Agriculture, Rural Development, Food And Drug Administration, And Related Agencies Appropriations Act, 2005
Mr. Chairman, will the gentleman yield? Mr. Chairman, I originally had drafted an amendment which would have de-funded a position at the Food and Drug Administration Center for Veterinary Medicine, which funded a bureaucrat for which we…
Mr. Chairman, will the gentleman yield?
Mr. Chairman, I originally had drafted an amendment which would have de-funded a position at the Food and Drug Administration Center for Veterinary Medicine, which funded a bureaucrat for which we have been embattled in trying to protect one of my constituents, a small business located in my district.
I will not be offering that amendment and instead will be engaging in a colloquy with the chairman of the subcommittee, and so I appreciate his yielding to me.
Let me provide the chairman some background, since I know this issue is
fairly new to him, and I want to state the facts for the record here. In my district, I am proud to represent a third generation small family-owned business that manufactures veterinary pharmaceuticals. These are pharmaceutical, drugs, for cows, chickens, and pigs. They found a niche market where there was a monopoly player. They went out to engage in competition with this particular pharmaceutical manufacturer in a certain type of antibiotic for pigs and chickens.
They also found there was a firm in the Kansas City area that held a license for this particular drug. And by the way, this particular antibiotic drug has been approved by the Center for Veterinary Medicine for over 40 years and, as I stated earlier, was already being distributed by a soon-to-be competitor.
Now, this company in Omaha, Nebraska, wrote to the Center for Veterinary Medicine inquiring about the status of that drug and that license and received approval from the FDA to purchase that license and engage in the manufacture and selling of that approved drug. At the appropriate time, Mr. Chairman, I will submit a copy of that letter for the Record, but I will paraphrase here.
Director of the CVM says in this letter regarding that license and that drug, ``You may rely on this letter to verify the approved status of the product.''
That was in about 2002, when they engaged in the manufacture, sale and distribution of this antibiotic. In August of 2003, the FDA, with absolutely no warning, in the rules and regs published the suspension of that license, stating that there was ``confusion about the license,'' which was certainly news to my constituents.
Now, when they asked about the confusion, there was no answer, no clarity provided by the Center for Veterinary Medicine, which left them with one procedural option, which was a hearing. They have still not received that hearing.
Unfortunately, Mr. Chairman, it came to a boiling point this last week when they at last sat down with my constituent. Mr. Sundlof and Mr. Beaulieu, his counsel, sat down, and I will tell you, as reported to me from my constituent and his counsel, it was probably one of the ugliest meetings I have ever heard of from a constituent meeting with a Federal agency and bureaucrats. And, really, it was unacceptable behavior. I will not even mention the phrases and wording that they used because it would violate the House rules.
I felt that probably the best way of dealing with that, since we cannot do anything with bureaucrats that act this way, other than de- fund their positions, was to ask the chairman for some help and some guidance on how to deal with this particular situation; A, the treatment that my constituent received at this meeting, and particularly the problem that he is faced with right now, in having a letter saying you are approved and then a mysterious reversal of that.
So if the chairman has some words of wisdom and guidance for me, I would appreciate it.
Department of Health
& Human Services,
Rockville, MD, December 17, 1998.
Dr. Donald A. Gable,
Manager, Pharmaceutical Regulatory Affairs, Boehringer
Ingelheim Vetmedica, Inc., Elwood, KS.
Dear Dr. Gable: This letter will confirm receipt of your
certification letter dated November 17, 1998, as an amendment
to your letter dated September 18, 1998, sent to CVM in
response to my letter of July 29, 1998. The letter related to
NOPTRACIN' MD-50, (bacitracin methylene
disalicylate) Type A medicated articles which is the subject
of the NADA 141-137.
In accordance with my letter, your certification will be
used along with information in our files as the
administrative record of an approval for NADA 141-137, which
provides for a Type A Medicated Article,
Noptracin' MD-50 (bacitracin methylene
disalicylate) for use for the indications and under the
conditions of use specified in the labeling attached to your
letter.
The agency will begin the work of codifying the approval
via publication in the Federal Register. This task most
likely will be accomplished as part of an action affecting a
number of products currently listed in 21 CFR 558.15. We will
make every effort to bring this process to a conclusion as
rapidly as possible given resource constraints and public
health priorities. In the meantime, you may rely on this
letter to verify the approved status of NADA 141-137.
If you have any questions concerning the agency's position
regarding this NADA and the subject products, please do not
hesitate to call me.
Sincerely yours,
Stephen F. Sundlof, D.V.M., Ph.D.
Director, Center for Veterinary Medicine.
Mr. Chairman, will the gentleman yield?
Mr. Chairman, I appreciate the gentleman yielding me this additional time and the effort he and perhaps the appropriators may extend to see if we can change the dynamic here.
And I might note, Mr. Chairman, that the gentleman from Iowa (Mr. Latham) is also apprised of this situation.