Sample accountability managers grapple with Vermont's new reporting requirements

May 31, 2011
Pharmaceutical Commerce, Pharmaceutical Commerce - May/June 2011,

Vermont’s amended program directly affects how samples are distributed to healthcare providers; ambiguities remain in who and what need to be reported

The PDMA Alliance, Inc. (pdmaaaliance.org), an industry voluntary group that brings together industry’s expertise in managing drug sampling programs, has just completed a member survey of Vermont’s Prescribed Product Gift Ban and Disclosure Law, which has been amended to include more specific guidance on sample programs. The overall law, which has been on the state books for a couple years, regulates money, gift-giving and other payments from pharma manufacturers to healthcare providers (including, but not limited to, prescribing physicians). To anticipate compliance with this law, PDMA Alliance just surveyed its members on how advanced their preparations are.

According to the survey, 75% of respondents have already made changes to their reporting procedures, and 56% indicate that these changes are still going on. However, only 25% of respondents indicate that they are satisfied with the data being collected; it’s either too soon to tell, or there’s more data yet to be appropriately collected and managed. Nearly nine out of 10 respondents say that the new regulations have compelled sample accountability managers to work more closely with other commercial departments at manufacturers: the departments cited include Finance, Public Affairs, Government Relations, Compliance, and Managed Markets, in addition to working more closely with vendors.

The data suggest that “The pharmaceutical industry's reaction to the Vermont regulations varies greatly, from major implications (e.g. consideration of withdrawing from activity in the state) to minor (e.g. minimal changes to processes),” says Deb Segura, executive director of PDMA Alliance. “This is in part due to the lack of clarity in the regulations themselves, and in the State’s attempts to explain the details to the industry.”

The topic is expected to be a centerpiece of PDMA Alliance’s annual meeting, Sept. 25-28, in San Antonio.