TGaS offers guidance through murky regulatory waters

By Nick Taylor

- Last updated on GMT

Related tags Pharmacology

TGaS Advisors has launched a new version of its commercial compliance benchmark (CCB), which aims to help companies adhere to the array of guidance affecting their operations.

CCB has been revised to bring it in line with regulatory developments and explains to companies the best practices that should be implemented to prosper in this environment.

Robert Melillo, a practicing attorney who partnered with TGaS to develop the benchmark, said: “Pharma companies face daunting compliance challenges that directly impact marketing priorities and the allocation of resources​.

"We believe the Commercial Compliance Benchmark (CCB) will give TGaS Advisors’ clients what they need to cost effectively develop and maintain the best possible compliance practices​."

PricewaterhouseCoopers predicted that over the next five years the majority of states will require pharmaceutical companies to provide detailed information on sales and marketing expenditure.

Furthermore, legislation has been proposed that would go a lot further, requiring companies to track and report an array of expenditures. State level differences in what information has to be disclosed and the submittal process creates a patchwork regulatory system.

Stephen Gerard, managing partner, TGaS Advisors, believes CBB can help companies in this environment, commenting: "The new benchmark will give clients a thorough understanding of the dynamic regulatory climate and a way to evaluate their own compliance status internally and against their industry peers​."

The guidance covers state reporting issues, the Prescription Drug Marketing Act (PDMA), Pharmaceutical Research and Manufacturers of America (PhRMA) codes and guidance from the US Department of Health and Human Services (HHS).

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