US generic drugmakers say Senate HCR Bill 'gratuitously extends biologic monopolies'

Adding its comments on the US Senate Health Care Reform proposal introduced a day earlier (The Pharma Letter November 19), Generic Pharmaceutical Association (GPhA) president and chief executive Kathleen Jaeger has strongly criticized its provisions with respect to copy versions of biological medicines, or biogenerics, referred to as biosimilars in Europe, where legislation for their approval is already in place.

Ms Jaeger declared: 'Just when you think the pro-BIO and PhRMA [Pharmaceutical Research and Manufacturers of America] provisions in health care reform couldn't get any more favorable for them, the Senate health care reform bill has further disappointed consumers by adding additional monopoly protection to expensive biologic medicines. Regardless of the motivation, the biologic provision in this bill takes the already egregious and unwarranted 12 years of exclusivity and extends it. The Senate leadership had the opportunity to address the deficiencies of the House HCR bill and to fulfill the Senate HELP Committee's commitment to close down a major loophole known as 'evergreening,' and deliver a more reasonable biogenerics pathway to consumers, labor, businesses, generic manufacturers and employers. Instead, they have provided further hurdles to access more affordable medicines.'

Continuing in this vein, she said: 'We have strongly urged Congress to put patients over brand company profits by fixing the generic biologics provisions of HCR. Yet, the relentless and powerful brand industry has managed not only to maintain outrageous and excessive product monopolies - but somehow increase their profits under the Senate HCR bill. As it stands now, the Senate version not only does nothing to increase timely access, but rather it further delays competition from more affordable generic medicines.'

'It's an absolute and unequivocal shame that what should be a biogeneric provision designed to expand access to lifesaving medicines and to substantially reduce health care costs - a potential 'HCR game changer' - benefits only brand companies. In the name of true health care reform, it is incumbent upon Congress to strip the anti-consumer biologic provision out of health care reform,' Ms Jaeger stressed.