WASHINGTON, Sept 18, 2008 /PRNewswire via COMTEX/ -- Advisors Say Exclusivity Period Should Be As Short As Possible to Ensure Biogenerics Reach Consumers Senior policy advisors to the Presidential campaigns of John McCain and Barack Obama today strongly affirmed the candidates support for increasing access to generic medicines as a means to reduce health care costs in our struggling economy as well as the need to create an FDA approval pathway for biogenerics with as short a period of exclusivity as possible. Dora Hughes, health policy advisor to Senator Obama, and Douglas Holtz-Eakin, Senior Policy Advisor to Senator McCain, stated their candidates support for generics and biogenerics at the 2008 Annual Policy Conference of the Generic Pharmaceutical Association (GPhA). The advisors echoed remarks delivered by Congressman Nathan Deal (R-GA) who cited a paper released yesterday by a Boston University professor which stated that the Hatch-Waxman exclusivity model has been successful and prolonged periods of exclusivity would harm innovation and competition. “Our two Presidential candidates understand the true value that generic medicines play in our nation’s health care system,” GPhA President and CEO Kathleen Jaeger told conference participants. “As American families increasingly struggle with rising health care costs, both parties are talking about increasing access to affordable generic -- and biogeneric -- medicines. And that’s music to not only our ears, but to countless patients across the country.”
Recognizing that the Hatch-Waxman Act contains three to five years of market exclusivity, both Hughes and Holtz-Eakin firmly stated that Senators McCain and Obama would want to see as short a market exclusivity period as possible in order to get affordable biogenerics to market. BIO and PhRMA have been pushing for an unprecedented and unwarranted 14 years of market exclusivity in biogenerics legislation. Hughes told conference participants that this period is excessively long and Holtz-Eakin noted that Senator McCain’s instincts are to move to as short a period as possible.
Other issues critical to ensuring that safe, effective and affordable generics get to consumers in a timely manner such as authorized generics, citizen petitions and free trade agreements were also discussed at the conference. Senator Obama’s campaign indicated that these issues would be part of his health care reform package.
The senior advisors also expressed the need for a strong FDA, including increasing funding for the Agency. GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk active pharmaceutical chemicals, and suppliers of other goods and services to the generic drug industry. Generics represent 65% of the total prescriptions dispensed in the United States, but only 20% of all dollars spent on prescription drugs. For more information about the industry, visit www.gphaonline.org.
SOURCE Generic Pharmaceutical Association (GPhA)
http://www.gphaonline.org
