In a draft paper, the FDA advises firms to authenticate each new drug with a unique blend of pigments and other non-reactive agents – known as physical-chemical identifiers (PCIDs) – which will enable medics and wholesalers to distinguish brand drugs from their imitators. The FDA hopes that this will lead to a safer market.
Pharmaceutical manufacturers have already been investigating readily available technologies that may make drug products more difficult to duplicate, outlines the paper, entitled Draft Guidance for Industry: Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting. The term 'solid oral dosage form' (SODF) covers any drug made into tablets or capsules.
'One approach that pharmaceutical manufacturers [are] considering involves adding a trace amount of inactive ingredient(s) to an existing section of the dosage form,' the paper states. 'A unique physical-chemical characteristic of that ingredient makes it possible to detect and authenticate legitimate dosage forms and identify counterfeits.'
FDA commissioner Margaret A Hamburg said: 'Drug counterfeiting is a serious public health concern. We look forward to working with industry to help ensure that consumers are not exposed to products containing unknown, ineffective or harmful ingredients.'
According to the FDA, most of the chemicals that pharma groups are likely to use as PCIDs are already in wide circulation, in the form of food additives and colourants. This ensures that they have established reliable safety profiles.
The draft paper also notes: 'Examples of substances that may be incorporated into SODFs as PCIDs include inks, pigments, flavours, and molecular taggants. Such PCIDs may allow product authentication by their presence alone or may be used to code the product identity into, or onto, the SODF.
'Many identifying characteristics, such as pigments or flavours, could be easily observed by healthcare practitioners and pharmacies,' added the paper, '[while others] could require the use of instrumental detection.' Several common methods of detecting the presence of PCIDs already exist, such as holography, laser scanning devices and excitation/fluorescence detection.
The FDA also urges pharma firms to work with PCIDs that will not harm the effectiveness of the drugs they are attached to. In addition, it suggests a range of protocols for informing regulatory groups about the presence of the indicators in their products. These include the exact chemical composition of each one; a justification for their safety; product-development information, including any test results; a description of the manufacturing steps that allow PCIDs to be put into the doses, and an assurance of quality. The group recommends that PCIDs should be used at the lowest possible levels.
Industry experts have been invited to comment on the draft guidance, in advance of a final version of the paper, which will be published later this year. Download a full copy of the draft from the FDA's official website.