The Vermont Attorney General's Office (AG's Office) is offering to accept a payment to the State in the amount of $10,000 per reporting period to settle failures to report under the Prescribed Products Gift Ban and Disclosure Law (Law) for prior reporting years. According to the Law, manufacturers of prescription drugs, biological products, and medical devices are required to disclose to the AG's Office the value, nature, purpose, and recipient of any allowable expenditure or permitted gift. Manufacturers are also required to submit samples disclosure reports that include the product, recipient, number of units, dosage, and other information for all samples provided to Vermont health care providers. Disclosure reports are due to the AG’s Office by April 1st of each year. According to the Law, each failure to disclose constitutes a separate violation, which may result in a civil penalty of no more than $10,000 per violation.
The AG's Office has indicated that this offer applies only to medical device and biologic manufacturers whose obligation to comply with the Law began on or after July 1, 2009, but who failed to report their activities for any of the following reporting periods:
- FY10 (July 1, 2009 – June 30, 2010)
- FY11 (July 1, 2010 – June 30, 2011)
- 2011 (July 1, 2011 – December 31, 2011)
- 2012 (January 1, 2012 – December 31, 2012)
This offer is also available to those manufacturers that anticipate failure to report for 2013 (January 1, 2013 – December 31, 2013).
Please note that this offer is for "amnesty from additional financial penalties the Attorney General is authorized to seek under the Law for failures to report, and from the back-payment of registration fees. It does not apply to other violations of the [L]aw, such as gift ban violations." This offer will be open until May 1, 2014. Entities wishing to take advantage of this offer must email [email protected] on or before May 1st, and include the following information:
- The manufacturer's name;
- The reporting period(s) for which the manufacturer failed to report; and
- The name, physical address, email address and phone number of the person the AG's Office should communicate with about the unreported activity.
Additionally, the manufacturer would be required to execute an Assurance of Discontinuance to secure its future compliance with the Law. The AG's Office has indicated that it "does not anticipate seeking full disclosure for unreported activity." The AG's Office may, however, require disclosure of some aggregate information related to the activity at a later date.
This offer comes days after the AG's Office announced that it had settled with 3 manufacturers for violations of the Law. In this instance, the manufacturers paid a total of $102,500 to the State in fees and civil penalties. Additionally, one manufacturer donated $35,000 to the Vermont Head Start Tooth Tutor Program, a program that helps provide children with access to adequate dental care. Also note that in September 2013, the AG’s Office settled with 25 manufacturers for violations of the Law. In this instance, the manufacturers paid a total of $25,250 to the State in fees; one manufacturer paid $36,000 in civil penalties to settle gift-ban violations. In both instances, each of the manufacturers self-reported and agreed to prospective compliance with the Law.