Drug Samples The Next Horizon?

Transcription

1 Fourth Annual Summit On Disclosure, Transparency and Aggregate Spend for Drug, Device and Biotech Companies Drug Samples The Next Horizon? Marilyn May, Esq. Senior Litigation Counsel, US Attorney's Office, Eastern District of Pennsylvania Judy Fox Director, US Commercial Compliance Compliance Implementation Services CIS Kate Whelley McCabe, Esq. Assistant Attorney General, Vermont Office of the Attorney General, Marjorie E. Powell, Esq. Senior Assistant General Counsel, PhRMA. John Patrick Oroho, Esq. (Moderator) Executive Vice President, Porzio Pharmaceutical Services; Principal, Porzio, Bromberg & Newman PC

2 Vermont - Sample Disclosure VT. STAT. ANN. tit WHO must report? Manufacturers of prescribed products, which includes medical devices WHAT must be reported? All free samples, vouchers, coupons of prescribed products provided to health care practitioners Product type, name, number of units, dosage, discount amount, and recipient WHEN is the report due? Vermont AG Sample Disclosures are due annually, by April 1, beginning in Report covers the previous calendar year. WHAT is considered a sample? sample is: 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. Excludes Samples distributed through clinical trials or qualifying research projects. (2011 samples must be reported with allowable expenditures/permitted gifts disclosures)

3 Vermont - Sample Disclosure Report samples only if a patient receives from a health care provider Samples Prescription products intended to promote sales Includes starter packs, coupons, vouchers for free/discounted product Note: broader definition than federal As between expenditure/gift or sample, report with expenditures: Distribution of reasonable amounts of OTC Product. Evaluation or demonstration unit of medical device Starter pack of only educational materials 2011 prescription product distributed through clinical trial or qualifying research project (2012 clinical trial or research project product is no longer reportable for 2013) Donation of prescription product to free clinic Note: narrower than industry definition Prescription drugs provided through the manufacturer's patient assistance program (PAP) for free or at a reduced price are not required to be reported.

4 Vermont - Sample Disclosure Recipients Health care providers Vermont licensed health care professionals with regular practice in Vermont (Includes providers and agents/employees) Hospitals/Nursing homes (not separate foundation) Pharmacists Health benefit plan administrators Others authorized to dispense/purchase prescribed products for distribution in Vermont

5 Vermont - Sample Disclosure P.P.A.C.A will NOT preempt Vermont Samples Disclosure Law

6 6 Federal Law - Sample Disclosure

7 Federal Law - Sample Disclosure Patient Protection and Affordable Care Act P.L SEC. 1128H. Reporting of information relating to drug samples WHO must report? Manufacturers and authorized distributors of record of covered drugs only. WHAT must be reported? Samples distributed by mail or representative (common carrier) Aggregated by recipient name, address, professional designation, and signature, identity and quantity of samples requested and distributed. WHEN is the report due? Federal Sample Disclosures are due annually, by April 1, beginning in Report covers the previous calendar year. 7

8 Vermont v. Federal Disclosure

9 Vermont v. Federal Disclosure Vermont Samples include: Prescribed product Starter packs Coupons Vouchers Medical devices Biologics Requires the disclosure of: Manufacturer Name of recipient Recipient License Number or Federal Tax ID Date delivered Quantity of samples Contents Prescribed product type Name Units Dosage and product description 2011 Samples distributed through clinical trials or research projects should be reported as permitted gifts. (2012 clinical trial or research project product is no longer reportable for 2013) Federal disclosure Samples include: Covers applicable drugs which refers to pharmaceuticals. Anticipated regulations may expand definition Requires the disclosure of: Identity of drug samples distributed Quantity of drug samples distributed Name of recipient Address of recipient Professional designation Signature of practitioner making the request or individual who makes or signs on behalf of practitioner Does not stipulate any difference between samples given to a clinical trial or research project and those distributed to patients 9

10 Prescription Drug Marketing Act PDMA

11 Prescription Drug Marketing Act PDMA

12 PDMA & Impact on Sample Distribution Standards for distribution and accountability of prescription samples, including: Storage Standards Record Keeping Inventories Security Auditing Theft/Loss Reporting *The PDMA establishes civil and criminal penalties for violations of the regulations by manufacturers, distributors and their representatives.*

13 PDMA & Impact on Sample Distribution PDMA ensures that all prescription drug manufacturers who distribute drug samples in interstate commerce will operate according to the minimum standards.

14 PDMA Requirements: Drug Sampling Permits the distribution of samples only to licensed practitioners with prescriptive authority License practitioner submits a written request which includes name, address, professional title, state license number or authorization number, DEA, the name of the manufacturer and authorized distributor of record, the product name, strength, quantity, and the date of the request. - Manufacturers must validate practitioner s information - Upon delivery, recipient signs for the sample and receipt is returned to manufacturer Provides conditions for storage and maintenance of drug samples Records of transmittal must be maintained for a period of 3 years Must conduct and record physical inventory and reconciliation report 14

15 Samples May Not: Be distributed to practitioners who have not been validated (this includes instances in which no sample, pending, or no match appears in validation system) Be distributed to commercial wholesalers or retail pharmacies, even if directed by a licensed practitioner Be distributed at conventions, hospital displays, other displays or symposia Sampling to any prohibited recipient is a Group I violation 15

16 Sample Distribution Mid-levels PDMA defers to individual state laws for authorization to sample midlevels Samples Management should provide sales reps with updated state requirements for mid-levels twice per year in conjunction with validation of the state license 16

17 PDMA v. Federal Disclosure

18 PDMA v. Federal Disclosure Samples include: PDMA Drug sample means a unit of a prescription drug that is not intended to be sold and is intended to promote the sale of the drug. Drug coupon means a form that may be redeemed, at no cost or at reduced cost, for a drug that is prescribed in accordance with section 503(b) of the act. Requires the disclosure of: The name of the manufacturer Practitioner Name Practitioner Address Professional designation Identity drug sample Strength of the drug sample requested The quantity requested Dosage Date of request Signature of requester Samples include: Federal Disclosure Covers applicable drugs which refers to pharmaceuticals. Anticipated regulations may expand definition Requires the disclosure of: Identity of drug samples distributed Quantity of drug samples distributed Name of recipient Address of recipient Professional designation Signature of practitioner making the request or individual who makes or signs on behalf of practitioner

19 PDMA v. Federal Disclosure PDMA Anti-diversion law Criminal and civil penalties for manufacturers, distributors and sales reps Enacted in part because Congress believed that consumers were at risk of receipt of misbranded, adulterated, expired or counterfeit drugs Federal Enacted to support transparency efforts Accountability for the quantity of drugs distributed Allows the tracking and reporting of sample quantities physicians are requesting 19

20 PDMA v. Federal Disclosure PDMA (a) Manufacturers or authorized distributor of record may distribute a drug sample to a practitioner licensed to prescribe (1) The licensed practitioner executes and submits a written request to the manufacturer or authorized distributor of record Federal Section 6004 Prescription Drug Sample Transparency Allows either a license physician or any individual who makes or signs for the request on behalf of the physician to be reported This may appear as contradictory information 4 20

21 PDMA v. Federal Disclosure PhRMA has sent CDER a letter requesting clarification on the signature requirement and the aggregation by signature. PhRMA has also requested for CDER to set safe measures for the confidentiality of the sample information disclosed, referencing Vermont s method as a possible solution.

22 PDMA v. Federal Disclosure Due to lack of guidance from the FDA regarding the sample reporting requirement, PhRMA has urged the FDA to delay the date of the first report until 180 days after the rule is finalized.

23 Vermont v. Federal v. PDMA

24 VT v. Federal v. PDMA

25 Questions or Comments?