[Ip-health] Indy Star: Obama asks for more from drug makers on biologis

[Sarah Rimmington]

Here's a key snippet-  a quote from Pres Obama this weekend about
generic biologic drug exclusivity periods:
The plan passed by a Senate committee would give drug makers 12 years of
exclusivity before facing competition from cheaper generic versions.
Obama has pushed for only seven years, while the House plan would grant
just five.

A shorter period of exclusivity is backed by consumer groups, including
AARP, which has called it a major concern in the reform debate.


Obama said that although setting exclusivity periods isn't an exact
science, research indicates that after seven years, breakthrough drugs
recoup the research investment and make "really good profits."


"If you extend that 12 years, obviously it's better for (drug makers')
bottom line," he said. "But it also means you're keeping important drugs
off the (generic) market and driving up those costs further."







indystar.com


July 25, 2009

Obama asks for more from drug makers

Additional savings, fewer years before medicines can go generic would
help, he says
/
By Maureen Groppe
Star Washington Bureau/

WASHINGTON -- Further negotiations with drug companies are needed to get
more savings for health-care reform beyond the $80 billion the industry
already has agreed to, President Barack Obama said Friday.


In an interview with The Indianapolis Star and other media outlets,
Obama also argued for a shorter period of market exclusivity for
biologic drugs -- such as insulin made by Indianapolis-based Eli Lilly
and Co. -- than drug makers want.

Reimbursement rates for government-purchased drugs and how best to
foster generic competition for certain types of drugs are two of many
issues in the health-care debate that could determine whether drug
companies such as Lilly fight the plan and encourage Indiana's
congressional members to vote against it.


But they also could help the president meet his goal of insuring
millions of people who aren't insured now while slowing runaway growth
in health-care spending.


Lawmakers still haven't agreed on how to meet those goals, and Congress
will miss the president's initial deadline of passing health-care
legislation before the August recess.


But Obama said Friday he was pleased with the progress made.


"We have never been closer to reforming our health-care system in a
fundamental way."


Obama also said a group of fiscally conservative House Democrats known
as Blue Dogs -- which includes Rep. Baron Hill, D-Seymour -- are playing
a constructive role in the debate.


Opposition from Hill and other Blue Dogs on the House Energy and
Commerce Committee stalled its work on the House health-care bill this week.


But Obama, who has been meeting with the group, said he agrees with two
of its members' main priorities: that the bill not add to the federal
deficit and that it control long-term health-care inflation.


John C. Lechleiter, Lilly's chairman and chief executive office, warned
in a speech at the U.S. Chamber of Commerce in May that health reform
proposals could stifle the incentive for drug makers to develop more
life-saving and life-extending products.


He is concerned, for example, about the approval process Congress might
create for generic versions of biologic medicines -- like Lilly's
insulin, human growth hormone and sepsis treatment. Such a process
already exists for drugs, such as Prozac, that are made from chemicals.


The plan passed by a Senate committee would give drug makers 12 years of
exclusivity before facing competition from cheaper generic versions.
Obama has pushed for only seven years, while the House plan would grant
just five.

A shorter period of exclusivity is backed by consumer groups, including
AARP, which has called it a major concern in the reform debate.


Obama said that although setting exclusivity periods isn't an exact
science, research indicates that after seven years, breakthrough drugs
recoup the research investment and make "really good profits."


"If you extend that 12 years, obviously it's better for (drug makers')
bottom line," he said. "But it also means you're keeping important drugs
off the (generic) market and driving up those costs further."




--
Sarah Rimmington
Attorney
Essential Action, Access to Medicines Project
Washington, DC
Tel: +1 (202) 387-8030
Cell: +1 (202) 422-2687
www.essentialaction.org/access/