Manufacturers of over-the-counter (OTC) drugs: Get ready for change. The Over-the-Counter Drug Safety, Innovation, and Reform Act promises to modify the regulatory system that oversees most OTC medications—and the OTC Monograph system.
Anyone who develops and produces an OTC drug for marketing and sale in the U.S. needs to understand the changes the OTC Reform Act may usher in—including impacts to product development and labeling, notes industry veteran Norma Skolnik in her ProfEdOnDemand webinar, “OTC Drug Safety, Innovation & Reform Act.”
OTC Monograph Changes to Remove Gridlock?
OTC Monograph changes are long overdue—especially since OTC drugs account for approximately 60 percent of the medicines on the market in the U.S, wrote Jeff Needham, president of U.S. Consumer Healthcare for Perrigo, for The Hill.
The current regulatory system, which is more than 40 years old, involves a long, clumsy rulemaking process—one that can hold up OTC products designed to treat colds, headaches, and upset stomachs.
What needs to change: “While the Monograph system has served us well, it’s based on an outdated model that requires notice and comment rulemaking, an increasingly slow and cumbersome process,” Needham wrote. “As a result, the system has become gridlocked and the process to update product labels with new safety information, approve new ingredients, or make other changes can take several years or more.”
Other industry insiders agree. Scott Melville, president and CEO of the Consumer Healthcare Products Association (CHPA) notes, in another opinion article for The Hill: “The current system doesn’t allow for responsiveness to an emerging safety concern or a pathway for the development of innovative products to meet consumer needs. That’s no way to regulate medicines that consumers depend on.”
New Law Passes House, Awaits Senate Action
In March 2018, Rep. Robert E. Latta (R-OH) introduced the OTC Reform Act in the U.S. House of Representatives. It passed in July and was then handed off to the Senate, where it has languished on the legislative calendar.
Meanwhile, the U.S. Food and Drug Administration has moved ahead with changes to the current Monograph system. In May, the agency announced a partial withdrawal of a proposed rule from 2002 that would have affected internal analgesic, antipyretic, and antirheumatic OTC drugs because of changes in the agency’s understanding of the risks linked to ibuprofen.
Specifically, the agency withdrew the rule due to ibuprofen-linked safety issues raised in 2014 concerning an increased risk of heart attacks and strokes which may be worsened by heavy use of the medication, reported the Regulatory Affairs Professionals Society.
OTC Reform: Get to Know Labeling Changes
OTC drug compliance is sure to change if and when the new bill passes, adds Norma Skolnok. As she explains in her instructive webinar, there will be plenty of new details to grapple with, such as new labeling rules and guidance on which products are (and are not) covered.
There should be plenty of benefits, too. The new law will affect future products that aren’t currently covered by the existing OTC Monograph system, and the OTC Reform act will help manufacturers introduce new and innovative products. Now is the time to get to know this upcoming law and what it will mean for your business.