In January 2019, a handful of Rhode Island state senators introduced Senate Bill 136, An Act Relating to Business and Professions – Prescription Drug Sales – Representative Disclosure Act. The legislation, if passed, would require prescription drug manufacturers to file a detailed list of each pharmaceutical sales representative and pay an annual fee for each name listed with the department of business regulation.
The bill also notes that the department is responsible for providing electronic access to the most recent list provided by each manufacturer to all providers of health care, licensed, certified or registered in the state, operators of pharmacies, and operators of medical facilities, in addition to the general public via the department’s website.
If someone is not listed on the current list, they are not allowed to market prescription drugs on behalf of a manufacturer to any provider of health care, any pharmacy or employee thereof, or an operator or employee of a medical facility.
Annual Report Requirements
In addition to being registered on the list, each person included on the list must file a report with the department on March 1 annually. The annual report must include a list of providers of health care, pharmacies and employees, and operators and employees of medical facilities to whom the representative provided: anything of value worth more than $10.00 or total compensation with a value that exceeds $100.00 in aggregate; and the name and manufacturer of each prescription drug for which the pharmaceutical sales representative provided a free sample.
The department is then responsible for reviewing and analyzing those annual reports and compiling a report of its own on the activities on pharmaceutical sales representatives in the state. That report is due by June 1 of each year and shall be posted on the department’s website in addition to being submitted to the governor, the director of the department of health, the commissioner of the office of health insurance, and the speaker of the house and senate president.
Fees and Penalties
The director of the department will charge each manufacturer $55.00 annually for each pharmaceutical sales representative listed by the manufacturer.
If a manufacturer fails to provide the information required by the legislation, the attorney general may bring a civil action against the company for injunctive relief, costs, and attorneys fees, in addition to a civil penalty of no more than $10,000 per violation. Each unlawful failure to provide the information shall constitute a separate violation.
Rhode Island Senate Hearing
On March 28, 2019, the Rhode Island Senate Committee of Health and Human Services held a hearing during which they discussed the legislation. The first witness, speaking in support of the legislation, noted that other states such as Nevada and cities such as Chicago have implemented similar legislation. He also suggested copying the language from the state of Washington and Nevada where the confidentiality of the information that’s contained in the registry is protected and only available to the department of health and the attorney general.
Senator Joshua Miller, Chairman of the Committee, mentioned concerns that representatives voiced in Washington, Nevada, D.C., and Chicago, about their safety. The witness noted that he was unaware of any anecdotal evidence that such concerns were valid, stating it has been in place for many years, but that he was happy to check with other counterparts in other states.
In response to a question by Senator James Sheehan about data, the witness mentioned a JAMA article that outlined a relationship between detailing and increased use of opioids and overdose deaths, and also testified that he believes the opioid crisis is still alive and well in Rhode Island, while also mentioning some of the other provisions in the D.C. law that he encourages Rhode Island to add, including continuing education and ethics requirements.
Kelly Ryan spoke on behalf of PhRMA in opposition to the bill. While she noted that the association understands the impetus behind the bill and does not condone the behavior the bill is trying to prevent, the bill goes beyond simply preventing bad actors. She noted that interactions are already regulated at the federal level, including via federal laws such as the Anti-Kickback Statute and Open Payments. She also noted that the bill as is currently written goes further than the Nevada legislation as it creates another level of reporting above and beyond Sunshine Act reporting and provides an “incredible level” of detail of relationships between manufacturers and physicians.
Ryan also noted that in October 2018, the Sunshine Act was expanded to include non-physician prescribers as well and a lot of the information the bill requires to be provided is already provided under Sunshine Act. Sample reporting has been in place for decades.
Ryan also mentioned that in the bill as currently written, the reporting function and responsibility falls on the shoulders of the individual, but the penalty falls on the manufacturer. She noted that this could be a problem if staff changes mid-way throughout the year and the individual does not file the report as required and the manufacturer does not have control over the individual any longer, it may result in manufacturers being fined penalties beyond their control.
The legislation seems to be in an early draft at this stage, as it states that manufacturers would be required to inform the department of a change in their list within thirty days of the change, “by any means acceptable to the department,” and that failure to do so “may result in a penalty to be determined by the department.”
Overall, the Chairman of the Committee seemed open to amending the legislation and adding or subtracting certain pieces of it. Time will tell what those changes will be, and whether they will be successful in passing the bill.