Submission Number: 560891-00543
Received: 9/24/2012 7:39:56 PM
Commenter: James DeBell
Agency: Federal Trade Commission
Initiative: Request for Comments and Announcement of Workshop on Pet Medications Issues, Project No. P121201
Attachments: No Attachments
It is interesting to read the American Optometric Association's comments relative to similar mandated prescription portability. In their comments they retroactively evaluate the effect on consumer safety, consumer cost, and the inherent risk to the patient stemming from the 2004 Fairness to Contact Lens Consumer Act (FCLCA). They site the FCLCA "negatively affects the contact lens wearing population and is a cautionary tale for the pet medication industry." The AOA further sites a higher rate of disregard for FDA recommendations and increased complications with contact lenses. With the "passive verification" system (if a prescription is NOT DENIED within 8 hours it is considered verified and can be filled)there have been "complaints from members on this rule being abused...from unscrupulous business practices."
How does all this translate to our profession ? With all due respect to the contact lens industry - there is little inherent risk of death from this prescription mandate - it is a medical device not a pharmaceutical. However this is a viable risk in our industry since we use oral and injectable products via a prescription.
The crux of the problem lies with the newly established "backward" prescription. Traditionally a prescriber wrote or called in a prescription to a pharmacy - the prescriber instigated this process. Nowadays the consumer instigates a drug order on line, the pharmacy then "verifies" the prescription and it is sent. The veterinarian may not even recommend the medication or it may even be contraindicated or lethal. The owner may have read an article, decided that a drug may work for their pet and placed the order. The FTC and the associated interested parties have not defined pet medications. Are we discussing Schedule 6 drugs or are we also talking about narcotics. This is why we have the FDA - to keep the controlled drugs outside of the general population's whims. In our race for consumer "fairness" we may lose sight of safety.
The other recommendation from the FCLCA was to consider rescinding licensure of pharmacies in each state for fear of increased cost to consumers(Why not recend my DEA license and its $700+ cost to me and each of the vets ?). The suggestion was to register the sellers. If implemented this would disallow any state the capacity to sanction the seller since there was now no inherent regulatory action that could be taken for any violation. Can't lose a license you don't have!
If the availability and affordability of these medications is truly the essence and driving force for the consumer then take them all OTC.
Why won't this happen? Because the FDA wants these pharmaceuticals
to be in the hands of the ones who know them the best and can limit and prudently justify their use - it's not a matter of price competition - it's safety.