Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 970.000 - Pharmaceutical And Medical Device Manufacturer Conduct › Section 970.004 - Definitions

Current through Register 1525, July 5, 2024
The following terms as used in
				105 CMR 970.000 shall have
				the following meanings, unless the context or subject matter clearly require a
				different interpretation:
Annual Reports
, the annual reports
				submitted by the Secretary of Health and Human Services to Massachusetts
				pursuant to Sec. 1128G(d)(2) of Part A of title XI of the federal Social
				Security Act.
Authorized Entity
, the attorney
				general, the district attorney with jurisdiction over a violation, or the
				department of public health.
Biologic
, a virus, therapeutic serum,
				toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic
				product, immunoglobulin product, or analogous product, as defined by Section
				351 of the Public Health Service Act applicable to the prevention, treatment,
				or cure of a disease or condition of human beings and regulated as a drug under
				the Federal Food, Drug, and Cosmetic Act.
Bona Fide
Services
, an arrangement for services including, but
				not limited to, research, participation on advisory boards, collaboration with
				501(c)(3) organizations dedicated to the promotion of health and the prevention
				of disease, and presentations at pharmaceutical or medical device manufacturing
				company-sponsored medical education and training including U.S. Food and Drug
				Administration (FDA) required education and training involved in producing safe
				and effective medical devices, provided such an arrangement is formalized in a
				written agreement specifying the services to be provided, based on the fair
				market value of the services and characterized by the following factors:
(a) a legitimate need for the services clearly identified in
				advance;
(b) a connection between the competence and expertise of the
				health care practitioner and the purpose of the arrangement;
(c) the number of health care practitioners retained is not
				greater than the number reasonably necessary to achieve the identified
				purpose;
(d) the retaining pharmaceutical or medical device
				manufacturing company maintains records concerning the arrangement and makes
				appropriate use of the services provided by the health care
				practitioner;
(e) the venue and circumstances of any meeting with the health
				care practitioner is conducive to the services and activities related to the
				services are the primary focus of the meeting; and
(f) the decision to retain a health care practitioner is not
				unduly influenced by a pharmaceutical or medical device manufacturing company's
				sales personnel.
Charitable Donation
, the provision of
				financial support to a 501(c)(3) or the in-kind provision of drugs, biologics
				or medical devices for charity care of patients.
Clinical Trial
, a genuine research
				project involving a drug or medical device that evaluates the safety or
				effectiveness of the particular drug, biologic or medical device in the
				screening, prevention, diagnosis, evaluation or treatment of a disease or
				health condition, or evaluates the safety or efficacy of the drug or medical
				device in comparison with other therapies, and which has been approved by the
				FDA and, if the trial involves volunteer human research subjects, it has been
				approved by a duly constituted Institutional Review Board (IRB) after reviewing
				and evaluating it in accordance with the human subject protection standards set
				forth at 21 C.F.R. Part 50, 45 C.F.R. Part 46, or equivalent standards of
				another federal agency.
Commissioner
, the Commissioner of the
				Department of Public Health.
Covered Recipient
, a person authorized
				to prescribe, dispense, or purchase prescription drugs or medical devices in
				Massachusetts, including a hospital, nursing home, pharmacist, health benefit
				plan administrator, or a health care practitioner. A person who otherwise meets
				this definition but is a
bona fide
employee of a
				pharmaceutical or medical device manufacturing company shall not be a covered
				recipient for the purposes of payments by that company. Additionally, consumers
				who purchase prescription drugs or medical devices are not covered
				recipients.
Conference or Meeting
, any convening
				where responsibility for and control over the selection of content, faculty,
				educational methods, materials, and venue belongs to the event's organizers in
				accordance with their guidelines, held in a venue that is appropriate and
				conducive to informational communication and training about medical
				information, where:
(a) the gathering is primarily dedicated, in both time and
				effort, to promoting objective scientific and educational activities and
				discourse (one or more educational presentation(s) should be the highlight of
				the gathering); and
(b) the main purpose for bringing attendees together is to
				further their knowledge on the topic(s) being presented.
Department
, the department of public
				health.
Genuine Research Project
, a project
				intended to add to medical knowledge about the care and treatment of patients
				that constitutes a systematic investigation, designed to develop or contribute
				to generalizable knowledge when the results can be published by the
				investigator and reasonably can be considered to be of significant interest or
				value to scientists or health care practitioners working in the particular
				field of inquiry.
Health Care Practitioner
, a person who
				prescribes prescription drugs for any person and is licensed to provide health
				care in Massachusetts, or a partnership or corporation comprised of such
				persons, or an officer, employee, agent or contractor of such person acting in
				the course and scope of his or her employment, agency or contract related to or
				in support of the provision of health care to individuals. Hospitals are not
				healthcare practitioners. Additionally, full time employees and board members
				of pharmaceutical or medical device manufacturers are not health care
				practitioners.
Hospital Setting
;
(a) a hospital;
(b) academic medical center; or
(c) pharmaceutical or medical device specialized training
				facility, where the facility, as certified to the Department by the
				pharmaceutical or medical device manufacturing company, is specifically
				designed to approximate the conditions of a surgical suite, or the conditions
				of a working clinical laboratory or to provide medical training on large and/or
				technical medical devices, such as surgical equipment, implants, and imaging
				and clinical laboratory equipment.
Medical Device
, an instrument,
				apparatus, implement, machine, contrivance, implant, in vitro reagent or other
				similar or related article, including any component, part or accessory, which
				is:
(a) recognized in the official National Formulary or the United
				States Pharmacopeia or any supplement thereto;
(b) intended for use in the diagnosis of disease or other
				conditions or in the cure, mitigation, treatment or prevention of disease, in
				persons or animals; or
(c) intended to affect the structure or function of the body of
				a person or animal, and which does not achieve its primary intended purposes
				through chemical action within or on such body and which is not dependent upon
				being metabolized for the achievement of its primary intended purposes.
Modest Meals and Refreshments
, food
				and/or drinks provided by or paid for by a pharmaceutical or medical device
				manufacturing company or agent to a health care practitioner that, as judged by
				local standards, are similar to what a health care practitioner might purchase
				when dining at his or her own expense.
Non-faculty
, a health care
				practitioner who does not serve as a speaker or provide actual and substantive
				services as a faculty organizer or academic program consultant for a continuing
				medical education (CME) event, third-party scientific or educational
				conference, or professional meeting.
Person
, a business, individual,
				corporation, union, association, firm, partnership, committee or other
				organization.
Pharmaceutical
or
Medical
				Device Manufacturer Agent
, a person who, while employed by or
				under contract with a pharmaceutical or medical device manufacturing company,
				engages in detailing, promotional activities or other marketing of prescription
				drugs, biologics, or medical devices in Massachusetts to any physician,
				hospital, nursing home, pharmacist, health benefits plan administrator, other
				health care practitioner or person authorized to prescribe, dispense or
				purchase prescription drugs, biologics or medical devices; provided, however,
				that "pharmaceutical or medical device manufacturer agent" shall not include a
				licensed pharmacist, licensed physician or any other licensed health care
				practitioner with authority to prescribe prescription drugs, biologics or
				medical devices who is acting within the ordinary scope of the practice for
				which he or she is licensed, a wholesale drug distributor licensed under M.G.L.
				c. 112, § 36A, a representative of such a distributor who promotes or
				otherwise markets the services of the wholesale drug distributor in connection
				with a prescription drug or a retail pharmacy registered under M.G.L. c. 112,
				§ 37 if such person is not engaging in such practices under contract with
				a manufacturing company.
Pharmaceutical or Medical Device Manufacturing
				Company
, any entity that:
(a) is engaged in the production, preparation, propagation,
				compounding, conversion or processing of prescription drugs, biologics, or
				medical devices, either directly or indirectly, by extraction from substances
				of natural origin, or independently by means of chemical synthesis or by a
				combination of extraction and chemical synthesis; or
(b) is directly engaged in the packaging, repackaging,
				labeling, relabeling or distribution of prescription drugs, biologics, or
				medical devices;
provided, however, that "pharmaceutical or medical device
				manufacturing company" shall not include a health care practitioner, physician
				practice, home health agency, hospital licensed under M.G.L. c. 111, § 51,
				a wholesale drug distributor licensed under M.G.L. c. 112, § 36A or a
				retail pharmacy registered under M.G.L. c. 112, §§ 37 through
				39C.
Prescription Drugs
, drugs upon which
				the manufacturer or distributor has placed or is required by federal law and
				regulations to place the following or a comparable warning: "Caution federal
				law prohibits dispensing without prescription."
Sales and Marketing Activities
, for
				the purposes of disclosure under
				105 CMR
				970.009, sales and marketing activities
				include advertising, promotion, or other activity that is intended to be used
				or is used to influence sales or the market share of a prescription drug,
				biologic or medical device; to influence or evaluate the prescribing behavior
				of a covered recipient to promote a prescription drug, biologic, or medical
				device; to market a prescription drug, biologic, or medical device; or to
				evaluate the effectiveness of a professional pharmaceutical or medical device
				detailing sales force. Sales and marketing activities also include any product
				education, training, or research project that is designed or sponsored by the
				marketing division of a pharmaceutical or medical device manufacturing company
				or has marketing, product promotion, or advertising as its purpose.
Sales and marketing activities also include the provision of
				any fee, payment, subsidy or other economic benefit with a value of at least
				$50 to a covered recipient except as follows: Sales and marketing activities do
				not include clinical trials and genuine research, particularly where the
				primary purpose is to generate data in support of an application filed with the
				FDA seeking approval for a new drug, biologic or medical device or "new use" or
				similar marketing or labeling claim requiring FDA approval. Clinical trials
				that are posted on clinicaltrials.gov will be deemed exempt from disclosure.
				Sales and marketing activities also shall not include the provision of
				prescription drugs to a covered recipient solely and exclusively for use by
				patients, demonstration or evaluation units, in-kind items used for the
				provision of charity care, or confidential price concessions established in
				contracts between pharmaceutical or medical device manufacturing companies and
				insurers, pharmacies, pharmacy benefit managers or health plan administrators
				and their affiliates that are offered in connection with the acquisition of
				drugs, biologics or medical devices or the management of a health plan's
				formulary.
Secretary
, the Secretary of the United
				States Department of Health and Human Services.