[Ip-health] Obama and McCain Advisors on Parallel Imports, Generic Uptake, Reverse Payments, and Biogenerics

[Mike Palmedo]

Advisers To Major Presidential Candidates Discuss Positions on
Reimportation, Generics, Biotechnology Medications

Kaiser Daily Health Policy Report
September 19, 2008

Democratic presidential nominee Sen. Barack Obama (Ill.) and Republican
presidential nominee Sen. John McCain (Ariz.) have begun "reviewing
their support" for prescription drug reimportation in response to recent
cases of contaminated medications and other products from other nations,
advisers to the candidates said on Thursday during the annual conference
of the Generic Pharmaceutical Association in Washington, D.C.,
Reuters/Boston Globe reports. According to Reuters/Globe, the advisers
indicated that the candidates had not "abandoned reimportation but had
realized it would be more difficult."

Dora Hughes, a health care policy adviser to Obama, said, "Both
candidates were in favor of reimportation and sort of subsequent to the
heparin incident (there's) a lot less enthusiasm," adding, "We have a
better understanding of the challenges that go along to support the
importation." Douglas Holtz-Eakin, a senior policy adviser to McCain,
said, "We now realize the challenges for doing that are greater than
before" (Heavey, Reuters/Boston Globe, 9/18).

Other Issues

The advisers also said that both candidates would make expanded use of
generic medications one of the top priorities on their health care agendas.

Hughes said, "We know that expanding the use of generics and eliminating
barriers to that goal must be a centerpoint of any health reform
effort." She added that Obama supports the elimination of reverse
payment agreements, under which brand-name pharmaceutical companies pay
generic pharmaceutical companies to delay market entry of generic
medications.

Holtz-Eakin said, "Controlling health care costs has to be the
imperative of any effective health care reform," adding, "Senator
McCain's instincts are to make the period as short as possible so that
you can get products to market more quickly." According to Holtz-Eakin,
McCain also would seek to revise the tax code to discourage the shift in
prescription drug manufacturing to other nations. He said, "The simplest
way to make sure supply chains are safe is to make sure they begin and
end in the U.S." (Perrone, AP/BusinessWeek, 9/18).

The advisers also said that both candidates support legislation to allow
FDA to approve generic versions of biotechnology medications. Both
candidates also support the shortest possible period of market
exclusivity for brand-name biotechnology companies under such
legislation, the advisers said.

Hughes said that "14 years (of data exclusivity), as requested by the
biotech industry, is excessively long," adding that "we're tilted toward
the shorter period." Holtz-Eakin said, "The basic instinct should be:
push the period down to the shortest period that maintains the
appropriate innovation incentives" (McCarthy, CQ HealthBeat, 9/18).

[snip]


--
Mike Palmedo
Research Coordinator
Program on Information Justice and Intellectual Property
American University, Washington College of Law
4910 Massachutsetts Ave., NW Washington, DC 20016
T - 202-274-4442 | F 202-274-0659
mpalmedo@wcl.american.edu