PROPOSALS TO RELAX U.S. DRUG LAWS POSE PROBLEMS
The Reagan Administration's soon-to-be
published proposals to make experimental therapies more rapidly
and widely available to terminally ill patients pose product
liability problems for drug companies, experts in the
pharmaceutical field said.
    Details of the proposals will be published in the Federal
Register shortly and will become effective after a 90-day
comment period.
    Under the proposed policy, announced Tuesday by
Commissioner of Food and Drugs Frank E. Young at a press
conference, patients with life threatening diseases who are not
enrolled in clinical trials would be allowed access to an
experimental therapy. The policy also allows drug companies to
sell the promising drugs to patients.
    Previously drugs like AZT could be rushed into wider use
free-of-charge if the agent was shown to be effective. Under
the new policy, the FDA could only refuse to permit a physician
to administer an experimental drug if it was shown to be
unsafe.
    Financial analysts said the plan would likely benefit
biotechnology companies with few or no products approved for
marketing in the U.S., but would have little economic impact on
large drug companies with many other sources of revenue.
    "Charging a fee for still experimental drugs could help
biotech companies' near-term financial situation and help make
them less dependent on outside sources," said Teena Lerner, a
biotech analyst at L.F. Rothchild.
    Other observers were concerned that drug companies would be
put into a legal bind if promising drugs later proved to have
devastating side effects.
    "Before a lot of drug companies release these drugs they
are going to have to think long and hard about liability--the
product liability problems are enormous," said a
Washington-based lawyer who specializes in the drug field.
    Patients in clinical trials normally sign lengthy informed
consent papers before taking an investigational drug. The
lawyer said no more than two cases had gone to trial for suits
against a drug company's investigational drug.
    "The new proposals are a whole new kettle of fish," said
the lawyer. "Drug companies are right now probably meeting with
their insurance companies."
    Burroughs-Wellcome Co, the U.S. arm of the British firm
Wellcome PLC that makes AZT, Merck and Co Inc <MRK>,
Hoffman-LaRoche Inc and SmithKline Beckman Corp <SKB> said it
was too soon to comment on the policy.
    "I'm very uncomforable with this," said Wellcome
spokeswoman Kathy Bartlett. "We haven't had a chance to
formulate a response yet. It's too early."
    But some financial analysts say the proposals would benefit
drug companies.
    "I find the proposal to be a very significant alteration of
the FDA's past policies that should positively affect (drug
companies') stocks," said drug analyst Davis Saks, with Morgan,
Olmstead, Kennedy and Gardner.
    Saks also warned that many health care providers would balk
at the proposal, and would call it "amoral" to charge patients
with life-threatening diseases for drugs that otherwise would
be given out for free in clinical trials.
    Jeffrey Warren, spokesman for the Pharmaceutical
Manufacturers Association, which represents the major drug
firms in the U.S., said "A mechanism already exists at the FDA
permitting certain seriously ill patients access to
experimental drugs and perhaps that system can be approved."
    Warren acknowledged that the PMA may not be able to come up
with a consensus among its membership when the rules are
formally published.
    He also admitted that product liability problems could be a
concern to major drug companies.
    Jeffrey Levi, executive director of the National Gay and
Lesbian Task Force, which is actively in AIDS policy and
funding issues, cited the drug Suramin from Bayer AG <BAYRY>,
which had shown early promise as an AIDS treatment, but on
wider clinical testing was shown to have deadly side effects.


 Reuter
