Jan 19, 2022
The process of transferring FDA-approved prescription medications to nonprescription, over-the-counter (OTC) status is known as “Rx-to-OTC switch.” This process provides consumers with convenient, cost-effective access to safe and effective medicines without the required assistance of a healthcare provider. When an ingredient is first introduced as an OTC medicine, it typically has been marketed by a manufacturer as a prescription medicine first. Then, after a sufficient amount of time has passed to enable the manufacturer to gather appropriate scientific information on the product, the manufacturer may elect to submit a new drug application, or NDA, to FDA so that it may be considered for OTC status. FDA experts review the application and determine if that product has a high enough safety profile and if labeling can be developed so that the medicine can be marketed safely and effectively as an OTC medicine.
OTC medicines are cost-effective first-line therapies for many ailments. The Rx-to-OTC switch process has a positive impact on the U.S. healthcare system process by driving down overall healthcare costs. For example, according to a study conducted by researchers at Northwestern University, using OTCs to treat certain upper respiratory infections could save $4.75 billion annually.
There is a lot more to consider than just the cost of prescription co-payments, which vary greatly from insurance plan to insurance plan. Other circumstances to consider include the fee for the doctor’s visit, travel costs, and time off from work. Even more alarming is the number of Americans who do not have healthcare insurance. According to the last government statistics available, there are nearly 47 million uninsured Americans. The Congressional Budget Office says that as many as 60 million Americans may lack health insurance at some point in any year. And many of those with health coverage do not necessarily have a drug plan. OTC medicines continue to be an extremely cost-effective option for millions of consumers each year.
106 ingredients, indications, or dosage strengths have made the switch from Rx to OTC status or have been newly approved since 1976. That translates to more than 700 OTC products on the market today. A list of ingredients that have made the switch from Rx to OTC is available online.
Technically, anyone could submit a Citizen’s Petition to FDA to switch a product from Rx to OTC status. However, the holder of the approved new drug application (NDA) — the company that developed the drug for prescription use — knows the most about the drug and is in the best position to determine whether and under what circumstances it would be appropriate to request a switch. FDA should consult with the NDA holder about whether the switch process should be initiated, but the sponsor needs to develop the evidence and drive the switch process to manage the risk of prematurely or inappropriately removing prescription safeguards.
FDA must look at the safety and effectiveness of the product, the benefit-to-risk ratio, and whether the labeling can be written in such a way that consumers can use the products safely without the intervention of a healthcare provider.
There is only one historical example of FDA attempting the switch of a Rx drug to OTC status on its own initiative. In 1982, FDA issued a tentative final monograph which included metaproterenol for asthma. Due to a hailstorm of negative comments, the agency rescinded its decision shortly thereafter.
Theoretically, FDA could make a recommendation to switch a product; however, the agency would need to follow a resource-intensive, complex process. There are unresolved and debated questions concerning such an approach, including the use of proprietary data, formal hearing rights, under what authority FDA would seek to do so, and the lack of regulations.
While drug user-fee schedules do apply, each case is handled on its own merits and actually may take longer than the predetermined ten-month targeted timeframe. There are a number of reasons that the approval process may be delayed. For example, FDA may ask a manufacturer to provide additional data on the safety, effectiveness, or use of the product. The agency also may ask a manufacturer to modify a product’s labeling so that it is more understandable. The important thing to remember is that each switch application is considered on its own merits.
A third class or BTC class of drugs does not currently exist in the United States. In general, when most people talk about a third class of drugs, they are referring to a category of medicines available without a prescription, but only in pharmacies or through a pharmacist. Under this system, some OTC medicines would not be available in other convenient retail outlets, such as grocery stores without a pharmacy.
No, not necessarily. Existing law and regulation provide sufficient flexibility for companies to work with FDA to explore new or different approaches to moving prescription medicines to nonprescription status. Recent examples in which an application sponsor has voluntarily committed to innovative distribution, information support, or educational mechanisms include the emergency contraceptive levonorgestrel, orlistat to help in weight loss, and nicotine replacement therapies to help stop smoking.
Yes, because we think a change in law is unnecessary. CHPA and its member companies have always advocated for expanded access to OTC medicines through Rx-to-OTC switch. It makes sense to find ways to safely expand access to medicines for consumers whenever possible, and we believe flexibility is built in to the existing framework, with manufacturers having the opportunity to work with FDA and design the appropriate tools to address any challenges to that particular medicine.