Drug Samples… The Next Horizon?

Marilyn May, Esq.

Senior Litigation Counsel, US Attorney's Office,

Eastern District of Pennsylvania

Kate Whelley McCabe, Esq.

Assistant Attorney General,

Vermont Office of the Attorney General

,

Judy Fox

Director, US Commercial Compliance

Compliance Implementation Services CIS

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

Fourth Annual Summit On Disclosure, Transparency and

Aggregate Spend for Drug, Device and Biotech Companies

Vermont - Sample Disclosure

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 2012. 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)

VT. STAT. ANN. tit. 18 § 4632

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.

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

Vermont - Sample Disclosure

P.P.A.C.A will NOT preempt Vermont Samples Disclosure Law

Vermont - Sample Disclosure

6

Federal Law - Sample Disclosure

7

Patient Protection and Affordable Care Act P.L. 111-148SEC. 1128H. Reporting of information relating to drug samples

Federal Law - Sample Disclosure

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 2012. Report covers the previous calendar year.

Vermont v. Federal Disclosure

Vermont v. Federal Disclosure

9

Vermont Federal disclosure

Samples include:

Prescribed product

Starter packs

Coupons

Vouchers

Medical devices

Biologics

Samples include:

Covers “applicable drugs” which refers to pharmaceuticals.

Anticipated regulations may expand definition

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

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”

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)

Does not stipulate any difference between samples given to a clinical trial or research project and those distributed to patients

Prescription Drug Marketing Act“PDMA”

Prescription Drug Marketing Act“PDMA”

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.*

PDMA & Impact on Sample Distribution

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.

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

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)

15

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

Sample Distribution

Mid-levels – PDMA defers to individual state laws for authorization to sample mid-levels

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

PDMA v. Federal Disclosure

PDMA Federal Disclosure

Samples include:

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.

Samples include:

Covers “applicable drugs” which refers to pharmaceuticals.

Anticipated regulations may expand definition

Requires the disclosure of:The name of the manufacturerPractitioner Name Practitioner Address Professional designationIdentity drug sampleStrength of the drug sample requestedThe quantity requestedDosageDate of requestSignature of requester

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”

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

PDMA v. Federal Disclosure

PDMA§ 203.30

– (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

204

This may appear as contradictory information

PDMA v. Federal Disclosure

PhRMA has sent CDER a

letter requesting clarification

on the signature requirement

and the aggregation by

signature.

PDMA v. Federal Disclosure

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.

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.

Vermont v. Federal v. PDMA

VT v. Federal v. PDMA

Questions or Comments?