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• H.B. 4084, the Pharmaceutical Availability and Affordability Act, created the West Virginia Pharmaceutical Cost Management Council in 2004.

• W.Va. Code 5A-3C-13 directs the Council to promulgate a rule to collect pharmaceutical advertising data

• The statute states that the data will enable the state to determine the scope of advertising costs and aide the state in purchasing drugs effectively.

Why is reporting necessary?

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• All drug manufacturers and/or labeler whose prescription drugs are dispensed in West Virginia or to a West Virginia resident.

• 5A-3C-3 (4) “Drug Manufacturer” or “pharmaceutical manufacturer” means any entity which is engaged in (A) the production, preparation, propagation, directly or indirectly by extraction from substances of natural origin, or independently by means of chemical syntheses or by a combination of extraction and chemical syntheses; or (B) the packaging, repackaging, labeling, relabeling or distribution of prescription drug products. “Drug manufacturer” or “pharmaceutical manufacturer” does not include a wholesale distributor of drugs or a retail pharmacy licenses under state law.

• 5A-3C-3 (7) “Labeler” means an entity or person that receives prescription drugs from a manufacturer or wholesaler and repackages those drugs for later retail sale and that has a labeler code from the federal Food and Drug Administration pursuant to 21 CFR §207.20 (1999)

Who must report?

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• The Company must list the total number of West Virginia prescribers provided directly or indirectly, gifts, grants, or payments of any kind in excess of $100 for the purpose of advertising prescription drugs.

• Annual payments in excess of $100 must be reported in increments of $2,500 until all payments to providers made by the company are reported

What must be reported?Payments to Prescribers

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What Must Be Reported? Payments to Prescribers Table

Annual aggregate amount of fees, food, entertainment, recreational activities, travel expenses, gifts, grants or other payments

Total Number of Prescribers

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• The name of any prescription drugs advertised using DTC advertising reaching or targeting West Virginia, the type of advertising used and the total amount spent.

• For national and regional media buys, the Company should report WV’s share by the following formula:

Total spent x (population of target area/population of WV) = WV share

What must be reported?Direct-to-Consumer Advertising

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What must be reported?Direct-to-Consumer Table

Name of Drug (chemical name and brand name)

Type of Advertising Total Expenditure on Advertising

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Company must list the name of any disease-specific patient support or advocacy group operating in West Virginia which received directly or indirectly gifts, grants, or payments of any kind totaling $10,000 or more for the purpose of advertising prescription drugs.

What must be reported?Payments to Patient Support or Advocacy Groups

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What must be reported?Payments to Patient Support or Advocacy Group Table

Name of Advocacy Group Amount of Annual Payments

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• Company must list the name of any pharmacy licensed in West Virginia which received directly or indirectly gifts, grants, or payments of any kind totaling $10,000 or more for the purpose of advertising prescription drugs.

What Must be Reported?Payments to Pharmacies

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What Must be Reported?Payments to Pharmacies Table

Pharmacy Type of Advertising Amount of Payment

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• Companies may but are not required to report the following exempted information described in 5A-3C-13(c).

Free samples intended for patients

Payments, compensation and reimbursement in connection with a “bona-fide” clinical trial

Scholarship or other support for medical students, residents and fellows to attend significant education, scientific or policy-making conferences

What is exempted from reporting?

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• First report is due March 1, 2008 for period from July 1, 2007 to December 31, 2007. Reports due each year thereafter on April 1 for the preceding calendar year.

• For first report, all reporting thresholds are prorated to reflect the 6-month period.

• Report shall be mailed to:

West Virginia Pharmaceutical Cost Management Councilc/o West Virginia Department of Administration

Capitol Complex, 1900 Kanawha Boulevard, EastCharleston, West Virginia 25305

When and where is the report due?

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• Pharmaceutical Availability and Affordability Act

www.legis.state.wv.us/WVCODE/05a/masterfrmFrm.htm

• Title 206 Series 1, Prescription Drug Expense Reporting

www.wvsos.com/adlaw/emergency/206-01era.pdf

Where can the statute and rule be found?

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• Shana Phares, Pharmaceutical Advocate and Designated Chair, Pharmaceutical Cost Management Council

304-558-0079 or sphares@wvgov.org

• Bill Hicks, Assistant General Counsel, Department of Administration and Counsel to the Pharmaceutical Cost Management Council

304-558-4331 or bhicks@wvadmin.gov

Who can answer questions?