A teleconference was held to review and discuss the volunteer surrender of Tennessee
pharmacist license #22971 for Barry James Cadden, D.Ph. Dr. Cadden is the pharmacist in
charge for New England Compounding Center and has been charged with violating T.C.A § 4-5-
3205(c) and board rule 1140-01-.06.
Dr. Warren called the meeting to order and to ensure that each participant was connected a roll
call vote was taken. Dr. Eidson made the motion to proceed with the meeting electronically. Dr.
Kizer seconded the motion. The motion carried with a roll call vote. Mr. Smith informed the
board of the need for a motion to determine if the matter or matters to be discussed meet the
following requirements; the subject matters requires timely action, the physical presence of all
members is not possible and the participation by some or all of the members of the board by
electronic or other means is necessary. Ms. McDaniel made the motion that this meeting does
meet the requirements listed. Dr. Kizer seconded the motion. The motion carried with a roll call
vote.
Mr. Smith informed the board that Dr. Barry James Cadden has signed an Agreed Order to
voluntarily surrender his license and Dr. Cadden understands that this action is considered a
revocation and will be reported to the national database. Dr. Eidson asked for clarification of
board rule 1140-01-.06 listed as number 5 in the Consent Order under Stipulation of Fact. Mr.
Smith stated that this was not summary suspension but listed that rule as a notice that the board
could have preceded with a summary suspension. Dr. Eidson asked what are the difference in Tennessee Board of Pharmacy
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October 23, 2012
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this order and the consent order signed by New England Compounding Center. Mr. Smith stated
that the differences include that New England Compounding Center consent order was based on
an inspection report by the Massachusetts Board of Pharmacy and the sterility of certain drug
products compounded and dispensed by the pharmacy, specifically methylprednisolone acetate
and Dr. Cadden paragraph three states that “On or about October 3, 2012, NECC voluntarily
surrendered its pharmacy license in its home state of Massachusetts. NECC’s Surrender
Agreement states that it relates to an inspection conducted on October 2, 2012.
Ms. McDaniel asked if the Department of Agriculture is the group that tags the vials and does the
investigation or if the Department of Agriculture is working with the Department of Health for
the collection of the medication sent from New England Compounding Center since the
Department of Agriculture is responsible by statute. Dr. Holt stated that the collection of the
medication is being directed by Commissioner Dreyzehner as part of the investigation and that
he doesn’t know if they are working with the Department of Agriculture or not. Ms. Young
stated that the Tennessee Food, Drug and Cosmetic Act which deals with adulterated drugs is
administered by the Department of Agriculture, and that the collection of the medication is not
part of this consent order. Ms. McDaniel asked how many vials have been shipped into
Tennessee. Ms. Young stated that the coordination on the public health end with the collection of
suspect drugs is being handled by the FDA, New England Compounding Center and the
Tennessee Department of Health Epidemiologist. They are trying to determine which product
was contaminated and how many patients were exposed to the product. Ms. Young stated that
she doesn’t believe that an investigation has been started on the pharmaceutical stand point but
that they are trying to complete the investigation as it pertains to the public health, safety and
welfare to the citizens of Tennessee. Ms. McDaniel stated that the reason she was asking about
the number of vials sent into Tennessee is that she is ready to assess a civil penalty to the
pharmacist today. Mr. Smith explained that a civil penalty cannot be assessed today because a
hearing would have to be scheduled and proof shown of the number of contaminated drugs and
the number of victims are not fully known at this time. Mr. Smith stated that Dr. Cadden would
be given the right to present proof of his own, but he cannot submit proof of the revocation of his
license and has no right to appeal this part of the order. Dr. Cadden can submit proof if the board
decides to have a hearing concerning the assessment of penalties. Ms. McDaniel asked Dr. Holt
about the process in which the Board of Pharmacy asses penalties during the regular course of
business through the compliant summary report. Dr. Holt stated that they complainant can appeal
the penalty. Ms. Young states that individuals that have agreed to the assessment of penalties
were due to the negotiation between them, their attorney if they have one, and the Office of
General Counsel and would result to a Consent Order. If the individual chooses not to accept the
Consent Order then the next phase is to file Notice of Charges for a hearing before the board.
Ms. Young stated that with respect to the board of pharmacy, many individuals agree to the
assessment of penalties and do not contest. Ms. McDaniel stated that the board had assessed a
fine on someone and they wanted to negotiate the fine and that this was done before a Consent
Order was issued. Ms. McDaniel stated that during the normal course of a board meeting the
board has assessed the penalty upfront and then we send the Consent Order. Ms. Young stated
that when a complaint has been filed with the board of pharmacy that the complaint is givien to
the board in an anonymous manner with the facts. The board will make a recommendation based
on the facts presented. Once the recommendation has been voted on the Office of General Tennessee Board of Pharmacy
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October 23, 2012
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Counsel will prepare a Consent Order to send to the respondent and the respondent has the right
to sign the Consent Order and pay the penalty or request a hearing. Ms. McDaniel asked why we
cannot assess the penalty today and give Dr. Cadden the right to agree or disagree. Ms. Young
stated that the difference is that we know who the order is for and this was not a normal
complaint that came into the office anonymously. This order was generated by information given
by the media and the general public. Ms. Young also stated that Dr. Cadden has agreed to the
surrender of his license, not a penalty, and that the board cannot assess a penalty at this time. Dr.
Eidson asked about the Food, Drug and Cosmetic Act and that Ms. Young did not think that
these drugs were adulterated but according to T.C.A. § 53-1-108 (1)(A) which states that “A
drug or device shall be deemed to be adulterated if it consists, in whole or in part, of any filthy,
putrid or decomposed substance”. Ms. Young stated that she wouldn’t disagree if the facts were
proven and that we don’t have legal evidence to present at this point. Dr. Eidson stated that he is
concerned that the Department of Agriculture is not involved in the collection of the drugs and
that he would recommend that the Department of Agriculture get involved. Specifically that they
have authority to go get the contaminated drugs. Ms. Young stated that she will take the
recommendation back to Commissioner Dreyzehner concerning the collection of the
contaminated drugs. Dr. Warren stated what she is hearing is that the board wants to make sure
that if there is any contaminated product still out in the general population that it has been
collected, removed from possibility of administration to patients, and tagged for future
investigations. Dr. Eidson stated that this was correct and that they would like to have the
number of contaminated vials that has been collected. Dr. Warren stated that the board would
like to have that number at the November board meeting. Ms. McDaniel stated that she would
still like to recommend a civil penalty. Mr. Smith stated that they can recommend an assessment
of penalty but that the board cannot vote on it. The meeting was sunshined for the surrender of
Dr. Cadden’s Tennessee pharmacist license and the decision before the board is to accept the
Agreed Order or not. After further discussion, Dr. Eidson made the motion to approve the
Agreed Order as presented for the volunteer surrender of Dr. Cadden’s pharmacist license and to
notify the other boards where Dr. Cadden has a valid pharmacist license. Ms. McDaniel
seconded the motion. The motion carried with a roll call vote. Dr. Eidson made the motion to
authorize Dr. Holt to sign the Agreed Order on behalf of the board. Ms. McDaniel seconded the
motion. The motion carried with a roll call vote. Dr. Eidson asked that the board delay the
discussion of assessing civil penalties until additional information has been received pertaining
to the number of vials sent to Tennessee by New England Compounding Center and how many
were contaminated.
Ms. McDaniel made the motion to adjourn at 11:00 a.m. Dr. Eidson seconded the motion. The
motion carried.
The minutes were approved and ratified at the November 14-15, 2012 board meeting.
Source found here