West Virginia Prescription Drug Advertising Expense Reporting Rule RevisedMay 23, 2007
West Virginia continues to move forward with implementing its prescription drug advertising expense reporting law. On April 24, the West Virginia Secretary of State filed the West Virginia Pharmaceutical Cost Management Council’s revised emergency rule for Prescription Drug Advertising Expense Reporting. The rule will go into effect upon approval of the Secretary or the 42nd day after filling (June 5, 2007), which ever occurs first. While this rule is substantially similar to a December 2006 version of the rule, there are two key differences.
Generally, the rule requires all drug manufacturers or labelers whose drugs are dispensed in West Virginia to annually report the advertising expenses they incurred in the preceding calendar year. Advertising expenses required to be reported include:
- Direct or indirect gifts, grants, or payments to prescribers for advertising purposes;
- Direct-to-consumer (“DTC”) advertising;
- Direct or indirect gifts of $10,000 or more to a disease-specific patient support or advocacy group for advertising purposes; and
- Direct or indirect gifts of $10,000 or more to a pharmacy licensed in West Virginia for advertising purposes.
The first change from the December 2006 version of the rule eliminates the need to report for the 2006 calendar year. Instead, March, 1, 2008 is the deadline for filing the first report, which will cover only the period from July 1, 2007 through December 31, 2007. Subsequent annual reports must cover the full preceding calendar year and will be due on April 1, 2008.
The second change lowers from $1,000 to $100 the minimum annual aggregate amount of gifts, grants and payments that requires reporting on the prescription drug advertising expenses reporting form.
In addition, the revised rule also clarifies that national or regional DTC advertising expenses should be reported on a prorated basis. Such expenses are to be calculated by multiplying the total expenses by West Virginia’s most recent population (as reported by the U.S. Census Bureau), divided by the total population targeted by the DTC advertising.
Comments on the rule are due to the West Virginia Pharmaceutical Cost Management Council by May 25, 2007.