This presentation was the main portion of a March 15th, 2012 Congressional briefing in Washington DC on the state of counterfeits in America and the details, as currently known, of the fake Avastin incident.

1. Moving Beyond the
Avastin Incident:
The Continued Impact of
Counterfeit Drugs in the United States
March 15, 2012

2. Comprised of more than 65 non-profit organizations,
the Partnership for Safe Medicines is a
public health group committed to the safety of
prescription drugs and protecting consumers
against counterfeit, substandard or otherwise
unsafe medicines
PSM believes that just one unsafe medicine threatens patient
safety… we all must work together to educate and to help
protect patients around the globe

3. About the Partnership
 Key Messages
 Counterfeit medicines do exist
 They are not safe
 You can take action to avoid them
 Core Principles
 Protect our supply chain
 Regulate online drug sellers
 Unify in the fight against counterfeit drugs

4. A Public Health Threat
Counterfeit Drugs…
 Defraud consumers
 Deny patients therapies that can alleviate suffering and
save lives
 Can cause great harm and fatalities
 Allergic reactions
 Heavy metal poisoning
 Promote drug resistance strains of diseases
 Not limited to brand-name, prescription lifestyle drug
 Fake versions of generic and over-the-counter (OTC) drugs
 Global issues with widespread health challenges

5. Counterfeiting Incident System (CIS)
FACT: In 536 incidents, counterfeit products reached licensed wholesale
distributors and/or pharmacies in 37 different countries.
Source: Pharmaceutical Security Institute (PSI)

6. Finding Consumers
 Online Pharmacies
 Today, most fake drugs come directly into U.S. homes from fake online
pharmacies
 According to a study from NABP, 96 percent of the online pharmacies
they screened were not safe for consumers
 Drug Importation
 By marking the drugs "for export only," drug exporters can make
Canada a post office box for fake or low-quality drugs from China,
India, and other countries notorious for ineffective and sometimes lethal
products
 In 2012, 48 percent of counterfeit medicine seizures made by
law enforcement were of “commercial” size

7. Avastin 2012
 On Feb. 14, 2012, the U.S. Food and Drug
Administration (FDA) and pharmaceutical manufacturer
Genentech warned the public that counterfeit versions of
the anti-cancer drug Avastin had been distributed in the
United States by an unauthorized foreign supplier
 In a separate communication on the same day, the FDA
warned 19 medical practices that purchased
medications from the foreign supplier
 The counterfeit Avastin contained starch, salt, cleaning
solvents and other chemicals
 Did not include bevacizumab

9. Please Welcome…
 Senator Michael Bennet
 Connie T. Jung, R.Ph., Ph.D., U.S. Food and Drug
Administration's Center for Drug Evaluation and
Research
 Shay Reid, Pharmaceutical Distribution Security Alliance
(PDSA)

10. Outreach Activities
 Consumers
 Pharmacists & Healthcare Providers
 Policymakers

11. Public / Consumers
 Consumer Materials
 Safe Savings brochure
 SAFE DRUG checklist
 Facts About Importing
Drugs From Canada
 FAQs
 Languages
 English
 Spanish
 Chinese
 Vietnamese
 Tagalog

12. International Principles for Drug Safety
 Unify in the Fight Against
Counterfeit or Spurious
Drugs
 PSM India
 Secure and Protect the
Supply Chain
 Regulate Online Drug
Sellers

13. Annual Interchange
 Annual Meeting to discuss challenges and solutions to
the threat of counterfeit drugs
 Attendees and speakers include:
 Law enforcement
 Government regulators
 Academics
 Pharmaceutical sector/manufacturers
 Upcoming Interchange – September 28, 2012
 PSM partners receive priority attendance and a reduced
registration rate
 More details will be available soon on SafeMedicines.org

14. LEADER’s Guide for Pharmacists
 LEADER’s Guide for
Pharmacists
 Updated and expanded
resource about safe sourcing
 SAFE Sourcing Guide
 Archive of peer-reviewed
counterfeit drug research

15. Introducing…
LEADER’s Guides for Physicians & Nurses
 Physicians and nurses are often in a key role to safely source,
auditing the sourcing of patient medication, or spotting counterfeit-
induced therapeutic failure
 LEADER’s Guides already on the websites of the National
Association of the Boards of Pharmacy, the American College
Health Association, or the Institute for Safe Medication Practices
 To co-brand or distribute the documents, please contact us at
703-679-SAFE or editors@safemedicines.org
 Both documents are available for free at www.safemedicines.org
and also included in the USB you received today

16. Questions?

17. Primary Contacts
 Michelle Artz, Senior Director, Federal Alliance
Development & Public Affairs
 michelle@safemedicines.org or 202-835-3529
 Oversees the day-to-day operations
 Tara Goodin, Communications Team Member
 tara@safemedicines.org or 202-591-4041
 Keeps partners, the media, policymakers, and the public
informed about the dangers of counterfeit drugs
 Shabbir Safdar, Communications Team Member
 shabbir@safemedicines.org or 415-683-7526
 Creates PSM’s online presence and manages the website and
portals

18. Thank You
www.SafeMedicines.org