Recently, Connecticut Governor Ned Lamont signed legislation that enacts a series of initiatives focused on reducing health care costs and improving the delivery of health care to Connecticut residents. Included in the legislation is a requirement that pharmaceutical manufacturers that employ pharmaceutical sales representatives register with the Department of Consumer Protection. The law is wide-ranging with many facets, but this article focuses just on the pharmaceutical sales representative requirements within the law.
Definitions
By definition in the law, a pharmaceutical sales representative includes “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.”
A “pharmaceutical manufacturer” is defined as a
“(A) person, whether within or without the boundaries of the state of Connecticut, that produces, prepares, cultivates, grows, propagates, compounds, converts or processes a drug, device or cosmetic, directly or indirectly, by extraction from substances of natural origin, by means of 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) 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,” and includes virtual manufacturers as defined by the general statutes.
“Contact” is defined in the legislation as “any communication transmitted in person or by telephone, electronic mail, text message or other electronic means between a pharmaceutical representative and a prescribing practitioner or pharmacist, to promote or provide information relating to a legend drug.”
Registration Requirements
The law requires that beginning October 1, 2023, all pharmaceutical manufacturers that employ individuals to perform the duties of pharmaceutical sales representatives shall register on an annual basis with the Connecticut Department of Consumer Protection as a pharmaceutical marketing firm. No pharmaceutical manufacturer is permitted to have individuals acting as pharmaceutical sales representatives on their behalf unless they have obtained the required registration from the Department. All registrations will expire every year on June 30th and will need to be renewed.
Upon each registration and renewal, pharmaceutical marketing firms will need to provide a list of all individuals employed as a pharmaceutical sales representative. Additionally, if a pharmaceutical sales representative leaves the employment of the pharmaceutical marketing firm for any reason, the firm shall notify the Department no later than two weeks after the individual leaves employment that they are no longer employed by the firm. Similarly, any new hires brought on by the pharmaceutical marketing firm shall be provided to the Department no later than two weeks after the individual is hired. The list of current pharmaceutical sales representatives employed by each pharmaceutical marketing firm will be published online by the Department.
A link to the registration information can be found here.
Annual Reporting Requirements
Not only must each pharmaceutical marketing firm provide the list of pharmaceutical sales representatives, but starting July 1, 2024, and annually thereafter, each firm shall provide the Department with specific information regarding the performance for the previous calendar year for each of its pharmaceutical sales representatives. The information that must be provided on an annual basis includes:
- the aggregate number of contacts the pharmaceutical sales representative had with prescribing practitioners and pharmacists;
- the specialty of each of those prescribing practitioners and pharmacists;
- whether any product samples, materials, or gifts of any value were provided to either a prescribing practitioner or a prescribing practitioners staff or to a pharmacist; and
- an aggregate report of all free samples provided, by drug name and strength.
The Department will analyze the information and compile a report on the activities of pharmaceutical sales representatives in the state by posting a report online by December 1, 2024 (and annually thereafter).
Additionally, each pharmaceutical representative engaged in legend drug marketing in Connecticut shall disclose the following written information to each prescribing practitioner or pharmacist at the time of each contact:
- the list price of a legend drug when the pharmaceutical representative provides information concerning the legend drug, based on the dose and quantity of such legend drug as described in the medication package insert; and
- information on the variation efficacy of the legend drug marketed to different racial and ethnic groups, if such information is available.
Registration and Renewal Fee
The initial and annual registration fee is $150, and any pharmaceutical marketing firm that does not renew its registration prior to June 30 each year will need to pay a late fee of $100 for each year that the firm did not renew (in addition to the annual renewal fee).
A link to the legislation as enacted can be found here. The Connecticut Department of Consumer Protection website can be found here.