[Ip-health] Excerpt of Randall Tobias' prepared testimony before the Senate Appropriations Committee

[Mike Palmedo]

http://appropriations.senate.gov/hearmarkups/record.cfm?id=3D221702


Statement of Ambassador Randall L. Tobias U.S. Global AIDS Coordinator
=93HIV/AIDS Fiscal Year 2005 Budget Request=94 Hearing of The Subcommittee
on Foreign Operations of The Committee on Appropriations United States
Senate

May 18, 2004

[snip]

This past Sunday, Health and Human Services Secretary Tommy Thompson and
I held a joint press conference in Geneva where the World Health
Assembly in currently taking place. Our purpose was to make two very
important announcements that impact on these issues.

First, Secretary Thompson announced an expedited process for FDA review
of applications for HIV/AIDS drug products that combine already-approved
individual HIV/AIDS therapies into a single dosage. These combined
therapies are known as fixed dose combinations or FDCs. Drugs that are
approved by FDA under this process will meet all FDA standards for drug
safety, efficacy, and quality.

This new FDA process will include the review of applications from the
research-based companies that developed the already-approved individual
therapies and want to put them into fixed dose combinations, or from
companies who are manufacturing copies of those drugs for sale in
developing nations. There are no true generic versions of these AIDS
drugs because they all remain under intellectual property protection
here in the United States.

For my part, I announced that when a new combination drug for AIDS
treatment receives a positive outcome under this expedited FDA review,
the Office of the Global AIDS Coordinator will recognize that result as
evidence of the safety and efficacy of that drug. Thus the drug will be
eligible to be a candidate for funding by the President=92s Emergency
Plan, so long as international patent agreements and local government
policies allow their purchase. Where it is necessary and appropriate to
do so, I will also use my authority to waive the =93Buy American=94
requirements that might normally apply.

[snip]

If we don=92t apply appropriate scientific scrutiny to this vastly
expanded flow of AIDS medicines, we will run the risk of causing the HIV
virus to mutate and overcome specific drugs or even whole classes of
drugs. That could render our current drugs useless =96 and, incredibly, it
could leave Africa even worse off than it is today. That=92s why getting
this right at the outset is so important and requires great care.

Our commitment, from the beginning, has been to move with urgency to
help build the human and physical capacity that is needed to deliver
this treatment, and then to fund the purchase of AIDS drugs to be used
in providing this treatment, at the most cost effective prices we can
find =96 but only drugs that we can be assured are safe and effective.
Patients in Africa deserve the same assurances of safety and efficacy
that we expect for our own families here in the U.S. There should not be
a double standard. But how to do that has presented some serious
challenges. With our colleagues at the WHO, UNAIDS, the Southern African
Development Community, and many others, the U.S. Government has been
carefully examining this issue =96 and considering alternatives.

Many of the copies of the research-based AIDS drugs that are on the
market today in developing countries may well be safe and effective. The
challenge stems in part from the fact that they have never been reviewed
by any of the world=92s stringent regulatory authorities. And the same
will likely be true of the additional copies of those drugs that will
surely be coming on the market in the days to come, as new indigenous
companies enter this market =96 something we expect and hope will happen.

Many people and organizations have noted the World Health Organization=92s
prequalification pilot program and have urged that we simply rely on it.
We have the highest respect for the WHO and its program. However, the
WHO is not a regulatory authority and does not represent itself as such.

[snip]