Inspections
FDA aims to inspect prescription and nonprescription drug-manufacturing facilities every two years (8). OTC facility inspectors
focus on verifying drug-monograph compliance (3). Many of the drug recalls that have occurred during the past 18 months are
not tied to FDA approval or labeling, but rather to the manufacturing and supply-chain management of these products, points
out Jonathan M. Lewis, a principal at Advanced Biomedical Consulting. "Many OTC drugs are less 'risky' in FDA's eyes," he
says, "so these facilities often are not inspected nearly as frequently or with as much focus as compared with prescription
products, such as injectables."
Lewis suggests that preapproval inspections, which he says are rarely required for OTC drug products, be implemented. "These
inspections would help assess manufacturing conditions and regulatory compliance prior to marketing of these products," he
says.
Ravi Harapanhalli, principal consultant and late-stage services lead at Parexel Consulting, agrees. "Over the counter drugs
approved via an NDA/ANDA process don't need anything beyond what is currently applied with regard to ensuring product quality. However,
for monograph drugs, a requirement for cGMP inspection prior to marketing should be mandated to ensure appropriate product
quality and postmarketing recalls. If FDA cannot have the resources to do inspections, it should consider third-party audits
as an alternative for OTC drugs marketed under monographs. A system of third-party audits is already accepted for certain
low-risk devices."
Also, says Harapanhalli, "OTC drugs approved under an NDA or ANDA pathway seem to have fewer concerns of product quality compared
with the OTC drugs marketed under monographs. Because monograph drugs are neither pre-reviewed nor approved, a manufacturer
takes full responsibility to attest that their product meets the quality guidelines and requirements described in an OTC monograph."
This responsibility can be more difficult for smaller manufacturers of OTC products, adds Lewis. These smaller firms often
turn to outsourcing and do not have the finances or staff to audit their contract manufactures and suppliers. They end up
taking "more risk, often at the cost of quality, to produce these products domestically," says Lewis.
Resources are a constant challenge for FDA as well. Harapanhalli points out that many cGMP inspections of OTC sites uncover
manufacturing problems and that unfortunately, FDA does not have the resources it needs to perform all of its targeted biennial
inspections. As a result, consumer complaints and other triggers often prompt the agency to inspect OTC manufacturing sites.
On the positive side, FDA recently released a guidance for industry on adverse-event reporting that requires manufacturers
of OTC monograph drugs to provide safety updates to the agency (9). But until FDA's budget sees a massive increase, inspections
of facilities, and seemingly low-risk facilities, may be put on the back burner.
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