Questions and Answers Regarding the Exclusive Sourcing Agreement
| Q: | Why has Abbott initiated this policy? | |||||||||
| A: | Discoveries of counterfeit product in the U.S. distribution
channel have highlighted risks to patients, healthcare providers, and customers
who have always recognized Abbott as providing high-quality products. The
safety and integrity of Abbott products are of the highest priority and the
threat posed to public health and safety by counterfeit products is taken very
seriously. Accordingly, Abbott has undertaken this initiative domestically to
help prevent any unsafe products from being introduced into the supply
chain. |
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| Q: | What divisions/business units of Abbott are included in this policy? | |||||||||
| A: | The divisions/business units of Abbott included in this policy
are as follows, and shall be referred to in this document as “Abbott”:
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| Q: | What is the geographic scope of the policy? | |||||||||
| A: | The scope of the policy currently applies to entities within
the 50 United States ONLY (excluding U.S. territories and Puerto Rico). We are
monitoring international markets and will work closely with
wholesalers/distributors and customers in taking further action, as
appropriate, to ensure the integrity of Abbott products and patient safety
throughout the world. |
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| Q: | Have Abbott’s Terms and Conditions been changed to incorporate Exclusive Sourcing Policy? | |||||||||
| A: | Yes. The Terms and Conditions of Sale of each of the
Divisions/Business Units included have been changed appropriately to
incorporate Wholesaler/Distributor adherence to this policy and may be accessed
at
www.abbott.com/corporate/prod_integrity/eas.cfm.
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| Q: | How does Abbott define and handle product returns from end-using customers to wholesalers/distributors? | |||||||||
| A: | Abbott's first responsibility is to ensure patient safety and
the integrity of the supply chain for products manufactured and sold by Abbott.
Wholesalers/distributors need to be vigilant in their treatment of returned
goods. Therefore, with regard to product returns between an end-using customer
and wholesaler/distributor, the policy defines product returns as products that
are sent back unused and meet the following requirements; however, please be
aware that the specific returns policies of individual wholesalers/distributors
may vary:
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| Q: | How does Abbott Define and handle product returns from wholesalers/distributors to Abbott? | |||||||||
| A: | With respect to product returns between a
wholesaler/distributor and Abbott, existing terms and conditions regarding
those product returns continue as written. Abbott accepts no liability for
counterfeit product accepted in return by wholesalers/distributors. |
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| Q: | Can wholesalers/distributors buy from and sell to each other products that are manufactured by Abbott? | |||||||||
| A: | No. If wholesalers/distributors buy Abbott products from any
source other than Abbott, they are not in compliance with this policy. Because
of the need to ensure product integrity and patient safety, as well as a secure
distribution channel, the policy does not allow trade between
wholesalers/distributors. Products shall be purchased from Abbott solely for
resale to end customers in the United States who are properly licensed entities
by the states in which they operate, for their own use or distribution to their
own consumers/patients. Any change or alteration of this policy potentially
creates a risk of unauthorized product entering secure distribution
channels. |
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| Q: | How does the policy impact international markets and U.S. wholesalers/distributors who have international branches? | |||||||||
| A: | The policy currently applies to the U.S. market. We are
monitoring international markets and will work closely with
wholesalers/distributors and customers in taking further action, if needed, to
ensure the safety of patients and the integrity of our products throughout the
world. Regarding U.S. wholesalers/distributors with international branches: The distribution policy does not allow purchases or transfers of Abbott’s products across borders by U.S. wholesalers/distributors. The policy relates to and governs U.S. trading practices of wholesalers/distributors purchasing products from Abbott in the United States. Because product requirements vary across world regions (dosage strength, quantities, etc.) to meet unique local needs and/or regulations, products developed by international business units of Abbott to meet those needs cannot be transferred to and used within the United States. |
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| Q: | What is Abbott doing to reduce the supply of products currently moving into the secondary market? | |||||||||
| A: | Abbott is committed to ensuring patient safety and the
integrity of our products throughout the world. Business practices and policies
are being evaluated and refined with priority placed on product integrity, to
assure appropriate control of products in the marketplace. Immediate emphasis
includes education in the marketplace about the risk and existence of
counterfeit product and the importance of a secure channel to minimize risks in
the secondary market. In addition, Abbott is working with the U.S. Food and Drug Administration (FDA), and exploring product protection programs, including the application of special features for our product packaging and product tracing. We believe it is vital for our customers and patients to receive genuine products so they can use our products with confidence. We are also monitoring markets to ensure the safety of patients and the integrity of our products. We will continue to develop and implement actions to address the issue. |
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| Q: | What is Abbott's policy on auditing wholesalers/distributors? | |||||||||
| A: | As previously outlined, we reserve the right to enforce the
commitments made in our notification letter of April 30, 2004, by requiring
within thirty (30) days after written request by Abbott, that the
wholesaler/distributor shall provide or cause to be provided, as elected by
Abbott, (i) a certification of compliance from a senior officer or executive
with financial oversight responsibility for the wholesaler/distributor, or (ii)
the opportunity for an audit of the relevant books and records of the
wholesaler/distributor. In addition, Abbott reserves the right to cease
shipments to the wholesaler/distributor if Abbott in its sole discretion in
good faith believes the wholesaler/distributor may not have complied with the
policy. |
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| Q: | How does Abbott communicate the status of wholesalers/distributors? | |||||||||
| A: | Abbott provides a listing of wholesalers/distributors approved
to purchase Abbott products at: www.abbott.com/corporate/prod_integrity/pdf/dist_list.pdf.
Regular updates are made to this listing. |
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| Q: | Who can I contact if I wish to place an order or have questions on my order? | |||||||||
| A: | Abbott Pharmaceutical Products Division (1 800) 255-5162 Abbott Diabetes Care (1 800) 537-3575 |
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| Q: | Where should potential violations to the Exclusive Sourcing Agreement be reported? | |||||||||
| A: | Abbott Global Product Protection D-GS27, Building J48 200 Abbott Park Road Abbott Park, IL 60064 Phone: (1 847) 936-5959 |
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| Q: | Where should suspicions or leads on counterfeit, diverted or stolen Abbott product be reported? | |||||||||
| A: | Abbott Global Product Protection D-GS27, Building J48 200 Abbott Park Road Abbott Park, IL 60064 Phone: (1 847) 936-8352 |
