Welcome to 2020, where, more than ever, patients and caregivers are taking control of their health care decisions and an increasing array of consumer health care products is helping them get well, stay healthy, treat minor ailments and even manage some chronic conditions. The marketplace is evolving before our eyes, including the manufacturers, who are innovating every day to continue meeting the demands of consumers and retailers.
Some of the drivers of transformation today include the rapid pace of change, the growing influence of technology and the complex interdependence of all of the stakeholders in the consumer health care marketplace. But perhaps the most important factor is that modern consumers no longer look to just over-the-counter medicines when considering their health and wellness. They are looking at how dietary supplements can play an important part in healthy living and how O-T-C medical devices for categories like oral care, family planning and hearing loss can also contribute to optimal self-care.
Fortunately, the Consumer Healthcare Products Association’s mission to “empower self-care by preserving and expanding choice and availability of consumer health care products” remains just as relevant today as when the association was founded in 1881. CHPA has consistently evolved to meet the needs of our member companies and their consumers, and to shape the environment in which our industry operates. It’s therefore exciting to announce that CHPA’s scope has been expanded to now include a more holistic approach to self-care: O-T-Cs, dietary supplements and consumer medical devices (CMDs) — a broader spectrum of consumer health care that reflects the way today’s consumers truly see it.
CHPA is the only industry association that approaches self-care from this perspective, and in 2020 CHPA will implement a leadership agenda in each of these three core self-care categories.
For more than four years, CHPA has led the effort to modernize the 40-year-old structure that oversees the regulation of most O-T-Cs — the O-T-C monograph system. At the time of this printing, CHPA is optimistic that enactment of O-T-C monograph reform is near, and we are actively working to get the legislation passed by Congress and signed into law. In cooperation with FDA, manufacturers, lawmakers and others, we hope to begin 2020 with a reformed system that will allow our member companies to operate under a more transparent and accountable regulatory framework that provides more incentives for innovation and more resources for FDA — and ultimately, more choices for consumers.
Prescription-to-O-T-C switch — traditionally a major driver of growth in the consumer health care marketplace — has slowed significantly in recent years. Part of CHPA’s leadership agenda in 2020 will be to work with FDA to look closely and creatively at regulatory approaches that enable more prescription-to-O-T-C switches that could expand the nonprescription drug market, such as using digital technologies or other conditions to assure consumer safe use. A robust pathway for switch can ensure healthier growth for the industry and save our health care system billions of dollars by reducing unnecessary medical visits or the use of more expensive prescription drugs.
Flexible spending arrangements (FSAs) and health savings accounts (HSAs) are valuable programs that allow consumers to save money by setting aside pretax funds to pay for their health-related expenses. Up until 2011, O-T-Cs were included as eligible expenses in these plans, but a provision in the Affordable Care Act removed O-T-C medicine eligibility. Since then, CHPA has been supporting bipartisan, bicameral legislation in Congress to restore O-T-C eligibility, and now with the 2019 Restoring Access to Medicines Act, next year may be the year that consumers will once again be able to use their FSA/HSA savings to purchase O-T-C medicines — another boon to growth. Legislation approved by the House Ways and Means Committee in late 2019 restored O-T-C eligibility under FSAs and HSAs and, for the first time, expanded eligibility to feminine hygiene products. We hope to see this legislation enacted into law in 2020.
CHPA has represented the dietary supplement category since 1999, and 2020 will see renewed legislative and regulatory leadership from CHPA in this area. Our ultimate aim is more effective regulation and more innovation, both of which would benefit consumers. CHPA seeks to strengthen confidence in the dietary supplement sector among consumers, retailers, regulators and legislators, while also providing new opportunities for members to bring new products to market.
CHPA’s leadership agenda to strengthen both regulation and enforcement of supplements includes support for mandatory product listing, FDA authorization of third-party current Good Manufacturing Practices (cGMP) inspectors, and support for additional FDA resources. To promote innovation, CHPA will advocate for new dietary ingredient (NDI) innovation incentives, push for novel pathways for evidence-based health claims, and encourage a fresh look at the definition of “dietary ingredient.”
Perhaps the topic of most interest — and uncertainty — today among manufacturers, retailers, regulators and lawmakers is cannabidiol (CBD). CHPA is committed to urging FDA and the Federal Trade Commission to make faster progress on regulation and enforcement of CBD in the marketplace. CHPA supports efforts to encourage FDA to develop a legal pathway for CBD as an NDI, and in fact recently filed a citizen petition with FDA expressing the urgent need to do so. But just as a pathway for legal use is needed, so is proper enforcement. CBD-containing products masquerading as supplements threaten to undermine the confidence of consumers and pose many risks. Consumer products claiming to contain CBD and those making outlandish, unsubstantiated drug claims must be addressed. Sustainable growth in CBD, and safe use by consumers, can only be achieved with a clear and enforceable regulatory pathway.
Consumer Medical Devices
In recent years, there has been an explosion of new consumer products, regulated as medical devices, that offer consumers accessible and effective self-care solutions. Today’s consumers expect safe, effective, affordable solutions to help them manage family health, and they want to find them in one convenient location: your stores. Products such as toothbrushes, condoms, bandages, pregnancy/ovulation test kits, health monitoring devices, and others make important contributions to consumer health and represent an expanding category of consumer health care products to manufacturers, retailers and consumers.
In fact, recent research by CHPA and IRI showed that CMDs for treatment of mild conditions save Americans approximately $8 billion per year by reducing clinical visits, since 28 million people would seek doctor’s office visits if certain testing devices were not available.
Two years ago, driven by member demand and visionary leadership, CHPA began to explore a greater role in the CMD sector, funding a pilot program to identify issues, provide association support and build institutional capacity to become a leader influencing the CMD regulatory environment. Now, after this successful pilot, CHPA is all in: CMDs have formally become the third pillar in CHPA’s scope of work, in addition to O-T-Cs and supplements.
CHPA has started to build a working relationship with the FDA division responsible for policy and regulation of devices, the Center for Devices and Radiological Health (CDRH). Additionally, in 2020 we will concentrate on such topics as reducing the burden of the unique device identifier (UDI) requirement, drug-device combinations, training for professionals in our industry on CMD topics, and more.
At CHPA, we are looking forward, actively evolving with the shifting landscape in our industry, and helping to redefine and shape the consumer health care marketplace of the future. CHPA’s expansion as the association representing holistic self-care — O-T-Cs, dietary supplements, and CMDs — better aligns with the strategic direction of our member companies and with modern consumer preferences and behaviors, while remaining consistent with CHPA’s enduring vision — happier, healthier lives through responsible self-care. This is an exciting time, indeed, for self-care. We at CHPA will continue to help lead the way.
Scott Melville, president, CEO at Consumer Healthcare Products Association.