[Politech] Problems with FDA's proposal to do RFID tagging of drugs

From: Declan McCullagh (declan@private)
Date: Sun Feb 22 2004 - 21:13:59 PST

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    You can find the FDA final report here:
    http://www.fda.gov/oc/initiatives/counterfeit/report02_04.html#radiofrequency
    >Use of mass serialization to uniquely identify all drug products intended 
    >for use in the United States is the single most powerful tool available to 
    >secure the U. S. drug supply. Mass serialization involves assigning a 
    >unique number (the electronic product code or EPC) to each pallet, case, 
    >and package of drugs and then using that number to record information 
    >about all transactions involving the product, thus providing an electronic 
    >pedigree from the point of manufacture to the point of dispensing. This 
    >unique number would allow each drug purchaser to immediately determine a 
    >drug's authenticity, where it was intended for sale, and whether it was 
    >previously dispensed.
    
    ---
    
    From: Marcel Waldvogel <marcel@private>
    Date: Thu, 19 Feb 2004 15:42:39
    To:dave@private
    Cc:Steve Bellovin <smb@private>
    Subject: Re: [IP] FDA suggests RFID tagging of drugs
    
    Dave, Steve,
    
    My interpretation of the appropriate sections in the FDA document seem
    to use the RFID only passively: it will return its unique electronic
    product code (EPC) for each query, and not using a challenge-response
    scheme. My interpretation seems to be further supported by the
    comparison of RFID to 2-D bar codes, which certainly are passive. Such a
    use allows for easy copying of the EPC to counterfeit drugs. When the
    system is to be used offline (which could be a goal; this is not
    stated), it might even be possible to generate unique-looking EPCs.
    
    Without a cryptographic challenge-response scheme, which would break
    compatibility to other RFID systems and probably be too expensive to
    manufacture, it does not provide any protection against counterfeiting.
    It only makes customers carrying drugs easily identifyable, which will
    aid in discrimination, tracking, and profile-building.
    
    In summary, I expect the system to be completely BAD (Broken As
    Designed). But nevertheless, I find it fascination how easily and
    frequently even educated people attribute almost-magical properties to
    technology.
    
    -Marcel
    http://marcel.wanda.ch/
    
    Dave Farber wrote:
    
     >Delivered-To: dfarber+@ux13.sp.cs.cmu.edu
     >Date: Wed, 18 Feb 2004 22:25:01 -0500
     >From: Steve Bellovin <smb@private>
     >Subject: FDA suggests RFID tagging of drugs
     >To: dave@private
     >
     >The FDA has released a report calling for the RFID tagging of
     >pharmaceuticals to help defend against counterfeiting.  The word
     >"privacy" barely occurs in the report -- there's simply a reference to
     >HIPAA -- and it is not listed among the important unresolved issues.
     >
     >The report is at 
    http://www.fda.gov/oc/initiatives/counterfeit/report02_04.html
     >
     >
     >               --Steve Bellovin, http://www.research.att.com/~smb
     >
    
    
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