The Pharmaceutical Research & Manufacturers of America (PhRMA), the drug industrys trade association, submitted proposals to FDA last week to prevent drug counterfeiting.
First, PhRMA wants FDA to immediately require that pedigree papersdocuments tracing sales of all drugs back to the manufacturerbe provided to prospective buyers before transactions take place. A pedigree requirement was part of the 1987 Prescription Drug Marketing Act, but FDA stayed its implementation in response to objections from wholesalers. Paper pedigrees, combined with due diligence, provide the most cost-effective, currently available method for ensuring that drugs do not enter the distribution system, the association says.
However, one problem is that the Prescription Drug Marketing Act exempts some wholesalers from the pedigree paper requirement. The statutory requirements should be changed so that all wholesalers are required to provide pedigree papers, PhRMA says.
In addition, detailed background checks should be required to prevent unscrupulous individuals from becoming wholesalers, PhRMA says.
PhRMA also recommends that an electronic track-and-trace systembar codes or radio-frequency identification chips to track drugs throughout the distribution systembe developed. However, technological problems will take at least five years to solve before such a system can be implemented, PhRMA says.
PhRMA wants the federal penalty for counterfeiting increased from the current maximum of three years imprisonment to 20 years and also recommends criminal penalties for businesses that purchase drugs without trying to verify their source.