[Ip-health] Baltimore Sun Op-Ed: Drug competition in peril

[Sarah Rimmington]

The following op-ed by John's Hopkins med student (and UAEM member) Jane
Andrews regarding biogenerics appeared in both the Baltimore Sun and the
Chicago Tribune last Friday.

www.baltimoresun.com/news/opinion/oped/bal-op.biosimilars28aug28,0,7541644.=
story
<http://www.baltimoresun.com/news/opinion/oped/bal-op.biosimilars28aug28,0,=
7541644.story>


    Drug competition in peril


      Legislation would stymie generic versions of expensive biologic
      medications

By Jane Andrews

August 28, 2009

When Congress members return in two weeks, they will be discussing a
health care reform bill that attempts to provide care for the uninsured
and to address our skyrocketing health care costs.

Simultaneously, however, the House and Senate are considering proposals
that would prevent lower-cost pharmaceuticals from coming to market by
regulating generic versions of biologics known as follow-on biologics or
"biosimilars."

Biologics, protein-based pharmaceuticals produced within living cells,
include all vaccines, most new cancer agents, and critical arthritis and
psoriasis drugs. According to the Federal Trade Commission, they
represent 14 percent of the U.S. pharmaceutical market and are its
fastest-growing component.

They are also among the most expensive drugs sold in the U.S. For
example, the anti-cancer agent Avastin costs upward of $50,000, and the
popular anti-rheumatoid arthritis drug Enbrel sells for $15,000-$20,000
a year. Americans spent $40.3 billion on biologics in 2007.

Currently, there is no mechanism for approving generic forms of these
drugs. The proposals before Congress are an attempt to create a pathway
for allowing these biosimilars into the market. But the legislation
favors pharmaceutical companies and hurts patients by offering
brand-name companies 12 years of market exclusivity before generics can
come to market. Traditional chemical drugs receive five years of market
exclusivity before generics may be produced.

Even worse, current proposals permit brand-name companies to make minor
modifications to their products at the end of a 12-year market monopoly,
and then receive another 12 years of exclusivity. This process would
yield a perpetual monopoly. The current legislation would virtually
eliminate the possibility of generic competition.

The Federal Trade Commission released a fact-finding report in June
estimating that follow-on biologics would take eight to 10 years to
develop and cost $100 million to $200 million. Due to high production
costs and slow market acquisition, the FTC recommended zero years of
market exclusivity for biologics, a far cry from the currently proposed
12 years.

Not only do the policies surrounding biologics have implications for
health care in the United States, but keeping generic biologics out of
the market would also make new vaccines prohibitively expensive for
developing countries. Given that poor countries are dependent on
generics even for inexpensive medications like ibuprofen and
acetaminophen, flawed biosimilars legislation would make expensive,
lifesaving cancer and autoimmune medications inaccessible.

As a student of medicine and public health at the Johns Hopkins
University, I am amazed that the Association of American Universities
(AAU), a consortium of 62 leading public and private research
universities, has publicly supported a proposal for regulation of
biosimilars that eliminates the possibility of generic competition.
While virtually all other consumer groups publicly opposed the proposal
in Congress, the AAU appears to be supporting a policy that would solely
benefit pharmaceutical companies, cost the United States billions of
dollars, and reach beyond our borders to restrict access to lifesaving
medicines to people in developing countries.

In the United States, our families and neighbors struggle to obtain
costly drugs for rheumatoid arthritis, cancer and multiple sclerosis.
This is a sad state of affairs for a country that spends more per capita
on health than anywhere else in the world. In poorer countries,
biologics produced in the U.S. are a pipe dream.

Maryland Sen. Barbara A. Mikulski and Rep. John P. Sarbanes of the
state's 3rd Congressional District both sit on committees influential in
crafting legislation for biosimilars. Before Congress went to recess,
Representative Sarbanes admirably voted against the current proposal,
while Senator Mikulski openly supported the bill (and was praised by the
Biotechnology Industry Organization).

At the end of September, we will either be presented with a bill that
promotes generics and thus increased access to medications for patients,
or a bill that prevents generics from coming to market and will mean
higher-priced medications for patients in our future. Senator Mikulski
and Representative Sarbanes: Do not let the pharmaceutical industry fool
you. The rest of us are not sold.



Jane Andrews is a medical student and public health student at the Johns
Hopkins University and a member of Universities Allied for Essential
Medicines. Her e-mail is jandrews at jhsph dot edu.

Copyright =A9 2009, The Baltimore Sun <http://www.baltimoresun.com/>

<http://www.essentialmedicine.org>

--
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/