Whether it's a headache, occasional heartburn or runny nose, we all know the routine: stop by the local drugstore on the way home and pick up some over-the-counter (OTC) medicine. Twist off the top, pop a few pills and hopefully get some quick relief. Perhaps some of us read the directions first, although most of us have been taking these drugs for years and already “know” exactly how to take them. Unlike prescription drugs, for which you generally need to see a doctor for a refill, OTC medications are for the most part freely available and you can pick them up without having to talk to anyone or obtain approval—just go to the store, pick it up and you're on your way, which fits squarely within the routine of most fast-paced American families. For most ailments you probably don't think twice about it, but what about those OTC products that used to require a prescription? How does a medication transition from requiring physician approval to being thrown in your cart with ordinary household products? Are consumers fully aware of the risks and side effects associated with these medications? Or proper dosage instructions?

Historically, there were no federal regulations to protect the public from dangerous drugs. The original Federal Food, Drug, and Cosmetic Act of 1938 did not even distinguish between prescription and OTC drugs. Rather, the law was focused broadly on overseeing several categories of drugs and ensuring that they were safe and effective. As quoted on the FDA's website, “It was a menacing marketplace filled with products such as William Radam's Microbe Killer and Benjamin Bye's Soothing Balmy Oils to cure cancer,” says John Swann, a historian at the Food and Drug Administration in Rockville, Maryland. “Products like these were, at minimum, useless remedies that picked the pocket of the user, but they could also be downright harmful.”

As the medical industry continued to expand, it became abundantly clear to legislators that drug regulation was desperately needed. In the years that followed, the FDA and the industry grappled with the question that remained unanswered in the 1938 law: which drugs could be sold directly to consumers and which drugs required prescription. This question was addressed and arguably resolved (at least somewhat) in 1951 when Congress passed the Durham-Humphrey Amendment. The Durham-Humphrey Amendment specifically addressed and created the two-tier drugs system we recognize today: prescription and nonprescription drugs (Juhl RP. Prescription to over-the-counter switch: a regulatory perspective. Clin Ther. 1998; 20 (Supp. 3): C111-C117).

The amendment mandated that habit-forming, toxic or potentially dangerous drugs be dispensed only by prescription (http://www.fdareview.org/issues/history-of-federal-regulation-1902-present/#p06). Congress concluded that some drugs represented a serious risk to consumers who were likely unable to use them without physician supervision and guidance. That is, self-care and self-treatment were too risky, even if the drugs conferred a benefit to many consumers. Currently, the FDA is still expected to employ this risk-benefit analysis when evaluating the safety and efficacy of drugs, as well as the ability of an average consumer to self-diagnosis and treat.

However, drug manufacturers have convinced the FDA that many prescription drugs are safe and effective for OTC consumer use, thus allowing these drugs to be “switched” and marketed and sold without a prescription, fully accessible to consumers for self-care. For these drugs, patients, without a physician's oversight, expect to achieve therapeutic outcomes without significant risk to their safety. After all, if these drugs were dangerous to consumer health, how can they be sold at your local drug store without physician recommendation or approval? And, with changes in advertising in the past few decades, the purchase and use of OTC medications is highly encouraged by pharmaceutical companies. We have all seen the frequent pharmaceutical commercials proudly telling consumers that certain drugs are “now available without a prescription.” Over-the-counter drug advertising is less regulated than prescription drug marketing, thus selling directly to consumers comes with the benefit of bypassing an expert middleman: your doctor.

So how does a drug—whether for a headache, heartburn or allergies—make its way through the regulatory process and onto the store shelf? The process of reclassifying drugs from prescription to OTC status is referred to as a “Rx to OTC switch.” According to the FDA, there are two regulatory pathways for all OTC drug products—a new drug application, or a drug monograph. A common path to OTC approval is through the submission of a “new drug application” or NDA. Under the NDA process, manufacturers usually supplement a prescription drug application, arguing to the FDA that administration of the drug can be done without consultation with a doctor. The FDA then requires labeling studies to show that typical consumers can read and understand when and how to take the drug and its potential side effects. Under the NDA process, some drugs are approved initially as OTC drugs, but most are first approved for prescription use and later switched to OTC. The other process, which began in 1972, is an OTC drug monograph, based on drug formulas and conditions that are generally recognized as safe and effective. The monographs are essentially “recipes” listed in the federal regulations, (21 CFR Parts 331-358). The monographs are part of the OTC Drug Review process and approved by advisory panels.

In either case of regulatory approval, a risk-benefit comparison must be taken into account by the FDA and consumer-friendly labeling must be produced by the manufacturer. Manufacturers are required to prove to the FDA that consumers can self-diagnose, self-treat, and self-manage by label comprehension and actual use studies. After all, under the current regulatory framework, OTC drugs are heavily marketed directly to consumers. Meaning that manufacturers are telling consumers—buy our product when suffering from a variety of different ailments. Therefore, while OTC products are intended to supplement the medical options of the consumer, they have started to become more of a substitute to a prescriber's medical knowledge and expertise.

Understandably, the prescription-to-OTC switch allows consumers to have OTC access to an increasingly wide range of medicines. In fact, the OTC market now includes more than 30,000 products. According to the Consumer Healthcare Products Association (CHPA), a trade association of drug manufacturers and marketers, more than 100 OTC ingredients, strengths, or indications are on the market today that were available only by prescription less than 40 years ago. Currently, 93 percent of adults in the United States prefer to treat with OTC medicines before seeking professional care.

The OTC process is clearly convenient—you can skip the doctor and go straight to the store. Due to prescription-to-OTC switches, families can now easily buy and use a wider range of antihistamines, pain relievers, heartburn reducers, nicotine replacement therapies, and more without having to go to the doctor. OTC drugs are also generally cheaper than prescriptions, thereby allowing more consumers to self-treat. For example, when nicotine replacement therapies went OTC, there was a 150 to 200 percent increase in their purchase and use in the first year after the switch. increased OTC access resulted in thousands of smokers reducing or quitting smoking.

The same thing happened with heartburn or acid reflux medications, many of which are known as proton-pump inhibitors (PPI) for the way they reduce the efficacy of acid in the stomach. According to the CHPA, in the case of heartburn medicines generally, consumers saved an average of $174 per year in avoided prescription costs and office visits while the OTC heartburn category earned $1.4 billion in U.S. sales in 2010.

What is the incentive for drug manufacturers to make the Rx-to-OTC switch? Upon patent expiration, pharmaceutical companies risk losing sales revenue unless they come up with effective strategies for brand expansion. Transition to the OTC market not only devalues a prescription product, but it also places the brand in a newly competitive consumer market. For this reason, manufacturers will often enter deals with other companies to market its OTC product, so nothing interferes with revenue for its branded drugs. For example, Pfizer paid AstraZeneca $250 million plus royalties for the rights to sell OTC Nexium, the popular gastroesophageal reflux disease (GERD) drug, when it went “off-patent” in 2014. Pharmaceutical companies with the capability to market and sell large quantities of its drugs significantly benefit from popular prescription drugs turned OTC.

However, to the dismay of ordinary consumers, the safety and efficacy of PPIs, many of which are available OTC, is now being litigated in a New Jersey court. Plaintiffs allege that PPIs were only meant to be a temporary fix to acute acid reflux, and that long-term use is associated with severe injuries, including gastric cancer and kidney disorders. PPIs have been widely advertised to consumers and heavily promoted to physicians as a daily treatment for heartburn, resulting in an overuse of the drugs. PPIs are among the highest-selling classes of drugs in the United States, with billions of dollars in annual sales. Especially since many of the PPI-class of heartburn drugs are now available OTC, U.S. consumers are consistently over-treating with these drugs. As “Larry the Cable Guy,” primary spokesperson for Prilosec OTC, misleadingly says: “one pill each morning, 24 hours, zero heartburn.”

In sum, this two-tier system has been in place for decades, but OTC drugs, as seen in recent litigation, can be just as dangerous or deadly as prescription drugs, when over-used and taken without guidance from your treating physician.

Catelyn McDonough joined Anapol Weiss as an associate in 2016. She focuses her practice on asbestos and medical mass tort litigation, including but not limited to pharmaceuticals and faulty medical devices. Contact her at [email protected].