Posts
On May 27, 2010, Vermont Senate Bill 88, An act relating to health care financing and universal access to health care in Vermont (S.88) became law, without the Governor’s signature. Among other things, S.88 amends Vermont's Pharmaceutical Marketing Disclosure Law by requiring manufacturers of prescribed products to disclose to the Vermont Attorney General's Office all free samples of prescribed products provided to health care providers during the preceding calendar year. The bill authorizes the Vermont Attorney General to publicly report aggregated sample distribution information.
Each manufacturer of prescribed products shall disclose to the office of the attorney general all free samples of prescribed products provided to health care providers during the preceding calendar year.
“Sample” is defined as a unit of a prescription drug, biological product, or medical device that is not intended to be sold and is intended to promote the sale of the drug, product, or device. The term includes starter packs and coupons or other vouchers that enable an individual to receive a prescribed product free of charge or at a discounted price.
What Information is Required to be Reported?
This bill requires manufacturers to identify for each sample the product, recipient, number of units, and dosage.
When is the First Report Due?
The first report is due on April 1, 2012 for the previous year's sampling activity.This section will not apply to samples of prescription drugs required to be reported under Sec. 6004 of the Patient Protection and Affordable Care Act (refer to the white paper “Physician Payment Sunshine Provisions Health Care Reform” for additional information on Sec. 6004), if as of January 1, 2011, the office of the attorney general has determined that the U.S. Department of Health and Human Services will collect and report state- and recipient-specific information regarding manufacturer distribution of free samples of such prescription drugs.
What are the Penalties for Noncompliance?
Failure to Disclose - A civil money penalty of no more than $10,000 per violation. Each unlawful failure to disclose shall constitute a separate violation.
Will the Information Submitted be Available to the Public?
This bill authorizes the Vermont Attorney General to publicly report aggregated sample distribution information. Public reporting will not include information that allows for the identification of individual recipients of samples or connects individual recipients with the monetary value of the samples provided (i.e. including the names or license numbers of individual recipients).
Current Controversy over Sample Disclosure
With the passing of this bill, Vermont has become the first state to enact sample disclosure reporting requirements. This bill was passed without Governor Douglas’ signature. He states, “… the drug sample reporting provision adds burdensome new regulations that are unnecessary and could make it difficult for low-income Vermonters to receive needed medications. These sections do not represent meaningful reform; rather they detract from the serious work ahead.” Although S.88 includes these provisions, Governor Douglas decided to allow the bill to become law because it includes a critical expansion of the innovative Vermont Blueprint for Health.
This provision was initiated over concerns that there is a correlation between the distribution of samples and the prescribing patterns of doctors who receive them. A number of senators objected to the sample disclosure requirements. Rutland senator Kevin Mullin argued that the bill would have a chilling effect on the use of free samples in Vermont.
Do you think the disclosure of this information will deter practitioners from accepting or requesting products? Should manufacturers be required to report the distribution of free samples and is there a benefit to making this information available to the public? Please share your opinions here...
Hey Man ! I just went through complete post written by you and found it very much useful for me..thanks for sharing . I am looking for more good things from your side.
ReplyDelete