New MaPP 5200.11 (here) provides an outline of internal FDA policy applied when an NDA product makes a full OTC switch. A partial OTC switch means there is a “leave behind” indication in the NDA product that still requires a prescription. This can be a use, a dose, or a related disease state. This MaPP does not apply to a partial Rx to OTC switch. A full Rx to OTC switch implies that there are no longer any Rx indications and the NDA product will become an OTC product only. The FDA believes, and provides the rationale, that when there is a full Rx-OTC switch, then all products marketed under the NDA and all ANDAs must be marketed as OTC.
Thus, in the case of a partial switch, the “FDA believes that the best way to read the language in section 503(b)(4) of the FD&C Act is to allow simultaneous marketing of drug products with the same active ingredient as prescription in one case and nonprescription in another case if some clinically meaningful difference, such as a difference in indication, strength, route of administration, dosage form, or patient population, exists between the drug products that makes the prescription drug product safe only under the supervision of a healthcare practitioner licensed by law to administer the drug product.” However, in a full switch, “absent a clinically meaningful difference between the products that makes the prescription drug product safe only under the supervision of a healthcare practitioner licensed to administer the drug, simultaneous marketing of two drug products with the same active ingredient as a prescription drug product and a nonprescription drug product would result in the prescription drug product being misbranded.”
In the case of a full switch, the FDA expects an ANDA applicant to revise its labeling to comply with the Reference Listed Drug’s new OTC labeling within six months. The MaPP notes that the Agency does not consider an NDA product that makes a full switch to be a “different listed drug.” For an ANDA with the pre-switch Rx labeling, the “FDA may withdraw approval of an ANDA if FDA finds that the labeling for the drug product that is the subject of the ANDA is no longer consistent with that for the RLD,” meaning the new RLD OTC labeling.
Even though it is an ANDA applicant’s responsibility to monitor labeling changes for the RLD upon which its application is based, MaPP 5200.11 discusses that the FDA is taking a proactive role in notifying ANDA applicants of full Rx to OTC switches and the need for label changes. This is likely due to some of the more recent Rx to OTC full switches where ANDA applicants continued to distribute and sell their products as the pre-switch Rx versions well beyond a reasonable time for revising the labels. For instance, marketing for Rx MiraLAX continued after the brand’s OTC switch in 2006 until the FDA intervened in 2018 to stop the Rx sales.
The new MaPP provides the OGD’s internal process for notification to ANDA applicants of Rx to OTC switches and the FDA’s expectations regarding the timelines for label changes along with the process for referral for regulatory action should an ANDA applicant not comply with required label changes.
