[Ip-health] GPhA: McCain & Obama Advisors Affirm Support for Increased Access to Generic Medicines and Creation of an FDA Approval Pathway for Biogenerics]

[robert weissman]

Senior Advisors to Presidential Candidates John McCain and Barack Obama
Affirm Support for Increased Access to Generic Medicines and Creation of
an FDA Approval Pathway for Biogenerics

Advisors Say Exclusivity Period Should Be As Short As Possible to Ensure
Biogenerics Reach Consumers

WASHINGTON, Sept. 18 /PRNewswire/ -- 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)


CONTACT:  Andrea Hofelich of Generic Pharmaceutical Association (GPhA),
+1-703-647-2495

Web Site:  http://www.gphaonline.org/