drug samples… the next horizon? - global health care between expenditure/gift or sample, report...
TRANSCRIPT
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
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
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
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 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.