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Digg It - Ramifications of the Options Backdating Scandal for 2007; Some Questions
What are the top 3 ramifications of the options backdating scandal?
If you remove the usual
If you remove the usual
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
tax consequences, shareholder lawsuits, restatement, etc. What things do we see coming down i
; 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
terms of legislation/new rules and regulations and where are the opportunities?
1. Revisiti
1. Revisiti
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ng Executive compensation: It supposed to be aligned with shareholder, but as examples of Cyb
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ronics points out, not exactly. We see examples of Google, Apple and Yahoo paying their Chief
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
Executives only $1 as their pay and rest in options compensation. Will this change? Will com
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
anies completely stop paying salaries? Or will they stick to giving options to top executives
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
alone?
2. Board of Director accountability: Boards do have a responsibility to shareholders
2. Board of Director accountability: Boards do have a responsibility to shareholders
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
Would we see an increase in number of boards requesting higher coverage from D&O insurance?
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
Are boards going to have their own "internal spies" in each company to help report on interna
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
controls audits? Will board members request oversight and have responsibility over internal
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
olicies and procedures?
3. Fewer people use stock options: Many companies have started to re
3. Fewer people use stock options: Many companies have started to re
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
duce overall the number of stock grants and options to employees. There are many reasons, inc
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
uding expensing of stock options, backdating scandal, etc. What other alternative forms exist
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
of incentive pay? Restricted stock has the same problems as options, i.e. if priced at the w
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
ong time, they will have potential to drain stock holder value.
4. Audit responsibilities: M
4. Audit responsibilities: M
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
any clients we have currently deploy another set of auditors (besides the one they already us
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
) to have an "independent" third party for internal investigation. Will this continue after t
.
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
he backdating has been squared away? Is there a need for a auditor to audit your auditor?
In
In
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
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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