Counterfeit Prescription Drugs Counterfeit Prescription Drugs

U.S. Drug Distribution SystemU.S. Drug Distribution System

Reputation– Safest in the World

Federal Food, Drug and Cosmetic Act– Overseen by the FDA

FDA Approval Process

– Prohibits interstate– Importation shipping

Closed System

FDA Personal Importation FDA Personal Importation PolicyPolicy

Patient with serious medical conditionUnder Direct Physician SupervisionDrug unapproved in the USAMaximum 3 month supplyEffective treatment NOT available

domesticallyDrug NOT available in the USA

FDA Counterfeit ProblemFDA Counterfeit Problem

Case Count– 1997 Six cases– 1998 Four cases– 1999 Six Cases– 2000 Six Cases– 2001 20 cases– 2002 22 cases

Recent Counterfeits– 2002

Epogen/Procrit Zyprexa/Serostim Diflucan

– 2003 Procrit Lipitor/Viagra

Recently the FDA ordered three medicines from “Canada”

When they arrived one thing was clear…..

Where did the medicines come from?What exactly is in them?Getting medicines from Canada isn’t the

answer, but it does raise a lot of questions.

SOURCES-- US Senate Drug Importation Hearings: Health, Education, Labor & Pensions

Committee May 20th, 2004 & Judiciary Committee July 14th , 2004 US Food and Drug Administration: FDA Tests Results of Prescription Drugs

from Bogus Canadian Website Show All Products Are Fake or Substandard July 13th 2004.

Defining CounterfeitsDefining Counterfeits

No active ingredientsIncorrect amount of active ingredientsWrong ingredientsHigh levels of impuritiesExpired productsStored at wrong temperatureStored under unsafe conditions

Dangers of Illegal Drug Dangers of Illegal Drug ImportationImportation

Counterfeit Allergic reactions Improper medical supervision Consumer Protection Laws

– HIPAA

Safety and Liability Potential Venue

– Organized crime/terrorism

Importation By the NumbersImportation By the Numbers

If all USA residents bought their rx drugs from Canada that nation’s supply would be exhausted in 38 days.

If just ½ of the elderly in the USA were to buy drugs from Canada, it would have to boost its drug supply by 2.5 times.

Did you know…….Did you know…….

Canada doubled the value of its drug imports since 1999 from 2.4 billion to 4.7 billion last year. In 2003, 44% of those drugs came for the USA. The rest came from over 80 countries, including Ireland, Italy, Mexico, India, Cuba, Colombia and Guyana.

Did you know…..Did you know…..

Health Canada will not guarantee the safety of medicines shipped outside its borders, and the FDA does not have the fiscal wherewithal to manage Canadian imports.

A Prudential Financial report disclosed Canada initially purchases from Bulgaria, Singapore, Argentina, South Africa and Pakistan.

Effective and Timely Change?Effective and Timely Change?

“What drives patients to illegally import drugs from countries where they are afraid to drink the water, but not afraid to put their lives in the hands of unregulated drug distributors?”

“If the importation of drugs from Canada is unsafe, then show us the bodies!”

Anti Drug Counterfeit StrategyAnti Drug Counterfeit Strategy

FDA ActionsManufacturersDistribution SystemRFID Technology

– Digital Electronic Pedigree

Counterfeit Alert Network

NABP Consumer IncidentsNABP Consumer Incidents

Consumer Fraud– Delayed/no delivery

Bait & Switch Incorrect Charges $ No/invalid

prescription Foreign Language

Label

Drug switching/wrong product

Duplicate therapy Appear to be in

Canada, based elsewhere

Suspect Counterfeit DrugsSuspect Counterfeit Drugs

Voluntary Reporting FDA MedWatch

– 1-800-332-1088 – www.fda.gov/medwatch/safety

Contact ManufacturerNation Boards of Pharmacy

– www.nabp.org

Caveat Emptor