Despite the difficult realities of COVID-19, and the tremendous challenge, pain and uncertainty it has created, 2020 was also a year of incredible progress for self-care in the United States. From manufacturers to retailers, we at Consumer Healthcare
Products Association are proud of the pivotal role our extended industry has played in providing and maintaining access for consumers to safe and beneficial nonprescription products to prevent sickness and to treat minor — and major — medical conditions. It is not an exaggeration to say the role of consumer self-care has never been more apparent or more necessary than has been evident this year. Thanks to each of you and your respective organizations for providing such heroic services at such a challenging time in our nation’s history.
At CHPA, we began 2020 by embarking upon a board-approved strategic repositioning to ensure that our association “represented the aisle” and was evolving along with science, regulation and consumer preferences. This year, we completed our evolution to become an association of self-care companies focusing on three categories of personal health care: over-the-counter drugs, dietary supplements and consumer medical devices. Our new logo and tagline — Taking Healthcare Personally — highlights the broader scope of our representation as we move forward.
Moving forward into 2021, we are focused on taking steps in the legislative, regulatory, media and business arenas to achieve our association’s vision of “happier, healthier lives through responsible healthcare.” And we are excited about the future of each category and the contributions they will make to our health care system.
It’s more evident than ever that O-T-C medicines not only provide safe and effective relief for a wide variety of symptoms and conditions, but they also make an important contribution to health system sustainability. Personal health care products alleviate unnecessary burden by allowing people to safely, conveniently and cost-effectively self-manage their health without visiting their health care provider. It’s no wonder that for every $1 that Americans spend on O-T-C medicines, the U.S. health care system saves more than $7.
Major legislative victories that CHPA worked to achieve for the self-care industry in 2020 promise to have a major positive effect on personal health care in 2021 and beyond, including modernizing the OTC Monograph system that regulates most nonprescription drugs, and restoring eligibility for O-T-C medicines under tax-preferred Health Savings Accounts (HSAs) and Flexible Spending Arrangements (FSAs).
Monograph reform opens the door for more flexible and timely O-T-C regulations to better leverage advances in science, to incentivize and reward innovation and to provide additional resources to Food and Drug Administration, to allow for more efficient and nimble regulation of this fast-growing category of pharmaceuticals. CHPA is committed to working with FDA to implement this new law and ensure that it meets the objectives of Congress in a timely fashion, which will ultimately deliver more value to retailers and consumers.
Restoring eligibility of O-T-C medicines under tax-preferred HSA and FSA accounts was a decade-long effort that will make self-care more affordable for millions of Americans. Congress even expanded eligibility to include, for the first time, feminine care products. CHPA is leading the charge to educate consumers about the benefits of the new law with a consumer-focused media campaign: TaxFreeOTC.org. It is one example of how CHPA is working to drive consumer awareness of this new benefit.
Following this year’s achievement of O-T-C regulatory reform, CHPA is now aiming for dietary supplement regulatory reform. Our goal, in collaboration with other supplement associations, is to have more effective regulation, enforcement and innovation in the dietary supplement category through modernization of FDA’s 26-year-old regulatory statute known as the Dietary Supplement Health and Education Act (DSHEA). We are working to strengthen confidence in the dietary supplement sector among consumers, retailers, regulators and legislators, while also expanding opportunities for members to bring new products to market.
The leadership plan outlined by our board of directors is to strengthen the regulation and enforcement of supplements, including support for mandatory product listing, FDA authorization of third-party current Good Manufacturing Practices (cGMP) inspectors, and support for additional FDA resources to better enforce regulation of this fast-growing and evolving personal health care category. CHPA will also advocate for new dietary ingredient (NDI) innovation incentives, push for new pathways for evidence-based health claims and encourage a renewed look at the definition of “dietary ingredient.” Additionally, on the heels of success with HSA/FSA eligibility for O-T-Cs, CHPA’s public policy agenda for 2021 includes working to make dietary supplements HSA/FSA-eligible as well.
Further, CHPA will continue urging FDA to make progress on regulation and enforcement of cannabidiol (CBD), including developing a legal pathway for CBD as an NDI. CBD-containing products masquerading as supplements threaten to undermine the confidence of consumers and pose many risks; products claiming to contain CBD, and those making unsubstantiated claims, need to be addressed. A national approach to CBD is critical, as states continue to create an uneven patchwork of regulations, making it difficult for manufacturers and retailers to contribute to CBD innovations and to comply with an unstable landscape and uneven laws. Sustainable growth in CBD, and safe use by consumers, can only be achieved with a clear, enforceable national regulatory pathway.
Consumer medical devices
Products such as toothbrushes, condoms, feminine care products, bandages, at-home test kits, health-monitoring devices, and others are important for personal health care and represent an expanding category of consumer health care products. CHPA research last year showed that certain O-T-C devices used for the purpose of treatment or testing provide approximately $8 billion in savings per year to the U.S. health care system by reducing clinical visits. If certain consumer medical devices were unavailable O-T-C, 2 8 million people would seek doctor’s office visits.
CHPA is developing a strong working relationship with the FDA Center for Devices and Radiological Health (CDRH), and in 2021 we will concentrate on issues such as reducing the burden of the unique device identifier (UDI) requirement, drug-device combinations, training for professionals in our industry on device topics, Medical Device User Fee Act (MDUFA) reauthorization, and more.
The next two decades
The world is changing, and the personal health care industry is changing with it, for the better. CHPA is now the only industry association representing a broad spectrum of self-care products — O-T-Cs, dietary supplements and consumer medical devices — uniquely aligned with how consumers and retailers view self-care, as well.
As the headwinds of COVID-19 continue to shape how Americans manage their personal health care, CHPA and our industry will continue to evolve, act and react to shape regulations and influence the marketplace of the future. CHPA’s vision of “happier, healthier lives through responsible self-care” remains central to our mission to have a positive impact on changes that bring growth to the industry.
Scott Melville is the president and chief executive officer at the Consumer Healthcare Products Association.