Source: http://www.workerscompzone.com/2011/02/
Timestamp: 2019-04-24 03:52:04+00:00

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As I write this at Super Bowl halftime, the cheeseheads are ascendant.
Like many of you, I’m glued to our yearly ritual.
After today’s game, the players union and the owners still face a standoff over the future of the game. Will players be forced into concessions? More games?
My law partner Michael Gerson represents quite a few NFL players. Our office has seen first hand the physical and mental sacrifices some of these players make.
Even a casual observer of today’s game had to have noticed a number of players going off the field to the locker room after injuries. Charles Woodson is out.
This year there’s been a growing chorus of concern about player injuries, particularly concussions. Players are bigger and evidence is mounting over some of the game’s effects.
That’s the question posed by Ben McGrath, writing in The New Yorker.
It’s a question being raised despite the sport’s incredible popularity. In a piece in today’s San Francisco Chronicle, Al Saracevic muses on whether football will fall out of favor like boxing.
Who doesn’t love a good food fight?
banana cream pie. I’ll never forget the battle of the sloppy joes when there was a power failure at the dining hall my freshman college year.
And who could forget the cinematic food fights in Animal House, The Great Race, and Blazing Saddles?
But now the comp world has its own food fight.
Not an actual gooey slinging fest, mind you. But “food” is at the heart of the struggle. This time the struggle over “medical foods”.
Recently RAND researchers have produced a study for CHSWC (California Commission on Safety, Health and Workers’ Compensation) on compound drugs and medical foods.
It’s likely that the eventual CHSWC report on the issue will be a basis for legislative action.
The RAND study notes that “the issues surrounding compound drugs, medical foods, and co-packs rest on uncertainties regarding whether the products are medically appropriate…”. RAND recommends that “The MTUS should be updated and expanded to address compound drugs as a product class” as well as “the medical appropriateness of medical foods”.
Moreover, the RAND study concludes that “physician-dispensing creates financial incentives that affect use of compound drugs, medical foods, and co-packs”and suggests various legislative or regulatory fixes to control abuse.
But the purveyors of “medical foods” are fighting back.
It appears that Physician Therapeutics has been awarded a $750,000 National Institutes of Health grant from the U.S. government to study medical foods and co-packs as alternatives to some of the side effects of opioids and non-steroidal anti-inflammatories. Apparently the study will focus on medical foods for Gulf war syndrome victims and elderly with sleep disorders.
Wasted money or visionary use of funds by your government under the Patient Protection and Affordable Care Act?
Time will tell whether the research is meritorious or bogus, but the suppliers and providers of medical foods and co-packs appear ready to fight back in the comp system.
The Physician Therapeutics website claims that “all medical food products use “Targeted Cellular Technology” (trademark), “a patented process that allows very small quantities of neurotransmitter precursors to enter the cells and produce specific neurotransmitters”.
This proprietary application of neurotransmitter science is designed to promote the production and release of the neurotransmitters norepinephrine, epinephrine, dopamine, serotonin, acetylcholine, histamine, glutamine and nitric oxide.
The above products are drugs within the meaning of section 201(g) of the Act, [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases. Further, they are “new drugs” within the meaning of section 201(P) of the Act [21 U.S.C. § 321(P)] because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under sections 301 (a) and (d) and 505(a) of the Act [21 U.S.C. §§ 331(a), (d) and 355(a)], a new drug may not be introduced into or delivered for introduction into interstate commerce unless an FDA approved application is in effect for the drug. Based on our information, you do not have any FDA-approved applications on file for these drug products.
Additionally, because the above prescription drug products are intended for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written for them so that a layman can use these products safely for their intended uses, as described in 21 C.F.R. § 201.5. Consequently, their labeling fails to bear adequate directions for their intended uses, causing them to be misbranded under section 502(1)(1) of the Act [21 U.S.C. § 352(1)(1)]. Because the products lack required approved applications, they are not exempt under 21 C.F.R. § 201.115 from the requirements of section 502(1)(1) of the Act. The introduction or delivery for introduction into interstate commerce of these products without approved new drug applications violates sections 301(a) and (d) of the Act [21 U.S.C. §§ 331(a) and (d)].
Further, as explained in the warning letter dated (b)(4) to (b)(4) the above drug products are adulterated under 21 U.S.C. § 351(a)(2)(B), and thus your firm may not introduce or deliver them for introduction into interstate commerce, 21 U.S.C. § 331(a).
The violations cited in this letter are not intended to be an all-inclusive statement of violations that may exist in connection with your products. In particular, violations cited in this letter are not necessarily limited to drug products manufactured by (b)(4) and may apply to all drug products that you market and distribute without FDA-approved applications. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to assure that your film complies with all requirements of federal law and FDA regulations.
You should take prompt action to Correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure, and,’ injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. If you no longer market the above products, your response should so indicate, including the reasons that, and the date on which, you ceased production.
Shell was quoted in workcompcentral.com as saying that “our response to the warning letter took the position that our medical foods are both safe and effective for their intended use, which is as precursors to neurotransmitters and therefore the definition of a drug is “safe and effective for their intended use”.
Further, Shell was quoted as saying that “the issue is whether these are new drugs or old drugs, and since they were grandfathered in in 1962, amino-acid preparations are not a new drug”.
In fairness to both Shell and the FDA, I’ve not seen followup correspondence that my have been generated by the company or regulators. Physician Therapeutics’ website does not provide those details.
When a new AD of the Division of Workers’ Compensation is appointed, the efficacy of “medical foods” and the scientific data thereon can be hashed out as part of an amended MTUS. As part of such a process, medical foods manufacturers may be able to produce their data, presumably data on which the NIH relied in providing significant public research funding.
All of this is a “food fight” that needs to take place in the sunshine of scientific peer review and open public policy analysis.
But Shell did make one point in comments to workcompcentral that may be worth noting. Shell apparently claims that his company was not contacted by the RAND authors of the study performed for CHSWC.
Going forward on these types of studies, it would probably serve the comp community (and CHSWC) well for RAND or other CHSWC study contractors to contact subject “stakeholders” for their input and comment, even if only to “solicit their side of the story” and create an extra appearance of fairness. This has been a problem with a recent study on liens, where many providers claimed that they were not consulted about their perspective on the widely perceived lien problem before a report was generated.

References: § 321
 § 321
 § 201
 § 352
 § 201
 § 351
 § 331