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Legal Aspects of Building an Age Management Practice
This home-study segment covers selected aspects of practice, unique
to age management medicine (AMM). The material assumes you have an
understanding of legal requirements for traditional medical
practice—and will seek legal counsel, regarding any issues
concerning individual practices and legal issues specific to them.
For the purpose of our discussion, let’s first establish a
definition for AMM: It is a proactive, preventative approach to
healthcare for an aging population, which is focused on preservation
of optimum human function and quality of life, making every effort
to modulate the process of aging prior to the onset of degenerative
aging.
The basic tenets of AMM are patient evaluation through extensive
medical history, lifestyle assessment, physical examination and
laboratory evaluation to establish personalized proactive treatment
plans. These proactive programs consist of proper diet, exercise,
stress management and appropriate medical interventions.
Unique aspects of the specialty exists:
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AMM is proactive—patients are not necessarily “sick”
-
AMM has a greater use of dietary supplements and
alternative medicines than a traditional reactive practice
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AMM seeks balanced hormones, using estrogens,
androgens and human growth hormone (“hGH” or “somatatropin”), when
GHD has been established
Laws Governing hGH (Somatatropin)
Strict regulations mandate how hGH can be prescribed, manufactured,
distributed and sold. Therefore, it is critical for physicians to
acknowledge, understand and adhere to these laws.
Food Drug and Cosmetic Act
(FDCA) sanctions the FDA, giving it broad authority to oversee the
efficacy and safety of drugs. Two broad categories of offenses exist
under the FDCA:
(i)
Adulteration and
(ii)
Misbranding 21 U.S.C. §331
Normally, the FDA does not oversee physicians or the practice of
medicine. However, since hGH is highly regulated by the FDA and the
Drug Enforcement Administration (DEA), the FDA has been scrutinizing
and investigating physicians for acts related to hGH.
Legal Context of Growth Hormone Laws
With a unique status under the FDCA, hGH is the only drug having
off-label distribution expressly forbidden.
In fact, off-label
distribution is a federal felony. And it is the only
noncontrolled substance for which the DEA has been granted
jurisdiction.
DOJ
hGH/Steroids Statutory Overview
FDCA: Definition &
Prohibited Distribution of hGH
As used in the FDCA, “the term ‘human growth hormone’ means somatrem,
somatropin, or an analogue of either of them.”
21 U.S.C.
§333(e)(4)
The following prohibitions state
distribution parameters:
[W]hoever knowingly distributes, or possesses with intent to
distribute, human growth hormone
for any use in humans other than the treatment of a disease or other
recognized medical condition, where such use has been authorized by
the Secretary of Health and Human Services under section 505 and
pursuant to the order of a physician, is guilty of an offense punishable by not more than 5 years
in prison.
21 U.S.C. §333(e)(1)
Whoever commits any offense set forth in paragraph (1) [illegal
distribution of human growth hormone] and such offense involves an individual under 18 years of age is punishable by not more
than 10 years imprisonment, such fines as are authorized by title 18, United States Code,
or both.
21 U.S.C. §333(e)(2)
It should be noted that hGH is the only noncontrolled substance,
which expressly warrants the same penalties as violation of the
Federal Controlled Substances Act:
Illegal distribution of hGH is
considered a felony
violation of the Federal Controlled Substances Act for the purposes
of forfeiture.
21 U.S.C. §333(e)(3)
Also, hGH is the only noncontrolled substance over which the DEA has
jurisdiction: The Drug Enforcement Administration is authorized to
investigate offenses punishable by this subsection.
21 U.S.C.
§333(e)(4)& (5)
Prohibited hGH
Distribution: Elements of an Offense
Under 21 U.S.C. §333, the elements of the criminal offense are
stated as . .
-
Knowingly
-
Distributes (or possesses with intent to distribute)
-
For any use other than
-
The treatment of a disease or other recognized medical
condition, where such use has been authorized by the Secretary of
Health and Human Services under section 505 (i.e., and indicated
use) and
-
Pursuant to the order of a physician
An examination of each element gives further insight as to what each
part embodies.
Knowingly—the mens rea (guilty mind) or criminal
intent. The term "knowingly" or "knew" means a person with respect
to information has actual knowledge of the information, or acts in
deliberate ignorance or reckless disregard of the truth or falsity
of the information.
21 U.S.C. 321(bb)
Distributes (or possesses with intent to distribute)—no
definition of “distribute” exists in the statute, but FDA
regulations define “distribute” as a means to sell, offer to sell,
deliver, or offer to deliver a drug to a recipient, except that the
term “distribute” does not include, per
21 U.S.C. § 203.3(h):
-
Delivering or offering to deliver a drug by a common
carrier in the usual course of business as a common carrier; or
-
Providing of a drug sample to a patient by: (i) A practitioner licensed to prescribe such drug; (ii) A health care professional acting at the direction and under
the supervision of such a practitioner; or (iii) The pharmacy of a hospital or of another health care entity
that is acting at the direction of such a practitioner and that
received such sample in accordance with the act and regulations
For any use other than—the treatment of a disease or
other recognized medical condition, where such use has been
authorized by the Secretary of Health and Human Services
under section 505 (i.e. an indicated use) and pursuant to
the order of a physician. The FDA appears to interpret this element
to mean no off-label use.
Department of Justice: Prohibited hGH Distribution
The Department of Justice (DOJ) has practical considerations for
prosecution.
Since section 333(f)(1) allows physicians to distribute hGH in
connection with either (1) “treatment of a disease” or (2) “other
recognized medical condition,” which has been authorized by the
Secretary of Human Services,
additional evidence is necessary to prove that a physician is a
drug dealer. Obtaining such evidence can be difficult.
Consideration should be given to attempting “controlled buys” using
undercover agents or informants.
The DOJ “Practical Considerations” . . .
Often, both search warrants and grand jury subpoenas for the
physician’s medical files will be utilized. Of course, in so doing,
care must be given to protect the bona fide privacy interests of any
legitimate patients the physician might have.
According to the DOJ Civil Resource Manual for Human Growth Hormone
and/Steroids there are unanswered questions:
-
Can the writing of a prescription for hGH be
considered distributing?
-
Considering that §333(e)(1) requires distribution for
only FDA approved uses and “pursuant to the order of a
physician,” how would this latter phrase be considered when
prosecuting a physician who would be the one writing the order?
And with regards to the FDCA and prohibited hGH distribution,
this question is unanswered: Can the writing of a prescription
for hGH for an off-label use be considered aiding, abetting,
conspiring or otherwise assisting with the unlawful distribution of
hGH?
FDA Communication About hGH
The following excerpts are from
a memo by Mark W. Askine—Regulatory Operations Officer—sent to
California Pharmacists Association on August 11, 2005. Mr. Askine
worked in the Division of New Drugs and Labeling Compliance, Office
of Compliance Center for Drug Evaluation and Research, FDA.
FDA is aware that hGH is increasingly being used by
individuals for anti-aging or athletic purposes. Although it
appears that many individuals are obtaining hGH for these
purposes without help from physicians or other healthcare providers,
others obtain hGH prescriptions, or the drug itself, directly from
doctors. Some physicians operate or are associated with
anti-aging clinics that provide hGH products and heavily promote use
of hGH for this purpose.
FDA has a long-standing policy generally not to interfere with
the practice of medicine,
which includes a physician’s prescription of an FDA-approved drug
for an off-label use. However,
specific laws apply to hGH . . . Under section 303(e) of the Federal
Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C. § 333(e)), it is a
crime to knowingly distribute, or possess with intent to distribute,
human growth hormone “for any use in humans other than the treatment
of a disease or other recognized medical condition where such use
has been authorized [under a new drug application approved by the
FDA] and pursuant to the order of a physician.”
This hGH provision . . . does not differentiate between
physicians and non-physicians, or between pharmacists and
non-pharmacists. Violation of
the law is punishable by up to five years in prison, or ten years if
the offense involves a minor, and fines (up to $250,000 for an
individual or $500,000 for an organization, or twice the gross gain
or loss from the offense).
FDA Warning Letter to Genentech
On August 25, 2003, the FDA sent a warning letter to Genentech, Inc.
for circulating promotional material, which stated indications for
hGH, but failed to mention the risks of somatropin. Although the
letter did not accuse Genentech of using hGH for off-label purposes,
the FDA opined on the indicated use and diagnostic criteria.
Nutropin and Nutropin AQ are also approved for the replacement of
endogenous GH in adult patients with GH deficiency who meet two
criteria:
-
Biochemical diagnosis of adult GH deficiency by means of a
subnormal response to a standard growth hormone stimulation test
(peak GH < 5 µg/L); and,
-
Adult-onset patients who have
adult GH deficiency either alone or with multiple hormone
deficiencies (hypopituitarism) as a result of pituitary disease,
hypothalamic disease, surgery, radiation therapy, or trauma or
childhood-onset patients who were GH deficient during childhood,
confirmed as an adult before replacement therapy with Nutropin
is started.
Manufacturer’s Prescribing Information: Indicated Uses for Adults
Humatrope (Lilly)
Adult Patients—Humatrope is indicated for replacement
of endogenous growth hormone in adults with growth hormone
deficiency who meet either of the following two criteria:
-
Adult Onset: Patients who have growth hormone deficiency
either alone or with multiple hormone deficiencies
(hypopituitarism), as a result of pituitary disease,
hypothalamic disease, surgery, radiation, therapy or trauma.
-
Childhood Onset:
Patients who were growth hormone-deficient during childhood who
have growth hormone deficiency confirmed as an adult before
replacement therapy with Humatrope is started.
Nutropin (Genentech)
Adult Patients—Nutropin® [somatropin (rDNA origin) for
injection] is indicated for the replacement of endogenous growth
hormone in adults with growth hormone deficiency who meet either of
the following two criteria:
-
Adult Onset: Patients who have adult growth hormone
deficiency, either alone or associated with multiple hormone
deficiencies (hypopituitarism), as a result of pituitary
disease, hypothalamic disease, surgery, radiation therapy, or
trauma; or
-
Childhood Onset:
Patients who were growth hormone deficient during childhood as a
result of congenital, genetic, acquired, or idiopathic causes.
In general, confirmation of the
diagnosis of adult growth hormone deficiency in both groups
usually requires an
appropriate growth hormone stimulation test.
However, confirmatory growth hormone stimulation testing may
not be required in patients with congenital/genetic growth hormone
deficiency or multiple pituitary hormone deficiencies due to organic
disease.
Saizen (Serono)
Adult Patients—Saizen is indicated for replacement of
endogenous growth hormone in adults with growth hormone deficiency
who meet either of the following two criteria:
-
Adult Onset: Patients who have growth hormone deficiency
either alone, or associated with multiple hormone deficiencies
(hypopituitarism), as a result of pituitary disease,
hypothalamic disease, surgery, radiation therapy, or trauma; or
-
Childhood Onset: Patients who were growth hormone
deficient during childhood who have growth hormone deficiency
confirmed as an adult before replacement therapy with Saizen is
started.
In both of these patient populations, growth hormone
deficiency should be confirmed by an appropriate growth
hormone stimulation test.
FDA Enforcement Actions
The FDA enforces its aggressive initiative to “improve the health of
consumers by providing them with scientifically accurate,
FDA-approved information about the health effects of foods and
dietary supplements” as well as expose “false health claims that
mislead Americans, endanger their health” fighting against “false
and misleading health claims on all regulated products.”
Cases in point . . .
A physician in Reno, Nevada, indicted for allegedly selling hGH.
Below are the allegations against him:
The physician sold “Bio-tropin” to an FDA agent who
said he previously had a tumor removed from his lung and that he did
not feel like he was 25 years old any more
Indictment in
United States v. Forsythe (number 03:06:CR147-BES-VPC) U.S.
Dist. Court for Nevada
DOJ Press
Release from U.S. Attorney, District of Nevada
Read the DOJ
Press Release from U.S. Attorney, District of Nevada.
The owner of Genapharm, Inc. pled guilty to criminal charges for
counterfeiting hGH and for selling drugs directly to
consumers including counterfeit Nutropin AQ.
On February 18, 2004, the FDA issued a warning letter to Tony Stires
at Global Internet Alliance for selling “T-10 hGH” for
anti-aging. The alleged anti-aging claims in the letter included . .
.
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hGH restores muscle mass
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hGH decreases body fat
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hGH increases sexual function
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hGH thickens the skin, reducing wrinkles
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hGH restores lost hair
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hGH improves cholesterol profile
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hGH improves vision
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hGH improves memory; and
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hGH elevates mood and improves sleep
The FDA also issued a warning letter to Cocoon Nutrition for selling
“GH-Liquid Spray Growth-600 ng (growth hormone)” over the Internet.
Also, the FDA issued a warning to “AffordableHGH.com” for selling
hGH and making statements that “fountain of youth flows from needle”
and “human growth hormone therapy is one of the most promising
anti-aging treatments.”
Focus of FDA Investigations
Rising political pressures resulting from scandals in sports have
led to more investigations for hGH. The factors appearing to be
relevant for FDA prosecutions:
-
The person
prosecuted sells or assists in selling hGH
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Most patients who ask
for hGH obtain a prescription or the drug directly
-
There is little if
any documentation of exams, labs and other medical records
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hGH is sold without a
prescription
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Clear wrongdoing that makes
it easy to obtain a conviction from a jury
Only FDA Approved hGH Products Should be Prescribed
Although physicians do not generally dispense drugs, they play a
role in making sure the proper products are dispensed. If physicians
sell hGH—which is an
ill-advised and risky practice—they should
only sell FDA approved products.
The Orange Book
The only lawful US products are listed in the Orange Book—Food
And Drug Administration Center for Drug Evaluation and Research
Approved Drug Products with Therapeutic Equivalents. The
Orange Book lists the name of the “applicant” that filed the
new drug application, not necessarily the company selling the
product. There may be a difference between the names on this chart
and the entity marketing the products.
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Nutropin (Genenteh)
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Humatrope (Lily)
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Norditropin (Novo
Nordisk)
-
Genotropin
(Pharmacia Upjohn)
-
Omnitrope (Sandoz)
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Tev-Tropin (Ferring/Teva)
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Serostim (Serono)
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Saizen (Serono)
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Zorbtive (Serono)
There are no generic forms of hGH are available.
-
“A” products in the
Orange Book are
those for which actual or potential bioequivalence problems have
been resolved with adequate in vivo and/or in vitro
evidence supporting bioequivalence
-
“B” products in the
Orange Book are
those the FDA considers not to be therapeutically equivalent
to other pharmaceutically equivalent products
The hGH products listed in the Orange Book are all “B”
drugs, which means the FDA considers them not to be therapeutically
equivalent to other pharmaceutically equivalent products.
State laws only permit substitution of drugs listed as “A” drugs in
the
Orange Book.
NOTE:
Write prescriptions “Dispense as Written” to
ensure no substitution of “generic.”
Know The Risks: Prescribing hGH from Unregistered Facility
If a physician has reason to believe an hGH product dispensed by a
pharmacy comes from an unregistered facility, the physician faces
additional legal risk, including potential malpractice risk if the
product is contaminated.
Even if a physician monitors hGH levels and finds them to be
acceptable, a product from an unregistered manufacturer may contain
undetected contaminants. The fact is hGH is one of the most
frequently compounds seized by customs—hGH products from China and
Australia have been seized and placed on the FDA/customs import
detention list because they are unapproved drugs.
The risks are clear and far-reaching . . .
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Potential AMA Code of Ethics violation AMA Code of Medical Ethics states that a physician places the safety
and interests of patients above all other interests.
AMA
Code of Medical Ethics (1998 AMA Doc. #1, p.5 §8.03)
A physician has a duty to obtain informed consent and a duty to warn
about risks associated with medication or treatments.
AMA Code of Ethics
§8.08
A physician should not refer a patient unless the
physician is confident the services provide will be performed
competently and in accordance with scientific and legal standards.
AMA
Code of Ethics at §3.04
-
AMA Code of Ethics considerations
If a physician is prescribing hGH from pharmacies that do not
dispense FDA approved products, the physician could violate the Code
of Ethics unless the patient is warned that (1) the product may come
from foreign countries and (2) may not be manufactured in accordance
with FDA standards.
-
Violation of AMA Code of Ethics could lead to (1)
additional evidence of negligence in a malpractice claim arising
from contaminated hGH; (2) grounds for disciplinary action by state
licensing board.
Compliance: Steps to take
-
Do not prescribe for anti-aging or for any other
off-label use
-
Do not sell hGH—let patients buy hGH from a licensed
pharmacy
-
Prescribe hGH that is FDA approved
-
Conduct thorough history and physical examination and
order appropriate lab tests
-
Document all signs, symptoms, and test results that
form the clinical basis for the diagnosis of GHD
-
Conduct thorough follow up
-
Do not prescribe to athletes
Prescribing Testosterone: Controlled Substances Acts
Both state and federal laws apply and must be followed. Individuals
who prescribe or dispenses controlled substances must have two
registrations.
A federal registration issued by the DEA: Recent change to DEA
regulations requires physicians who prescribe from offices in more
than one state to obtain separate DEA registrations for each state.
A state registration or license: The state license might simply be a
license to practice medicine or separate state controlled substances
license.
Federal Law: Prescribing Testosterone
The 1990 Anabolic Steroids Control Act classified anabolic steroids
as Schedule III. Then in 2004, Congress amended the Act in light of
the ongoing issues surrounding professional athletes. The 2004 Act
directed the United States Sentencing Commission to reevaluate the
criminal sentencing guidelines for illegal use of anabolic steroids.
Subsequently, the Steroids Working Group of the United States
Sentencing Commission issued the
2006 Steroids Report,
which provides details of the law governing steroids
Anabolic steroids, including testosterone and some 50 related
compounds, are classified as Schedule III controlled substances.
21 USC § 802
DEA regulations mandate that controlled substances be issued for a
“legitimate medical purpose.”
21 CFR § 1306.04
Additionally, if a prescription is not for a legitimate
medical purpose, the prescriber is subject to the criminal
penalties under the Controlled Substances Act.
The key question for prescribers is: What does “legitimate
medical purpose” mean? Courts interpret the meaning of “legitimate
medical purpose in this way: When
a law and implementing regulations do not specifically define
terms, they should be given their “ordinary meaning.”
e.g., Asgrow Seed Co. v. Winterboer,
513 U.S. 179, 187 (1995)
The US Supreme Court unanimously held that physicians violate the
Controlled Substances Act “when their activities fall outside the
usual course of professional practice.”
United States v. Moore,
423 U.S. 122 (1975)
A recent US Supreme Court decision indicates a state standard
applies to determining whether a CS prescription is for a legitimate
medical purpose.
Gonzales v. Oregon. The Bush administration asserted that
Oregon’s Death with Dignity Act violated the federal CSA because
using drugs to end life cannot be a legitimate medical purpose.
In Gonzales v. Oregon, the Court concluded the CSA does not
allow the
Attorney General to prohibit doctors from prescribing regulated
drugs for use in physician-assisted suicide under state law
permitting the procedure.
In a 2004 case, the Supreme Court reiterated the fact that the
regulating the practice of medicine is left to the states. “The
statute and our case law amply support the conclusion that Congress
regulates medical practice insofar as it bars doctors form using
their prescription-writing powers as a means to engage in illicit
drug dealing and trafficking as conventionally understood. Beyond
this, however, the [CSA] statute manifests no intent to regulate the
practice of medicine generally.”
Gonzales v. Raich
State Law: Prescribing Testosterone
Some states regulate anabolic steroids more strictly than the
federal CSA. Physicians must consult with legal counsel who
understands the interplay between federal and state laws and who
understands where laws regulating steroids and hGH can be found.
Here are some examples:
Utah law states that a license can be sanctioned by prescribing
“anabolic steroids for the purpose of manipulating human hormonal
structure so as to (A) increase muscle mass, strength or weight
without medical necessity and without a written prescription by any
practitioner in the course of professional practice; or (B) improve
performance in any form of human exercise, sport or game.”
Utah Code Ann. §
58-37-6(4) (a)(viii)
Oklahoma law states: “A valid medical purpose for the use of
anabolic steroids or human growth hormones shall not include
bodybuilding, muscle enhancement or increasing muscle bulk or
strength of a person who is in good health . . .”
Violation of this section is a felony punishable by three years
imprisonment in the State Penitentiary.
63 Okl. St. § 2-312.1
Compliance: Steps to Laws Governing Testosterone
Here are the prime points of focus:
-
Obtain all state and federal licenses and registration
and keep them current
-
Know the red flags: In an AMM practice, where patients
are likely to be middle aged or older, prescribing testosterone for
young individuals will raise a red flag
-
DO NOT PRESCRIBE TESTOSTERONE FOR ATHLETES
-
Conduct a thorough physical and tests and prescribe
testosterone only for individuals who manifest clinical signs and
symptoms of deficiency
Federal Trade Commission Act: Concerns About Promotions to the
Elderly
The directive of the Federal Trade Commission (FTS) is to prevent
unfair competition and to protect consumers from unfair or deceptive
acts or practices. The FTC has authority to protect consumers by
enforcement authority under some 40 statutes.
Statutes
Enforced by FTC
The Federal Trade Commission Act created the FTC in 1914 and is the
primary source of the FTC’s authority.
FTC Act at the FTC website 15 U.S.C. §§ 41-45
The FTC has used its authority to take legal action against some who
have claimed certain products would stop or reverse the aging
process, cause weight loss, increase muscle, regrow hair and remove
wrinkles.
A claim or practice is deceptive if:
(i) it is likely to mislead consumers acting reasonably under the
circumstances; and
(ii) is material, that is, likely to affect consumers’ conduct or
decisions with respect to the product.
A practice is unfair if the injury to consumers it causes or is
likely to cause:
(i) is substantial;
(ii) is not outweighed by countervailing benefits to consumers or to
competition; and is not reasonably avoidable by consumers
themselves.
15
U.S.C § 45(a)
The US Government has conducted several studies to evaluate
“anti-aging” products and medical practices. In 2001, the GAO issued
a Report to the Chairman, Special Committee on Aging, U.S. Senate:
Health
Products for Seniors: “Anti-Aging” Products Pose Potential for
Physical and Economic Harm
Federal Concerns: “Anti-Aging” Products & Practices
Practitioners engaged in AMM should read the GAO Report to
understand what products and practices the government is concerned
about.
See also
Reisman, N.R., Legal Issues Associated with Current and Future
Practice of Anti-Aging Medicine, Journal of Gerontology,
vol 59A, 7, 674-681(expressing concern about fraud
and FTC prosecution in age management practice).
The GAO report listed “Herbal and Specialty Supplements” with known
adverse effects and contraindications. The examples include the
following, among many others:
-
DHEA
-
Kava Kava
-
Ginkgo biloba
The GAO Report listed FDA actions against entities marketing
products. Some examples include . . .
· Cholestin (“red yeast rice”) imported by Pharmanex and
determined to be illegal new drug and not a dietary supplement
· Various products distributed Hillestad®
Pharmaceuticals (e.g., ginkgo biloba and St. John’s wort) contained
unlawful disease claims; court ordered company to change the claims
in catalogues and on the website
The GAO Report listed FTC actions against companies with illegal
advertising. For example . . .
·
Action against Maxcell Bioscience, Inc. for making
anti-aging claims for “Longevity Signal Formula with DHEA” and for
“Anabolic/Catabolic Test;” company was ordered to stop making claims
and to pay consumers $150,000
FTC & FDA: Concurrent Jurisdiction
Often the FDA and FTC have overlapping jurisdiction. The FTC
investigates drug advertising and dietary supplements.
FTC: FTC Targets Bogus Anti-Aging Claims for Pills and Sprays
Promising Human Growth Hormone Benefits ($20 Million Fine).
Two Florida businesses have agreed to a federal court order
requiring them to pay up to $20 million in consumer redress—the
largest monetary judgment ever obtained in an FTC health fraud
case—to settle charges that they deceptively claimed that
their pills and sprays would increase consumers’ human growth
hormone (hGH) levels and provide anti-aging benefits,
including weight loss and increased cognitive function. In addition,
the Commission has issued warning letters to more than 90 Internet
marketers making similar claims.
FTC Press Release June
9, 2005
FTC Press release, January 4, 2007.
“FTC Recovers $25 Million to Settle Allegations of deceptive
Marketing for Xenadrine EFX, CortiSlim, TrimSpa, and One-A-Day
WeightSmart.”
The FTC’s complaint alleged defendants made false or
unsubstantiated claims for rapid and substantial weight loss. The
complaint alleged that one study, however, subjects taking product
lost an average of only 1.5 pounds over 10 weeks, while a placebo
control group lost an average of 2.5 pounds.
State Consumer Protection Laws
Each state has an unfair trade practice act or consumer protection
act similar to the FTC Act. These laws, like the FTC Act, are
intended to prevent false or misleading claims.
Here are some examples of state claims for unfair trade practices:
· Plaintiff stated a valid claim for deceptive trade
practice by alleging in vitro fertilization advertisements
contained misrepresentations about success rates. Karlin v. IVF
America, 690
N.Y.S.2d 495, 712 N.E.2d 662 (1999)
· Plaintiff stated a claim under consumer protection act
when pharmacy advertised a drug interaction detection system that
did not catch an error.
Arbor Drugs, Inc.,
544 N.W.2d 727 (Ct. App. Mich. 1996)
The next potential step: In these types of scenarios, one can
imagine a creative attorney crafting a claim for unfair trade
practices when a patient doesn’t feel younger after receiving
treatment from an AMM clinic.
Federal Concerns: “Anti-Aging” Products & Practices
There are practice implications you need to be cognizant of, such as
making sure any products prescribed, sold or recommended are from
reliable companies that comply with all laws. For dietary
supplements, make sure products are not making therapeutic claims.
Also, be certain the dietary supplement actually contains the active
ingredient.
To avoid claims of deception, understand the distinction between
disease claims and permitted structure function claims.
FDA Guidance–
Substantiation for Dietary Supplement Claims
Realize that liability risk increases substantially if products not
complying with federal and state laws are prescribed. Prevent harm
to patients from useless or harmful products.
Risks: Profiting from Labs & Drugs
Read the AMA Principles of
Medical Ethics § 8.09:
“Under no circumstances may physicians place their own
financial interests above the welfare of their patients. . . . For
a physician unnecessarily to . . . prescribe a drug . . . for the
physician’s financial benefit is unethical.”
Violations of ethical standards can lead to disciplinary actions by
medical licensing boards or civil penalties. In Utah, it is
considered unprofessional conduct to violate “any generally accepted
professional or ethical standard applicable to an occupation or
profession.”
Utah Code Ann. § 58-1-501(2)(b)
New York defines professional misconduct as:
“Exercising undue influence on the patient, including the promotion
of the sale of services, goods, appliances, or drugs in such manner
as to exploit the patient for the financial gain of the licensee or
of a third party.”
N.Y. Art. 131-A § 6530(17)
The central theme of these types of laws and the AMA Ethics Code is
that exploiting the physician-patient relationship for personal gain
is frowned upon. Physicians profiting directly from prescriptions or
lab work comes too close to this type of behavior and should avoid
such behavior.
It is ill advised for physicians engaged in AMM practices to
increase profits by marking up prescriptions or laboratory work. If
a physician earns extra money by prescribing and/or dispensing
certain drugs, the physician has an incentive to place his or her
financial interests above the patient’s welfare. At the least, this
arrangement creates the appearance of impropriety.
Addressing Medicare
Typically, AMM practices do not accept insurance or Medicare since
many AMM services are not covered. The fact is coverage
determinations can be tricky, uncertain and time consuming.
The quandary: How does a physician deal with Medicare patients when
the physician accepts Medicare? Medicare does not cover many AMM
services; therefore, a physician would bill the patient for such
non-covered services.
Many tests and labs are covered by Medicare. These labs might not be
covered, if the reason for the labs is related to AMM.
For covered services, a physician must bill Medicare and only
collect the applicable co-payment from the patient.
A physician may opt out of Medicare and may then charge the patient
for services that would otherwise be covered. By opting out, the
physician cannot bill for any Medicare beneficiaries (other than
limited circumstances).
For services not covered by Medicare, a physician can provide the
services and charge the patient.
Program Memorandum (Carriers)
HCFA Pub. 60B, Transmittal No. B-97, January 1, 1998
A problem arises when it is unclear whether a service is covered.
If a physician submits a bill for labs that are not covered (because
they are for non-covered age management services), there is a risk
the bill constitutes a false claim and could trigger a claim under
the federal False Claims Act.
31 U.S.C.
§3729 et seq
Under the False Claims Act, a provider may have to pay a penalty of
$5,500 to $11,000 per claim plus triple damages—the results can be
catastrophic. One solution might be for physicians to practice for two clinics. One clinic would
accept Medicare and would be able to bill Medicare for covered
services, such as treatment of specific diseases. Meanwhile, the
other—the AMM clinic—would not accept Medicare (i.e. the clinic and
providers who work there would opt out of Medicare).
If a physician chooses the dual clinic option, it’s essential to
obtain advice of counsel, regarding the following:
·
Must have 2 different tax IDs
·
Must be separate legal entity
·
Must understand tax consequences
· Must understand CMS’s position to make sure the dual
clinic approach is proper under its current interpretation of the
law
Other Legal Considerations
Numerous additional elements must be examined, such as risks from
failed patient expectations; fraud (misrepresenting results of
physical exams and labs to pressure patients into additional
therapy); product liability based on selling drugs or endorsing a
particular product; agency issues (negligence or claims based on
employees and related workers), etc
Reisman, N.R.,
Legal Issues Associated with Current and Future Practice of
Anti-Aging Medicine, Journal of Gerontology, 2004, vol 59A, 7,
674-681
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