O-T-Cs remain a trusted first line of defense for health care providers and consumers.

Scott Melville

One of the most enduring outcomes of the global pandemic is the tremendous acceleration of self-care as a cornerstone of health care. Now, more than ever, consumers are taking greater responsibility for, and control over, their own health care. While it’s exciting to see broad industry growth, there’s no denying that consumer demand, and the pandemic’s impact on the supply chain, have created some unprecedented challenges for manufacturers and retailers alike. With change and challenge comes opportunity, and the self-care industry is poised to emerge stronger and smarter from the many lessons learned over the past year. As the only trade association representing a broad spectrum of self-care categories — over-the-counter medicines, dietary supplements and consumer medical devices — our depth and breadth of experience is helping our members shape the future of consumer health care.

Over-the-counter medicines

O-T-Cs remain a trusted first line of defense for health care providers and consumers. The availability of O-T-C medicines provides symptomatic relief for an estimated 60 million people who otherwise would not seek treatment. A top priority for CHPA is educating individuals and families about the health and economic benefits of using O-T-C medicines. In collaboration with our retailer partners, we want to find better ways to connect with consumers and advance health literacy so that consumers fully understand their options for self-care. Helping consumers make informed decisions about self-diagnosis and self-selection will improve and expand self-care.

Indeed, educating consumers is particularly critical now, as we see growing momentum behind prescription-to-nonprescription (Rx-to-O-T-C) switch. At CHPA’s 2021 Regulatory, Scientific and Quality (RSQ) Conference, speakers commented on the importance of Rx-to-O-T-C switch from different vantage points. Consumer advocates, regulators, researchers, as well as technology, legal and industry experts all made the same point: Today’s consumer needs and demands access to more O-T-C options. And we know from previous research, that for every $1 spent on O-T-C medicines, the U.S. health care system saves $7, so enabling more self-care benefits everyone.

FDA’s 2018 draft guidance “Innovative Approaches for Nonprescription Drug Products” acknowledged that certain types of medicines only available by prescription today may one day be “switched” to O-T-C use if manufacturers can identify novel ways to help consumers correctly self-select and safely use them. Many companies today are doing just that — a recent study published in the American Journal of Cardiology demonstrated the effectiveness of technology-assisted self-selection of nonprescription statin therapy. It’s a great example of the potential for digital technologies, or other self-assessment tools, to assure safe use and allow consumers greater access to more O-T-C medicines. We’re hopeful that FDA will issue a proposed rule in the near future. It’s necessary to realize the potential that digital technologies can have on the future of self-care.

Removing the cost-barriers of O-T-C medicines is another key element to accelerating self-care. Insurance firms, as well as consumers, will save if more health plans offer O-T-C drug benefits as added benefits — a growing area in plan design. CHPA recently released results of a study assessing O-T-C benefit programs for Medicare Advantage enrollees, finding that the total monthly medical costs were less for those who purchased certain types of O-T-C drugs under the plan. However, only about 30% of O-T-C allowances are actually used by eligible enrollees each year, leaving $5 billion unused in aggregate — that’s a lot of benefit left on the table. Our industry is working to educate retailers and consumers about these important plan benefits.

The 2020 restoration of O-T-C medicine eligibility under tax-preferred HSA and FSA accounts, long championed by CHPA, provided another important win for consumer cost-savings, and CHPA continues to educate consumers about this important and valuable health care benefit. We’re pleased that our industry’s retail partners have so quickly operationalized the new benefit, making it easy for consumers to find HSA- and FSA-eligible products in their stores.

Dietary supplements

Across the store, shoppers are looking for self-care solutions that provide a holistic foundation for wellness. More consumers are paying attention to preventive health care and incorporating dietary supplements as part of their overall self-care plan. It’s therefore no surprise that we’ve seen unprecedented growth and utilization in this category.

While it’s good to see a rise in demand, this surge in consumer interest has opened the door to some bad actors. So we’re working with other industry stakeholders to push for modernization of the regulatory framework for supplements — to protect consumers, promote innovation, and raise the bar on quality and compliance. CHPA and its members recognize that safety, product integrity and industry transparency are key tenets to building trust in consumer health care products.

To that end, we remain focused on dietary supplement reform — modernizing the Food and Drug Administration’s regulatory statute known as the Dietary Supplement Health and Education Act (DSHEA). CHPA is a strong advocate for improvements such as: mandatory product listing, a master file for new dietary ingredient notification (NDIN), innovation incentives, third-party certification for cGMP inspections and a standardized definition for “dietary ingredient.” Our goal is to strengthen confidence and safety in the dietary supplement sector, thereby expanding opportunities for industry to bring new, safe and beneficial products to market.

Having successfully reinstated O-T-C eligibility under HSA and FSA accounts in 2020, we’ve turned our attention to expanding eligibility to dietary supplements, and we championed legislation introduced in Congress this year to do just that. We’re pleased that Reps. John Curtis (R., Utah) and Josh Gottheimer (D., N.J.) introduced H.R. 5214, and we encourage broader industry support for this as an important new health care benefit to millions of consumers who participate in HSA or FSA programs.

Consumer medical devices

From face masks to thermometers, pulse oximeters — and now hearing aids — at-home use of consumer medical devices and remote care allow people to manage more of their health on their own. There is great opportunity for advancement in the device sector in the year ahead. For example, more than 30 million adult consumers suffer from hearing loss, yet only one-fifth seek out a hearing device. Currently, hearing aids are only available by prescription, but FDA’s new proposed rule to allow nonprescription sales of hearing devices will be a game changer for consumers, many of whom will, for the first time, have access to more affordable, innovative product options. Think of this as the latest “wearable device” to soon hit the market.

More broadly, consumers, and the larger health care system, are embracing digital health technology and recognizing its potential for enhancing access, promoting efficiencies and reducing health care costs. Our members are working on innovative ways to utilize new technologies with product offerings that promise to better connect patients, health care professionals and care. Retailers recognize this, too, and are already leading the way with digital health care offerings, through a mix of virtual and physical health care services.

The future of self-care

The pandemic has amplified the trends we’ve seen growing over the past several years. Consumers understand the importance of self-care products for hygiene and health (such as hand-sanitizers), prevention (such as immune support), and overall wellness and fitness (such as sleep monitors and other wearable devices). According to a recent IRI/CHPA study, nearly 70% of Americans do something to support their health and wellness several days a week or more, and this commitment to wellness is expected to grow.

The self-care industry has evolved quickly, yet deliberately, developing solutions that enable people to be more proactive about preventive health care. This acceleration provides a window of opportunity to connect with consumers and address their needs in a way that elevates self-care to an essential part of their lives. And it is our job to help consumers make better decisions by providing transparent, understandable information, as well as safe and beneficial products.

We are acutely aware of the immediate and fundamental challenges facing retailers and manufacturers today; at the same time, we are focused on and eager to take advantage of the opportunities in front of us. Our commitment to ensuring consumers have ready access to O-T-C drugs, dietary supplements and consumer medical devices has never been stronger, and CHPA’s vision of “happier, healthier lives through responsible self-care” remains a cornerstone of our mission.

Scott Melville is the president and CEO of the Consumer Healthcare Products Association.