“There are two ways to be fooled. One is to believe what isn't true; the other is to refuse to believe what is true.”
― Søren Kierkegaard
Congress should not be fooled by the recent letter asking it to add office use into section 503A of the DQSA. Click here to view a copy of the letter. Office use compounding is still available under federal law. Congress nor the public should believe any different. It is just that it has to be done by a 503B registered outsourcing facility--one of the major purposes of the DQSA. Is it that compounding pharmacies and the groups that purport to represent them want to have their cake and to eat it to? I think the answer is yes. They want to avoid having to voluntarily register and be subject to an FDA inspection. One might first ask what are they afraid of? Why do they not want the FDA to inspect them? Do they not have the high standards many claim they do? What do they not want their customers and consumers to know about? Are they not willing to improve by allowing an inspection to uncover any flaws? Wouldn't it be great to be a compounding pharmacy who registered, was inpected and passed with flying colors?
Second, what would Congress say to all those compounding facilities that have already voluntarily registered, built new facilities, been FDA inspections, made improvements and are ready and willing to provide office use compounded medications in compliance with the DQSA?
Third, has the DQSA really been in operation long enough to determine whether such an amendment is truly needed.
Next, one might look at what the impact such an amendment would have. If Congress amends the DQSA as this letter suggests, it would be wrong on several levels. Federal law will be turned back to very much like it was pre-NECC outbreak. Congress will not be able to blame or hold the FDA responsible for any future outbreaks at that point. Moreover, organizations that represent these groups will not be able to point the finger at the FDA and say why didn't you do your job. Those days will be over. And finally the industry itself will have to share all the blame.
What about all the possible lives saved and illnesses prevented by the inspections the FDA has accomplished and the violations uncovered since the DQSA was passed? What would Congress say about that.
Congress should also consider all the states who are now on board with the DQSA and who have asked for help in this complex, interstate area. Congress should also consider how many states do not currently allow office use compounding and look at how they are able to operate without allowing it.
Finally, the statements of a few of Congress cannot control the intent of the majority who did not make those statements. Beyond these being individual statements of a few, the limited utility of these statements must be remembered. If the language of the DQSA was challenged in court,
{s}uch statements are likely to be of limited utility:
They would only be probative (if at all) should the statutory language
of the DQSA on this topic be deemed ambiguous. E.g., United States v.
Rojas-Contreras, 474 U.S. 231, 235 (1985).
Even when interpreting ambiguous statutory language, courts generally
give little, if any, weight to individual floor statements by members of
Congress. E.g., Consumer Prod. Saf. Comm’n v. GTE Sylvania, Inc., 447 U.S. 102, 118 (1980).
At least one other compounding bill expressly preserved an ability for
pharmacies to engage in office compounding insofar as consistent with
the law of the pharmacy’s state of domicile. H.R. 3089, 113th Cong. §
2(a)(1)(C) (2013). The DQSA as enacted contains no such preservation
clause.
quoted from NABP presentation found here. The very fact these few statements have limited use in court is the very reason these groups have no choice but to seek an amendment---an amendment that if passed would potentially render the compounding portion of the DQSA meaningless. Is that what Congress and the American public want--another law on the books rendered meaningless!
― Søren Kierkegaard
Congress should not be fooled by the recent letter asking it to add office use into section 503A of the DQSA. Click here to view a copy of the letter. Office use compounding is still available under federal law. Congress nor the public should believe any different. It is just that it has to be done by a 503B registered outsourcing facility--one of the major purposes of the DQSA. Is it that compounding pharmacies and the groups that purport to represent them want to have their cake and to eat it to? I think the answer is yes. They want to avoid having to voluntarily register and be subject to an FDA inspection. One might first ask what are they afraid of? Why do they not want the FDA to inspect them? Do they not have the high standards many claim they do? What do they not want their customers and consumers to know about? Are they not willing to improve by allowing an inspection to uncover any flaws? Wouldn't it be great to be a compounding pharmacy who registered, was inpected and passed with flying colors?
Second, what would Congress say to all those compounding facilities that have already voluntarily registered, built new facilities, been FDA inspections, made improvements and are ready and willing to provide office use compounded medications in compliance with the DQSA?
Third, has the DQSA really been in operation long enough to determine whether such an amendment is truly needed.
Next, one might look at what the impact such an amendment would have. If Congress amends the DQSA as this letter suggests, it would be wrong on several levels. Federal law will be turned back to very much like it was pre-NECC outbreak. Congress will not be able to blame or hold the FDA responsible for any future outbreaks at that point. Moreover, organizations that represent these groups will not be able to point the finger at the FDA and say why didn't you do your job. Those days will be over. And finally the industry itself will have to share all the blame.
What about all the possible lives saved and illnesses prevented by the inspections the FDA has accomplished and the violations uncovered since the DQSA was passed? What would Congress say about that.
Congress should also consider all the states who are now on board with the DQSA and who have asked for help in this complex, interstate area. Congress should also consider how many states do not currently allow office use compounding and look at how they are able to operate without allowing it.
Finally, the statements of a few of Congress cannot control the intent of the majority who did not make those statements. Beyond these being individual statements of a few, the limited utility of these statements must be remembered. If the language of the DQSA was challenged in court,
{s}uch statements are likely to be of limited utility:
They would only be probative (if at all) should the statutory language
of the DQSA on this topic be deemed ambiguous. E.g., United States v.
Rojas-Contreras, 474 U.S. 231, 235 (1985).
Even when interpreting ambiguous statutory language, courts generally
give little, if any, weight to individual floor statements by members of
Congress. E.g., Consumer Prod. Saf. Comm’n v. GTE Sylvania, Inc., 447 U.S. 102, 118 (1980).
At least one other compounding bill expressly preserved an ability for
pharmacies to engage in office compounding insofar as consistent with
the law of the pharmacy’s state of domicile. H.R. 3089, 113th Cong. §
2(a)(1)(C) (2013). The DQSA as enacted contains no such preservation
clause.
quoted from NABP presentation found here. The very fact these few statements have limited use in court is the very reason these groups have no choice but to seek an amendment---an amendment that if passed would potentially render the compounding portion of the DQSA meaningless. Is that what Congress and the American public want--another law on the books rendered meaningless!
6 comments:
Question: Given the current constraints of 503A & 503B, how would a Dermatologist legally order a bottle of compounded Cantharidin for in-office treatment of warts for his patients? How could the pharmacist legally dispense it? The amount of Cantharidin used is so small, it is impractical and not economical to provide this medication on a per-patient unit-dose basis. Also, Cantharidin, while a widely accepted treatment option by Dermatologists, is extremely caustic and would be best for the patient not to handle medication for their own safety.
Cantharidin should not be used to treat common warts due to paradoxical spread. The agent was proposed for the bulks list under the original FDAMA, and dermatologists recommend use for molluskum. There are important safety concerns with the active that require in-office application, and crystals are available for patient-specific in-office compounding. Even better if a drug company would sponsor development--I believe there are a few products that are patented and commercialized, but somehow avoiding the approval process (the non-self-insured may not be covered for unapproved drug use). Here's a great Pediatric Annals case challenge which includes a preliminary benefit-risk review:
http://www.childrensmercy.org/Content/uploadedFiles/Departments/Contact_Center/Referral_Forms/Dermatology/Mulluscum%20Contagiosum%20Cantharone%20Article.pdf?origin=publication_detail
Need to underscore VERY preliminary (limited) benefit-risk assessment--I'm not sure the cancer signal from animal studies has been adequately vetted re mitochondrial damage--doctors may not be following patients long enough or in enough numbers to observe/identify through clinical observation alone.
See:
http://cancerres.aacrjournals.org/content/32/7/1463.full.pdf
OK. I will try a different example to make it more clear, this time with something that clearly needs to be administered by a practitioner and has widely accepted medical use. Acyclovir injection. ASHP has it listed on short, they list other presentations available, but in my experience - if a medication is on the ASHP drug shortage list there are state or regional shortages of the medication. Given the current constraints of 503A & 503B, how is a practitioner to order and a pharmacy to supply this medication? Note: in some medical conditions, there is NO substitute for acyclovir.
I believe this is what the 503B registration was intended for if the drug is experiencing an FDA listed shortage. The trade off in risk might not be justified if produced outside GMPs, because the bulk active may be the issue for the shortage. Remember when compounding pharmacies had on their shelves grepafloxacin mislabeled as norfloxacin and it was not readily detected...
You are correct, however, 503Bs can only compounded items that a) appear on the _FDA_ drug shortage list OR b) appear on a list of approved APIs for compounding by the FDA. Since b) does not exist and we don't know when it will & acyclovir is NOT on the FDA drug shortage list, where does that leave the practitioner. Or, more importantly, the patient? And the mislabeled issue, I believe, came from an FDA registered manufacturer (unless you have a link to prove otherwise).
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