In July 2021, Oregon’s governor signed into law Senate Bill 763 requiring pharmaceutical representatives to obtain a license prior to marketing or promoting products to healthcare providers (HCPs). The law also included a provision granting the Department of Consumer and Business Services (DCBS) the authority to require licensees to submit disclosures related to their interactions with HCPs.

On October 5th, the DCBS held a meeting to discuss the proposed rules. The rules include an initial license requirement as well as an annual renewal, continuing education requirements, quarterly disclosure requirements and penalties for noncompliance.

The initial license requirements include the obligation for pharmaceutical representatives interacting with HCPs while within the state of Oregon to acquire a license from the DCBS prior to doing business in the state for 15 or more days in a calendar year. The license application includes a cost of $750 and proof of at least 10 hours of professional education. Education must be obtained through DCBS-approved courses. Licenses are to be renewed each year for the same fee with proof of an additional five hours of continuing education.

In addition to obtaining a license, under the proposed rules, pharmaceutical representatives will be expected to submit quarterly disclosure reports. The disclosure reports may include:

  • 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 each contact
  • The pharmaceutical products promoted
  • Any product samples, materials or gifts provided to the HCP and their value
  • Any other compensation provided to the HCP

The proposed due dates for quarterly reports are:

  • April 15 (expenditures from January 1 to March 31)
  • July 15 (expenditures from April 1 to June 30)
  • October 15 (expenditures from July 1 to September 30)
  • January 15 (expenditures from October 1 to December 31)

Licensees that violate any provision of the regulation may have their license suspended or revoked. Additionally, civil penalties range between $1,000 to $3,000 for each violation.

The DCBS will be hosting two additional public meetings on Tuesday, October 26th and Tuesday, November 16th. Individuals are encouraged to submit public comments in writing via email to DFR.rules@oregon.gov.

The DCBS has stated that a final rule will likely not be issued before January 1, 2022, but they are hopeful that a “temporary rule” will be effective. MediSpend will continue to monitor any changes or updates to Oregon’s law and will provide updates as they are available.

 

Lauren Howe
Compliance Attorney

October 21, 2021