[DOCID: f:hr377.110]
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110th Congress Report
HOUSE OF REPRESENTATIVES
1st Session 110-377
======================================================================
DEXTROMETHORPHAN DISTRIBUTION ACT OF 2007
_______
October 15, 2007.--Committed to the Committee of the Whole House on the
State of the Union and ordered to be printed
_______
Mr. Dingell, from the Committee on Energy and Commerce, submitted the
following
R E P O R T
[To accompany H.R. 970]
[Including cost estimate of the Congressional Budget Office]
The Committee on Energy and Commerce, to whom was referred
the bill (H.R. 970) to amend the Federal Food, Drug, and
Cosmetic Act with respect to the distribution of the drug
dextromethorphan, and for other purposes, having considered the
same, report favorably thereon with an amendment and recommend
that the bill as amended do pass.
CONTENTS
Page
Purpose and Summary.............................................. 1
Background and Need for Legislation.............................. 2
Hearings......................................................... 2
Committee Consideration.......................................... 2
Committee Votes.................................................. 3
Committee Oversight Findings..................................... 3
Statement of General Performance Goals and Objectives............ 3
New Budget Authority, Entitlement Authority, and Tax Expenditures 3
Earmarks and Tax and Tariff Benefits............................. 3
Committee Cost Estimate.......................................... 3
Congressional Budget Office Estimate............................. 3
Federal Mandates Statement....................................... 6
Advisory Committee Statement..................................... 6
Constitutional Authority Statement............................... 6
Applicability to Legislative Branch.............................. 6
Section-by-Section Analysis of the Legislation................... 6
Changes in Existing Law Made by the Bill, as Reported............ 7
Purpose and Summary
The purpose of H.R. 970, the Dextromethorphan Distribution
Act of 2007, is to prohibit a person from: (1) possessing or
receiving unfinished dextromethorphan unless the person is
registered with the Secretary of Health and Human Services as a
producer of a drug or device; or (2) distributing unfinished
dextromethorphan to any person other than a registered person.
Background and Need for Legislation
Dextromethorphan (DXM) is an over-the-counter (OTC) cough
suppressant commonly found in more than 120 OTC cold
medications either alone or in combination with other drugs
such as analgesics (e.g., acetaminophen), antihistamines (e.g.,
chlorpheniramine), decongestants (e.g., pseudoephedrine) and/or
expectorants (e.g., guaifenesin). The typical antitussive adult
dose is 15 or 30 mg taken 3 to 4 times daily. The anticoughing
effects of DXM persist for 5 to 6 hours after oral
administration. When taken as directed, side effects are rarely
observed.
DXM is abused by individuals of all ages, but its abuse by
teenagers and young adults is of particular concern. This abuse
is fueled by DXM's widespread availability and extensive ``how
to'' abuse information on various Web sites. The sale of the
powdered form of DXM over the Internet poses additional risks
due to the uncertainty of composition and dose.
DXM abusers report a heightened sense of perceptual
awareness, altered time perception, and visual hallucinations.
The typical clinical presentation of DXM intoxication involves
hyperexcitability, lethargy, ataxia, slurred speech, sweating,
hypertension, and nystagmus. Abuse of combination DXM products
also causes health complications--increased blood pressure from
pseudoephedrine, potential delayed liver damage from
acetaminophen, and central nervous system, cardiovascular, and
anticholinergic toxicity from antihistamines--that result from
other active ingredients. The use of high doses of DXM in
combination with alcohol or other drugs is particularly
dangerous and deaths have been reported.
The Food and Drug Administration (FDA) is particularly
concerned about the abuse of dextromethorphan. In 2005, FDA
issued an FDA Talk Paper warning against the abuse of DXM. The
agency is working with other health and law enforcement
authorities to address this serious issue and to warn the
public of potential harm, after five recently reported deaths
of teenagers that may be associated with the consumption of
powdered DXM sold in capsules.
Hearings
The Committee on Energy and Commerce has not held hearings
on the legislation.
Committee Consideration
The Committee on Energy and Commerce met in open markup
session on Thursday, September 27, 2007, and ordered H.R. 970
favorably reported to the House by a voice vote. No amendments
were offered during full Committee consideration. Pursuant to a
unanimous consent request by Mr. Dingell, a technical
correction to the bill was made, which is shown in the text
reported by the Committee.
Committee Votes
Clause 3(b) of rule XIII of the Rules of the House of
Representatives requires the Committee to list the record votes
on the motion to report legislation and amendments thereto.
There were no recorded votes taken during consideration or
ordering H.R. 970 reported to the House. A motion by Mr.
Dingell to order H.R. 970 favorably reported to the House was
agreed to by a voice vote.
Committee Oversight Findings
Regarding clause 3(c)(1) of rule XIII of the Rules of the
House of Representatives, the oversight findings of the
Committee are reflected in this report.
Statement of General Performance Goals and Objectives
The purpose of H.R. 970 is to restrict the distribution of
the drug dextromethorphan to any person other than FDA-
registered producers of drugs and devices.
New Budget Authority, Entitlement Authority, and Tax Expenditures
In compliance with clause 3(c)(2) of rule XIII of the Rules
of the House of Representatives, the Committee finds that H.R.
970 would result in no new or increased budget authority,
entitlement authority, or tax expenditures.
Earmarks and Tax and Tariff Benefits
In compliance with clause 9 of rule XXI of the Rules of the
House of Representatives, H.R. 970 does not contain any
congressional earmarks, limited tax benefits, or limited tariff
benefits as defined in clause 9(d), 9(e), or 9(f) of rule XXI.
Committee Cost Estimate
The Committee adopts as its own the cost estimate prepared
by the Director of the Congressional Budget Office pursuant to
section 402 of the Congressional Budget Act of 1974.
Congressional Budget Office Estimate
Pursuant to clause 3(c)(3) of rule XIII of the Rules of the
House of Representatives, the following is the cost estimate
provided by the Congressional Budget Office pursuant to section
402 of the Congressional Budget Act of 1974:
U.S. Congress,
Congressional Budget Office,
Washington, DC, October 12, 2007.
Hon. John D. Dingell,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
Dear Mr. Chairman: The Congressional Budget Office has
prepared the enclosed cost estimate for H.R. 970, the
Dextromethorphan Distribution Act of 2007.
If you wish further details on this estimate, we will be
pleased to provide them. The CBO staff contact is Julia
Christensen.
Sincerely,
Robert A. Sunshine
(For Peter R. Orszag, Director).
Enclosure.
H.R. 970--Dextromethorphan Distribution Act of 2007
Summary: H.R. 970 would restrict the distribution, receipt,
and possession of unfinished dextromethorphan to certain
entities registered with the Secretary of Health and Human
Services. It also would deem the product to be adulterated in
circumstances that violate the new requirements.
Dextromethorphan is an active ingredient commonly found in
cough medications available over-the-counter and is subject to
abuse by some individuals (particularly teenagers and young
adults). ``Unfinished'' dextromethorphan generally refers to
the bulk powdered form of the raw product.
CBO estimates that implementing H.R. 970 would cost less
than $500,000 in 2008 and about $11 million over the 2008-2012
period, assuming the appropriation of the necessary amounts.
Enacting the bill could affect direct spending and revenues,
but we estimate that any such effects would not be significant.
Because those prosecuted and convicted of violating the
bill's new requirements involving adulterated dextromethorphan
could be subject to criminal fines, the federal government
might collect additional fines if the legislation is enacted.
Criminal fines are recorded as revenues, then deposited in the
Crime Victims fund and later spent. Such expenditures are
classified as direct spending. CBO expects that any additional
revenues and direct spending would not be significant because
of the small number of cases likely to be affected.
H.R. 970 would impose a mandate on the private sector as
defined in the Unfunded Mandates Reform Act (UMRA) by requiring
people receiving, possessing, or distributing unfinished
dextromethorphan to register with the Secretary of Health and
Human Services. It would also be the duty of the person selling
unfinished dextromethorphan to confirm that the buyer is also
registered or exempt from registration. CBO estimates that the
aggregate cost of complying with those mandates would not
exceed the threshold established by UMRA for private-sector
mandates ($131 million in 2007, adjusted annually for
inflation). The bill contains no intergovernmental mandates as
defined in UMRA and would not affect the budgets of state,
local, or tribal governments.
Estimated Cost to the Federal Government: The estimated
cost of H.R. 970 is shown in the following table. The costs of
this legislation primarily fall within budget function 550
(health).
------------------------------------------------------------------------
By fiscal year, in millions of
dollars--
---------------------------------------
2008 2009 2010 2011 2012
------------------------------------------------------------------------
CHANGES IN SPENDING SUBJECT TO APPROPRIATION
Estimated Authorization Level... 1 2 2 3 4
Estimated Outlays............... * 2 2 3 4
------------------------------------------------------------------------
Note: * = less than $500,000.
Basis of estimate: For this estimate, CBO assumes that H.R.
970 will be enacted near the beginning of fiscal year 2008,
that the necessary amounts will be appropriated each year, and
that outlays will follow historical spending patterns for
similar activities of the Food and Drug Administration (FDA).
We estimate that implementing the bill would cost about $11
million over the 2008-2012 period, assuming the appropriation
of the necessary amounts. Enacting the legislation also could
affect direct spending and revenues, but CBO estimates that any
such effects would not be significant.
Spending subject to appropriation
H.R. 970 would restrict the possession, receipt, and
distribution of unfinished dextromethorphan to certain entities
registered with the Secretary of Health and Human Services
(with specific exceptions). It also would amend the Federal
Food, Drug, and Cosmetic Act to deem unfinished
dextromethorphan to be adulterated when it is possessed,
received, or distributed in violation of the new registration
requirements established under the bill.
CBO expects that FDA would be primarily responsible for
administering the new registration requirements and related
restrictions established under H.R. 970. Following enactment,
we expect that FDA would provide instruction to affected
entities (such as chemical manufacturers) concerning how to
comply with the bill's new requirements and that it might
coordinate with other federal and state agencies that monitor
or regulate dextromethorphan sales. We also anticipate that
ongoing administrative costs (mostly associated with enforcing
the new requirements) would be roughly $2 million to $4 million
annually. Based on information provided by FDA, 12 additional
agency staff (based on full-time equivalents) might be
necessary to administer and enforce the bill's new
requirements. However, CBO expects that staffing would build up
to such levels over several years. Taken together, CBO
estimates that such activities would cost less than $500,000 in
2008 and about $11 million over the 2008-2012 period.
Direct spending and revenues
Because those prosecuted and convicted of violating the
bill's new requirements involving adulterated dextromethorphan
could be subject to criminal fines, the federal government
might collect additional fines if the legislation is enacted.
Criminal fines are recorded as revenues, then deposited in the
Crime Victims fund and later spent. Such expenditures are
classified as direct spending. CBO expects that any additional
revenues and direct spending would not be significant because
of the small number of cases likely to be affected.
Intergovernmental and private-sector impact: H.R. 970 would
impose a private-sector mandate, as defined in UMRA, on people
that receive, possess, or distribute unfinished
dextromethorphan by requiring them to register with the
Secretary of Health and Human Services. CBO believes the
mandate would affect relatively few people. Many of them would
be exempt from registration, such as pharmacies and non-
commercial research institutions, and others would have already
registered to deal with other chemical products. H.R. 970 would
also impose a duty on the person selling unfinished
dextromethorphan to confirm that the buyer is registered or
exempt from registration. This verification process would
require additional administrative work for sellers, such as
chemical manufacturers, to confirm the buying party's
registration, but this cost would be negligible. CBO estimates
that the direct cost of these mandates would be less than the
threshold of $131 million in 2007 adjusted for inflation.
The bill contains no intergovernmental mandates as defined
in UMRA and would not affect the budgets of state, local, or
tribal governments.
Estimate prepared by: Federal Costs: Julia Christensen;
Impact on State, Local, and Tribal Governments: Lisa Ramirez-
Branum; Impact on the Private Sector: Keisuke Nakagawa.
Estimate approved by: Keith J. Fontenot, Deputy Assistant
Director for Health and Human Resources, Budget Analysis
Division.
Federal Mandates Statement
The Committee adopts as its own the estimate of Federal
mandates prepared by the Director of the Congressional Budget
Office pursuant to section 423 of the Unfunded Mandates Reform
Act.
Advisory Committee Statement
No advisory committees within the meaning of section 5(b)
of the Federal Advisory Committee Act were created by this
legislation.
Constitutional Authority Statement
Pursuant to clause 3(d)(1) of rule XIII of the Rules of the
House of Representatives, the Committee finds that the
Constitutional authority for this legislation is provided in
article I, section 8, clause 3, which grants Congress the power
to regulate commerce with foreign nations, among the several
States, and with the Indian tribes.
Applicability to Legislative Branch
The Committee finds that the legislation does not relate to
the terms and conditions of employment or access to public
services or accommodations within the meaning of section
102(b)(3) of the Congressional Accountability Act.
Section-by-Section Analysis of the Legislation
Section 1. Short title.
Section 1 establishes the short title of the Act as the
``Dextromethorphan Distribution Act of 2007''.
Section 2. Restrictions on distribution of bulk dextromethorphan.
Section 2 prohibits a person from: (1) possessing or
receiving unfinished dextromethorphan unless the person is
registered with the Secretary of Health and Human Services as a
producer of a drug or device, or (2) distributing unfinished
dextromethorphan to any person other than a registered person.
Section 2 excludes from such prohibitions common carriers that
possess, receive, or distribute unfinished dextromethorphan
between registered persons.
Changes in Existing Law Made by the Bill, as Reported
In compliance with clause 3(e) of rule XIII of the Rules of
the House of Representatives, changes in existing law made by
the bill, as reported, are shown as follows (new matter is
printed in italic and existing law in which no change is
proposed is shown in roman):
FEDERAL FOOD, DRUG, AND COSMETIC ACT
* * * * * * *
CHAPTER V--DRUGS AND DEVICES
Subchapter A--Drugs and Devices
ADULTERATED DRUGS AND DEVICES
Sec. 501. A drug or device shall be deemed to be
adulterated--
(a) * * *
* * * * * * *
(j) If it is unfinished dextromethorphan and is possessed,
received, or distributed in violation of section 506D.
* * * * * * *
SEC. 506D. RESTRICTIONS ON DISTRIBUTION OF BULK DEXTROMETHORPHAN.
(a) Restrictions.--No person shall--
(1) possess or receive unfinished dextromethorphan,
unless the person is registered under section 510; or
(2) distribute unfinished dextromethorphan to any
person other than a person registered under section
510.
(b) Exception for Common Carriers.--This section does not
apply to a common carrier that possesses, receives, or
distributes unfinished dextromethorphan for purposes of
distributing such unfinished dextromethorphan between persons
registered under section 510.
(c) Definitions.--In this section:
(1) The term ``common carrier'' means any person that
holds itself out to the general public as a provider
for hire of the transportation by water, land, or air
of merchandise, whether or not the person actually
operates the vessel, vehicle, or aircraft by which the
transportation is provided, between a port or place and
a port or place in the United States.
(2) The term ``unfinished dextromethorphan'' means
dextromethorphan that is not contained in a drug that
is in finished dosage form.
* * * * * * *
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