From: Bechtel, Christine
Sent: Tuesday, May 28, 2002 7:57 AM
To: Butler, Jennie C
Subject: FW: Risk Management of Prescription Drugs

Follow Up Flag: Follow up
Due By: Tuesday, May 28, 2002 5:00 PM
Flag Status: Flagged


Comments for psoting to Docket # 02N-0115  Risk Management of Prescription Drugs

-----Original Message-----
From: Alan.Hollister@sanofi-synthelabo.com
[mailto:Alan.Hollister@sanofi-synthelabo.com]
Sent: Friday, May 24, 2002 1:11 PM
To: fitzpatrickc@cder.fda.gov
Subject: Risk Management of Prescription Drugs


Dear Ms. Fitzpatrick,

I am writing to you about the announcement of a "Part 15" hearing on Risk
Management of Prescription Drugs.  Although I was unable to attend the
hearing, I trust that written comments may be submitted, and I would
appreciate it if you would forward the following comments to Dr. Nancy
Smith.

I have two comments--a specific one related to Scheduled Drugs, and more
general comments on communications and tools for risk management.

1.   The U.S. Department of Justice estimates that 70% of all drug-related
deaths are due to Scheduled prescription drugs that have been diverted into
the "black market".  Since the current estimates of drug-related deaths
exceed 100,000 per year, abuse of Scheduled prescription drugs is one of
the leading causes of death in the U.S..  Health care personnel are
particularly susceptible to the risks of abuse of prescription drugs, and
one of the leading causes for revocation of professional licensure is the
excessive prescribing of or use of Scheduled Drugs.  Scheduled prescription
drugs have been termed "gateway" drugs that introduce individuals to the
abuse of drugs, and the vast majority of people abusing illegal drugs are
simultaneously abusing Scheduled prescription drugs.  Therefore, Scheduled
prescription drugs have a crucial impact on the demand for and prevalence
of drug abuse, and are responsible for the majority of drug-related death
and disability.  Risk management intervention strategies for Scheduled
prescription drugs will have a greater impact on the health and welfare of
our nation that any other group of drugs.
     I urge you to consider a wide range of risk management strategies with
respect to Scheduled drugs.  These should include a much lower threshhold
for suspension of the distribution and/or manufacture of Scheduled drugs,
including the revocation of approval for drugs or delivery systems that
have been demonstrated to be a danger to our citizens.  Limits on
distribution can be coordinated with Drug Enforcement Administration data
on excessive purchase reports, distribution analyses, and the Drug Abuse
Warning Network reports, as well as individual state drug control and
licensure agencies.  Restricted availability programs for certain drugs, or
in certain areas, may also reduce the public heath risk of the abuse of
prescription drugs.  Education programs that identify both appropriate and
inappropriate use and prescribing of Scheduled drugs will also be a
pro-active method to manage the risk of these drugs.  By far the largest
and most rapid reduction in the risk of prescription drugs can be attained
by vigorous intervention in the availability, diversion, and mis-use of
Scheduled drugs.

2.   Effective communication of the risks associated with drugs and their
use is only successful when the behavior of physicians and the health care
community are changed.  As a person with long experience in teaching
medical students, residents, and continuing medical education courses, I
share the frustration the FDA has over the limited effect that drug
labelling and re-labelling has on drug use.  I support the effort to
provide a concise and clinically pertinent summary of drug labelling at the
beginning of each label.  I advocate a label for all drugs, including
generic drugs, in the Physicians Desk Reference and whenever they are
advertised.  I do not support the advertising of prescription drugs to the
general public.
     Information about tools for risk management in drug use is available
from intervention projects conducted by Drs. William Shaffner and Wayne Ray
(Ray WA, et al.: Reducing long-term diazepam prescribing in office
practice.  A controlled trial of education visits.  JAMA 1986; 256: 2536,
and a more recent project of Dr. Shaffner (for which I do not have the
reference) on the appropriateness of use of antibiotics).  In addition to
"Dear Doctor" letters that accompany re-labelling, support for continuing
education and county or state medical society education, pamphlets, and
interventions may be warranted, depending on the severity of the risk that
has been identified.  Further, restricted availability programs, via
pharmacies, training or specialty certification, or a continuing education
requirement, may also be tools to reduce risk.  Finally, the requirement
for prospective monitoring trials, or trials stimulated by spontaneous
reporting and "Medwatch" events may be effective in identifying,
clarifying, or eliminating low frequency signals of potential risk.
Ultimately, risk must be balanced against the disease entity involved, the
background or spontaneous frequency of events (e.g. Torsades de Pointes),
and the risks of alternative modes of therapy.

Thank you for the opportunity to comment on the risk management of
prescription drugs.  The views expressed are my own, and may not represent
those of my employer, or of the American Society for Clinical Pharmacology
and Therapeutics.

Yours truly,
Alan S. Hollister, M.D., Ph.D.
Senior Director, Clinical and Exploratory Pharmacology
Sanofi-Synthelabo Research
Chair, Government Affairs Committee
American Society for Clinical Pharmacology and Therapeutics