The Food & Drug Administration (“FDA”) oversees the approval, regulation and safety of prescription drugs and over-the-counter (“OTC”) drugs.
OTC drugs are those that may be bought directly by consumers and without prescription. The labels on OTC medication must provide enough information for consumers to decide whether to use products without a doctor’s supervision. Directions on the label must be straightforward and in a simple format so they can be easily followed. OTC drugs are considered safe and effective when the directions are followed. Examples include pain relievers and cold medication.
On the other hand, prescription drugs require a doctor’s supervision. Consumers are unable to select and use prescription drugs by themselves. This is primarily because prescription drugs often have dangerous side effects. Misuse of prescription drugs may be harmful. Examples of prescription drugs that cannot be include opioids and anti-anxiety medication.
The FDA recently proposed a new rule called “Nonprescription Drug Product with an Additional Condition for Nonprescription Use.” The rule would allow more drugs to be available to consumers over the counter. It would allow consumers to treat injuries and illnesses themselves with drugs that normally require a prescription. Physician oversight would no longer be necessary.
Under the new rule, drug manufacturers could have the same drug categorized as both prescription and OTC. In cases where a consumer cannot select and use a medication based on the label alone, and therefore would normally require a prescription, the manufacturer would be able to submit an application to the FDA proposing an additional condition to ensure consumers can select a medication themselves and use it without doctor supervision.
The proposed rule is broad and does not specify what conditions will fulfill the new requirements. But an example is a condition requiring consumers to complete a questionnaire regarding use of products prior to purchasing drugs OTC. This could be done on a phone or a store kiosk. The proposed rule would also require additional labeling and post market reporting.
The FDA has also not stated what drugs may apply. But it has indicated that drugs treating chronic conditions such as high blood pressure or diabetes may be included. The FDA is accepting comments on the proposed rule until October 2022.
