Chris Harvey- Senior Vice President, Sedgwick Brand Protection
As 2023 begins in earnest, the healthcare industry is evolving to meet more contemporary needs, including for patients who prefer the option of self-treatment. Those who choose to self-treat can self-diagnose their illness and select from the pharmacy the right over-the-counter (OTC) drug to treat their symptoms. Thanks to this approach, patients have more freedom to take an active role in their own health, while the pharmacist's position becomes more patient-and counseling-centered.
Access to OTC medication is crucial for patients to be able to self-treat. Today, many drugs that are sold OTC were once classified as prescription drugs. The pharmaceutical industry is seeing an increase in the number of drugs that may be declared suitable for usage without a prescription as more safety research and trials occur. The U.S. Food and Drug Administration (FDA) has been working alongside drug developers and manufacturers for years to enact regulations that would make OTC drugs more widely available to the public. These advances have benefits for stakeholders throughout the medication supply chain.
Regulations around drug types were clarified in 1951 with the Durham-Humphrey Amendment to the Food, Drug, and Cosmetic Act, which established two categories of drugs: prescription and nonprescription. The amendment required that any medications that can lead to dependence or be harmful to a patient must be prescribed by a doctor and adequately labeled to state that a prescription is required to obtain the medication. Over time, the federal government also became more proactive in confirming the efficacy and safety of prescribed drugs. The Kefauver-Harris Amendment of 1962 required that drug companies demonstrate the safety and effectiveness of their products before promoting them to the general public, which led to stronger labeling regulations for both prescription and OTC drugs.
Today, these legislative and regulatory changes now mean that drug makers must take into account three criteria before initiating the process to transition prescription treatments to OTC versions: benefit-risk evaluation, consumer-friendly labeling, and strategies for making the drug an effective substitute for prescription drugs.
The benefit-risk comparison primarily considers whether patients can safely achieve the desired medical outcome of the treatment. Although some risk or side effects associated with medications is unavoidable, the FDA weighs the likelihood of whether serious risk would occur if a patient were to self-medicate. The drug's status will remain "prescription-only" if it is extremely hazardous or addictive.
The use of the proper language and labeling is another prerequisite for companies to transition their products to an OTC drug. The language on a pharmaceutical label needs to be sufficiently clear for patients to use it for self-treatment, in order to reduce the risk of overdosing. Before moving to OTC, a manufacturer should take proactive steps to anticipate and minimize issues by making the labeling user-friendly. The active ingredient, uses, precautions, inactive ingredients, indication, directions, and other information (such as how the product should be stored) must be listed on the label.
Lastly, the pharmacological indications for the new OTC release must be comparable to those for the prescription drug. The OTC medication needs to have a low risk of abuse and be reasonably safe in terms of toxicity, drug-to-drug interactions (DDIs), side effects, and adverse effects. Numerous clinical trials are required to determine whether the OTC release can fulfill these requirements.
Since patients, drug manufacturers, and healthcare providers would all likely benefit from transitioning products to OTC medication, the FDA has been working to increase OTC medication availability while still prioritizing patient safety. As reported in Sedgwick’s Q3 2022 Recall Index, in June 2022, the FDA published a proposed rule that would apply to a “Nonprescription Drug Product with an Additional Condition for Nonprescription Use” (ACNU). The regulation would broaden the range of medications that could be offered OTC.
According to the agency's website, the only nonprescription drug items now available on the market are those for which the labeling alone provides patients with sufficient information to appropriately self-select and use the product. Consumers can confidently choose and utilize these medications properly without seeking the advice of a healthcare professional.
Under the proposed ACNU regulation, a producer may submit an application suggesting a step, or "additional condition," a patient must successfully complete to get a nonprescription drug product when the label instructions are insufficient to ensure proper use. This condition, or ACNU, would require a patient to correctly answer a series of questions on a self-selection test to be able to purchase a drug product without a prescription. An automated telephone response system or a mobile application may be used to administer the test.
One of the proposed rule’s sections covers establishing the standards for a new drug application (NDA) or abbreviated new drug application (ANDA) for a nonprescription drug product with an ACNU, including the obligation to submit a separate application for approval. According to the FDA, it won’t approve an NDA or ANDA for a nonprescription drug product with an ACNU if the application doesn’t meet the necessary standards, or if the applicant can’t show that labeling alone will guarantee that the patient can self-select or use the drug product correctly in a nonprescription setting. A nonprescription medication product with an ACNU would likewise be subject to post-market reporting requirements.
Hogan Lovells lawyers hypothesize that the ACNU might be a means for the FDA to employ questionnaires and modern technology rather than only relying on doctors as "gatekeepers" for the choice of particular drugs. From this perspective, the ACNU may allow some prescription medications, particularly those for long-term diseases including hyperlipidemia, diabetes, and hypertension, to be made available without a prescription.
The ACNU could have impacts on three main stakeholder groups: patients, healthcare providers, and drug manufacturers. For patients, the main benefits of OTC medications relate to convenience, expense, and time. Purchasing OTC medications may be more convenient because they remove the need for a trip to the doctor’s office. Switching to nonprescription drugs may also be more cost-effective, because OTC medications tend to be priced more competitively. Finally, the patient doesn't have to wait while their prescription is processed.
For healthcare providers, the main benefit of the switch to OTC is that it may save time. Switching some medications from prescription to OTC may lessen the number of patients visiting doctors for prescriptions, freeing them up to see patients with more severe medical conditions. Pharmacists can save time with OTC medications because customers can choose pharmaceuticals from aisles in a grocery store rather than bringing in a prescription to be filled, enabling pharmacists to fill more prescriptions in a day and give more attention to more patients. However, it’s important to note that caring for patients using OTC drugs can also be more challenging, as monitoring and visiting with these patients is more difficult when they no longer have to make as many trips to the doctor to receive their medication.
Lastly, manufacturers that transition a drug to nonprescription status will have more flexibility in their marketing and advertising strategies. OTC medications have fewer legal requirements for advertising compared to prescription drugs. Manufacturers of OTC drugs are allowed to communicate directly with customers, such as through commercials. In contrast, advertisements for prescription pharmaceuticals must have a doctor explaining the risks. Even with this increased flexibility, the Federal Trade Commission (FTC) has authority over language used in the sales and marketing of non-prescription drugs and regulations that require the disclosure of any risks of medications.
The U.S. has already seen several recent success stories that prove the benefits of OTC drugs and products to stakeholders. For example, in October 2022, the FDA cleared the path for consumers to purchase hearing aids over the counter without a prescription. Millions of Americans may have put off purchasing hearing aids because of the inconvenience of going to the doctor for an exam. Now consumers with mild-to-moderate hearing loss can purchase hearing aids online or in stores without having to schedule an appointment with a doctor to obtain a prescription.
Given these recent events, prescription drug manufacturers should assess their offerings to see if there’s a benefit to selling any of them with an ACNU, or if medical supervision is indeed required. More broadly, all kinds of businesses must be constantly aware of any related changes in their own fields, whether driven by customers, regulators, or competitors.
If companies are not closely monitoring changes to their legal and compliance obligations, they are making their company vulnerable to more risk. With our connected and globally-oriented society, what may seem like a small issue for a company’s brand can be shared around the world with the touch of a button. Staying appraised of regulatory changes will mitigate potential damage legally, financially and reputationally.
Chris Harvey is senior vice president of brand protection at Sedgwick. With 15 years’ experience, he is recognized as an expert in the recall industry and routinely speaks on best practices at trade shows, conventions, and conferences. Throughout his career, Chris has managed more than 1,200 recall and in-market remediations, including hundreds for the largest U.S. and global brands. He also serves on the board of directors of the International Consumer Product Health and Safety Organization (ICPHSO).
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