HHS Task Force on Drug Importation
Detailed Drug Importation Questions For Task Force Public Docket and Meetings
The Drug Importation Task Force has been asked by the Department of
Health and Human Services (HHS) to compile information and provide
advice to assist in responding to the eleven issues the Department
was requested by Congress to study and report on as outlined in the
Conference Report to P.L. 108-173.
As part of this effort, HHS has opened a public docket and is
requesting public comment. As part of the issues mandated by
Congress for HHS to consider, the Department has requested that the
Task Force and the public provide comments on more specific
questions relevant to evaluation of the Congressionally-mandated
issues. These are grouped below with the Congressional issues
in bold and the additional Task Force inquiries listed below each.
SCOPE AND VOLUME OF IMPORTED DRUGS
I. Assess the scope, volume and safety of unapproved
drugs, including controlled substances, entering the United States
via mail shipment.
A. In conducting the study, Congress directed the Department to take
into account the distinctions between drugs that are biological
products with licenses under section 351 of the Public Health
Service Act (PHSA) and drugs with approved applications under
subsection (b) or (j) of section 505 of the Food Drug and Cosmetic
Act (FDCA). The Task Force seeks information relating to the
scope, volume and safety for importation of these differing types
of products.
B. Are there product characteristics that might be associated with
lower risk when imported without going through the usual FDA
approval and regulatory process? (For example, the type of product
(injectable, controlled substance, etc.), country of origin of the
import, Internet mail-order vs. personally transported products,
manufacture in U.S. (though not approved for U.S. use) or other
country, inclusion of U.S.-approved patient labeling, or
characteristics of the shipping entity (e.g., pharmacy that
primarily serves individuals of another nation, vs. a pharmacy set
up primarily or entirely to handle drugs that will be consumed by
residents of the United States).
C. The Task Force seeks additional information on the volume of
various categories and the types of imported products, and on ways
in which products of different risk levels could be reliably
distinguished or otherwise differentiated at the border or
elsewhere.
D. The Task Force seeks information on whether or not these imports,
or some of these imports, could meet U.S. approval standards or the
equivalent. What is the scope and volume of drugs
commercially available in other countries that are actually
FDA-approved? For imported drugs that are not U.S.- approved,
what approaches can be used to determine whether they are
equivalent to U.S. approved drugs?
E. If the scope of imported products is not limited to specific list
of authorized products, how would FDA, working with other Federal
agencies, identify, track and limit or prohibit importation of
products that are not eligible for importation?
F. What proportion of these different kinds of imported drugs meet
typical standards of U.S. pharmacy practice (e.g., no faxed
prescriptions from individuals, proper oversight by practicing
pharmacist, proper repackaging and labeling, proper notification
procedures in the event of product recall)?
G. If FDA, working with other Federal agencies and state partners,
could not assure the same level of safety for imported drugs as
consumers expect from drugs purchased at a state licensed pharmacy
within the traditional U.S. regulatory system, would a different
level of risk would be acceptable and how could that risk be
conveyed accurately to consumers?
H. Should certain products be excluded from importation because of
special risk concerns? What impact would limiting the number, types
or categories of drugs that would be legally authorized to be
imported have on the ability of the FDA and other Federal agencies
to assure the safety of such products? The Task Force seeks
input on how to establish risk-based criteria for any such
limitations, e.g., chronic-use medicines, small-molecule drugs less
sensitive to shipping conditions, medicines with wide therapeutic
indices, medicines not subject to risk management or
controlled-substance restrictions, medicines not prone to misuse.
IMPACT ON PHARMACEUTICAL DISTRIBUTION SYSTEM
II. Assess the pharmaceutical distribution chain and the
need for, and feasibility of, modifications in order to assure the
safety of imported products.
A. The Task Force is seeking information and comments on whether it is
appropriate or necessary to limit importation to specific persons
(e.g. pharmacists, wholesalers, individuals under certain
circumstances) in order to adequately assure the safety of imported
drugs, and how such limitations would impact the availability of
such products. Should importation be limited only to
distributors, pharmacies or other entities that are licensed or
approved by the exporting country? Because foreign drug
safety systems generally focus on the safety and security of the
domestic drug supply of the foreign country, should a licensure or
certification process overseen by U.S. regulators be used to help
assure safety for U.S. consumers?
B. The Task Force is seeking information on the appropriateness of any
additional requirements for the import distribution system that may
be needed to assure import safety, including changes involving:
limitations on ports of entry; enhanced chain of custody
requirements; prohibitions on importer resale; other changes in
wholesale distribution as a result of importation; additional
labeling of imported products; additional recordkeeping
requirements; or any additional limitations on foreign sources of
products that would be needed to assure the safety of imported
products.
C. What processes and criteria would be necessary to ensure (i.e.,
certify) that a specific importer (pharmacy, wholesaler, etc.)
abides by standards of pharmacy practice that are at least as
rigorous as U.S. pharmacy standards? Would limiting the
countries from which importation be permitted (e.g., Canada) make
the process of certification less costly and more effective?
D. Should legal importation be limited to wholesale shipments, rather
than a much higher volume of small individual drug shipments?
E. Should legal importation by individuals be restricted to pharmacies
that actually serve a significant number of citizens in the
exporting countries, or should entities that only export to the
United States be allowed?
F. Does FDA, or other Federal agencies, need additional authority to
inspect facilities making products intended for importation into
the United States? If inspection authority is needed, what
types of inspections are needed?
G. Would additional requirements for drug pedigree and “track
and trace” records be useful in assisting FDA and other
Federal and state agencies to assure the security of these drug
imports, i.e., to prevent the introduction of drug products from
illegitimate sources? What other mechanisms would be required
to enable tracking these products to ensure compliance with
applicable considerations or restrictions that are put on them as a
result of US law or regulations?
H. Would special import packaging and prior notification be
useful?
I. How would adequate reporting for foreign sources be assured if
quality problems are discovered with imported products after they
have entered U.S. commerce and provided to patients? What
reporting requirements would be needed for adverse events and how
would they be enforced?
III. Determine the extent to which foreign health agencies
are willing and able to ensure the safety of drugs being exported
from their countries to the U.S.
- The Task Force seeks information on the role that foreign health
agencies would be willing or able to play in assuring safety of
drugs exported to the United States, or if necessary, implementing
additional protections to ensure safety of exported or transshipped
drugs?
ADEQUACY OF SAFETY PROTECTIONS AND RESOURCES
IV. Identify the limitations, including limitations in
resources and in current legal authorities that may inhibit the
Secretary’s ability to certify the safety of imported
drugs.
A. The Task Force seeks comments on the changes in law, regulations,
and guidances as well as increases in resources needed for the
Agency and its other Federal and state regulatory partners to
provide a level of safety assurance comparable to that provided by
the federal and state regulatory systems that are currently
required by law to assure the safety of legal medications.
The Task Force is seeking additional information on whether, and to
what extent, in order to assure the safety of imported prescription
drugs, the government needs:
-
modified authorities to limit the incoming distribution channels to
enable the federal agencies to redirect inspectional and compliance
resources to manage this new flow of drugs;
limitations on importation to U.S.-licensed pharmacists from
licensed Canadian wholesalers and individuals; requirements for registration of foreign sellers who would consent
to inspection; requirements for enhanced chain of custody requirements to enable
track and trace of illegal or illicit imports that pose a safety
risk to US consumers; any additional controls to address transshipment of products from
third countries; -
any additional labeling and other information on imported drug
products to enable U.S. inspectors to properly inspect the drugs
and to adequately inform consumers about the origin of such
products.
any additional information disclosure requirements for pharmacies
selling drugs on the Internet. -
any additional authorities for U.S. inspectors to test imported
products and to suspend or otherwise refuse admission to products
that pose a serious safety risk.
B. What impact would restricting importation to products
manufactured in certain countries (e.g., U.S.) have
on adequately regulating these products? How would
limitations on importations relating to products shipped
from certain countries, certain entities within countries,
and/or certain ports of entry affect the ability to assure drug
safety?
C. How do authorities currently available to FDA and USDA to promote
the safety and security of food imports, such as registration,
plant and distributor inspection authority, recordkeeping
requirements, and prior notice of importation, provide useful
information on the development of a system for safety assurances
for drug imports?
V. Estimate agency resources, including additional field
personnel, needed to adequately inspect the current amount of
pharmaceuticals entering the country.
A. The Task Force seeks information on prioritizing various components
of an importation program to provide options at various funding
levels. For example, could importation be limited to select
countries, select importers, or select classes of drugs as a means
to manage costs, and if so, what should be the priority?
B. Should the costs of an importation program be financed by federal
appropriations, user fees on importers, a combination of the two,
or some other means?
C. In addition to additional resources to enhance field operations and
hire and train additional inspectors to assure the safety and
efficacy of any new channel of imported drugs, what other
programmatic changes would be required to generate and collect data
about these products, including their equivalence to FDA-approved
products if they are not FDA-approved, and to assure good
manufacturing practices are utilized in their development?
D. Clearly, FDA would need resources to implement a drug importation
program. Are there other federal agencies that should be
considered for funding (Customs, USPS)? Are there non-Federal
entities that may need new resources for an importation program?
E. In addition to funds to implement a new program, are there other
activities that the Task Force should consider too build in to its
recommendations? For example, testing/demonstrations of
particular aspects of importation, or a comprehensive evaluation of
a new program?
VI. Identify ways in which importation could violate U.S.
and international intellectual property rights and describe the
additional legal protections and agency resources that would be
needed to protect those rights.
- What kinds of protections from unapproved competitors would be
available for generic manufacturers that have undergone the FDA
abbreviated new drug application process? If foreign
pharmacies export generics that are approved in their own countries
but not in the U.S., will that undermine the incentive for generic
companies to seek U.S. approval?
ROLE OF NEW TECHNOLOGIES
VII. Estimate the costs borne by entities within the
distribution chain to utilize anti-counterfeiting technologies that
may be required to provide import security.
A. What is the evidence on the feasibility of imposing
anti-counterfeiting technologies for drugs not subject to current
U.S. regulatory requirements, and the ability of these technologies
to prevent counterfeit or otherwise unsafe drugs from entering the
U.S. drug supply along with legitimate drugs?
B. How quickly could the technologies and other steps included in the
FDA’s recent initiative on securing the current legal drug
distribution system against counterfeits be expanded to help assure
the security of additional types of imported drugs?
C. What are the costs associated with implementing these new
technologies? What would be the cost to entities within the U.S.
pharmaceutical distribution system of any new regulations?
LIABILITIES, OTHER COSTS, AND IMPACTS ON INNOVATION
VIII. Assess the potential short- and long-term impacts on
drug prices and prices for consumers associated with importing
drugs from other countries.
A. What are the likely new costs that would be borne by entities
within the distribution chain to utilize anti-counterfeiting
technologies and undertake other steps that may be required to
provide assurances of import security?
B. What is the evidence on savings for patients from existing parallel
importation programs? In legalized systems of parallel importation,
to what extent do international differences in drug prices
translate into price differences for consumers, or are a
substantial part of the price differences “captured” by
middlemen or arbitrageurs?
IX. Assess the impact on drug research and development,
and the associated impact on consumers and patients, if importation
were permitted.
- What would be the impact on research and development of drugs and
the associated impact on consumers and patients, if changes in
importation laws were to be implemented?
X. Identify the liability protections, if any, that should
be in place if importation is permitted for entities within the
pharmaceutical distribution chain.
- What, if any, liability concerns would exist for entities in the
U.S. drug distribution system if importation of drugs from another
country were permitted?
ROLE OF NEW TECHNOLOGIES
XI. Analyze whether anti-counterfeiting technologies could
improve the safety of products in the domestic market as well as
those products that may be imported.
- Identify the magnitude of the counterfeit drug problem currently
existent in the U.S. To what extent is the development
of Internet pharmacies contributing to that problem?
Last revised: April 5, 2004
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