Pennsylvania Rep. Mike Zabel (D-PA-163) reintroduced the Pharmaceutical Manufacturing Prohibited Gifts Act (H.B. 593), adding an amendment recommended by the Insights Association that would protect bona fide marketing research with health care professionals.
While last year’s version of the Act (H.B. 2643) would have potentially prohibited respondent incentives for physicians participating in pharmaceutical and medical device marketing research, even though incentives are usually only offered by independent marketing research companies and the sponsoring manufacturers are not typically aware of which doctors participated, Rep. Zabel’s new bill reflects discussions with IA and the association’s mobilization of more than 80 grassroots insights professionals to effect changes to the language.
“We understand and appreciate Pennsylvania’s concerns with the opioid epidemic and the pharmaceutical industry’s influence over physicians, but the only influence sought through respondent incentives is to encourage a difficult to reach but highly important community to participate in research,” commented Howard Fienberg, VP Advocacy for the Insights Association.
In endorsing the new version of the Pharmaceutical Manufacturing Prohibited Gifts Act, Fienberg said, “we thank Rep. Zabel and his cosponsors for recognizing both the importance of Pennsylvania health care providers being properly represented in marketing research and the insights industry’s efforts to help develop and deliver medicines, devices and services to address unmet patient needs across the Commonwealth.”
The Insights Association, the leading nonprofit organization representing the marketing research and data analytics industry, has helped other jurisdictions over the years to protect the use of respondent incentives in pharmaceutical and medical device marketing research, including the District of Columbia, Maine, Massachusetts, Minnesota, New Jersey, and the federal Physician Payments Sunshine Act.
Definitions in H.B. 593
"Allowable expenditures" are defined to include: payments to sponsors of educational events under limited circumstances; “[h]onoraria and payment of the expenses of a health care professional who serves on the faculty at a bona fide significant educational, medical, scientific or policymaking conference or seminar" in limited circumstances; payments for bona fide clinical trials; payments for research projects (including marketing research) that constitute “a systematic investigation,” are “designed to develop or contribute to general knowledge and reasonably can be considered to be of significant interest or value to scientists or health care professionals working in the particular field of inquiry"; payments "for technical training of individual health care professionals on the use of a device if the commitment to provide the expenses and the amounts or categories of reasonable expenses to be paid are described in a written agreement between the health care provider and the manufacturer"; royalties/licensing fees paid "in return for contractual rights to use or purchase a patented or otherwise legally recognized discovery for which the health care provider holds an ownership right"; reasonable expenses for participating in employment interviews; sponsorship of CME educational programs; "[i]tems with a total combined retail value, in any calendar year, of not more than $50”; and “[o]ther reasonable fees, payments, subsidies or other economic benefits provided by a manufacturer of prescribed products at fair market value.”
Most importantly, the new addition to that list, as recommended by IA, is: “Payment to a practitioner for participation in bona fide marketing research conducted by a third party, if the payments are made by the third party and the sponsoring manufacturer is not informed of the identity of the participating practitioner.”
A "bona fide clinical trial" is an “FDA-reviewed clinical trial that constitutes research, as that term is defined in 45 CFR Â§ 46.102 (relating to definitions for purposes of this policy), and reasonably can be considered to be of interest to scientists or health care professionals working in the particular field of inquiry.”
The bill adds a new definition of “bona fide marketing research,” as requested by IA: “The collection and analysis of data regarding opinions, needs, awareness, knowledge, views, experiences and behaviors of a population, through the development and administration of surveys, interviews, focus groups, polls, observation or other research methodologies, in which no sales, promotional or marketing efforts are involved and through which there is no attempt to influence a participant's attitudes or behavior.”
A ”gift” means:
- “anything of value provided for free to a health care provider”; or
- “except as provided for allowable expenditures, any payment, food, entertainment, travel, subscription, advance, service or anything else of value provided to a health care provider, unless: (i) it is an allowable expenditure; or (ii) the health care provider reimburses the cost at fair market value.”
Pennsylvania H.B. 593 defines a "health care professional” as:
- “A person who is authorized by law to prescribe or to recommend prescribed products, who regularly practices in this Commonwealth, and who either is licensed by the Commonwealth to provide or is otherwise lawfully providing health care in this Commonwealth.”
- ”A partnership or corporation made up of the persons described in paragraph (1)”;
- ”An officer, employee, agent or contractor of a person described in paragraph (1) who is acting in the course and scope of employment, of an agency or of a contract related to or supportive of the provision of health care to individuals.”
- “The term shall not include a person described in paragraph (1) who is employed solely by a manufacturer.”
A "health care provider" is “a health care professional, hospital, nursing home, pharmacist, health benefit plan administrator or any other person authorized to dispense or purchase for distribution prescribed products in this Commonwealth. The term does not include a hospital foundation that is organized as a nonprofit entity separate from a hospital."
"Manufacturer" means a “pharmaceutical, biological product or device manufacturer or any other person who is engaged in the production, preparation, propagation, compounding, processing, marketing, packaging, repacking, distributing or labeling of prescribed products. The term does not include: (1) a wholesale distributor of biological products or a retailer or a pharmacist licensed under the act of September 27, 1961 (P.L.1700, No.699), known as the Pharmacy Act; or (2) a manufacturer whose only prescribed products are classified as Class I by the United States Food and Drug Administration, are exempt from premarket notification under section 510(k) of the Federal Food, Drug and Cosmetic Act and are sold over-the-counter without a prescription.”
The Pharmaceutical Manufacturing Prohibited Gifts Act defines “marketing” to include “promotion, detailing or any activity that is intended to be used or is used to influence sales or market share or to evaluate the effectiveness of a professional sales force.”
A "prescribed product" is defined as a “drug as defined in section 201 of the Federal Food, Drug and Cosmetic Act, a compound drug or drugs, a device as defined in this section, a biological product as defined in section 351 of the Public Health Service Act, (58 Stat. 682, 42 U.S.C. § 201 et seq.), for human use or a combination product as defined in 21 CFR § 3.2(e) (relating to definitions). The term does not include prescription eyeglasses, prescription sunglasses or other prescription eyewear.”
Prohibition on “gifts” to physicians
Per the Pennsylvania Pharmaceutical Manufacturing Prohibited Gifts Act, drug and device manufacturers, “or any agent thereof” would be prohibited from offering or giving “any gift to a health care provider.”
The prohibition excepts drug samples, device loans, demo units, educational materials, scholarships to educational conferences, drug/device rebates and discounts, FDA-approved labels, donations to free clinics, and “provision of coffee or other snacks or refreshments at a booth at a conference or seminar.”
Moreover, “[e]xcept for allowable expenditures, no manufacturer or other entity on behalf of a manufacturer” would be allowed to “provide any fee, payment, subsidy or other economic benefit to a health care provider in connection with the provider's participation in research.”
Violations would be subject to civil penalties of up to $10,000 each.
Pennsylvania H.B. 593 would go into effect 60 days after passage.