Pursuant to Vermont's Prescribed Products Gift Ban and Disclosure Law, manufacturers of prescription drugs, biological products and medical devices are required to disclose to the Vermont Attorney General's Office the value, nature, purpose, and recipient of any allowable expenditure or permitted gift. Manufacturers are also required to submit samples reports that include the product, recipient, number of units, dosage and other information for all samples provided to health care providers.
The AG’s Office recently indicated in a memorandum that it made updates to the 2012 Guide to Vermont’s Prescribed Product Gift Ban and Disclosure Law, which it will incorporate into an amended Guide by June 1, 2012. Among other updates, the amended Guide will include the following:
- With respect to reporting of information on over-the-counter drugs, nonprescription medical devices, and items of nonprescription durable medical equipment, manufacturers are only required to report the product, dosage, number of units, and recipient information of these products. Because these are the same categories of information required to be reported for samples of prescription products, manufacturers should disclose the distribution of such over-the-counter products using the samples form and the sample database.
- Regarding the permissibility of distribution of over the counter products, the AG’s Office will not enforce the gift ban for lotions, eye drops, and like products in 2012. Any distribution of these products that occurs on or after January 1, 2013, will be treated as unlawful. This is a departure from the AG’s Office’s previous position that these products were permissible under the exception to the gift ban allowing for the distribution of reasonable amounts of over-the-counter drugs, nonprescription medical devices, or nonprescription durable medical equipment to health care practitioners for free distribution to patients.
- As for capital equipment and related consumables for medical devices, the AG’s Office clarifies that manufacturers may place capital with a recipient to use without payment based on an agreement that the recipient will purchase a related consumable. Manufacturers are also permitted to provide a recipient with consumables for usage without payment as part of a contracted-for use or purchase of a related medical device. The placement of such capital or the provision of such consumables need not be reported.
Click HERE to view a copy of the 2012 Guide to Vermont’s Prescribed Product Gift Ban and Disclosure Law.
Click HERE to view a copy of the memorandum regarding updates to the 2012 Guide.