Comment from Michael Benesch

Discussions should be held regarding independent testing similar to the EU model. A new initiative should be funded to research the feasibility, logistics and standards of regular independent testing. Many consumers have reported a significant difference in quality from one generic manufacturer to another and are often unable to request a specific generic manufacturer from larger pharmacies. Insurance is also usually reluctant or unwilling to cover brand name. Amongst certain communities, namely those prescribed stimulants for ADHD treatment, their pharmacy experience is described as "generic roulette". I myself have experienced a particular generic from the manufacturer Mallinckrodt which causes increased lethargy and lack of focus. The same medication, Adderall 20mg XR, manufactured by Lannett caused an opposite reaction. Leading to issues with hyperfocus and hyperactivity. A report has been posted to Medwatch regarding this particular case. As the Senate Special Committee on Aging has been investigating, it is evident that poor quality generic medication has been allowed to enter our market. Resources should be allocated by the FDA to fund research into implementing independent batch testing of prescription medications for quality, purity, efficacy, and bio equivalency. It is clear that relying on manufacturer provided data and utilizing a facility inspection and risk-based approach is ineffective at regulating our prescription drug market, especially regarding overseas generic manufacturers. This proposal aligns with other core workshop topics regarding bioequivalency and quality testing and contamination by nitrosamines.