AMELIA ISLAND, Fla. — The Consumer Healthcare Products Association this year will be focusing on restoring OTC eligibility under flexible spending accounts and helping to finalize OTC monographs, Scott Melville, CHPA president and CEO, told attendees of the 2014 CHPA Annual Executive Conference Tuesday morning.
Restoring OTC eligibility under flexible spending arrangements and health savings accounts is one of CHPA’s top legislative priorities, Melville reported. "John Gay and our government affairs team are working everyday on Capitol Hill to grow bipartisan support for fixing this bad healthcare policy," he said. "And our efforts are making a difference."
House Ways and Means Committee chairman Dave Camp recently included a provision to strike “the medicine cabinet tax” in his recently introduced comprehensive tax reform proposal, Melville noted. "With the federal budget impasse behind us, and with a concession by President Obama that he will support reasonable improvements to his signature law, it’s time to get this done and restore OTC eligibility once and for all."
Regarding regulatory initiatives, CHPA is working toward finalizing the OTC monographs. "As most of you know, the FDA recently announced it will hold a public hearing next week to obtain input on the OTC Drug Review, the regulatory framework for most OTC medicines that has been in effect since 1972," Melville said. "We’ll be there, as will many of you, to make unmistakably clear our views — we don’t believe broad sweeping changes to the monograph system are necessary. This regulatory framework has served the U.S. public well for over four decades," he said. "After all, 300 time-tested ingredients and hundreds of thousands of OTC products are regulated under this system, and it’s 80% complete."
And the monograph system does not operate in a vaccuum, Melville added. There is a Drug Facts Labeling protocol that provides a framework for safe use that’s familiar to consumers, and mandatory serious adverse event reporting that ensures FDA has access to the latest safety information. "And in the rare instances when safety concerns have arisen around certain ingredients, this industry has responded, often before official FDA action," Melville said.
CHPA is pushing to have the remaining 20% of monographs that are currently in tentative status finalized. "FDA can be more transparent about what’s inside the rulemaking process and explain why these monographs have languished in regulatory limbo for so long," Melville said. "And if there are lingering questions on the science behind some ingredients, the agency can be specific and call on industry to submit additional data, as it has done for over four decades."
Melville also updated members on the status of piecemeal consumer take back programs being implemented by local governments.
CHPA, along with other industry representatives including the Pharmaceutical Research and Manufacturers of America, has filed a lawsuit in federal court to stop King County Washington, which includes the city of Seattle, from enacting an ordinance that requires all pharmaceutical manufacturers, prescription and OTC, to build and pay for consumer take back programs. "The entire pharmaceutical industry needs to do a better job of educating lawmakers, regulators, and consumers that environmentally sound disposal options already exist," Melville said. "A state-by-state or county-by-county patchwork approach is unnecessary, inefficient, and, we think, unconstitutional."
While the CHPA focus is on FSA eligibility and monographs, the industry has much to be proud of, Melville noted.
Melville cited several recent industry success stories, including the reduction in the number of emergency room visits by children ages three and younger due to accidental overdose of OTC medicines. "These results represent real progress in the worthiest of all causes — keeping children safe and healthy," Melville said. "They reflect credit on an industry that recognizes what’s best for our customers is best for us."
That reduction in ER visits represents a tangible outcome of the industry's collective action to take infant's cough-cold products off the market and revise all cough-cold labels to specify not to use those medicines in children under four some seven years ago. CHPA and member companies also "joined forces with the Centers for Disease Control to educate parents, conduct research and take action through the nation-wide PROTECT Initiative," Melville said.
Melville also noted that the industry's efforts in reducing the misuse of dextromethorphan also are generating concrete results. "Years ago, your association began a campaign that was based on the premise that if parents are educated, teens are influenced and access is restricted, we can reduce the misuse of cough medicine containing dextromethorphan or DXM," Melville said. "That premise was validated when an annual government survey recently reported that abuse rates are lower today than they have been since the government started tracking this behavior. And this during a time when prescription medicine abuse is on the rise."
Today, CHPA stands in support of bipartisan legislation introduced this past year in the U.S. Congress to prohibit DXM sales to minors. On the state level, the commonwealth of Virginia earlier this month became the third state to limit DXM sales to adults only, Melville said.
To augment awareness around the value of OTC medicines, Melville announced that CHPA is placing more heft behind its CHPA Educational Foundation, which is being re-launched this year with a new vision — "Happier, healthier lives through responsible self-care." CHPA Educational Foundation is being led by executive director Emily Skor and director Shelly Ducker, who report to a board of directors specific to the Foundation.
"With this new structure and leadership in place, we will make further progress to ensure consumers use, store and dispose of consumer healthcare products safely and appropriately," Melville said.