DarshanTalks Podcast

[et_pb_section fb_built="1" _builder_version="3.29.3" custom_padding="||5px|||" fb_built="1" _i="0" _address="0"][et_pb_row _builder_version="3.29.3" module_alignment="center" collapsed="off" _i="0" _address="0.0"][et_pb_column type="4_4" _builder_version="3.29.3" _i="0" _address="0.0.0"][et_pb_audio audio="https://media.blubrry.com/darshantalks/content.blubrry.com/darshantalks/655904237-darshantalks-responding-to-an-fda-inspection-part-1.mp3" title="@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IiIsImFmdGVyIjoiIn19@" artist_name="@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9hdXRob3IiLCJzZXR0aW5ncyI6eyJiZWZvcmUiOiIiLCJhZnRlciI6IiIsIm5hbWVfZm9ybWF0IjoiZGlzcGxheV9uYW1lIiwibGluayI6Im9mZiIsImxpbmtfZGVzdGluYXRpb24iOiJhdXRob3JfYXJjaGl2ZSJ9fQ==@" album_name="DarshanTalks" _builder_version="3.29.3" _dynamic_attributes="title,artist_name" background_color="rgba(0,0,0,0)" background_layout="light" custom_padding="52px||22px|||" hover_enabled="0" border_color_all_image="rgba(0,0,0,0)" _i="0" _address="0.0.0.0"][/et_pb_audio][et_pb_text _builder_version="3.29.3" background_size="initial" background_position="top_left" background_repeat="repeat" custom_margin="-18px||15px|||" hover_enabled="0" _i="1" _address="0.0.0.1"]How can you ensure readiness and compliance for FDA inspections?

[et_pb_section fb_built="1" _builder_version="3.29.3" custom_padding="||5px|||" fb_built="1" _i="0" _address="0"][et_pb_row _builder_version="3.29.3" module_alignment="center" collapsed="off" _i="0" _address="0.0"][et_pb_column type="4_4" _builder_version="3.29.3" _i="0" _address="0.0.0"][et_pb_audio audio="https://media.blubrry.com/darshantalks/content.blubrry.com/darshantalks/655903910-darshantalks-responding-to-an-fda-inspection-part-2.mp3" title="@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IiIsImFmdGVyIjoiIn19@" artist_name="@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9hdXRob3IiLCJzZXR0aW5ncyI6eyJiZWZvcmUiOiIiLCJhZnRlciI6IiIsIm5hbWVfZm9ybWF0IjoiZGlzcGxheV9uYW1lIiwibGluayI6Im9mZiIsImxpbmtfZGVzdGluYXRpb24iOiJhdXRob3JfYXJjaGl2ZSJ9fQ==@" album_name="DarshanTalks" _builder_version="3.29.3" _dynamic_attributes="title,artist_name" background_color="rgba(0,0,0,0)" background_layout="light" custom_padding="52px||22px|||" hover_enabled="0" border_color_all_image="rgba(0,0,0,0)" _i="0" _address="0.0.0.0"][/et_pb_audio][et_pb_text _builder_version="3.29.3" background_size="initial" background_position="top_left" background_repeat="repeat" custom_margin="-18px||15px|||" hover_enabled="0" _i="1" _address="0.0.0.1"]How can you ensure readiness and compliance for FDA inspections?

Bioethics can be broken down into several primary components according to the Belmont Principles—components including beneficence, nonmaleficence, justice, and autonomy—however, there is merit in looking at some of the basic underpinnings of these ethical ideas.  Although the Belmont Principles provide some guidance insofar as deciding what course of action is morally justified, there are certain areas where they are insufficient, and in these cases, it can be useful to look at the more basic reasons behind why these principles were established in the first place.

The Prescriptive Model

One of the more fundamental theories underlying the Belmont Principles is what can be colloquially called the “prescriptive model.” In other words, this is an instance in which an outside authority such as the government, has decided what is right and wrong.  This can include governments deciding that they have the right to govern in the first place, or religious leaders determining what is a morally correct way of behaving, or the entire concept of ethics as a whole.

Rights-Based Ethics

Yet another deep underpinning of the Belmont Principles can be found in what is known as “Rights Theory,” or the idea that you have to come to a clear moral picture of what is moral or immoral while also considering how culture may have influenced what you consider morally right.  If one considers the morality involved in hurting a puppy, although doing so is not illegal, it is considered a highly immoral act in many societies because dogs are such cherished household pets. The immorality of hurting a puppy might be less pronounced in different societies in which dogs are considered less important, however, which demonstrates the variability of what we consider morally ethical. 

There is room for a certain amount of ethical grey area, particularly because there has been an evolution in our thinking and morals concerning what is right and wrong.  If we apply Rights Theory to Nazi prison experiments, for example, it could appear that the experiments being performed on prisoners did not violate moral standards because there were no explicit rules against that sort of testing.  However, in retrospect, it appears clearly immoral that prisoners were being tested on because they had not given their informed consent, and also because they had clearly been forcibly coerced into participating.

Utilitarian Theory

The third underlying theory of the Belmont Principles is the utilitarian theory, which considers any course of action which would yield the greatest good for society to be the ethically moral course to take.  In the case of the Nazi prison experiments, it seems that using the findings from these experiments to help further scientific findings would be the morally just course of action under the utilitarian theory because it would help the greatest amount of people.  However, under opposing theories, this appears to be a morally unjust undertaking because it ignores the suffering that the Nazi prisoners underwent as a consequence of the experiments. The other major problem facing this theory is that it remains impossible to measure utility because it is such a variable concept.  For instance, if one considers the utility that one thousand dollars would provide to a rich person such as Warren Buffett compared to the utility that would be provided to someone of a much lower economic class, it is obvious that the utility would be much higher for the person with less economic means. The fact that utility remains so difficult to quantify means that utilitarianism as a theory is hard to use when trying to determine the morally just course of action.

Conclusion

Many have been assigned blame for the nation’s prescription opioid epidemic--including clinicians, patients, and pharmaceutical distributors.

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Disclaimers:

1. This discussion is merely an oral discussion and should not be relied upon solely on its own to support any conclusion of law or fact.

2. The discussion does not and should not reflect any individual products status as safe, efficacious, adulterated or misbranded or meeting or not meeting expectations at a local, state, federal, or international agency or organization.

3. The discussion should not be construed to be complete advice that is right for you and may not necessarily represent a specific product.

4. This discussion is provided for general educational purposes and should not be construed as legal advice, regulatory advice or medical advice.

5. This does not create an attorney-client relationship

[et_pb_section fb_built="1" _builder_version="3.29.3" custom_padding="||5px|||" fb_built="1" _i="0" _address="0"][et_pb_row _builder_version="3.29.3" module_alignment="center" collapsed="off" _i="0" _address="0.0"][et_pb_column type="4_4" _builder_version="3.29.3" _i="0" _address="0.0.0"][et_pb_audio audio="https://media.blubrry.com/darshantalks/content.blubrry.com/darshantalks/655905113-darshantalks-10-ways-to-communicate-with-the-fda.mp3" title="@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IiIsImFmdGVyIjoiIn19@" artist_name="@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9hdXRob3IiLCJzZXR0aW5ncyI6eyJiZWZvcmUiOiIiLCJhZnRlciI6IiIsIm5hbWVfZm9ybWF0IjoiZGlzcGxheV9uYW1lIiwibGluayI6Im9mZiIsImxpbmtfZGVzdGluYXRpb24iOiJhdXRob3JfYXJjaGl2ZSJ9fQ==@" album_name="DarshanTalks" _builder_version="3.29.3" _dynamic_attributes="title,artist_name" background_color="rgba(0,0,0,0)" background_layout="light" custom_padding="52px||22px|||" hover_enabled="0" border_color_all_image="rgba(0,0,0,0)" _i="0" _address="0.0.0.0"][/et_pb_audio][et_pb_text _builder_version="3.29.3" background_size="initial" background_position="top_left" background_repeat="repeat" custom_margin="-18px||15px|||" hover_enabled="0" _i="1" _address="0.0.0.1"]Communicating regularly with the FDA is good practice for drugmakers looking to ensure compliance with laws and regulations.

Not all products have to meet the U.S. Federal Drug Administration’s (FDA) approval: certain biologics and dietary supplements do not require it, and there are alternative pathways for OTC drugs and other products to skip the process.

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Disclaimers:

1. This discussion is merely an oral discussion and should not be relied upon solely on its own to support any conclusion of law or fact.

2. The discussion does not and should not reflect any individual products status as safe, efficacious, adulterated or misbranded or meeting or not meeting expectations at a local, state, federal, or international agency or organization.

3. The discussion should not be construed to be complete advice that is right for you and may not necessarily represent a specific product.

4. This discussion is provided for general educational purposes and should not be construed as legal advice, regulatory advice or medical advice.

5. This does not create an attorney-client relationship

Drugmakers have become increasingly entangled in kickback and bribery schemes, and as a consequence, face millions in settlement to the U.S. government.

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Disclaimers:

1. This discussion is merely an oral discussion and should not be relied upon solely on its own to support any conclusion of law or fact.

2. The discussion does not and should not reflect any individual products status as safe, efficacious, adulterated or misbranded or meeting or not meeting expectations at a local, state, federal, or international agency or organization.

3. The discussion should not be construed to be complete advice that is right for you and may not necessarily represent a specific product.

4. This discussion is provided for general educational purposes and should not be construed as legal advice, regulatory advice or medical advice.

5. This does not create an attorney-client relationship

Although e-cigarettes were initially introduced as a less harmful alternative to traditional tobacco products, and meant to be a way for smokers to slowly decrease their consumption of nicotine, the marketing tactics used to advertise these products have recently come under scrutiny.  E-cigarette companies such as Juul Labs, Inc. and Philip Morris have come under fire for releasing advertising campaigns which inadvertently targeted children, and have led to more than 3.6 million middle and high school students becoming e-cigarette users in the year of 2018 according to a finding reported by the National Youth Tobacco Survey.  Despite the ban that has been placed on advertising campaigns which attempt to sell nicotine products to minors, companies have attempted to sidestep this ban by using influencer-based marketing. Influencer based marketing involves marketing ones products by using an “influencer,” or person on a popular social media platform who has a lot of followers, to endorse the nicotine product.  The problem with this type of marketing is that the consumers of this type of marketing are primarily minors, who are being bombarded by ads endorsing nicotine use. 

Influencer Marketing

The type of marketing that is used on online platforms such as Instagram or Twitter can be difficult to regulate—it often flies under the radar, and because the platforms themselves do not exist for a long time, it can be difficult to track effectively.  In the case of e-cigarettes, companies were paying “influencers,” or people with a broad network of online followers, to promote their products. This type of marketing proved subtle, as influencers posed their photos in natural ways which did not read to the casual viewer as being an advertisement. One of the more notable instances of this type of marketing was the early social media campaign for Juul vaping products—the Juul company made use of influencers and hashtags to market their product, and as a result, minors began using their products and sharing videos of themselves vaping on various social media platforms.  As a response to this drastic increase in nicotine use among minors, lawsuits began to be filed against tobacco companies, and these companies were then forced to air court mandated anti-smoking statements on primetime television and in newspaper ads. This response was ineffective, primarily because the children who were using nicotine products were not reading newspapers or watching primetime television—they were instead on social media platforms like Facebook or Instagram. 

Government Response

The government’s response to the marketing of nicotine products to children has been relatively swift and comprehensive. The FTC, for instance, has mentioned having a strong case against the tobacco companies, and has been going after influencers for non-disclosure regarding the marketing of nicotine products.  Additionally, the FDA has required leading tobacco company Philip Morris to provide them with a detailed analysis of the age range that they were targeting in their online marketing campaign before they were permitted to release their new vaping product, “IQOS.” Even more drastic than this, the FDA has required tobacco giant Philip Morris to turn their social media marketing efforts over to the FDA for review 30 days before their launch.

Insys admits to orchestrating a nationwide sham "speaker program" and Mallinckrodt raises drug price by over 100,000% (not a typo) and bribes docs to prescribe.

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Disclaimers:

1. This discussion is merely an oral discussion and should not be relied upon solely on its own to support any conclusion of law or fact.

2. The discussion does not and should not reflect any individual products status as safe, efficacious, adulterated or misbranded or meeting or not meeting expectations at a local, state, federal, or international agency or organization.

3. The discussion should not be construed to be complete advice that is right for you and may not necessarily represent a specific product.

4. This discussion is provided for general educational purposes and should not be construed as legal advice, regulatory advice or medical advice.

5. This does not create an attorney-client relationship

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