Читать книгу Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) - William Gregory - Страница 88

OTC products are regulated by CDER’s Office of Non-prescription Drugs and are drug products that can be sold in the United States without a prescription and, thus, without any medical professional intervention. That is, they are sold without a clear medical diagnosis being made by a medical professional and, thus, are purchased largely for symptoms as self-diagnosed by the lay public. Some products are not truly over the counter and are held by the pharmacist “behind the counter” such that the consumer must speak with the pharmacist, who will/should assess the need and appropriateness of the patient and product. OTC products have benefits that outweigh their risks, have low potential for misuse and abuse, can be adequately labeled, and do not require a health practitioner for their safe and effective use.

Drugs can enter the OTC market in several ways. A drug may be approved via the usual NDA process and then may be moved to OTC status through various routes. One is the “Rx to OTC switch”. Other drugs that are “generally recognized as safe and effective (GRAS/E)” are listed in the FDA’ s “OTC monograph(s)” that specify which drugs may be marketed without further studies, FDA review, or approval. There are also so-called negative monographs that limit specific indications for certain drug ingredients. The monographs are very detailed specifications in the Code of Federal Regulations that specify ingredients, doses, formulations, indications, and labeling.

The FDA can act quickly to restrict marketing or remove a product from sale if there is significant risk or lack of evidence for effectiveness, or if the FDA finds that the usual notice and public procedure method are impracticable, unnecessary, or contrary to the public interest. The FDA can, thus, issue a rule requiring immediate label changes and marketing restrictions. In non-urgent situations, the FDA can use the notice and comment rulemaking mechanism to change marketing status.

Regarding safety reporting, OTC reporting by industry was not required until December 2007 for OTCs that did not have NDAs. That is, there was no requirement for AEs to be collected, analyzed, or submitted by manufacturers. This changed in 2007 when FDA issued a guidance that required reporting of serious AEs for OTC products found to be “associated with the drug”. These were to be reported via MedWatch by manufacturers, packers, and distributors, using the 3500A-form. This essentially required that all serious AEs (whether in the label or not) must be reported to FDA within 15 calendar days. Requirements for minimal validity criteria are essentially the same as for drugs. Manufacturers are now required to submit reports electronically, but others are not yet required to use electronic means to make OTC case reports.