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Main Subject - Selling Truth as a Differentiator
The last few years have been a period of heightened scrutiny and scandal for the financial services industry. Most recently, the SEC issued a r
According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
eport on pension consultants regarding conflicts of interest and the objectivity of advice given to retirement plan sponsors. It’s become vital
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
to the success of insurance and financial advisors that they differentiate themselves with their exemplary ethics, that they operate by a high
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
er moral code and that they communicate that higher standard to their clients. Why? Because research proves that ethics builds trust, and trust
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
sells — in the long-term and - in the short-term, as well.
Taken from the SEC report and the information provided by the Dept of Labor, below
Taken from the SEC report and the information provided by the Dept of Labor, below
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
are Affirmations of Ethical Behavior for Financial and Insurance Industry Representatives.
The Ten Affirmations of Ethical Behavior
1. If reg
1. If reg
ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
istered with the SEC or a state securities regulator as an investment adviser I will provide my clients with all the disclosures required under
easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
those laws (including Part II of Form ADY).
2. I will describe any relationship I have with money managers that I recommend, consider for reco
2. I will describe any relationship I have with money managers that I recommend, consider for reco
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
mmendation, or otherwise mention to the plan.
3. I will describe any payments I receive from money managers I recommend, consider for recommen
3. I will describe any payments I receive from money managers I recommend, consider for recommen
and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
dation, or otherwise mention to the plan for consideration.
4. I have prepared policies and procedures to address conflicts of interest or
4. I have prepared policies and procedures to address conflicts of interest or
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
o prevent conflicting payments or relationships from being a factor when providing advice to my clients.
5. I will monitor and reconcile the a
5. I will monitor and reconcile the a
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
mount of commissions paid when using brokerage commissions to pay consulting fees and alert plan sponsors when consulting fees have been paid i
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
n full.
6. I have established procedural steps to ensure that the plan receives the best execution for its securities trades when the consulti
6. I have established procedural steps to ensure that the plan receives the best execution for its securities trades when the consulti
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
ng fees are paid with the plan’s brokerage commissions.
7. I will describe any arrangements with broker-dealers under which I will benefit if
7. I will describe any arrangements with broker-dealers under which I will benefit if
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
oney managers place trades for their clients with such broker-dealers.
8. If hired, I will acknowledge in writing whether or not I have a fidu
8. If hired, I will acknowledge in writing whether or not I have a fidu
t?
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
ciary obligation as an investment adviser to the plan while providing consulting services.
9. I will acknowledge whether or not I consider mys
9. I will acknowledge whether or not I consider mys
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
elf a fiduciary under ERISA with respect to the recommendations I provide the plan?
10. I will describe the percentage of my plan clients that
10. I will describe the percentage of my plan clients that
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
utilize money managers, investment funds, brokerage services or other service providers from whom I receive fees?
Post these affirmations on y
Post these affirmations on y
.
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
our website and include them in your marketing materials. If you complete the affirmations for prospective clients, you will have distanced you
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
rself from the scandal ridden and differentiated yourself in an industry where the value added to products and services is quickly commoditized
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
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