Expanded Avenues for Rx-to-OTC Switch Empower Consumers and Can Provide Billions in Value to Healthcare System

Washington, D.C. (March 22, 2012)—The Consumer Healthcare Products Association (CHPA) provided remarks to the U.S. Food and Drug Administration (FDA) today at the agency’s public hearing, “Using Innovative Technologies and Other Conditions of Safe Use To Expand Which Drug Products Can Be Considered Nonprescription.” FDA convened the meeting to obtain comment and information on a new paradigm it is considering to approve prescription drugs for nonprescription (also known as over-the-counter or OTC) use under conditions of safe use.

“OTC medicines are a trusted first line of treatment for everyday relief,” said CHPA President and CEO Scott M. Melville. “OTC medicines empower consumers to take immediate care of themselves and their families. Enhancing the path to switch medicines from prescription to OTC status can save consumers time and money and expand their access to important medicines. CHPA applauds FDA for holding this meeting and recognizing the contribution that OTC medicines make to consumers and to our nation’s over-burdened healthcare system.”

A recent Booz & Company study reported that 240 million people each year treat illnesses with OTC medicines, bought off-the-shelf without a prescription. According to the study, an estimated 60 million of these consumers would not otherwise seek treatment. OTC medicines save the entire U.S. healthcare system $102 billion annually. The study goes on to note that for every dollar spent on OTC medicines, the healthcare system saves six to seven dollars. 

The hallmark of OTC medicines is the consumers’ ability to pick a product off the shelf, read the package label, and appropriately and safely self-select the medicine to treat their condition. However, consumers are seeking and obtaining information beyond the traditional label to make informed OTC product selections. It is appropriate that the U.S. regulatory system recognize this consumer capability and factor it into decisions on future prescription-to-OTC switches.

Tools and technologies, beyond the traditional Drug Facts label, can assist consumers in making appropriate OTC selections. For example, diagnostic tests, health kiosks, smart phones, self-screeners, and pharmacist consultations can help consumers accurately recognize conditions and select and use an appropriate medicine. “Ultimately we envision a future where innovative switches are made possible by tools and technologies, on a data-driven case by case basis,” continued Melville. 

The United States has a long history of prescription-to-OTC switches that have allowed families to conveniently buy and use antihistamines, pain relievers, heartburn reducers, nicotine replacement therapies, vaginal yeast infection treatments, and more.

At today’s meeting, CHPA provided examples of successful switches in the past 40 years, which have involved more than 100 medicines:

  • When frequent heartburn medicines were made available without a prescription, consumers saved an average of $174 per year in avoided prescription costs and office visits.  This additional access also drove a $750 million savings to the healthcare system. (Nielsen 2009)
  • When nicotine replacement therapies used to quit smoking went OTC, there was a 150 percent to 200 percent increase in their use in the first year after the switch. (Shiffman 1997; Keeler 2002)
  • Doctor visits for the common cold fell by more than 100,000 a year from 1976 to 1989 following the late-1970s and early-1980s switches of a number of decongestants and antihistamines (Temin 1992)
  • When vaginal yeast treatments were made available without a prescription, studies found that women were as accurate as their doctors in recognizing the recurrence of vaginal yeast infection. (Lipsky 2000)

“CHPA looks forward to collaborating with FDA to expand consumer access to safe and effective medicines using the tools and technologies available in the marketplace today,” said CHPA’s Melville.

Contact: Shelley Ducker, 202.429.3528 (w) or 202.255.0561 (m)

CHPA is the 131-year-old-trade association representing U.S. manufacturers and distributors of over-the-counter medicines and dietary supplements.