the 5th annual summit on disclosure, transparency, and ... · 4/3/2012 · spend for drug, device...

The 5th Annual Summit on Disclosure, Transparency, and Aggregate Spend for Drug, Device and Biotech Companies

Washington, D.C. / The National Disclsure Summit / February 19-21, 2013

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2012 Porzio Life Sciences

John Patrick Oroho, Esq. (Moderator)Executive Vice President and Chief Strategy Officer,Porzio Life Sciences, LLCPrincipal, Porzio, Bromberg & Newman P.C.

Marjorie E. Powell, Esq.Senior Assistant General Counsel,PhRMA

SPEAKERS:

An Overview and Comparison

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2012 Porzio Life Sciences3

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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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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 representativeAggregated 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

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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

Finalized Sunshine Act regulations were released by CMS on February 1

The Federal Register published the regulations on February 8

Effective date: April 9, 2013

Data collection begins: August 1, 2013

First report due: March 31, 2014

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§ 403.904 Reports of payments or other transfers of value to covered recipients.◦

(i) Exclusions from reporting.

(3) Product samples, including coupons and vouchers that can be used by a patient to obtain samples, which are not intended to be sold and are intended for patient use.

PREAMBLE FINAL REGULATIONS

An Overview

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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

SamplesPrescription products intended to promote salesIncludes 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 practitionersProduct 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 federalAs between expenditure/gift or sample, report with

expenditures: Distribution of reasonable amounts of OTC ProductEvaluation or demonstration unit of medical device“Starter pack” of only educational materialsDonation of prescription product to free clinic

Note: narrower than industry definitionPrescription 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.

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

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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 15

An Overview and Comparison

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Standards for distribution and accountability of prescription samples, including:

Storage StandardsRecord Keeping InventoriesSecurity AuditingTheft/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 distribute drug samples in interstate commerce will operate according to the minimum standards.

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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 informationUpon delivery, recipient signs for the sample and receipt is returned to manufacturer

Provides conditions for storage and maintenance of drug samplesRecords 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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Understanding the Difference

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PDMA Federal DisclosureSamples 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 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 distributedQuantity of drug samples distributedName of recipientAddress of recipientProfessional designationSignature of practitioner making the

request or “individual who makes or signs …on behalf of practitioner”

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Vermont Federal disclosureSamples include:

Prescribed productStarter packsCouponsVouchersMedical 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:ManufacturerName of recipientRecipient License Number or Federal Tax IDDate deliveredQuantity of samplesContentsPrescribed product typeNameUnits Dosage and product description

Requires the disclosure of:Identity of drug samples distributedQuantity of drug samples distributedName of recipientAddress of recipientProfessional designationSignature 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 24

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PDMAAnti-diversion lawCriminal and civil penalties for manufacturers, distributors and sales repsEnacted in part because Congress believed that consumers were at risk of receipt of misbranded, adulterated, expired or counterfeit drugs

FederalEnacted to support transparency effortsAccountability for the quantity of drugs distributedAllows 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”

FederalSection 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

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This may appear as contradictory informationThis may appear as contradictory information

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PDMA Vermont FederalPRACTITIONER/REQUESTER INFORMATIONManufacturing Company NameThe name of the manufacturer and the authorized distributor ofrecord, if the drug sample is requested from an authorized distributor of recordPractitioner Name

Practitioner AddressPractitioner title/specialityNPI / State authorization numberDRUG SAMPLE INFORMATIONThe proprietary or established nameProduct type (i.e., Pharmaceutical, Biologics, Medical Devices,Combination Product)Strength of the drug sample requestedQuantity requested / units requested

Quantity distributed / units distributedSample type (i.e. prescribed product, voucher, other)DosageDate of requestDate deliveredProduct descriptionSignature of requester

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According to the FDA website utilizing the Gateway System requires the following:

Implementing the Gateway requires some process changes: Some new roles are necessaryNew administrative tasks are created:

Establishing webtrader accounts Obtaining digital security certificates

The archive process must be modifiedTechnical issues must be addressed as they arise.

The following staff and training are needed to develop a workable process with the Gateway in your company:

Gateway specialists must be chosen and trained. Specific staff involved (limited training needed):

Regulatory Operations Regulatory Affairs Information Technology Archive

SOPs and working practices must be createdor modified

Basic Requirements:All files must be submitted in XML format All files must be submitted within a folder. The total size of the folder may not exceed 2GB. Individual files must be smaller or equal to 200MB

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Sample Data Capture ◦

Requirement to Report Spend Detail Need to capture the correct level of detail:

Recipient Detail Product Detail

ESG Access ◦

Regulatory Personnel ◦

Process for requesting ESG accessReporting Logistics ◦

XML schema◦

File submission limitation Regulatory ◦

Signature Requested/Received

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Would require manufacturer or labeler of each prescription drug to report the marketing costs of such drug to the state department of health annually by July 1

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What to report:Advertising, marketing and direct promotion of product to state residentsExpenses associated with educational or informational programs, materials and seminars and remunerationMeals, entertainment, and gifts valued at more than $75Product samples, except for samples distributed to patients free of chargeAggregate cost of all employees and contractors of the manufacturer or labeler who directly/indirectly engage in marketing or promotional activities

the 5th annual summit on disclosure, transparency, and ... · 4/3/2012 · spend for drug, device...

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