Subject: FDA Clears Use of Experimental Drugs
Date: Published: 5/22/87 85 lines
Source:  WALL STREET JOURNAL. Copyright Dow Jones & Co. Inc. 

   FDA Clears Use of Experimental Drugs;
   Reagan Is Likely to Favor AIDS Testing
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   By Michel McQueen and Gerald F. Seib
   Staff Reporters of The Wall Street Journal

   WASHINGTON -- The Food and Drug Administration has
approved new regulations to make experimental drugs more
widely available to certain critically ill patients.
   The rules were announced yesterday by Otis Bowen,
secretary of health and human services.  They will allow
patients with serious or life-threatening diseases for which
there are no currently effective treatments to obtain drugs
that have undergone less testing than current rules require.
The new rules will be published in the Federal Register today
and take effect 30 days later.
   Potential beneficiaries include patients with acquired
immune deficiency syndrome, or AIDS, as well as certain heart
ailments, advanced and incurable cancers, and certain forms
of diabetes, the FDA said.
   Separately, a White House spokesman said President Reagan
is inclined to support mandatory testing for immigrants and
marriage-license applicants.  The president hasn't formally
set a policy regarding the contentious issue, which has
opened rifts within his administration, but a meeting of
cabinet officers to debate the matter is scheduled for next
week.
   The new FDA regulations stipulate that drug manufacturers
must continue testing the experimental products.  The
companies can't market the drugs to the general public and
must distribute them only through licensed medical
practitioners.  The drug makers can, however, charge patients
to recover the cost of researching, developing and
manufacturing the product under the same rules that currently
apply to medical devices.
   Companies also must notify the FDA that they intend to
make the drug available under the new rules, and the FDA can
block its distribution if there is inadequate evidence to
show that it could be effective.  Patients also must be
informed of the risks and must consent to the treatment.
   FDA Commissioner Frank Young proposed the new procedure
March 10, following a successful trial with an anti-AIDS
drug.  He made the proposal, he said in a statement, because
when no alternative therapies exist, "an experimental drug
may give the only hope."
   The new rules -- while a boon to companies eager for a
stake in the burgeoning AIDS-treatment market -- are viewed
with concern by some prominent scientists.
   "They'll destroy the entire clinical investigatory
process," Dr. Jerome Groopman of Boston's New England
Deaconess Hospital said in an interview earlier this spring.
"Dealing directly with vulnerable patients with AIDS and
cancer, the (regulatory) process should be as expeditious as
possible.  But allowing drugs to be distributed for profit
without data on toxicity and efficacy will hurt medicine."
   At the White House, presidential spokesman Marlin
Fitzwater said Mr. Reagan "would probably look favorably
upon" proposals to require mandatory testing for AIDS before
marriage and immigration.
   The issue of whether to require tests for those about to
marry and for immigrants has been hotly debated in recent
weeks, and Mr. Reagan's inclination to support testing puts
him at odds with his surgeon general, Dr. C. Everett Koop.
Dr. Koop has argued that such testing wouldn't detect many
AIDS cases and would divert funds from education and other
programs that can do more to control the disease.
   As head of the federal government, Mr. Reagan has the
power to order tests for immigrants, but testing for
marriage-license applicants will have to be decided by each
state.  The president can, however, use his office as a "bully
pulpit" to argue publicly for such tests, White House aides
said.
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   Marilyn Chase in San Francisco contributed to this
article.

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