Current through Register 1531, September 27, 2024
(1) By July 1,
2009, each pharmaceutical or medical device manufacturing company that employs
or contracts with a pharmaceutical or medical device manufacturer agent shall:
(a) adopt a marketing code of conduct in
compliance with the requirements of
105 CMR 970.000;
(b) adopt and submit to the Department a
description of a training program to provide regular training to appropriate
employees including, without limitation, all sales and marketing staff, on the
marketing code of conduct. The training program must:
1. ensure that all representatives who are
employed by or acting on behalf of the company and who visit health care
practitioners have sufficient knowledge of:
a.
the marketing code of conduct,
b.
general science, and
c.
product-specific information to provide accurate, up-to-date information,
consistent with state law and FDA requirements; and
2. provide for regular assessments of persons
who are employed by or acting on behalf of the companies to ensure that they
comply with the requirements of
105 CMR 970.000 and other
relevant company policies.
(c) certify to the Department to the best of
the company's knowledge, information and belief that it is in compliance with
105 CMR 970.000;
(d) adopt and submit to the Department
policies and procedures for investigating non-compliance with
105 CMR 970.000, taking
corrective action in response to noncompliance and reporting instances of
non-compliance to the appropriate state authorities; and
(e) submit to the Department the name, title,
address, telephone number and electronic mail address of the compliance officer
it has identified as responsible for certifying compliance with
105 CMR 970.000 and
implementing, monitoring, and enforcing the company's marketing code of
conduct.
(2) Each
pharmaceutical manufacturing company that uses non-patient identified
prescriber data to facilitate communications with health care practitioners
shall:
(a) maintain the confidential nature of
prescriber data;
(b) develop
policies regarding the use of the data;
(c) educate employees and agents about these
policies;
(d) designate an internal
contact person to handle inquiries regarding the use of the data;
(e) identify appropriate disciplinary actions
for misuse of the data; and
(f)
comply with the request of any health care practitioner not to make his or her
prescriber data available to company sales representatives.
(g) Before utilizing health care practitioner
prescriber data for marketing purposes, manufacturers must give health care
practitioners the opportunity to request that their prescriber data :
1. be withheld from company sales
representatives, and
2. not be used
for marketing purposes.
(h) Nothing in 105 CMR 970.005(2) shall
prohibit pharmaceutical manufacturing companies from using prescriber data to:
1. impart important safety and risk
information to prescribers of a particular drug or device;
2. conduct research;
3. comply with FDA mandated risk management
plans that require manufacturers to identify and interact with health care
practitioners who prescribe certain drugs or devices; or
4. track adverse events of marketed dugs,
biologics or devices.
(3) In all speaker and commercial consultant
contracts, pharmaceutical manufacturing companies shall require any health care
practitioner who is a member of a committee that sets formularies or develops
clinical guidelines and also serves as a speaker or commercial consultant for
the company to disclose to the committee the nature and existence of his or her
relationship with the company. This disclosure requirement must extend for at
least two years beyond the termination of any speaker or consultant
arrangement.
(4) Beginning on July
1, 2010, and annually on or before July 1st of each
year thereafter, each pharmaceutical and medical device manufacturing company
must certify to the Department that it has conducted annual audits to monitor
compliance with
105 CMR 970.000.
(5) Each pharmaceutical and medical device
manufacturing company must report all incidents of non-compliance with
105 CMR 970.000 to the
Department and to the Office of the Attorney General in a format specified by
the Department.
(6) Each
pharmaceutical and medical device manufacturing company must register with the
Department annually and must pay the $2,000 annual registration fee established
by the Department. The annual registration fee replaces the disclosure fee
described in
105 CMR
970.009(2), which is no
longer required after July 1, 2012.
