[Ip-health] Advocates Try To Pressure NIH To Respond To Norvir Petition

Claire Cassedy claire.cassedy at keionline.org
Mon Sep 16 12:28:01 PDT 2013


http://www.pharmalive.com/advocates-try-to-pressure-nih-to-respond-to-norvir-petition

Advocates Try To Pressure NIH To Respond To Norvir Petition


Posted Thu, 09/12/2013 - 8:08am by Ed Silverman 1

Last year, several non-profit groups asked the US National Institutes of
Health to grant a so-called march-in petition that would allow them to make
and sell the Norvir HIV medication sold by AbbVie. Why? The drug was
created with federal funds and is currently much more expensive in the US
than in other countries with comparable incomes.

So far, though, the agency has not acted on the request, frustrating the
advocacy groups that want to make the medicine more accessible to
Americans. And so, in a bid to pressure the agency to move faster, one
group conducted a survey showing most Americans are unaware their taxpayer
dollars are used to fund such inventions and want drugs to be priced the
same in the US as in other countries.

Specifically, 62 percent of those queried say they were not previously
aware of the extent of US government funding of medical research, including
research leading to patented inventions. And nearly 72 percent want the NIH
to require patent holders not to charge US residents more than what is paid
in Canada, Europe and other high-income countries for the same drug. Nearly
19 percent were unsure (read more here).

“The NIH has acted as though the march-in request is not urgent and has
given the impression that the NIH is not concerned about price
discrimination against US consumers,” says Jamie Love of Knowledge Ecology
International, which focuses on intellectual property issues and access to
drugs. “We wanted to show the NIH and anyone else in the government or the
Congress how the taxpayers view this issue.”

“I think the survey results illustrate the disconnect between the people
who pay taxes and the people who spend the money. It is truly appalling
that in more than three decades the NIH has failed to use the march-in
provision to protect the public from abuses by patent owners." The survey,
by the way, canvassed 170 US residents.

Norvir is commonly used in HIV drug cocktails, including the Kaletra AIDS
pill. Abbott Laboratories, which last year spun off AbbVie, battled patient
advocates, consumers and even a rival drugmaker after raising the price by
some 400 percent in 2003, but only in the US. The move prompted shareholder
resolutions, protests at Abbott (ABT) headquarters, a boycott by doctors
and state Attorney General investigations.

A survey conducted last year found that prices charged in eight,
high-income countries for a single 100mg tablet or capsule ranged from
$1.02 to $2.16, compared with $10.29 for the average wholesale price in the
US and $12.63 for a cash payment at a CVS pharmacy in the Washington DC
area, according to the petition request sent to the NIH, according to the
march-in petition (here is the petition).

The petitioners are asking the NIH to set a policy that would grant
march-in requests when US residents face substantially higher prices than
the patent owners charge in other countries with comparable incomes. The
petition was also signed by the American Medical Students Association, the
US Public Interest Research Group and the Universities Allied for Essential
Medicines.

But how would the organizations actually make and market a version of
Norvir if the NIH were to grant the request? Love says they would import
the drug from one of the FDA-approved suppliers to PEPFAR, the US
President’s Emergency Plan for AIDS Relief.

As we reported at the time the petition was filed, the organizations
concede this may be an uphill battle. In the 31 years since the Bayh-Dole
Act became law, which established a framework for determining ownership
interests in federally funded inventions, the NIH has never granted a
request for a march-in petition. In fact, one of the groups unsuccessfully
sought a march-in petition in 2004 for the same drug.

For this reason, the groups are also asking the NIH to "adopt a clear
policy on march-in petitions in cases where patents on medical inventions
are necessary to effect significant health benefits of a second product
used or is potentially useful to prevent, treat or diagnose medical
conditions or diseases involving humans.”

So far, the NIH has not indicated its intent, but did meet with the
advocacy groups last March. KEI released notes from that meeting, which you
can read here. We asked the NIH when a response to the petition may be
forthcoming and will update you accordingly. [UPDATE: An NIH spokesperson
wrote back to say this: "This is a pending legal matter and NIH does not
comment on pending legal matters."] We also asked AbbVie (ABBV) for its
reaction to the survey and will provide you with any reply that is sent.



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