“The Blue Sheet” Vol. 36, no. 8

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"The Blue Sheet"

February 24, 1993

NIH is already aggressively using a version of
competitive funding of similar projects in an attempt to
keep down the commercial prices of products developed
under CRADA agreements. Wyden wants to turn the
competition between different projects into a shared
market arrangement for one product.
Wyden is also preparing to propose that price be a
specific factor in CRADA bidding by commercial sponsors. "The companies that bid for the right to obtain this
R&D subsidy would have to compete on the basis of the
price to be charged for the drug therapies produced by
the partnership" with the government.
If NIH selects only one company for a CRADA,
under Wyden's plan, that sponsor would have to bring
the product to market at a price below existing marketed
therapies.
Wyden said that "government negotiators and the
chosen sponsor would have to agree in advance of closing the deal on a specific price discount that considered
existing drug therapies for the same purpose."
Healy, Chabner To Testify Before Aging Cmte.
Pryor has scheduled five panels for the Feb. 24
hearing. In addition to Wyden, Pryor will hear from
representatives of the Office of Technology Assessment,
NIH and the National Cancer Institute, the Pharmaceutical Manufacturers Association and consumer groups.
Among the consumer witnesses tentatively scheduled to appear are Ralph Nader (Center for the Study of
Responsive Law), Derek Hodel (AIDS Action Council)
and Caroline Decker (Arkansas AIDS Foundation). NCI
Division of Cancer Treatment Director Bruce Chabner is
listed as one of the NIH/NCI witnesses with NIH Director Bernadine Healy.
At the previous Wyden hearing, Chabner defended
the pricing decisions by Bristol-Myers Squibb on Videx
and Taxol following discussions with NIH. Chabner has
argued that the flexibility of the current "fair pricing"
language in CRADA contracts has allowed NIH and
NCI enough latitude to negotiate effectively with commercial sponsors.
Peter Arno, Albert Einstein College of Medicine, is
scheduled to testify with the OTA representatives. Arno
suggested at the Wyden hearing in January that NIH
could turn to the Health Care Financing Administration
to seek pricing reviews for products developed under
CRADA agreements. Arno also objected to commercial
sponsors riding exclusive marketing positions based on
government patents.

NIH REAUTHORIZATION BILL APPROVED BY SENATE; BAN
ON IMMIGRANTS WITH HIV/AIDS UPHELD
The NIH reauthorization bill cleared the Senate by
an overwhelming 93-4 margin Feb. 18 after two full
days of debate.
The major change made by the Senate in the legislation came in the form of an amendment which would
codify the government's existing policy barring permanent immigration by aliens who are HIV-positive. After
extensive wrangling over the immigration issue, the
Senators approved the provision, which was introduced
by Sen. Don Nickles (R-Okla.), by a vote of 76 to 23.
Attempting to block the move by Nickles, Sen.
Edward Kennedy (D-Mass.) introduced an amendment
that would have left in place the existing HIV immigration policy for a period of 90 days.
Under the Kennedy measure, HHS would have been
required to assess the impact on public health expenditures and private health insurance costs of a change in
policy, after which the president would have been free
to remove HIV status from the list of conditions under
which an alien may be refused permanent entry into the
country. The Kennedy amendment was defeated, however, by a 56 to 42 vote.
President Clinton recently ordered HHS Secretary
Donna Shalala to review the current list of health conditions which constitute grounds for refusing aliens entry
into the country. Clinton also promised to lift the ban
during his presidential campaign.
The House version of the NIH reauthorization bill
(HR 4), introduced by Rep. Henry Waxman (D-Calif.)
Jan. 5, is scheduled to be marked up by the Energy and
Commerce/Health Subcommittee Feb. 24. Two anti-HIV
immigration bills introduced in the House the week of
Feb. 15 indicate that the idea of a ban on immigration
of HIV-positive foreigners has support among some
representatives; HR 887 was introduced by Rep. John
Duncan (R-Tenn.) along with eight cosponsors, and HR
985 was introduced by Rep. Bill McCollum (R-Fla.) and
65 cosponsors.
During Senate floor debate, Nickles cited both
health and cost concerns in rallying support for his
measure to retain HIV status on the list of excludable
health conditions for immigrants. "This change in policy
that is promoted by President Clinton is not only a
decision that will cost lives, but it will cost hundreds of
millions of dollars" in health care services, he asserted.
As a cosponsor of the amendment, Sen. Nancy
Kassebaum (R-Kan.) stated that the "chief issue has
become cost," rather than whether or not HIV-infected

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