Connecticut is the latest state to join the efforts of jurisdictions such as Oregon, Nevada, Washington D.C., and the City of Chicago, Illinois, in further regulating the activities of pharmaceutical representatives. In June, Governor Ned Lamont signed into law "An Act Protecting Patients and Prohibiting Unnecessary Health Care Costs" (the “Act”), which imposes new registration, reporting, and disclosure requirements on pharmaceutical representatives in the State of Connecticut. The Act builds on Governor Lamont’s policy initiatives, which aim to improve the delivery of care and reduce healthcare costs for Connecticut residents and includes the initiative to regulate pharmaceutical marketing practices. The Act sets forth certain requirements for pharmaceutical manufacturers and “pharmaceutical representative(s)” which remain subject to further clarification based on any forthcoming guidance and regulations from the Connecticut Department of Consumer Protection (“CT DCP”).
The Act went into effect on October 1, 2023 and requires pharmaceutical manufacturers that employ any individual to perform duties of a so-called “pharmaceutical representative”[i] in Connecticut to: (a) register annually with the CT DCP as a “pharmaceutical marketing firm;” (b) report to the CT DCP various information on all individuals employed by the pharmaceutical marketing firm as a pharmaceutical representative; and (c) disclose each pharmaceutical representative’s activity in the past calendar year in an annual report to the CT DCP.[ii] In addition to these requirements, pharmaceutical representatives engaged in legend drug marketing in Connecticut must disclose in writing, at the time of each contact, the following information to prescribing practitioners or pharmacists: (i) the list price of a legend drug, based on the dose and quantity of such legend drug as described in the medication package insert; and (ii) information on the variation efficacy of the legend drug marketed to different racial and ethnic groups, if such information is available.[iii] The Act also authorizes the CT DCP to impose penalties for instances of non-compliance or violations of the Act.
Definitions
Unlike similar requirements in other jurisdictions, the Act primarily focuses on drug manufacturers and prescription drugs, but is generally applicable to “pharmaceutical manufacturers”, including virtual pharmaceutical manufacturers, that employ “pharmaceutical representatives” where:
“Pharmaceutical manufacturer” is defined to include (a) “a person, whether within or without the boundaries of the state of Connecticut, that prepares, cultivates, grows, propagates, compounds, converts or processes a drug, device or cosmetic, directly or indirectly, by extraction from substances of natural origin, by chemical synthesis or by a combination of extraction and chemical synthesis, or that packages, repackages, labels or relabels a container under such manufacturer's own trademark or label or any other trademark or label, or a drug, device or cosmetic for the purpose of selling the drug, device or cosmetic;” or (b) “a sterile compounding pharmacy, as defined in section 20-633b of the general statutes that dispenses sterile pharmaceuticals without a prescription or a patient-specific medical order intended for use in humans.”
“Pharmaceutical representative” is defined broadly to include “any person, including, but not limited to, a sales representative, who markets, promotes or provides information regarding a legend drug for human use to a prescribing practitioner and is employed or compensated by a pharmaceutical manufacturer.” [iv]
Of note is that in previous versions of the bill “medical science liaisons” were included within the definition of pharmaceutical representative; however, this language was removed in the final version of the Act.[v] Though the definition of “pharmaceutical representative” includes those persons who “[provide] information” to prescribing practitioners, based on the exclusion of medical science liaison from the definition of pharmaceutical representative, pharmaceutical manufacturers may be inclined to restrict the definition of “pharmaceutical representative” to persons who act and provide such information in a promotional or marketing capacity unless further guidance or regulations indicate otherwise. It remains to be seen whether subsequent regulations will further clarify the applicability of this law to certain individual roles that may not neatly fall within the Act’s definitions. In the meantime, pharmaceutical manufacturers employing individuals who promote, market, or provide information on legend drugs to prescribing practitioners and pharmacists in Connecticut may consider evaluating employee roles and job descriptions to ascertain whether certain employed individuals may need to be included or excluded from any reporting and disclosure requirements under the Act.
What Do Pharmaceutical Manufacturers Need to Do?
Register. As of October 1, 2023, a pharmaceutical manufacturer that employs individuals as pharmaceutical representatives must register as a pharmaceutical marketing firm with the CT DCP and renew their registration annually, and by no later than June 30th of each year. Failure to timely renew a registration will result in a late fee of $100 for each year that the pharmaceutical marketing firm did not properly renew, in addition to the annual renewal fee. Additionally, each pharmaceutical marketing firm must: (a) provide the CT DCP with a list of all individuals employed by the firm as a pharmaceutical sales representative with its initial registration and each annual renewal and (b) notify the CT DCP of any individuals who are hired by the firm or no longer employed by the firm within two weeks of the change.
Report. In order for any individual to hold themselves out as a pharmaceutical representative to prescribers or pharmacists in Connecticut, that individual’s employer must be registered as a pharmaceutical marketing firm, and any person who is not on a pharmaceutical marketing firm’s registration list, which will be posted publicly on the CT DCP’s website, may not act as a pharmaceutical representative on behalf of such firm. Given the Act’s broad definitions, this may mean that in Connecticut, employees who traditionally may not be considered “pharmaceutical representatives” must be included in the list of pharmaceutical representatives disclosed to the CT DCP if their duties involve the marketing, promotion or provision of information regarding a legend drug for human use to a prescribing practitioner or pharmacist.
Disclose. Further, starting July 1, 2024, each pharmaceutical marketing firm must provide the following information from the prior calendar year for each of its pharmaceutical representatives, where “contact” is defined as any communication transmitted in person or by telephone, electronic mail, text message or other electronic means to promote or provide information related to a legend drug: (a) the aggregate number of contacts each pharmaceutical representative had with prescribing practitioners and pharmacists; (b) the specialty of each prescribing practitioner or pharmacist with which a pharmaceutical representative had contact; (c) whether the pharmaceutical representative provided any product samples, materials, or gifts of value to any pharmacist or to any prescribing practitioner or their office staff members; and (d) an aggregate report of all free samples provided by the pharmaceutical representative, organized by drug name and strength.[vi] As with the list of pharmaceutical representatives provided by registered pharmaceutical marketing firms, the CT DCP will compile and post a report of all disclosures made pursuant to this annual requirement.
Penalties
Pharmaceutical manufacturers should ensure they are in compliance with the Act’s requirements as the CT DCP is authorized by the Act to (a) refuse to issue or renew a firm’s registration, (b) revoke, suspend, or impose conditions on a firm’s registration, and (c) impose penalties of up to $1,000 per violation.
Other Jurisdictions of Note
In addition to Connecticut, each of the jurisdictions below have a similar requirement for individuals marketing or promoting pharmaceuticals to healthcare professionals (“HCP”).
Oregon. Effective January 1, 2022, an individual in Oregon who acts as a pharmaceutical representative for more than 15 days during the calendar year must have, and renew annually, a license from the Department of Consumer and Business Services (“DCBS”). An applicant will also need to satisfy certain prelicensure requirements and complete continuing education to maintain their license. Furthermore, pharmaceutical representatives must maintain their own disclosure log documenting their interactions with health care providers, which is also published on the DCBS website.[vii] Violations can be subject to a penalty of $1,000 to $3,000 per violation, where each day that an individual is in violation of this law constitutes a separate violation.[viii]
Chicago, Illinois. Effective July 1, 2017, the Chicago Municipal Code requires that an individual who markets or promotes pharmaceuticals to HCPs within the City of Chicago for more than 15 calendar days during the year must have a license from the City of Chicago’s Department of Business Affairs and Consumer Protection. Certain exemptions include medical science liaisons, wholesale distributors, and pharmaceutical representative managers or supervisors who do not interact directly with HCPs while in the City of Chicago. As with Oregon’s requirements, licensees in Chicago must also complete an educational course for both the initial license as well as any subsequent renewals, which are subject to audit by the Chicago Department of Public Health. Violations of the educational requirements can be subject to fines $1,000 to $3000 per day of violation.[ix]
Nevada. Effective October 1, 2017, an individual who resides in or visits Nevada for five or more days per year to engage in the marketing of prescription drugs, to engage HCPs regarding a drug product, or to distribute FDA regulated product samples and information must be registered as a pharmaceutical representative with the Nevada Department of Health and Human Services by October 1st of the year or within 30 days of hire, and in either case, must be registered before initiating any activities as a pharmaceutical representative. Exclusions include individuals attending any conferences or conventions in Nevada not solely marketed to Nevada licensed HCPs, activities related to clinical trial or investigational drugs, and activities performed by distributors who do not represent a single manufacturer.[x] As with the Act, an employing manufacturer in Nevada can submit the names of all pharmaceutical representatives in a single registration report and must update the Department of Health and Human Services of any changes to their employees who may be starting any activities as a pharmaceutical representative or who is terminated. [xi]
Washington D.C. Effective October 1, 2008, an individual who operates as a pharmaceutical detailer who sells, provides information on, or promotes a pharmaceutical product in any way must be licensed with the District of Columbia Board of Pharmacy. Licensing requirements include proof of graduation from a higher education institution in addition to licensure fees and a notarized statement that the candidate will abide by certain requirements, including a code of ethics. As with other jurisdictions, an applicant must also complete continuing education and may, subject to the Board of Pharmacy’s request, be required to provide information regarding communications with HCPs in the District of Columbia.[xii]
What’s Next?
As evidenced by the Act and the existing laws in Oregon, Nevada, Washington D.C., and the City of Chicago, there is a growing trend in jurisdictions seeking to regulate pharmaceutical representatives who engage with prescribing practitioners and pharmacists. Some jurisdictions go beyond registration, reporting, and disclosure requirements and impose stricter licensing and education requirements. Pharmaceutical manufacturers and individuals engaging in the marketing, promotion, or discussion of drug products with HCPs should ensure that they are abiding by the registration or licensing requirements of the jurisdictions in which they operate, and should keep an eye out for legislation in other jurisdictions as it is possible that other jurisdictions will start exploring similar requirements. Further, as requirements for licensure, registration, renewal, continuing education and disclosures vary, it is important to carefully assess and confirm that all pharmaceutical manufacturers and individual pharmaceutical representatives are in compliance with each jurisdiction’s requirements.
As Connecticut begins to enforce the Act, pharmaceutical manufacturers should continue to keep a close eye on any implementing regulations and monitor the CT DCP’s Website on Pharmaceutical Marketing Firm Registration for any updates to the registration, reporting, and disclosure requirements.
FOOTNOTES
[i] See Connecticut Public Act No. 23-171 Sec. 3. (2023).
[ii] See Connecticut Public Act No. 23-171 Sec. 4. (2023).
[iii] See Connecticut Public Act No. 23-171 Sec. 5. (1)(2) (2023).
[iv] Connecticut Public Act No. 23-171 Sec. 3. (8) (2023).
[v] Compare OLR Bill Analysis sHB 6669, at p. 7 (Apr. 5, 2023) with OLR Bill Analysis sHB 6669 (File 453, as amended by House “A”), at p. 5 (June 7, 2023).
[vi] See Connecticut Public Act No. 23-171 Sec. 3. (2023); See Connecticut Public Act No. 23-171 Sec. 4(f). (2023).
[vii] ORS 731.244, Or Laws 2021, ch 593(2021).
[viii] Id.
[ix] Municipal Code of Chicago Sec. 4-5-010.
[x] Drugs and Medicine – Diabetes – Records and Recordation. 2017 Nevada Laws Ch. 592 (S.B. 539).
[xi] Nev. Rev. Stat. Ann. § 439B.660.
[xii] SafeRx Amendment Act of 2008.