Oregon Publishes Proposed Rules on Pharmaceutical Representative Licensure & Disclosure

On October 5, Oregon’s Department of Consumer and Business Services (“DCBS”) held a public meeting  to discuss the proposed rules for the licensing of pharmaceutical representatives. This was in response to Senate Bill 763 that was enacted during the 2021 Legislative Session (see our previous coverage here). The proposed rules include sections on licensure requirements and renewal, education and continuing education requirements, quarterly reporting requirements, prohibited conduct, and civil penalties and license revocation. While rule adoption or any other action must occur prior to the law’s operative date of January 1, 2022, Numi Lee Griffith, Senior Policy Adviser for DCBS, stated that a permanent rule will probably not be issued by January 1, 2022, but instead DCBS will likely issue a “temporary rule that will be effective on that date and…hopefully the content will be more or less finalized at that point.”

License Requirements and Renewal (see 836-200-XXX1-XXX3, XX12(1))

A pharmaceutical representative who does business with health care professionals (“HCPs”) while both are within the State of Oregon must acquire a license from DCBS prior to doing business in the state on fifteen or more days in a calendar year.

The cost of obtaining a license is $750 and licenses are valid from January 1 through December 31. The initial licensure also requires the applicant to show they have completed at least ten hours of professional education. Licensees will be expected to pay a $750 renewal fee along with submitting documentation that shows they have completed five hours of continuing professional education.

Licensees will also be expected to report any changes to the information submitted in an initial license application, a renewal application, or any “material changes made in the licensee’s business operations” (e.g., termination for cause and any complaints made to the licensee, their employer, or a company the licensee represents regarding the business activities conducted under the license).

Education and Continuing Education Requirements (see 836-200-XXX4-XX11)

Prior to obtaining an initial license, applicants must complete a DCBS-approved course of at least ten hours. The coursework must contain at least the following components: (A) An introduction to the pharmaceutical representative license; (B) An overview of the ethical standards and disclosure requirements required of licensees under Oregon law; (C) The comparative clinical effectiveness of pharmaceutical products; (D) The comparative cost effectiveness of pharmaceutical products; and (E) Professional ethics.

Prior to renewal, licensees must complete at least five hours of continuing education that has been approved by DCBS. Examples of the subject areas include general medical and pharmaceutical terminology and abbreviations, the comparative cost effectiveness of pharmaceutical products, and how to read and analyze peer-reviewed literature on pharmaceutical products.

Education providers will be expected to register with DCBS and register each course (60 days in advance). DCBS will review each course registration for the purpose of evaluating, assigning credit hours, determining compliance with the content requirements, and certifying the course.

Given that the rulemaking is in the beginning stages, it is highly unlikely DCBS will be able to approve courses prior to January 1, 2022, which would make it impossible for a pharmaceutical representative to apply for an initial license. Numi Griffith acknowledged that given it was already October that it may be “unrealistic” to have the initial education requirements in place for this year and would address the issue at the next public meeting.

Quarterly Reporting Requirements (see 836-200-XX12(2)-(3))

Under the proposed rules, licensees will be expected to report the following:

• A list of HCPs within the state that the licensee contacted;
• The number of times the licensee contacted each HCP;
• The location and duration of the licensee’s contact with each HCP;
• Which pharmaceutical products the licensee promoted;
• Whether the licensee provided the HCP with any product samples, materials or gifts and, if so, the monetary value of the samples, materials or gifts; and
• Whether and how the licensee otherwise compensated the HCP for contact with the licensee.

The proposed rules establishes that reporting will be done in quarterly intervals (April 15, for the quarter beginning January 1, and ending on March 31; July 15, for the quarter beginning April 1, and ending on June 30; October 15, for the quarter beginning July 1, and ending on September 30; and January 15, for the quarter beginning October 1, and ending on December 31).

Numi Griffith stated the quarterly intervals are modeled on the state’s quarterly reporting requirements for lobbyists. She explained that “the quarterly schedule might seem [] aggressive but [her] thought is that it is better to be keeping track of all of your meetings with doctors for three months at a time rather than for an entire year.”

Committee member Asher Lisec, representing the Pharmaceutical Research and Manufacturers of America, did not object to the quarterly intervals and instead asked that the rule be amended to permit the licensee’s employer (i.e., the compliance department) to report on their behalf. Committee member Brian Van Hoy, representing G&M Health, LLC, believed it would be better for the intervals to occur annually. Numi acknowledged she was “agnostic on the frequency…and maybe it [made] more sense to have that be an annual requirement.”

Prohibited Conduct, Civil Penalties and License Revocation (see 836-200-XX13-XX14)

The proposed rules prohibit licensees from certain conduct, such as engaging in any deceptive or misleading marketing of a pharmaceutical product, using a title that could reasonably lead a HCP or an HCP’s employee to believe the licensee is a HCP if they are not licensed as a HCP, attending a patient examination without the patient’s consent, or making or filing any false statement, report, or document to or with DCBS.

DCBS has the authority to impose civil penalties and revoke licenses for violating any provision of the law or regulation, including failure to file timely quarterly reports. Under the law, civil penalties range between $1,000 to $3,000 for each violation.

Scheduled Public Meetings

DCBS will be hosting two additional public meetings on Tuesday, October 26 and Tuesday, November 16 (additional information can be found here). Due to time limitations and to ensure that public comments are correctly recorded, individuals are strongly encouraged to submit public comments in writing via email to DFR.rules@oregon.gov. This is an opportunity for the industry to voice their concerns, especially with the quarterly reporting requirements.