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Paras Lunagariya
Northeastern University
RGA 6203 Pharma and Medical Device Law
Prof. Christopher T. Fulmer
Final Paper
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Introduction
The term "off-label use" of a prescription drug refers to the use of a drug for a purpose other than
what regulatory authorities first licensed it for. A medicine must pass extensive testing before
regulatory bodies like the U.S. Food and medicine Administration (FDA) approve it to verify its
safety and effectiveness for a given ailment or indication. Healthcare professionals may,
however, lawfully prescribe a medicine for unapproved purposes once it has received approval
for a specified indication. Their professional judgment and evaluation of the relevant data form
the basis of this practice. When a medicine shows promise in treating a different ailment or when
there are no approved therapies for a certain condition, off-label usage may take place.
It's significant to remember that, despite being legal, off-label usage can include certain hazards.
The data supporting the drug's effectiveness and safety may be restricted since it hasn't been
subjected to the same amount of examination for the off-label application. Furthermore, the dose
and administration instructions could not follow the authorized indication, which could raise the
risk of negative consequences. Despite these dangers, off-label usage occasionally offers
beneficial therapeutic choices, especially when there are few other options available. Before
deciding to use a medication off-label, healthcare professionals must carefully assess the
advantages and hazards. They must also educate patients of the prescription's off-label status and
seek their informed permission.
When prescribing a drug for its approved use, healthcare professionals must ensure the
following:
1.
Regulatory organizations like the FDA have thoroughly assessed and decided on the risks
and advantages of taking the medicine for that approved application.
2.
The choice to take the medication is backed by solid scientific evidence, which includes
proof from research and clinical trials.
3.
Healthcare personnel are educated about the safe and efficient ways to utilize medicine
for allowed use, in accordance with the recommendations and instructions provided on
the labeling of an approved drug.
The approved drug labeling contains key details that healthcare professionals should be aware of
and disclose to patients. These details include:
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1.
The ailments and disorders that the medicine has been authorized to treat. Healthcare
practitioners can better comprehend the right indications for the drug's prescription with
the use of this information.
2.
Instructions for using the medication to treat ailments and diseases that have been
authorized. This contains details about the dose, frequency, administration method, and
any essential safety measures.
3.
Detailed information about the possible hazards posed by the medicine, including side
effects already known to the user, drug interactions, limitations, and cautions. This makes
it possible for medical practitioners to make wise choices and adequately monitor
patients.
4.
Information that people should get from healthcare professionals before beginning
the medication. This can entail informing the patient of the prospective advantages,
hazards, and alternatives and getting their informed permission.
A drug is used off-label when it is used in a way that is not intended by the manufacturer. This
statement might suggest that the material is
1.
Treating a different disease or medical condition than the one for which it was initially
approved: A medication may be given to treat a different disease or medical condition.
For instance, if there is evidence to support its efficacy, a drug that has been licensed for
the treatment of one form of cancer may be used off-label to treat another type of cancer.
2.
Different route of administration: Although a medicine may be licensed for one form or
route of administration (such as a capsule), a healthcare practitioner may nonetheless
recommend it for a patient in a different form (such as an oral solution) depending on
their individual requirements or preferences.
3.
Various dosages: When a medicine is prescribed "off-label," a different dosage than what
is specified on the authorized labeling may be used. This may happen if medical
practitioners decide that a particular patient's condition would be better served by a
higher or lower dose.
Off-label use occurs when a medicine is used in a way that is not expressly authorized by
regulatory bodies and is not disclosed on the drug's label. Pharmaceutical corporations are not
allowed to promote or advertise products for off-label applications, even if healthcare
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practitioners are allowed to administer medications off-label based on their medical judgment. In
the US, the Federal Food, medication, and Cosmetic Act (FDCA) governs medication marketing
and promotion. It forbids pharmaceutical firms from endorsing medicines for use that the FDA
has not authorized. The FDA's approval procedure entails assessing a drug's effectiveness and
safety for a certain indication.
Purpose
To protect patient safety, advance evidence-based medicine, and uphold the integrity of the
regulatory approval process for medications, off-label usage is regulated, and off-label
advertising is prohibited. The main goals are as follows:
1.
Patient Safety: Controlling off-label usage helps shield patients from the hazards that
might result from utilizing drugs in ways that are not authorized. Regulatory authorities
seek to reduce possible patient damage by requiring strong proof of safety and
effectiveness for certain purposes.
2.
Evidence-Based Medicine: Pharmaceutical firms are required to present proof of a drug's
effectiveness and safety for applications as part of the regulatory approval process. By
restricting promotion to authorized purposes, the emphasis is kept on scientifically
verified facts, promoting evidence-based medicine, and avoiding false advertising.
3.
Regulatory Oversight: Controlling off-label advertising makes sure that pharmaceutical
firms follow the rules set forth in the regulatory framework. It makes sure that drugs are
carefully examined before they are put on the market, preserving the integrity of the drug
approval system.
4.
Making Informed Decisions: By restricting advertising to permitted applications, medical
practitioners may choose drug prescriptions with greater knowledge. When weighing the
risks and rewards of using approved indications, they can depend on established data and
recommendations.
5.
Legal Responsibility: By forbidding off-label advertising, a legal framework is
established to make pharmaceutical firms and the agents who represent them responsible
for their marketing strategies. As a result, improper marketing is discouraged and public
confidence in the pharmaceutical sector is preserved.
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Drugs, equipment, and nutraceuticals that have been misbranded by the maker or are being
misused (using and marketing)
1.Why isn't the federal government acting or coming up with a strategy so that off-label
medications can be used and advertised as on-label medications?
2. By taking part in the play and failing to give the patient the treatment they need (the negative
reactions brought on by the drug's off-label usage), are doctors putting themselves in a
vulnerable position? (Cases in court launched against the physicians)?
A medicine's new FDA authorization can be expensive and time-consuming to obtain. To add
additional indications to a medicine that has previously received approval, the owner must file a
supplementary drug application. There is no assurance that the new indication's revenue will
cover the costs incurred and the time expended on the application procedure, though. Generic
drugs frequently lack the financial means necessary to obtain FDA approval for new indications.
Because of these monetary concerns, drug manufacturers can decide not to submit a request to
the FDA for a new medication indication.
When patients had adverse reactions after receiving medicine for off-label uses, doctors were the
target of legal claims. Legal defenses in such cases have included claims of medical malpractice,
the improper monitoring of the use of research medications, and insufficient informed permission
for off-label usage. Legal attitudes on off-label usage have been formed by prior court cases,
frequently focused on situations involving the use of medical equipment outside of their intended
use.
The FDA has created stringent guidelines for the use of medications and medical equipment in
research settings to ensure the safety of human study participants. However, once they are no
longer regarded as research tools, medical gadgets, and prescription drugs can be used off-label
without FDA regulatory monitoring. In this regard, a federal appeals court in Ohio noted that
although "off-label use of medical equipment is not prohibited by the U.S. Food and Drug
Administration," it "is solely an issue of medical judgment and can subject a physician to
professional responsibility based on their exercise of professional medical judgment."
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Overview
According to a WBI (2021b) analysis, most federal spending in the US is used to meet the
medical and prescription medication requirements of its people, especially those who are eligible
for Medicare and Medicaid. These people are most impacted by these costs. Given the
importance of these contracts for the security and well-being of American taxpayers, many
people who are truthful and courageous enough to reveal fraudulent practices opt to come
forward, which may result in legal action and perhaps incarceration for those responsible.
People who choose to report graft or corruption are given strong and complete protection under
the False Claims Act. According to the FCA's anti-retaliation rule, companies are not allowed to
retaliate against workers who have raised attention to misconduct through Qui Tam lawsuits.
Employers who are found to have broken the law and retaliated against whistleblowers risk
facing significant retaliation charges, in which the relator may be entitled to double back
payment, reinstatement, and legal expense reimbursement.
Whistleblower rewards are calculated as a portion of the total sum won by the authorities in a
successful legal action. Based on whether the government agrees to join the lawsuit, the
whistleblower's award might range between two levels, often from 15% to 25% and 25% to 30%.
Depending on the importance of insider knowledge and its contribution to the case's eventual
victory, the whistleblower may be given a different proportion for every circumstance. The
following are examples of typical fraud schemes which are subject to False Claims Act
prosecution and might result in qui tam cases:
Off-label marketing: It is against the law to promote medications for use that the FDA has
not authorized. Because the safety and effectiveness of medicine for off-label usage may
not have been sufficiently evaluated, this practice has the potential to mislead both
healthcare professionals and patients.
Bribery and kickbacks: It is unlawful and immoral to provide bribes or kickbacks to
medical experts, public servants, or other parties in return for business or special
treatment. Such behaviors undercut patient care and jeopardize the integrity of the
healthcare system.
Pharmaceuticals sold with adulterants: It is immoral and risky for patients' safety and the
general public's health to sell drugs that are of poor quality, poorly made, or contain
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poisonous ingredients. To stop the distribution of contaminated pharmaceuticals,
regulatory organizations implement stringent quality control procedures.
False claims for reimbursement or paying the government for services that were not
delivered are both fraudulent and against the law. These behaviors have the potential to
cheat public healthcare systems and squander cash that might be allocated for proper
healthcare.
Delivery of defective or inferior goods: Providing inferior goods that were acquired with
public monies is a kind of fraud that puts patients' health and safety at risk. To guarantee
the supply of safe and efficient products, public procurement procedures should place a
high priority on performance and adherence to standards.
Government contract collusion: Using unlawful and anti-competitive tactics, such as bid
rigging or the fixing of prices, to obtain government contracts is prohibited. These
activities have the potential to restrict free competition, drive up costs, and deny the
government and taxpayers the advantages of open and transparent procurement
procedures.
The Data, Evaluation, and Argumentation:
Mr. Herzog received a warning letter for breaking the Federal Food, Drug, and Cosmetic Act
(FD&C Act) on March 11, 2022. The off-label usage of nutritional supplements by CAG Food
Product Inc. and the misbranding of those products were violations. The goods' intended purpose
in treating, alleviating, preventing, or curing ailments, as stated on CAG Food Product Inc.'s
websites, qualified them as medicines under the Act. The FD&C Act was broken when these
items were introduced or delivered for these applications in interstate commerce. The FDA
suggested an examination of the websites and locations where clients buy nutraceuticals, per data
gathered by the Center for Drug Evaluation and Research in 2022. Regarding the use of these
nutraceuticals in the treatment, minimizing, avoiding, or cure of illnesses, the FDA discovered
"False Claims". According to section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act
(the Act) [21 U.S.C. 321(g)(1)(B)], the items were consequently categorized as medicines.
Examples of some website claims that offered proof that their goods were meant to be used as
drugs include:
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The website provides indications or claims about treating, mitigating, preventing, or curing
illness for products like Biotta Apple Beet Ginger Juice, Biotta Beet Juice, Biotta Carrot Juice,
Biotta Elderberry Juice, Biotta Golden Beet Juice blended with Turmeric, Biotta Celery Root
Juice, Biotta Breuss Vegetable Juice, Biotta Tart Cheese Juice, Juice Performer the Federal Food,
Drug, and Cosmetic Act's definition of medicines may apply to these goods.
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Case
United States v. Caronia, 703 F.3d 149 (2d Cir. 2012)
A notable court decision that dealt with off-label pharmaceutical product advertising and the First
Amendment rights of pharmaceutical salespeople is United States v. Caronia, 703 F.3d 149 (2d
Cir. 2012). In this instance, Alfred Caronia worked as a pharmaceutical sales agent for a business
that made the medicine Xyrem, which the FDA had authorized for the treatment of narcolepsy.
Caronia was caught on camera advocating for Xyrem usage that were not FDA-approved during
meetings with doctors, which indicates he was pushing off-label uses of the medication.
Based on his off-label advertising of Xyrem, Caronia was accused of conspiring to bring a
misbranded medicine into interstate commerce. Caronia countered that his words were just
providing accurate and non-misleading facts, and as a result, his First Amendment rights to free
speech were being violated. The Second Circuit U.S. Court of Appeals heard the case. The court
determined that Caronia's First Amendment rights were violated by the government's prosecution
of his off-label marketing. If the speech was not deceptive or fraudulent, the government might
control speech that was false or misleading, but it could not regulate speech that was true in
promoting off-label applications.
Significant discussion and controversy throughout the legal community, regulatory authorities,
and pharmaceutical business followed the Caronia ruling. While some claimed the ruling only
applied to the particular facts of the case, others said it would have consequences for how off-
label promotion is regulated. While the Caronia ruling set a precedent in the Second Circuit, it's
vital to keep in mind that its applicability and effects could differ in other jurisdictions. The case
serves as a reminder of the difficult moral and legal issues regarding off-label advertising and
how to strike a balance between free expression and public health protection.
UNITED STATES, ex rel. DEBRA PARKS, et al. Plaintiffs, v. ALPHARMA INC.
Debra Parks served as a sales representative for Alpharma Inc. from April 2002 to July 2006,
according to the lawsuit U.S., ex rel. Parks v. Alpharma Inc. Her duties included promoting
Kadian, a kind of slow-release morphine that Alpharma promoted as being superior to other
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opioids for treating pain. Parks frequently placed among Alpharma's top sales reps in the country
and enjoyed great success in her position.
The most Kadian was prescribed by Dr. Michael S. Kaplan, a well-known physician in the Parks area. Parks confessed in an email that she didn't like Dr. Kaplan personally, but that she relied on his prescriptions and worried about what may happen if he stopped writing Kadian prescriptions.
In 2004, Alpharma discussed working with Dr. Kaplan on a clinical trial agreement to assess the efficiency and financial effects of transferring patients from other opioids to Kadian. Parks argued in favor of Alpharma funding the study, highlighting the significance of Dr. Kaplan's prescription volume to her sales results.
Alpharma eventually provided funding for the Kaplan "switch" research and lavishly reimbursed Dr. Kaplan for his involvement. However, Parks later said that she objected to the switch trial and Alpharma's accompanying actions. She said that Alpharma hid the study's findings because they would have prevented continued advertising and sales of Kadian.
In August 2005, Dr. Kaplan also presented to the Alpharma sales team his own strategy for
transferring patients to Kadian. Parks said that Alpharma hired Dr. Kaplan to educate sales
employees so they could sell the Kaplan conversion process to other doctors, even though it was
presented as his own approach. Parks asserted that she voiced her concerns to Dr. Kaplan's
method's off-label usage, which Alpharma was not allowed to promote, and that many salesmen
didn't comprehend the conversion process.
Parks further said that she raised concerns with her Alpharma management during Dr. Kaplan's
presentation to Coventry Health Care in February 2006. Parks said that although being involved
in setting up Dr. Kaplan's attendance, she disagreed with the presentation's content and
Alpharma's remuneration policies. She contended that Dr. Kaplan's presentation was improper
because it was off label. Alpharma ultimately paid Dr. Kaplan for his Coventry lecture, however
the payment mechanism was in question.
Concerning four more alleged fraudulent schemes involving Alpharma, Parks made comparable
allegations with an emphasis on the off-label promotion of Kadian. Pharmaceutical corporations
are not allowed to advertise medications for off-label applications, even though doctors are
allowed to prescribe them.
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Parks said that by expressing her disapproval of Alpharma's off-label marketing tactics, she
warned the business about the potential for a qui tam case. She maintained that because the
phrase "off-label" in the pharmaceutical sector is synonymous with "fraudulent" or "illegal," her
complaints met the criteria for protected speech under the False Claims Act (FCA).
The False Claims Act (FCA), which forbids purposeful filing of false or fraudulent claims to the
federal government for consideration or payment, is analyzed in this case. The FCA's qui tam
provisions let private parties file civil cases on the country's behalf. Employees who are engaging
in or pursuing qui tam cases are protected from harassment, retaliation, and intimidation under
the Act's whistleblower protection, included in Section 3730(h).
If Parks' objections regarding off-label marketing were adequate to warn Alpharma of
prospective qui tam litigation, the case's examination would further dive into the applicability of
these legislative principles. To decide whether there was a legitimate claim under the FCA and
whistleblower protections, the court would consider the circumstances and facts submitted.
U.S ex rel. Marlene Sandler & Scott Paris v. Wyeth (Whistle blower case) (US FDA, 2010)
As part of a settlement to address criminal and FCA allegations relating to its misbranding and
introduction of the medication Rapamune into interstate commerce, Wyeth Pharmaceuticals has
agreed to give the federal government and various state governments $492.9 million. Wyeth had
pushed the medication, which was licensed for kidney transplant patients but was used off-label
in patients undergoing other types of transplants.
It is advised that the following relevant actions be taken to prevent further infractions involving
off-label marketing:
Respect regulations: When it comes to the advertising and marketing of medications,
pharmaceutical businesses must heed the rules set down by regulatory bodies like the
FDA.
Educate the sales team: Sales reps shouldn't be rewarded for using pharmaceuticals
outside of their permitted indications, thus they should be informed on these uses.
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Don't make false or misleading statements; instead, be truthful and accurate in your
marketing materials and communications when discussing the medications' authorized
uses.
Maintaining transparency: Businesses should refrain from offering improper financial
incentives or bribes in exchange for prescribing off-label applications and instead be open
and honest in their communications with healthcare practitioners.
Conduct adequate research: Companies should examine the efficacy and safety of
medications for off-label usage by conducting reliable, scientifically sound research.
Positive or unfavorable study findings should all be adequately communicated.
Report adverse events: Businesses should have procedures in place to track and report
any negative impacts or side effects related to the use of their medications, particularly
those caused by off-label usage.
Work together with regulatory agencies: Pharmaceutical firms should work together with
regulatory agencies to guarantee compliance and, if necessary, seek out guidance.
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Conclusion
In conclusion, off-label marketing of pharmaceutical drugs is a serious violation of regulations
and can have significant legal and ethical consequences. Pharmaceutical companies and
healthcare professionals must adhere to approved uses of drugs and avoid promoting them for
off-label purposes. The case examples mentioned earlier highlight the repercussions faced by
companies involved in off-label marketing.
To prevent future violations, it is crucial for companies to comply with regulations, provide
accurate and transparent information, educate sales personnel, conduct appropriate research,
report adverse events, and collaborate with regulatory authorities. These steps ensure that patient
safety remains the top priority and that pharmaceutical products are used appropriately and in
accordance with approved indications. From the viewpoint of the government and federal
system, the US is the only country that allows DTC and medication ads in general. This implies
that when we consider the industry, corporations always seek ways to circumvent the laws to
advertise and sell their products as rapidly as possible while reaping the greatest financial
rewards. Similar to how insurance goods are sold, or credit and debit card agreements are
formed, it is misleading. Although there is no proof to back up my argument that it is deceptive,
they have succeeded in utilizing the proper advertising flaws.
By following these guidelines, pharmaceutical companies can uphold ethical practices, maintain
compliance with regulatory agencies, and protect the well-being of patients.
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References
FDA, U. (2018, 02 05). Understanding Unapproved Use of Approved Drugs "Off Label".
Retrieved
from
https://www.fda.gov/patients/learn-about-expanded-access-and-
othertreatment-options/understanding-unapproved-use-approved-drugs-label
Wittich, C. M., Burkle, C. M., & Lanier, W. L. (2012, October). Ten common questions (and their answers) about off-label drug use
. Mayo Clinic proceedings. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3538391/
Tart cherry juice
. Biotta Juices. (n.d.). https://www.biottajuices.com/products/tart-cherry-
juice/
quality, A. f. (2015, September). Off- Label Drugs: What you need to know. Retrieved
from
https://www.ahrq.gov/patients-consumers/patient-involvement/off-label-
drugusage.html#: ~:text=Off%2Dlabel%20prescribing%20is%20when,are%20for%20off
%2D label%20use.
says, J. S. (n.d.). United States v. Caronia: A victory for Free Speech vs. off label promotion
. Policy & Medicine. https://www.policymed.com/2012/12/united-states-v-
caronia-a-victory-for-free-speech-vs-off-label-promotion.html
Wyeth Pharmaceuticals agrees to pay $490.9 million for marketing the prescription drug Rapamune for unapproved uses
. The United States Department of Justice. (2014, October
22). https://www.justice.gov/opa/pr/wyeth-pharmaceuticals-agrees-pay-4909-million-
marketing-prescription-drug-rapamune-unapproved
RICHARD BENNETT, D. J. (2011, April 11). U.S., ex rel. Parks v. Alpharma Inc..
Legal
research tools from Casetext. https://casetext.com/case/us-62
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