New Developments in the Drug Supply Chain Security Act

(1653 Ratings)

Produced on: July 27, 2015

Course Format On Demand Audio

Taught by

Categories:

Course Description

Time 90 minutes
Difficulty Advanced

The Drug Supply Chain Security Act outlines critical steps to building an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States. Drug manufacturers, wholesale drug distributors, repackagers, and many dispensers (primarily pharmacies) will have new and significant responsibilities under the Act. The development of the system will be phased in with new requirements over a 10-year period. However, several of these provisions will begin in 2015.  In this program, Angelo Cifaldi and Satish Poondi of Wilentz, Goldman, and Spitzer, P.A., discuss these new provisions and the legal impact they will have on the pharmaceutical industry and the individual pharmacy.  

 

Learning Objectives: 

I.    Grasp the history of the Act and  the new requirements imposed by the Act 

II.   Define key terms, including “pedigree,” “Drug Supply Chain Integrity,” and “product tracing”

III.  Comprehend the gray market that has emerged and its meaning in the legal and ethical contexts 

IV.  Identify good practices to prevent legal issues in the purchase of medications 

V.   Recognize the clinical and economic impact of drug shortages

VI.  Understand the impact of the Act as it relates to the pharmacy’s relationship with vendors, patients, and third party insurances

Faculty

Satish V. Poondi

Wilentz, Goldman & Spitzer P.A.

Satish Poondi is an associate at the law firm of Wilentz, Goldman & Spitzer, P.A. and a member of its Mass Tort/Class Action Team. Mr. Poondi is also a registered pharmacist, completing the Doctor of Pharmacy program at Rutgers University.

 

Mr. Poondi is active in the field of pharmacy academia. He is an advisor to multiple pharmacy organizations and a guest lecturer at the Ernest Mario School of Pharmacy at Rutgers University. Mr. Poondi regularly presents continuing education seminars relating to important pharmaceutical legal issues for programs sponsored by academic institutions, professional organizations, and retail chains. He routinely represents healthcare professionals before licensing boards, such as the New Jersey Board of Pharmacy, New Jersey Medicaid, Medicare, the Drug Enforcement Administration, the Office for Civil Rights, and many other regulatory agencies, as well as third party insurance companies. Additionally, he routinely provides guidance on the regulatory responsibilities associated with the sale and purchase of pharmacies. His clients include independent pharmacies, pharmacists, pharmacy technicians, retail chains, wholesalers, hospitals, and compounding pharmacies. 

 

In addition to his administrative law practice, Mr. Poondi also represents patients who were injured by pharmaceutical products against large pharmaceutical companies. Presently he is representing:

  • Patients that developed bladder cancer after taking Actos, a diabetes medication
  • Patients that developed heart attacks/strokes after taking Avandia, a diabetes medication
  • Patients that developed gastrointestinal complications, such as ulcerative colitis, after taking Accutane, a medication used to treat acne
  • Patients that suffered from psychotic episodes after taking a generic version of Wellbutrin XL that was recalled by the FDA
  • Patients that lost limbs after being administered Heparin, an anti-coagulant

 

Mr. Poondi also represents clients with lung cancer and mesothelioma caused by their exposure to asbestos.

 

Mr. Poondi is also an active member of the community. He is the Director of Legislative Affairs for the Asian American Retailers Association and Director of Communications for the Indian Business Association. He previously served on the Mayor’s Advisory Committee on Community Relations for the township of Edison. In addition, Mr. Poondi is on the Executive Board of various Middlesex County based community associations.

Angelo Cifaldi

Wilentz, Goldman & Spitzer P.A.

Angelo Cifaldi is a shareholder with Wilentz, Goldman and Spitzer P.A., where he is Co-chair of the Mass Tort/Class Action Team, a member of the management committee and the firm’s Vice President. He has been with the firm since he graduated cum laude from Seton Hall Law School in 1984. Before law school he graduated from Rutgers College of Pharmacy with high honors in 1981 and became a licensed pharmacist in New Jersey, a license that he still maintains. Mr. Cifaldi has two primary areas of practice: mass tort litigation and pharmacy administrative law.

 

During the past 30 years, Mr. Cifaldi, in conjunction with his Mass Tort/Class Action Team, has collected over one billion dollars for his clients. Mr. Cifaldi has successfully represented clients who have been the victims of asbestos exposure, including asbestosis, lung cancer and mesothelioma, defective prescription drugs and medical devices, chemical exposure, and environmental pollution, including ground water and air contamination.

 

Notably, Mr. Cifaldi has been on the forefront of asbestos and environmental litigation, and has achieved several successful single case recoveries. He achieved $38.5 million and $17.5 million resolutions for the victims of a ground water contamination. He has also handled various pro bono matters, the most notable being the representation of widows and relatives of the 9/11 terrorist attack on the World Trade Center.

 

As to his pharmacy administration practice Mr. Cifaldi represent hundreds of pharmacies, pharmacists, pharmacy technicians, wholesalers, and other healthcare providers in New Jersey, New York and Pennsylvania. He is considered a leading authority on pharmacy law in New Jersey and has handled numerous matters and hearings before the New Jersey Board of Pharmacy, DEA, FDA, Medicare and New Jersey Medicaid.

 

Mr. Cifaldi is also an adjunct associate professor of Pharmacy Law and Bioethics at Rutgers College of Pharmacy. He has been teaching Pharmacy Law at the school for over 25 years. In addition Mr. Cifaldi presents numerous continuing education seminars on pharmacy law related issue for groups such as Rutgers University, New Jersey Pharmaceutical Association, Garden State Pharmacy Owners Association, Indo American Pharmaceutical Society, New York State Department of Health-AIDS Institute, New Jersey Institute of Continuing Legal Education and others.

 

Mr. Cifaldi is also involved in civic activities as the chairman for the North Haledon Recreation Commission. He has held that position since 1983. He serves as the regional vice president of the American Amateur Baseball Congress. He also coaches a team of college and ex professional baseball players (over 25 years) in the Met League, a summer baseball league in Northern New Jersey. He is a former Councilman and Council President of the Borough of North Haledon and continues to be active politically in Passaic County.

Reviews

DB
Donald B.

Excellent

AK
Alexandria K.

The attorneys were engaging and informative. I really enjoyed this course.

MO
Mary Jane D. O.

Very informative especially for anyone in the healthcare industry.

DH
David H.

good program

LO
Lisa O.

Nice presentation - interesting subject.

KG
Kristina G.

Very interesting!

DW
Danielle W.

Very informative. I know nothing about drug supply chains, and I learned a lot. It's even scarier than I realized.

ES
Eric S.

Excellent.

SS
Steven S.

This might not be everybody's topic area but it is interesting.

TR
Tracie R.

I didn't think this would be interesting, but it was!

DS
Deborah S.

very interesting!

CM
CATHERINE M.

VERY KNOWLEDGEABLE

TF
Thomas F.

very good

WY
Wendy Y.

Excellent

TY
Tonya Y.

Very informative and well presented course.

AW
Andrietta W.

Excellent presentation. Presenters were knowledgeable, dispensing practical and useful information.

JM
Jeff M.

This was one of the better programs. Thanks!

DW
Donna W.

Both instructors are outstanding and it was great to have such current materials.

BC
Barbara C.

Unique subject matter but they did a good job with it. Impressive speakers.

AB
Amy B.

Very informative

MD
Matthew D.

They seemed fun.

JH
James H.

excellent and fascinating for a novice like myself

KH
Kelly H.

Very interesting session!

AA
Alan A.

Very informative on a law I did not at all know about in an interesting area.

JM
Joseph M.

Very eye opening and a well delivered presentation

AL
Ashley L.

Really liked these presenters

GD
Gary D.

The experience and academic accomplishments of the faculty shines in this training module. The importance of he topic cannot be overstated.

MC
Mark C.

Excellent presentation.

RH
Robert H.

Practical, useful, informative.

RK
Robert k.

Excellent presentation!

SB
Susan M. B.

Instructive program. Relevant to all-a medical catastrophe can impact any family and put them in need of specialized drugs etc. Well organized presentation and materials.

ST
Suzanne T.

Very informative.

JA
James A.

the more specific information was useful

KF
Kirl F.

Good

MS
Melissa S.

Riveting.

TS
Terence S.

very well done

TP
Tue P.

Both presenters are extremely knowledgeable.

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