:
TO  : MTS@gnv.ifas.ufl.edu ........ Tom Sanford
    : murray@seattleu.edu ......... MaryAnne Murray
    : stever@tessi.com ............ Steve Rintala
    : SMIRNES@IMIHSRA.BITNET ...... S. Palazzi, MD
    : PHIP@TEMPLEVM.BITNET ........ Tina Phipps, Ph.D.
    : RRICCIUT@WCU.BITNET ......... Rae Ricciuti
FROM: broedel@geomag.gly.fsu.edu .. Bob Broedel
    :
RE  : Food & Drug Admin Bulletin Board System
    :


The FDA has an Internet link to its FDA-BBS. If one has "telnet"
capability it can be reached at 150.148.8.48 (at "login", type
"bbs"). If one is calling via modem from Rockville, MD the BBS
access numbers are 227-6849 or 227-6857. If one is calling via
modem from outside the Rockville area the number is 800-222-0185.
If you are looking for a specific report or article, contact Karen
Malone in the FDA Press Office at (301)443-3285.

Here is a sample of what you will see on the FDA-BBS.

   TOPICS       DESCRIPTION  
*  NEWS         News releases
*  ENFORCE      Enforcement Report
*  APPROVALS    Drug and Device Product Approvals list
*  CDRH         Centers for Devices and Radiological Health Bulletins
*  BULLETIN     Text from Drug Bulletin
*  AIDS         Current Information on AIDS
*  CONSUMER     FDA Consumer magazine index and selected articles
*  SUBJ-REG     FDA Federal Register Summaries by Subject
*  ANSWERS      Summaries of FDA information
*  INDEX        Index of News Releases and Answers
*  DATE-REG     FDA Federal Register Summaries by Publication Date
*  CONGRESS     Text of Testimony at FDA Congressional Hearings
*  SPEECH       Speeches Given by FDA Commissioner and Deputy
*  VETNEWS      Veterinary Medicine News
*  MEETINGS     Upcoming FDA Meetings
*  IMPORT       Import Alerts
*  MANUAL       On-Line User's Manual 


P92-37                                Food and Drug Administration
FOR IMMEDIATE RELEASE                 Monica Revelle - (301) 443-4177
Dec. 8, 1992                          (Home) -- (410) 290-6575

    The Food and Drug Administration today announced that it will soon        
publish new rules to speed the approval of drugs for patients with 
serious or life-threatening illnesses, such as AIDS, cancer and 
Alzheimer's disease.
    "These final rules will help patients who are suffering the most 
serious illnesses to get access to new drugs months or even years 
earlier than would otherwise be possible," said HHS Secreatry Louis 
W. Sullivan, M.D.  "The effort to accelerate FDA review for these 
drugs has been a long-term commitment and indeed a hallmark of 
this administration."
    These rules establish procedures for the Food and Drug 
Administration to approve a drug based on "surrogate endpoints" 
or markers.  They apply when the drug provides a meaningful benefit 
over currently available therapies. Such endpoints could include 
laboratory tests or physical signs that do not in themselves 
constitute a clinical effect but that are judged by qualified   
scientists to be likely to correspond to real benefits to the 
patient.
    Use of surrogate endpoints for measurement of drug efficacy 
permits approval earlier than if traditional endpoints -- such 
as relief of disease symptoms or prevention of disability and 
death from the disease -- are used.
    The new rules provide for therapies to be approved as soon 
as safety and effectiveness, based on surrogate endpoints, can 
be reasonably established. The drug's sponsor will be required 
to agree to continue or conduct postmarketing human studies to 
confirm that the drug's effect on the surrogate endpoint is an 
indicator of its clinical effectiveness.
    One new drug -- zalcitabine (also called ddC) -- was approved 
June 19, using a model of this process, for treating the human 
immunodeficiency virus, HIV, the cause of AIDS.
    Accelerated approval can also be used, if necessary, when 
FDA determines that a drug, judged to be effective for the 
treatment of a disease, can be used safely only under a restricted 
distribution plan.
    "The new rules will help streamline the drug development and 
review process without sacrificing good science and rigorous FDA 
oversight," said FDA Commissioner David A. Kessler, M.D.  "While 
drug approval will be accomplished faster, these drugs and 
biological products must still meet safety and effectiveness 
standards required by law."
    The new procedures also allow for a streamlined withdrawal 
process if the postmarketing studies do not verify the drug's 
clinical benefit, if there is new evidence that the drug product 
is not shown to be safe and effective, or if other specified 
circumstances arise that necessitate expeditious withdrawal of 
the drug or biologic.
    FDA is a Public Health Service agency within HHS.

== end of als 4 ==