[Federal Register Volume 75, Number 86 (Wednesday, May 5, 2010)]
[Proposed Rules]
[Pages 24510-24514]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-10629]
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DEPARTMENT OF VETERANS AFFAIRS
38 CFR Part 1
RIN 2900-AN42
Drug and Drug-Related Supply Promotion by Pharmaceutical Company
Sales Representatives at VA Facilities
AGENCY: Department of Veterans Affairs.
ACTION: Proposed rule.
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SUMMARY: The Department of Veterans Affairs (VA) proposes to amend its
regulations regarding access to VA facilities to control the promotion
of drugs and drug-related supplies at VA facilities and the business
relationships between VA staff and sales representatives promoting
drugs and drug-related supplies. The purposes of the proposed rule are
to reduce or eliminate any potential for disruption in the patient care
environment, manage activities and promotions at VA facilities, and
provide sales representatives with a consistent standard of permissible
business practice at VA facilities. It would also facilitate mutually
beneficial relationships between VA and such sales representatives.
DATES: Comments must be received by VA on or before July 6, 2010.
FOR FURTHER INFORMATION CONTACT: Louis E. Cobuzzi, PBM Services (119),
Veterans Health Administration, Department of Veterans Affairs, 810
Vermont Avenue, NW., Washington, DC 20420; (202) 461-7362. (This is not
a toll-free number).
SUPPLEMENTARY INFORMATION: Under 38 U.S.C. 303, the Secretary of
Veterans Affairs is responsible for ``the proper execution and
administration of all laws administered by the Department and for the
control, direction, and management of the Department.'' The Secretary
has authority to prescribe all rules necessary to carry out the laws
administered by the Department, such as section 303 regarding control
and management of the Department. See 38 U.S.C. 501(a). VA has
implemented this authority, as it pertains to management of VA
facilities, in 38 CFR part 1.
VA proposes to amend 38 CFR part 1 to regulate access to VA medical
facilities by sales representatives (including account managers and
clinical liaisons) promoting drugs and drug-related supplies.
Currently, many policies regarding access to VA facilities are
established and maintained at the local level, either by Veterans
Integrated Service Network (VISN) leaders or by
[[Page 24511]]
administrators at particular facilities. A VISN, which we define in
proposed Sec. 1.220(a), is a network of all VA health care facilities
located in a particular region. There are 21 such regions, and the
areas that they service can be found at http://www.vacareers.va.gov/networks.cfm. The proposed rule would prescribe Department-wide rules
that must be followed at the VISN and local levels. We note that the
proposed rules are consistent with past VA policy and practice.
VA proposes this rule to prescribe the circumstances under which
sales representatives from pharmaceutical companies promoting drugs and
drug-related supplies may be granted access to VA facilities. This rule
is necessary to limit such access to those circumstances that benefit
VA from an educational standpoint, while avoiding potential disturbance
to patient care and ensuring compliance with standards of ethical
conduct. Pharmaceutical sales representatives have heavy interaction
with local VA staff each year, and this rule will ensure that their
activities do not negatively affect the quality of patient care. The
proposed rule would also assist these sales representatives by
providing clear standards, applicable to all VA facilities nationwide,
which are consistent with current practices at most VA facilities. The
proposed rule would require the Chief of Pharmacy or other official
responsible for such decisions to approve educational programs and
materials presented or furnished by these sales representatives, so as
to ensure that those programs and materials focus on clinician
education as opposed to marketing of drugs and drug-related supplies.
The proposed rule would generally deny sales representatives access to
patient care areas in VA facilities to ensure patient privacy, and
would require them to make appointments at the facilities they intend
to visit as opposed to open and unrestricted access. Further, the
proposed rule would prohibit sales representatives from furnishing any
food to VA staff or gifts above the de minimis value set forth in the
standards of ethical conduct for Federal employees, and would prohibit
VA employees' personal acceptance of drug samples.
We propose to designate this rule as Sec. 1.220. Currently, Sec.
1.218, regarding security and law enforcement at VA facilities,
describes general behavior that is prohibited on the grounds of VA
property. Proposed Sec. 1.220, would govern the behavior of particular
individuals (sales representatives) on the grounds of VA medical
facilities, but is not a security and law enforcement provision as it
is not our intention to prescribe a fine for failure to comply with
this rule. (VA is required to provide for a fine and/or imprisonment
for violations of the security and law enforcement provisions at Sec.
1.218 (38 U.S.C. 901)).
In proposed paragraph (a), we would set forth definitions
applicable to this section. In particular, we would use current policy
and practice to define ``Criteria-for-use'' as clinical criteria
describing how certain drugs may be used in VA. The criteria-for-use
are, and will continue to be, posted on VA's Web site at http://www.pbm.va.gov. The definition would note that local exceptions may
apply ``for operational reasons.'' An example of the need for a local
exception might be if a particular facility within a VISN (e.g., a
Community-Based Outpatient Clinic (CBOC)) did not have a physician with
the required expertise about a particular drug to prescribe. Under the
exception, a primary care provider might direct that the drug be
prescribed at a different facility within the VISN (e.g., a VA
hospital) where a suitable physician could be found. We note that such
exceptions at the local level are not posted on our Web site, or
elsewhere, because they are subject to change and because they do not
have any general effect on the approval of the drug for use within VA.
For example, if the particular facility hires a physician with the
required expertise to administer the drug within its approved criteria
for use, or if a physician within the facility obtains such expertise
through training. We also note that such exceptions have no effect on
the use of the drug elsewhere within the VISN. Thus, these exceptions
do not have a broad or national effect on pharmaceutical companies.
We would broadly define ``drugs'' and ``drug-related supplies''
because we intend these terms to be inclusive of all items typically
promoted by pharmaceutical sales representatives. Similarly, paragraph
(a) would define ``VA medical facility'' as ``any property under the
charge and control of VA used to provide medical benefits.'' These
broad definitions would ensure that the proposed rule applies to the
largest possible number of sales representatives and VA medical
facilities, including but not limited to hospitals, CBOCs, nursing
homes, and domiciliaries.
We would define ``VA National Formulary (VANF) drugs and/or drug-
related supplies'' as ``any drug or drug-related supply that must be
available for prescription at all VA medical facilities,'' and would
provide the public with a means to obtain the most current list of such
drugs or drug-related supplies. Non-VANF drugs or drug-related supplies
would be defined as drugs or drug-related supplies that are not
included on the list of VANF drugs or drug-related supplies.
Proposed paragraph (b) would set forth the general rule applicable
to the promotion of drugs and drug-related supplies. It would state
that notwithstanding Sec. 1.218(a)(8), regarding soliciting, vending,
and debt collection on VA property, VA would allow promotion in VA
medical facilities of VANF and non-VANF drugs or drug-related supplies
if the promotion is consistent with criteria-for-use, the drug is not
classified as non-promotable, and the promotion is otherwise consistent
with the proposed rule and with facility initiatives. It would clearly
be against the interests of VA and our patients to allow a promotion
that did not meet these three criteria, which are consistent with past
policy and practice. This rule would be an exception to Sec.
1.218(a)(8) because that rule bars solicitations ``of any kind'' on VA
property, and otherwise precludes behavior (such as posting signs and
distributing literature) that would be specifically authorized by Sec.
1.220.
Proposed paragraph (c) would apply only to the promotion of non-
VANF drugs or drug-related supplies without criteria-for-use. Such
promotions are generally for new molecular entities or new indications
for existing drugs, and such promotions must be regulated at the local
level in order to allow for different clinical approaches. The
promotion of new molecular entities would be permitted, but any
decision allowing the promotion of such a drug would be reconsidered if
the VANF committee reviews the drug and grants or denies VANF status.
Because new molecular entities generally do not have a history of
significant published studies in populations similar to the VA patient
population and may not be part of an established drug class, it is
important that the proposed rule allow VA medical professionals to
become educated through the promotion of such drugs but, at the same
time, ensure that promotions are consistent with National policy.
Proposed paragraphs (d) and (f) would be general rules applicable
to educational programs and materials (paragraph (d)) and the behavior
of sales representatives on the grounds of VA medical facilities
(paragraph (f)). These rules would attempt to balance the benefits of
such promotion against the need to maintain an appropriate clinical
environment at VA facilities, safeguarding the peace and privacy of
[[Page 24512]]
patients and ensuring that VA personnel are able to perform their jobs
without unnecessary interference. The rules would also avoid any
appearance of bias for or against particular drug manufacturers by
closely regulating the use of advertising material and display of brand
names, logos, and sponsorships. An appearance of bias in a drug
promotion situation could significantly undermine the trust of patients
or the public in VA doctors. Proposed paragraph (e), in addition to
furthering the policies described above that support paragraphs (d) and
(f), would regulate the receipt of gifts and donations to ensure that
VA maintains appropriate relationships with drug companies and
suppliers.
In paragraph (g), we would set forth the consequences for
noncompliance with this section. Any individual, or any company, that
fails to comply with this section would be subject to limitations on
the right to access VA facilities, which may include suspension of a
sales representative's access privileges, or, in extreme cases, denying
access to a company's entire sales force. Consistent with the
Secretary's delegations of authority to the Under Secretary for Health
and the Under Secretary's further delegation of authority to certain
Veterans Health Administration officials, the proposed rule would
authorize the director of the VA Medical Center of jurisdiction to
issue appropriate orders restricting access to facilities under the
director's control. This is the person who would be in the best
position to determine whether any violation of the proposed rule
requires restrictions on access to particular VA facilities or whether
an opportunity for corrective action by the individual or company will
suffice. In most cases, we expect that the infraction would be
adequately addressed by the sales representative and no formal action
would be required.
Procedurally, paragraph (g) would require the director to notify
the sales representative or company of the violation and any proposed
restrictions on access privileges before issuing any final order. The
director would be required to provide notice to a company's sales
manager if the proposed action would result in a denial of access
privileges for the company's entire sales force. Affected persons and
companies would have 30 days after the date of the notice to provide
the director a response; however, during that 30-day period the
proposed action would be enforced. This is necessary to ensure that
noncompliance does not continue during the 30-day period. After
considering the requirements of the proposed rule, the circumstances of
the improper conduct, and any response submitted by the sales
representative or company, the director would either resolve the matter
informally or issue a final order restricting access.
Under proposed paragraph (g)(4), in cases where the director issues
a final order suspending or permanently barring a company's entire
sales force, the director would be required to provide notice of the
company's right to a one-time appeal of the matter to the Under
Secretary for Health. Any such request for the Under Secretary's review
would be submitted to the director that issued the order within 30 days
of the date of the order. The director would then forward the initial
notice, the company's response, the director's order, and the company's
request for review to the Under Secretary for a final decision. The
director's order would be enforced until the Under Secretary's review
is complete. This mechanism provides important due process to companies
seeking to appeal such final orders.
We note that in most cases, sales representatives are considerate
of VA's needs and mission, and do not behave inappropriately.
Accordingly, we do not envision that the proposed paragraph (g) would
be invoked with regularity.
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 Executive
Order classifies a regulatory action as a ``significant regulatory
action,'' requiring review by the Office of Management and Budget (OMB)
unless OMB waives such review, if it is a regulatory action that is
likely to result in a rule that may: (1) Have an annual effect on the
economy of $100 million or more or adversely affect in a material way
the economy, a sector of the economy, productivity, competition, jobs,
the environment, public health or safety, or State, local, or tribal
governments or communities; (2) create a serious inconsistency or
otherwise interfere with an action taken or planned by another agency;
(3) materially alter the budgetary impact of entitlements, grants, user
fees, or loan programs or the rights and obligations of recipients
thereof; or (4) raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
the Executive Order.
The economic, interagency, budgetary, legal, and policy
implications of this proposed rule have been examined and it has been
determined to be a significant regulatory action under Executive Order
12866.
Unfunded Mandates
The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C.
1532, that agencies prepare an assessment of anticipated costs and
benefits before issuing any rule that may result in expenditure by
State, local, or tribal governments, in the aggregate, or by the
private sector, of $100 million or more (adjusted annually for
inflation) in any given year. This proposed rule would have no such
effect on State, local, or tribal governments, or on the private
sector.
Paperwork Reduction Act
The proposed rule does not contain any collections of information
under the Paperwork Reduction Act (44 U.S.C. 3501-3520).
Regulatory Flexibility Act
The Secretary hereby certifies that this proposed rule would not
have a significant economic impact on a substantial number of small
entities as they are defined in the Regulatory Flexibility Act, 5
U.S.C. 601-612. This proposed rule would not cause a significant
economic impact on health care providers, suppliers, or other small
entities. The proposed rule generally concerns the promotion of drugs
by large pharmaceutical companies and only a small portion of the
business of such entities concerns VA beneficiaries. Therefore,
pursuant to 5 U.S.C. 605(b), this proposed amendment is exempt from the
initial and final regulatory flexibility analysis requirements of
sections 603 and 604.
Catalog of Federal Domestic Assistance Numbers
The Catalog of Federal Domestic Assistance numbers and titles are
64.009 Veterans Medical Care Benefits, 64.010 Veterans Nursing Home
Care and 64.011 Veterans Dental Care.
List of Subjects in 38 CFR Part 1
Administrative practice and procedure, Archives and records,
Cemeteries, Claims, Courts, Crime, Flags, Freedom of Information,
Government employees, Government property, Infants and children,
Inventions and patents, Parking, Penalties, Privacy, Reporting and
[[Page 24513]]
recordkeeping requirements, Seals and insignia, Security measures,
Wages.
Approved: December 30, 2009.
John R. Gingrich,
Chief of Staff, Department of Veterans Affairs.
For the reasons set forth in the preamble, the Department of
Veterans Affairs proposes to amend 38 CFR part 1 as follows:
PART 1--GENERAL PROVISIONS
1. The authority citation for part 1 continues to read as follows:
Authority: 38 U.S.C. 501(a), and as noted in specific sections.
2. Add Sec. 1.220 to read as follows:
Sec. 1.220 Promotion of drugs and drug-related supplies at VA medical
facilities.
(a) Definitions. For the purposes of this section:
Criteria-for-use means clinical criteria developed by the
Department of Veterans Affairs (VA) at a National level that describe
how certain drugs may be used. VA's criteria-for-use are available to
the public at www.pbm.va.gov. Exceptions may be applied at the local
level for operational reasons.
Drugs means pharmaceuticals or chemicals intended for use by a
patient or, in some cases, for medical research.
Drug-related supplies means supplies related to the use of a drug,
such as test strips or testing devices.
New molecular entity refers to an active ingredient that has never
before been marketed in the United States in any form.
Non-VANF drugs or drug-related supplies are drugs or drug-related
supplies that do not appear on the VA National Formulary.
VA medical facility means any property under the charge and control
of VA used to provide medical benefits, including Community-Based
Outpatient Clinics and similar facilities.
VA National Formulary (VANF) drugs and/or drug-related supplies
means any drug or drug-related supply that must be available for
prescription at all VA medical facilities. A list of VANF drugs or
drug-related supplies is available at www.pbm.va.gov, or may be
requested by contacting the local office of the Chief of Pharmacy
Services.
Veterans Integrated Service Network (VISN) means one of the 21
networks of VA medical facilities.
(b) Permissible promotion of drugs and drug-related supplies.
Notwithstanding Sec. 1.218(a)(8), VA will allow promotion in VA
medical facilities of VANF and non-VANF drugs or drug-related supplies
if all of the following are true:
(1) The promotion is consistent with any existing criteria-for-use.
(2) The drug or drug-related supply has not been classified by VA
as non-promotable. A list of the drugs or drug-related supplies
classified by VA as non-promotable is available at www.pbm.va.gov, or
may be requested by contacting the local office of the Chief of
Pharmacy Services.
(3) The promotion is otherwise consistent with this section.
(4) The promotion is consistent with facility initiatives.
(c) Promotion of non-VANF drugs and drug-related supplies without
criteria-for-use. Under paragraph (b) of this section, non-VANF drugs
or drug-related supplies must be promoted consistent with any existing
criteria-for-use. Non-VANF drugs without criteria-for-use may be
promoted only if:
(1) Specifically permitted by the VISN Pharmacy Executive;
(2) Authorized by the Chief of Pharmacy with jurisdiction over the
VA medical facility at which the promotion occurs; and
(3) In a case where a VISN Formulary Leader has permitted the
promotion of a new molecular entity prior to any decision regarding its
VANF status, such permission must be reconsidered if the new molecular
entity:
(i) Is subsequently granted VANF status but is labeled non-
promotable; or
(ii) A decision is made to deny VANF status.
(d) Educational programs and materials. All educational programs
and materials must be approved by the person at the VA medical facility
to whom such approval responsibility has been delegated under local
policy, usually the Chief of Pharmacy Services. A summary of the
program and all materials must be provided well in advance of the
proposed date so that a determination of the program's suitability can
be made. Programs and materials must conform to the following
guidelines:
(1) Industry sponsorship must be disclosed in the introductory
remarks and in the announcement brochure. Sponsorship includes any
contribution, whether in the form of staple goods, personnel, or
financing, intended to support the program.
(2) Marketing activities cannot be conducted during an educational
program.
(3) Promotional materials are not to be placed in any patient care
area.
(4) Programs or materials must not offer patients an opportunity to
participate in manufacturer sponsored programs and/or require the
furnishing of Protected Health Information.
(5) Patient education materials must not contain the name or logo
of the pharmaceutical manufacturer or be used for promotion of specific
medications; unless the VA Pharmacy Benefits Management Service
determines that the logo or name is inconspicuous and legal
requirements (e.g., trademark requirements) make their removal
impractical. Even if such materials are approved by the VA National
Formulary committee, the materials must otherwise be approved by the
local facility in accordance with paragraph (d) of this section.
(6) Programs or materials regarding a new drug, drug-related
supply, or a new therapeutic indication for a drug, which is already on
the VANF but has not yet been reviewed by VA, must be clearly
identified as such.
(7) Programs or materials focusing primarily on non-VANF drugs or
drug-related supplies are discouraged; such programs or materials, as
well as programs or materials regarding VANF drugs or drug-related
supplies with restrictions, must be clearly identified as such.
(e) Providing gifts, drugs or other promotional items to VA
employees or facilities.
(1) General. No sales representative may give, and no VA employee
may receive, any item (including but not limited to promotional
materials, continuing education materials, textbooks, entertainment,
and gratuities) that exceeds the value permissible for acceptance under
government ethical rules (5 CFR 2635.204(a)). However, such items may
be donated to a medical center library or individual department for use
by all employees, in accordance with local policies. Gifts of travel in
support of VA staff official travel may be accepted by the Department
subject to advance legal review in accordance with 31 U.S.C. 1353, 41
CFR part 304, and VA policy regarding such gifts.
(2) Donations of drugs and drug-related supplies. Drug samples and
free drug-related supplies must be approved by the person at the
medical facility to whom such responsibility is delegated under local
policy, usually the Director. Information pertaining to the trial use
of these drugs or drug-related supplies must be forwarded to the VISN
Pharmacy Executive or VISN Formulary Committee. Drugs or drug-related
supplies donated for the intended purpose of patient use must be
delivered to the Office of the Chief of Pharmacy Services for proper
storage, documentation and dispensing. These donated items must not be
labeled ``sample,'' ``professional sample,'' or similar words, unless
VA grants an
[[Page 24514]]
exception in the interests of patient care. Drug or supply samples may
not be provided to VA staff for their personal use.
(3) Donations of food. Sales representatives may not provide food
items of any type or any value to VA staff (including volunteers and
without compensation employees) or bring food items into VA medical
facilities for use by non-VA staff (e.g., employees of affiliates).
This constraint applies to all sales representatives who have business
relationships with VA Clinical Services.
(f) Conduct of sales representatives. In addition to any other
rules in this section, sales representatives (i.e., promoters) of drugs
and drug-related supplies must conform to the following:
(1) Sales representatives must provide accurate information. Sales
representatives must ensure that all drugs or drug-related supplies are
discussed, displayed and represented accurately, in accordance with any
applicable Food and Drug Administration and VANF guidelines and
restrictions.
(2) Contacts are to be by appointment only. In order to minimize
the potential for disruption of patient care activities, a sales
representative must schedule an appointment before each specific visit.
Access to VA medical facilities by a sales representative without an
appointment is not permitted under any circumstances. VA medical
facilities may develop a list of individuals or departments that do not
wish to be called-on by sales representatives. A sales representative
must not attempt to make appointments with individuals or departments
on the list. The list may be obtained at the local office of the Chief
of Pharmacy Services.
(3) Contacts with VA staff without an appointment. A sales
representative visiting a VA medical facility for a scheduled
appointment may not initiate requests for meetings with other VA staff;
however, sales representatives may respond to requests initiated by VA
staff during the visit.
(4) Paging VA employees. The sales representative may not use the
public address (paging) system to locate any VA employee. Contacts
using the electronic paging system (beepers) are permissible only if
specifically requested by the VA employee.
(5) Marketing to students. Sales representatives are prohibited
from marketing to medical, pharmacy, nursing and other health
profession students (including residents). Exceptions may be permitted
when approved by, and conducted in the presence of, their clinical
staff member.
(6) Attendance at conferences. A sales representative is not
allowed to attend a medical center conference where patient-specific
material is discussed or presented.
(7) Patient care areas. Sales representatives generally may not
wait for scheduled appointments or make presentations in patient-care
areas, but may briefly travel through them, when necessary, to meet in
a staff member's office. Patient-care areas include, but are not
limited to:
(i) Patient rooms and ward areas where patients may be encountered;
(ii) Clinic examination rooms;
(iii) Nurses stations;
(iv) Intensive care units;
(v) Operating room suites;
(vi) Emergency rooms;
(vii) Urgent care centers; and
(viii) Ambulatory treatment centers.
(g) Failure to properly promote drugs or drug-related supplies
within VA.
(1) A sales representative's commercial visiting privileges at one
or more VA medical facilities may be restricted by the written order of
the director of the VA medical center of jurisdiction if the director
determines the sales representative failed to comply with the
requirements of this section. The director will notify the
representative of the noncompliance and of the director's proposed
action under paragraph (g)(3) of this section. The director will also
notify the manager or other appropriate supervisor of the sales force
if there have been instances of widespread misconduct by an individual,
or by multiple representatives of the same sales force, and the
director proposes to suspend or permanently revoke the sales force's
commercial visiting privileges at one or more VA medical facilities.
The notice will offer 30 days to provide a response; however, the
proposed action will be enforced effective the date of the notice.
(2) At the end of the 30-day period for a response, or after the
director receives a timely response, the director may, as appropriate
to prevent future noncompliance, issue a written order suspending or
permanently revoking the sales representative's or sales force's
commercial visiting privileges, impose a lesser sanction, or decide
that no further action is required. In determining the appropriate
action, the director shall consider the requirements of this section,
the circumstances of the improper conduct, any prior acts of misconduct
by the same sales representative or sales force, any response submitted
by the sales representative or sales force manager, and any prior
orders issued or other actions taken with respect to similar acts of
misconduct. Any final order issued by the director shall include a
summary of the circumstances of the violation, a listing of the
specific provisions of this section that the sales representative or
sales force violated, and the bases for the director's determination
regarding the appropriate remedial action.
(3) Actions that may be imposed under this section include
limitation, suspension, or permanent revocation of commercial visiting
privileges at one or more VA medical facilities. Instances of
widespread misconduct by an individual or multiple sales
representatives may result in the imposition of a VISN-wide or VA-wide
limitation, suspension, or revocation of commercial visiting privileges
of the entire sales force of a given manufacturer, if necessary to
prevent further noncompliance. The director will provide the sales
representative or sales force manager written notice of any final order
issued under this section.
(4) Notice concerning a final order suspending or permanently
revoking an entire sales force's commercial visiting privileges shall
include specific notice concerning the right to appeal the director's
order to the Under Secretary for Health. The sales force manager or
other corporate representative may request the Under Secretary's review
within 30 days of the date of the director's order by submitting a
written request to the director. The director shall forward the initial
notice, any response, the final order, and the request for review to
the Under Secretary for a final VA decision. VA will enforce the
director's order while it is under review by the Under Secretary. The
director will provide the individual who made the request written
notice of the Under Secretary's decision.
(Authority: 38 U.S.C. 501)
Editorial Note: This document was received in the Office of the
Federal Register on Friday, April 30, 2010.
[FR Doc. 2010-10629 Filed 5-4-10; 8:45 am]
BILLING CODE 8320-01-P