as private industry and academia, to ensure that all parties carry out their functions according to standards backed by empirical evidence.

Dr. Wang's presentation at the 3rd Nutraceutical and Functional Food Summit & Exhibition 2018, on June 6th in Singapore, addressed the role of USP in the health and nutrition industry, as well as the regulations and standards that govern the production and sale of health products in pre-market authorization and post-market surveillance. In a follow-up interview with the event organizer Duxes, she delved even deeper, highlighting the state of regulatory harmonization in Southeast Asia, her hopes for the future development of the industry, and solutions for the quality and safety challenges posed by globalization. Dr. Wang's analysis of the relevant issues, which this article highlights, follow from her role as presenter at the 3rd Nutraceutical and Functional Food Summit & Exhibition 2018, and is not endorsed by USP; her opinions should not be mistaken for USP's official positions on those topics.

A large portion of USP's work and Dr. Wang's focus, deals with compendial standards, or pharmacopeia. Compendial standards are the primary communication tool for researchers, policymakers, and pharmaceutical and supplement manufacturers, encompassing physical and written evidence, which establishes benchmarks for product quality. Simply put, compendial standards are the frame of reference that a regulator such as the U.S. FDA will cite, when determining if a product is what it claims to be, as well as the purity and strength of its ingredients. When a manufacturer claims that its supplement offers 95% of the benefits of a major ingredient on its label, the FDA can measure this claim against the compendial standard. Dr. Wang makes an analogy with currency:

"Each country has its own currency, but many countries accept U.S. dollars as well as the national currency … We are constantly striving to achieve an exchange and measurement system between the manufacturers and the regulators, in which standards can be converted from one jurisdiction to another."

Complicating this goal is the fact that compendial standards vary, especially in the supplement space. The traditional medicine category contains large discrepancies from jurisdiction to jurisdiction. India, for instance, has documentary compendial standards, but lacks matched physical standards for many traditional herbs. Thailand and China have a notably extensive database of traditional and herbal medicines documented, which are not included in the U.S. Pharmacopeia and other Pharmacopeia. This is also because unlike drugs, supplements regulations are less restrictive.

Nonetheless, there is overlap between the national standards, largely from extensive pharmacopeia harmonization efforts. The drugs category of compendial standards tends to be more uniform than that for supplements, due to laws and well-established regulatory guidelines and references. Some common product categories that are found almost universally, including pre-biotics, probiotics and coenzymes, have been the subject of intensive discussion, with the goal of developing up-to-date standards, drafting compliant regulation and stricter laws, and enforcing quality checks.

However, bridging this "currency" gap is only part of what Dr. Wang does. The bulk of her work is tailored to Southeast Asia, a region with a booming health product industry, and the complications that can accompany such explosive growth. She identified three overarching health and nutrition challenges in the region:

1) Need for actual implementation of regulatory harmonization: Southeast Asia's patchwork regulations for health and nutrition products depress trade within the ASEAN trading bloc.

2) Insufficient regulatory oversight of nutraceuticals, products that contain medicinal benefits but are not categorized as medicine: an estimated 2/3 of nutraceuticals sold on the internet are of sub-standard in quality.

3) Need for improvement in supply chain management: nutrition and supplement products have undergone a rapid transformation in recent years, and unchecked and unaudited supply chains fuel fraud and misrepresentation, threatening consumer health.

Nonetheless, Dr.Wang is optimistic that the remedies for solving each problem are available, through existing institutions and frameworks, and more open dialogue.

She regards the regional trading bloc ASEAN an important vehicle for achieving greater cohesion in the industry. The ASEAN platform for harmonizing health regulations has reached a critical juncture after more than a decade of discussions, with an agreed upon technical dossier that the committee can now propose to the individual member countries. Though its implementation is not imminent, the progress on harmonization signals an important step forward for the industry, and ASEAN's role as the pharmaceutical and health product watchdog in Southeast Asia.

"The issue of harmonization is particularly instrumental to ASEAN's health supplement industry growth. The ten countries share certain traits … All largely import raw materials from China and India …The first level of harmonization across ASEAN is a challenging process, but once achieved, it will bring unique benefits."

The emergence of many new nutraceuticals, over-the-counter products of a nutritional nature that contain active medicinal ingredients, is a challenge for food and drug regulators. These products fall short of being classified as pharmaceuticals or drugs, and in doing so, avoid the rigorous regulatory regime and market approval process. Prescribed drugs are defined by the dose, purity, strength and quality/quantity of active medicinal ingredients, typically over 90%, but Dr. Wang noted that nutraceuticals often contain a mixture of many ingredients with actives that are sometimes unknown.

Regulatory regimes for nutraceuticals, and related products, vary widely, as with compendial standards. Some jurisdictions, such as Taiwan, approve animal trials as the basis for health claims, while others require costly human studies that few manufacturers can afford. Specificity is the key when it comes to claims for health products, Dr.Wang pointed out, as a product is not merely the sum of its ingredients. "Consumers should be mindful that health claims are often claims about the ingredients, rather than the efficacy of the whole product itself," she explained.

"Consumers should be mindful that health claims are often claims about the ingredients, rather than the efficacy of the whole product itself."

Furthermore, the integrity of the ingredients themselves must be safeguarded in increasingly complex global supply chains. Economically motivated gains to adulterate and misrepresent products in new markets are expected to be on the rise; the means with which producers and distributors can do so are too numerous to state. In a slightly humorous example, Dr. Wang cited the prevalence of non-organic products that cross the world, only to become … organic products by label. In markets that price organic products is at least three times more expensive than non-organic products, the presence of fraud is only to be expected. The varying criteria for what constitutes "organic"further complicates the issue.

To combat this, Dr.Wang suggests that regulators should take an active role in establishing guidelines for maintaining traceable supply chains, which not only detail the origin of a product, but also the original basis of the claims that it makes in the context of a good manufacturing process and distribution practices. In her view, when the logistical challenge of tracking products around the globe, is integrated with a standard framework for assessing products, the product safety challenges associated with globalization can be largely mitigated.

Dr.Wang suggests that regulators should take an active role in establishing guidelines for maintaining traceable supply chains, which not only detail the origin of a product, but also the original basis of the claims that it makes in the context of a good manufacturing process and distribution practices.

Until that day comes, Dr.Wang will keep plugging away, working with both sides of the aisle, industry and government, to resolve a wide range of thorny issues: What constitutes a safe and quality drug, and how can it be measured accurately? To what extent are nutrition products and prescribed drugs complementary? What regulatory touch is light enough to ensure innovation, and heavy enough to protect consumers?

Her work doesn't absolve us from the task of being informed health product consumers, but it's nice to know that someone has taken on this challenge.

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