November 27, 2002



The Honorable Mark B. McClellan, M.D., Ph.D.
Commissioner
U.S. Food and Drug Administration
5600 Fishers Lane
Rockville, Maryland 20857
     Re: Support for the Petition for Continuation of Stay of
     Action; FDA Final Rule on Policies, Requirements and
     Procedures; Prescription Drug Marketing Act of 1987;
     Prescription Drug Amendments of 1992 (64 Fed. Reg. 67,720,
     December 3, 1999); Docket Nos. 92N-0927 & 88 N-0258.
Dear Commissioner McClellan:
The Office of Advocacy of the U.S. Small Business Administration
urges the U.S. Food and Drug Administration (FDA) to grant the
Request for Stay of Action and Effective Date of two provisions
in the above-referenced final rule affecting drug wholesalers.
Congress established the Office of Advocacy under Pub. L. 94-305
to represent the views of small business before Federal agencies
and Congress.  The Office of Advocacy is an independent entity
within the U.S. Small Business Administration (SBA), so the views
expressed by the Office of Advocacy do not necessarily reflect
the views of the SBA or the Administration.  Section 612 of the
Regulatory Flexibility Act (RFA) also requires the Office of
Advocacy to monitor agency compliance with the RFA, as amended by
the Small Business Regulatory Enforcement Fairness Act.(1)  On
August 13, 2002, President Bush underscored the importance of
agency compliance with the RFA and the Office of Advocacy's role
in giving a voice to small businesses in the rulemaking process
when he signed Executive Order 13272, entitled "Proper
Consideration of Small Entities in Agency Rulemaking."
Consistent with comments filed with the FDA under the previous
Chief Counsel for Advocacy (February 29, 2000), we remain
concerned that FDA has failed to adequately account for its
impact on small business and consider less burdensome
alternatives in drafting the Final Rule on Policies, Requirements
and Procedures; Prescription Drug Marketing Act of 1987;
Prescription Drug Amendments of 1992 (PD Amendments).

Over 4,000 small businesses will be affected by the PD Amendments
rulemaking.  Considering that this represents 94% of the
industry, we encourage the FDA to grant a further stay and
suspend the effective date of the requirements affecting the
definition of "ongoing relationship" and "authorized distributor
of record."

We have attached a copy of our office's previous comment letter
that offers a more detailed analysis of how the PD Amendments
rule will affect small employers.  Lastly, I want to offer any
support necessary to assist FDA to ensure compliance with
requirements under the RFA and Executive Order 13272 with regard
to this rule.
Please do not hesitate to contact me at (202) 205-6533 if you
have any questions regarding this letter.
Sincerely,



Thomas M. Sullivan
Chief Counsel for Advocacy

Enclosure

ENDNOTES

1.  Pub. L. No. 96-354, 94 Stat. 1164 (1980) (codified at 5
U.S.C.  601 et seq.) amended by Subtitle II of the Contract with
America Advancement Act, Pub. L. No. 104-121, 110 Stat. 857
(1996). 5 U.S.C.  612(a).