By Michelle Axelrod, Principal, Porzio, Bromberg & Newman and Vice President, Porzio Life Sciences
Pursuant to Vermont’s Prescribed Products Gift Ban and Disclosure Law (Law), manufacturers of prescription drugs, biological products and medical devices are required to disclose annually to the Attorney General’s Office (AG’s Office) the value, nature, purpose, and recipient of any allowable expenditure or permitted gift.
On September 6, 2012, the AG’s Office sent a memorandum to manufacturers of medical devices and biologics offering limited amnesty to those "whose obligation to comply with the [Law] began on or after July 1, 2009 but who failed to report their activities in any of the following reporting periods: FY10 (7/1/09-6/30/10), FY11 (7/1/10-6/30/11), or 2011 (7/1/11-12/31/11)."
Notably, this offer is limited to amnesty from the "financial penalties the [AG’s Office] is authorized to seek under the Law for failure to report, and does not apply to back-payment of registration fees or penalties for other violations of the law, such as gift ban violations."
In order to take advantage of this offer of limited amnesty, manufacturers of medical devices or biologics must email [email protected] on or before October 1, 2012, with 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 with whom the AG’s Office should communicate with about the unreported activity.
The AG’s Office has indicated that it “does not anticipate seeking full disclosure for unreported activity[.]” The AG’s Office does, however, “anticipate requiring disclosure – at a later date – of some aggregate information related to the activity.” Also note that the AG’s Office may seek to execute an Assurance of Discontinues “to secure a manufacturer’s future compliance with the law notwithstanding that manufacturer’s acceptance of the offer of limited amnesty.”
