HEALTH GAP Fact Sheet

State Department/HHS AIDS drug announcement: unnecessary program, new
barriers to generics.

The Devil is authoring the details...

[please note: due to this and other outrages against people with AIDS
in the US and worldwide, over 1000 marchers and more than 100 arrests
are expected at a demonstration on Thursday May 20 in Washington DC.
The march steps off at 11am from Folger Park passed the RNC and DNC
HQs to end at the Capitol Building for a civil disobedience demanding
action from the next President of the United States. To discuss the
march and rally and/or the new Bush Administration policy to erect new
hurdles against generic medications in developing countries, call
215.833.4102 -- for press release & demands, see also
http://www.champnetwork.org/index.php?name=May20]

17 May 2003

The unnecessary, duplicative, and burdensome process will require
generic companies to jump more hurdles and will delay US procurement
of medicines that have already been quality assured.

The requirements of the US approval process raises new barriers, in
particular for important new single products and fixed dose
combinations for which exclusive rights as a new chemical entity (NCE)
are retained. Specifically tenofovir, atanazivir, and emtricitabine.  

At this point, the FDA would deny approval to either of those three
products in a generic version or any generic FDC that contains those
products. This creates an unacceptable barrier and must be corrected.

Furthermore, the new FDA rules contain obvious contradictions. There
is no assurance from the US government that they will take a pro
public health approach in resolving these contradictions.

For example:  *     If  one or more of the approved drug components is
covered by a patent,  the FDA could not approve the 505(b)(2)
application until the patent expires or, if the patent is challenged
by the 505(b)(2) applicant and the applicant is sued, for 30 months or
until the patents are declared invalid or not infringed by a court,
whichever  is first. However, the application could be tentatively
approved."

In other words, 'The FDA cannot approve a patented drug. However, it
could be tentatively approved.'

http://www.fda.gov/oc/initiatives/hiv/default.htm

What did the US really announce? That it has developed system, with
brand new but undefined requirements of applicants. The new process
does not exist yet -- and it will take time to establish a new layer
of bureaucracy and obligation for generic manufacturers. The Bush
Admin is being applauded by an under critical public for overtly
creating new obstacles to generic competition.

The U.S. has timed its announcement so that major drug companies can
simultaneously announce their intention to develop combined blister
packs and combination products, suggesting that the program is
designed largely to expedite approval of U.S. products trying to catch
up with superior fixed-dose combination generic ARVs already approved
by the stringent WHO Pre-qualification Project.  Rather than join the
existing multilateral process as the WHO, however, the U.S. is
insisting on a go-it-alone process adding a unnecessary parallel
system that for all intents and purposes will merely duplicate WHO
approvals made six to twelve months ago.

The U.S. has also timed its announcement on the eve of the World
Health Assembly where it expected to receive enormous criticism from
activists and developing countries anxious to continue and expand the
procurement of generic FDCs two to four times cheaper than the most
highly discounted brand name drugs.

Summary points:  - The new process will be lengthy and is designed to
delay and discourage   generic manufacturers by erecting extensive new
barriers   relating to manufacturing and bioequivalence - The new
process does not exist yet, and the criteria are opaque.

- When the criteria are finalized, the it will take considerable time
and   expense for the generic companies to meet the arbitrary new
criteria

- The new process is a slap to the world communities' internationally
recognized drug quality standards. The new process duplicates and
sabotages an already functioning process at the WHO's Drug
Prequalification program. - While this shakes out over the next year
or so before the two-to-six-week   clock is ever initiated, countries
and recipients will be locked into   supply chain management,
procurement systems, and contracts with big   pharma drugs. (Note:
even though the "Draft Guidance" released today is   open for 60 days
of comment, HHS indicates it is effective immediately.   But a
manufacturer would likely to be hesitant to respond to guidelines
that are still apparently in draft form, even if they are "effective
immediately.")  - FDA's Draft Guidance indicates they will consider
completing Good   Manufacturing Practice inspections even before an
NDA is submitted, in   order to save time. This is particularly
important for companies that have   no existing relationship with the
FDA. The FDA must aggressively inform   generic companies that this
opportunity exists.

1. The go-it-alone process is worthless delay, and a wasteful
duplication of a system that is already working. The Bush
Administration's goal has long been to obfuscate and delay generics
until they have locked in countries and PEPFAR recipients to branded
drugs. Other than meeting that goal, the HHS process is entirely
unnecessary and duplicative of the WHO Prequalification Program.

The US is buying time, appearing to be finally finding religion on
this issue, when what they are really doing is making a bit of space
for the release of co packaged ARVs from big pharma. This will come at
the expense of access to low cost, already quality assured FDCs. And
co packaged drugs are still dramatically more expensive and complex
than single pill generic FDCs.

The Bush Administration is disregarding internationally recognized
standards, and pretending to fix a system that is not broken. The
WHO's Prequalification program is sufficiently rigorous, already
supports high standards, and has already amassed a collection of
bioavailability and other important data about generic FDCs and the
companies that manufacture those and other medicines. The US appears
to be making the absurd request of these companies that they start
over, and recreate those human studies according to FDA's standards.
This will waste time and money. Furthermore, these standards are
likely be unnecessarily arbitrary in a manner that disqualifies
generic products on non substantive matters.

Creating a new parallel system with different requirements of
manufacturers and processes for drug approval and different standards
for GMP undermines WHO prequalification. It will waste time and create
confusion. It is unnecessary. Quality assured generic FDCs exist now,
under internationally recognized standards established by the
international agency that sets public health norms.

WHO's prequalification project should be supported, not undermined by
parallel, conflicting processes.

2. The FDA's Good Manufacturing Practices criteria are different from
WHO's GMP. The go-it-alone Bush Administration will require new
inspections and the companies may have to meet new standards.

The new rules will make it very difficult for generic manufacturers to
apply for FDA clearance.

3. the FDA has different bioequivalence standards that will require
new tests to be performed and submitted.

4. Once companies submit to new inspections and remedy issues raised
under fluid new criteria still being established, AND perform and
submit new bioequivalence studies under possibly new evolving
criteria, THEN and ONLY THEN will the new
two-to-six-to-god-knows-how-many weeks long clock starts ticking on
this fraudulently unnecessary new process.

5. in the months it takes for this useless and duplicative process to
be developed -- and in the ensuing months thereafter when the
companies are made to jump through hoop after hoop -- the recipients
-- and countries -- will already be locked into supply chains and
procurement systems and contracts with big pharma. AND branded pharmas
will crow about taping a few pills to a package -- more expensive,
more difficult to take pills. This announcement is simply announcing
that the US will create a window for big pharma to fill market space
before the generic medications can even be approved.

6. US money pays for generic drugs that are WHO prequalified now. Why
stop?

If the US were truly concerned that FDCs pre qualified by WHO were not
"of quality," it would prevent its money from being used for ARV
treatment programs by the Global Fund immediately. It would stop USAID
from circumventing the "buy America" policy that has been circumvented
since Barcelona in 2002. The US knows that WHO standards are
acceptable--there is no need for a brand new process. It appears that
the real reasons that the US refuses to use the WHO pre-qualification
project are not related to ensuring quality and safety, but rather to
do with protecting brand name pharmaceutical company interests.

The US does not want its imprimatur on low cost generic, quality
assured FDCs. Should the rest of the world be made to bow to the US to
accommodate this ideological position?

The new system of approval by HHS is an excessive new barrier against
generic drug makers.

A more critical eye in the media is encouraged.

--  Paul Davis
Health GAP (Global Access Project)
www.healthgap.org