GPhA calls on US President to urge Congress to strike biogenerics from health care reform unless provisions substantially altered

Continuing the biosimilars argument between the USA's research-based and generic drugmakers, the Generic Pharmaceutical Association (GPhA) has called on President Barack Obama to 'urge congressional leaders to strike the biogeneric language from pending health care reform legislation unless the provisions are materially altered to ensure timely entry of safe and affordable biosimilars and biogenerics to the market.

The GPhA claims that 'inclusion of the current fatally flawed language is arguably worse than the effective monopoly that the biotech industry enjoys because it represents an empty promise to Americans who may falsely believe that the legislation will provide for meaningful competition. This simply will not increase access or contain drug spending costs; rather, it represents little more than camouflaged protection of the unacceptable and unsustainable status quo.'

In its letter to the President, the trade group notes that both the House and Senate health care reform bills contain language that would give a minimum of 12 years of market exclusivity to brand biologics. 'This unwarranted and excessive exclusivity period is in contrast to the White House's recommendation of a seven-year period and the findings of the Federal Trade Commission with respect to market exclusivity and incentives to innovate new medicines,' it argues.

Commenting on the issue, GPhA president Kathleen Jaeger stated that, 'as I have been frequently reported, most recently in the Time Magazine article last week, initially, and ironically, the brand drug industry was adamantly opposed biogeneric legislation. But rather than continue to oppose, they used their political weight and largesse to convince many members of Congress to essentially codify their monopolies. Any bill that delivers an empty promise to patients seeking access to affordable biogenerics while bestowing one of the biggest windfalls to the brand/bio pharmaceutical industry in 25 years clearly contradicts the fundamental tenets of health care reform.'