The 13th Annual Pharmaceutical Regulatory and Compliance ...

The 13th Annual Pharmaceutical Regulatory and Compliance Congress

and Best Practices Forum

Washington, D.C. / Pharmaceutical Regulatory and Compliance Congress / November 5-7, 2012

2© 2012 Porzio Life Sciences

John Patrick Oroho, Esq. (Moderator)Executive Vice President and Chief Strategy Officer,

Porzio Life Sciences, LLC

Principal, Porzio, Bromberg & Newman P.C.

Kendra Martello, Esq.Assistant General Counsel,PhRMA

Marilyn May, Esq.Senior Litigation Counsel, US Attorney’s OfficeEastern District of Pennsylvania, Department of Justice

Karen Rothschild, Esq.Regulatory Counsel, Office of ComplianceCenter for Drug Evaluation and Research, FDA

SPEAKERS:

An Overview

© 2012 Porzio Life Sciences

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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.”

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

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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.

VT. STAT. ANN. tit. 18 4632

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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

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

Sample Definition: Federal v. Vermont

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Beginning with 2012 sample data reports (due in 2013), clinical trial or research project products are no longer reportable.


Recipient is any:

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

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P.P.A.C.A will NOT preempt Vermont Samples Disclosure Law 8

An Overview and Comparison


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Beginning April 1, 2012, each manufacturer and authorized distributor of record of an applicable drug is required to report to the Secretary the following:

Samples distributed by mail - the identity and quantity of drug samples requested and distributed during the preceding calendar year.

Samples distributed by representative - the name, address, professional designation, and signature of the requesting practitioner or any individual that makes or signs for the request on behalf of the practitioner.

Aggregated by: The name, address, professional designation, and signature of the requesting practitioner or any individual that makes or signs for the request on behalf of the practitioner.

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WHO must report? Manufacturers and authorized distributors of record of covered drugs

only.

WHAT must be reported? Samples distributed by mail (common carrier) or representative

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.

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

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** The FDA will promulgate additional guidance in early 2013. Until further notice from the FDA, there is no new deadline and no action is required at this time for report submission


Vermont Federal disclosure

Samples include:

Prescribed product

Starter packs

Coupons

Vouchers

Medical devices

Biologics

Samples include:

Covers “applicable drugs” for which payment is available under title XVIII or a State plan under title XIX or XXI (or a waiver of such a plan).

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”

Beginning with the submission of 2012 data reports due in 2013, clinical trial or research project products are no longer reportable

Does not stipulate any difference between samples given to a clinical trial or research project and those distributed to patients 12

An Overview and Comparison


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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.*

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PDMA ensures that all prescription

drug manufacturers who distributedrug samples in interstate commercewill operate according to the minimumstandards.

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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

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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

Sampling to any prohibited recipient is a Group I

violation

Be distributed at conventions, hospital displays, other displays or symposia

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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.


Understanding the Difference


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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” for which payment is available under title XVIII or a State plan under title XIX or XXI (or a waiver of such a plan).

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

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”

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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

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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

This may appear as contradictory information

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Vs.Sales

Representatives

Health Care

Practitioners

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The FDA issued a Drafted Guidance “on Compliance Policy for Reporting Drug Sample Distribution Information” published on April 3, 2012.

The comment period ended on June 4, 2012.

The Drafted Guidance clarifies that the FDA will use the Electronic Submission Gateway System for sample disclosures.

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The FDA stated on its website that it “expects to issue further guidance regarding its compliance policy, including timing of agency enforcement decisions, in early 2013.”

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PDMA v. Vermont v. Federal


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PDMA Vermont FederalPRACTITIONER/REQUESTER INFORMATION

Manufacturing Company Name

The name of the manufacturer and the authorized distributor of record, if the drug sample is requested from an authorized distributor of record

Practitioner Name

Practitioner Address

Practitioner title/speciality

NPI / State authorization number

DRUG SAMPLE INFORMATION

The proprietary or established name

Product type (i.e., Pharmaceutical, Biologics, Medical Devices,Combination Product)

Strength of the drug sample requested

Quantity requested / units requested

Quantity distributed / units distributed

Sample type (i.e. prescribed product, voucher, other)

Dosage

Date of request

Date delivered

Product description

Signature of requester

The 13th Annual Pharmaceutical Regulatory and Compliance ...

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