[Federal Register: January 31, 2003 (Volume 68, Number 21)]
[Rules and Regulations]
[Page 4912-4913]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31ja03-9]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 203
[Docket No. 92N-0297]
RIN 0905-AC81
Prescription Drug Marketing Act of 1987; Prescription Drug
Amendments of 1992; Policies, Requirements, and Administrative
Procedures; Delay of Effective Date
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; delay of effective date.
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SUMMARY: The Food and Drug Administration (FDA) is further delaying,
until April 1, 2004, the effective date of certain requirements of a
final rule published in the Federal Register of December 3, 1999 (64 FR
67720). In the Federal Register of May 3, 2000 (65 FR 25639), the
agency delayed until October 1, 2001, the effective date of certain
requirements in the final rule relating to wholesale distribution of
prescription drugs by distributors that are not authorized distributors
of record, and distribution of blood derivatives by entities that meet
the definition of a ``health care entity'' in the final rule. The
agency further delayed the effective date of these requirements in two
subsequent Federal Register documents. Most recently, in the Federal
Register of February 13, 2002 (67 FR 6645), FDA delayed the effective
date until April 1, 2003. This action further delays the effective date
of these requirements until April 1, 2004. The final rule implements
the Prescription Drug Marketing Act of 1987 (PDMA), as modified by the
Prescription Drug Amendments of 1992 (PDA), and the Food and Drug
Administration Modernization Act of 1997 (the Modernization Act). The
agency is taking this action to address concerns about the requirements
raised by affected parties.
To the extent that 5 U.S.C. 553 applies to this action, it is
exempt from notice and comment because it constitutes a rule of
procedure under 5 U.S.C. 553(b)(3)(A). Alternatively, the agency's
implementation of this action without opportunity for public comment,
effective immediately upon publication today in the Federal Register,
is based on the good cause exceptions in 5 U.S.C. 553(b)(3)(B) and
(d)(3). Seeking public comment is impracticable, unnecessary, and
contrary to the public interest. As explained in the SUPPLEMENTARY
INFORMATION section, FDA has prepared a report for Congress and
concluded that although FDA can address some of industry's concerns
with the PDMA regulation through regulatory changes, other concerns
would have to be addressed by Congress through legislative action. The
further delay is necessary to give Congress additional time to consider
the information and conclusions contained in the agency's report, and
to determine if legislative action is appropriate. The further delay
will also give the agency additional time to consider whether
regulatory changes are appropriate and, if so, to initiate such
changes.
DATES: The effective date for Sec. Sec. 203.3(u) and 203.50, and the
applicability of Sec. 203.3(q) to wholesale distribution of blood
derivatives by health care entities, added at 64 FR 67720, December 3,
1999, is delayed until April 1, 2004. Submit written or electronic
comments by April 1, 2003.
[[Page 4913]]
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20857. All comments should be identified with the docket
number found in brackets in the heading of this document. Submit
electronic comments to http://www.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT: Aileen H. Ciampa, Center for Drug
Evaluation and Research (HFD-7), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-2041.
SUPPLEMENTARY INFORMATION: PDMA (Public Law 100-293) was enacted on
April 22, 1988, and was modified by the PDA (Public Law 102-353, 106
Stat. 941) on August 26, 1992. The PDMA, as modified by the PDA,
amended sections 301, 303, 503, and 801 of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C. 331, 333, 353, and 381) to, among
other things, establish requirements for the wholesale distribution of
prescription drugs and for the distribution of blood derived
prescription drug products by health care entities.
On December 3, 1999, the agency published final regulations in part
203 (21 CFR part 203) implementing PDMA (64 FR 67720). After
publication of the final rule, the agency received communications from
industry, industry trade associations, and members of Congress
objecting to the provisions in Sec. Sec. 203.3(u) and 203.50. On March
29, 2000, the agency met with representatives from the wholesale drug
industry and industry associations to discuss their concerns. In
addition, FDA received a petition requesting that the relevant
provisions of the final rule be stayed until October 1, 2001. The
agency also received a petition from the Small Business Administration
requesting that FDA reconsider the final rule and suspend its effective
date based on the severe economic impact it would have on more than
4,000 small businesses.
In addition to the communications regarding wholesale distribution
by unauthorized distributors, the agency received several letters on,
and held several meetings to discuss, the implications of the final
regulations for blood centers that distribute blood derivative products
and provide health care to hospitals and patients.
Based on the concerns expressed by industry, industry associations,
and Congress about implementing Sec. Sec. 203.3(u) and 203.50 by the
December 4, 2000, effective date, the agency published a notice in the
Federal Register of May 3, 2000 (65 FR 25639), delaying the effective
date for those provisions until October 1, 2001. In addition, the May
2000 document delayed the applicability of Sec. 203.3(q) to wholesale
distribution of blood derivatives by health care entities until October
1, 2001. The May 2000 document also reopened the administrative record
to give interested persons until July 3, 2000, to submit written
comments.
On May 16, 2000, the House Committee on Appropriations (the
Committee) stated in its report accompanying the Agriculture, Rural
Development, Food and Drug Administration, and Related Agencies
Appropriations Bill, 2001 (H. Rept. 106-619) that it supported the
``recent FDA action to delay the effective date for implementing
certain requirements of the Prescription Drug Marketing Act until
October 1, 2001, and reopen the administrative record in order to
receive additional comments.'' In addition, the Committee stated that
it ``believes the agency should thoroughly review the potential impact
of the proposed provisions on the secondary wholesale pharmaceutical
industry.'' The Committee directed the agency to provide a report to
the Committee summarizing the comments and issues raised and agency
plans to address the concerns.
After issuing the delay of the effective date, the agency announced
in the Federal Register of September 19, 2000 (65 FR 56480), that a
public hearing would be held to discuss the requirements at issue. The
hearing was held on October 27, 2000, and comments were accepted until
November 20, 2000.
In the Federal Register of March 1, 2001 (66 FR 12850), the agency
announced that it was further delaying, until April 1, 2002, the
effective date of Sec. Sec. 203.3(u) and 203.50, and the applicability
of Sec. 203.3(q) to wholesale distribution of blood derivatives by
health care entities. As explained by the agency, the effective date
was further delayed to give FDA additional time to consider comments
and testimony received, for FDA to prepare its report to Congress, and,
if appropriate, for Congress or the agency to make legislative or
regulatory changes. The report was completed and submitted to Congress
on June 7, 2001.
In its report to Congress, the agency concluded that it could
address some, but not all, of the concerns raised by the secondary
wholesale industry and the blood industry through regulatory changes.
However, to make other changes requested by the secondary wholesale
industry, Congress would have to amend section 503(e) of the act. As a
result, on February 13, 2002, FDA further delayed the effective date of
the relevant provisions of the final rule until April 1, 2003, in part
to give Congress time to consider the information and conclusions
contained in the agency's report and to determine if legislative action
was appropriate. Based on a recent petition submitted by affected
parties, FDA understands that members of Congress are, in fact,
considering the issues presented in the agency's report. Due to
competing legislative priorities, however, the issues have not yet been
resolved. Therefore, to give Congress additional time to determine if
legislative action is appropriate, the agency is further delaying the
effective date for Sec. Sec. 203.3(u) and 203.50, and the
applicability of Sec. 203.3(q) to wholesale distribution of blood
derivatives by health care entities. The further delay of the effective
date until April 1, 2004, will also give the agency additional time to
consider whether regulatory changes are warranted.
FDA has examined the impacts of this delay of effective date under
Executive Order 12866. Executive Order 12866 directs agencies to assess
all costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). The agency believes that this action is consistent with the
regulatory philosophy and principles identified in the Executive order.
This action will ease the burden on industry by delaying the effect of
Sec. Sec. 203.3(u) and 203.50, and the applicability of Sec. 203.3(q)
to wholesale distribution of blood derivatives by health care entities
while Congress considers taking legislative action. Thus, this action
is not a significant action as defined by the Executive order.
This action is being taken under FDA's authority under 21 CFR
10.35(a). The Commissioner of Food and Drugs finds that this delay of
the effective date is in the public interest.
Dated: January 23, 2003.
Margaret M. Dotzel,
Assistant Commissioner for Policy.
[FR Doc. 03-2293 Filed 1-30-03; 8:45 am]
BILLING CODE 4160-01-S