FDA approves two types of drug products –Prescription (Rx), and Over-The-Counter (OTC). Well, they also approve other types, i.e., Biologics etc., but for the purposes of this Blog post, it is the Rx and OTC that are applicable.
Prescription drugs require the intervention of a health care provider, and are typically for products where the patient cannot self-diagnose the condition for which the product is intended. Labeling for Rx drugs contain significantly more information than OTC products, and often have patient package inserts that provide additional information on the safe use of the product, along with more information on side effects etc. OTC products on the other hand, usually only contain the Drug Facts Label (DFL) that provides a brief set of instructions, warnings, and information about the dosage and administration, along with the ingredients contained in the product.
FDA has been evaluating ways in which to bring more OTC products to market, however, for some products, the DFL alone may not be enough to assure the patient can properly select or deselect themselves appropriately for the drug’s use, and can safely use the product without some additional supplemental information. In today’s Federal Register (here) FDA is announcing a Draft Guidance entitled, Innovative Approaches for Nonprescription Drug Products (here), which as the title suggests, is providing some suggestions as to how a firm may bring an OTC product through the submission of an NDA ((505(b)(1) or 505(b)(2)) application, with some additional labeling for the conditions for which the product is intended.
The Draft Guidance discusses a potential for “demonstrating safety and effectiveness for a nonprescription drug product in cases where the DFL alone is not sufficient to ensure that the drug product can be used safely and effectively in a nonprescription setting: (1) the development of labeling in addition to the DFL and (2) the implementation of additional conditions so that consumers appropriately self-select and use the product. The appropriateness and specific details of either of these approaches will depend on the circumstances that apply to a particular drug product.”
FDA’s belief is that this may open the door for a “wider range of nonprescription drug products, including drug products that may treat chronic conditions, or other conditions for which the limitations of the DFL present challenges for adequate communication of information needed for safe and effective use without the supervision of a health care practitioner. Approval of a wider range of nonprescription drug products has the potential to improve public health by increasing the types of drug products consumers can access and use, that would otherwise only be available by prescription.”
The Guidance provides example of the types of additional labeling and additional conditions of use (actions that consumers may be required to comply with prior to purchase), that may apply to the proposed OTC product. FDA of course, will apply these principles on a case-by-case basis.