The US Food and Drug Administration (FDA) is planning to release an additional interim report later this week on the issue of drug counterfeiting and measures that can be taken to keep fakes out of the marketplace, according to local press reports.
The final document from the agency, which started a consultation exercise on counterfeiting this summer, is due early next year. It took the action after seeing an increase in both the number of cases and the ability of counterfeiters to get their products into legitimate distribution channels.
The latest report will be made by the FDA's task force on counterfeiting, which was set up in July. At the time of its formation, the group was asked to provide an initial assessment of the situation after 60 days.
Speaking at a conference in Washington at the end of last week, Thomas McGinnis, the FDA's director of pharmacy affairs, suggested that counterfeit drugs seemed to be getting into the distribution network via smaller wholesale operations. Earlier this year, Pfizer was forced to recall 200,000 bottles of its cholesterol-lowering drug Lipitor (atorvastatin) after fake versions of the drug were discovered.
The pharmaceutical industry may have to resort to high-technology solutions to the problem of counterfeiting. For example, in the area of packaging, McGinnis said companies may need to use radio-frequency identity chips to track bottles of prescription drugs from manufacturers to pharmacies. This sort of technology is already used in the USA for passes used at highway toll booths.
The FDA is also interested in a programme developed by Swiss company Serono that tracks its AIDS wasting treatment Serostim (somatropin rDNA origin), which can only be sold at authorised pharmacies in the USA. Pharmacies must report a bar-coded tracking number to get reimbursement from third-party payers such as Medicaid. Serono implemented the programme after a series of cases in which bootleg Serostim was uncovered.
The FDA may consider relaxing some of its regulatory procedures so that companies can implement the packaging changes more easily, according to McGinnis.
The agency is scheduling a meeting on 15 October to discuss some of the preliminary feedback from interested parties on the counterfeiting issue.