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If you take some time to think about the big picture story around options backdating, here are some patterns that e

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

merge. Each is valid, and has some merit, but it gives you some reason why the general public is still not interest

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

d in the story and outraged by it, but the media and some institutional investors are.

1. CEO and Executive pay: R

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

alistically speaking this is a weak argument at best. CEO pay has always been big and its getting bigger because lo

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

of these executives have big risk jobs and are responsible for millions or billions of $ and thousands of employee

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

. Add to this the legal ramifications of doing a bad job, their job is not easy. Fortune's Rick Kirkland wrote a pi

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

ce on CEO pay and its an interesting read, but still does not offer any solutions.

2. Full Disclosure of pay for e

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

ecutives: SEC chairman Christopher Cox has stated full disclosure guidelines will be issued soon, and the "perks" t

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

at executives get do add up, but still this argument is also not very strong. There will always be the CEO parachut

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

deals, and tax perks etc. Again we fail to see this being the big change force.

3. Better internal controls: Most

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

companies before SOX did not have the best internal checks and balances processes for ensuring these "issues" were

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

tracked, reported and managed. Accounting, Finance and Legal were mostly "side roles" to Sales, Marketing, Manufact

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

ring and Engineering. Lack of internal controls is an issue for most companies that they need to fix. Its in our op

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

non this is a good but not the big "a-ha" compelling argument.

4. Poorly stated guidelines around gray areas: That

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

s why they are called gray areas in the first place. Most auditors and legal firms use "judgement" around these are

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

s such as grant and enforcement dates for options. The SEC's has stated they will have better guidelines around sum

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

er '06. This is also not a compelling argument for backdating not getting a bigger attention and outrage from the p

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

blic.

5. World cup Soccer: (grin) - We made this up. Newsweek had a piece about why this time the world cup soccer

.

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

has more attention of Americans. This is by far the most compelling argument why the general public does not care m

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

ch about the options backdating story.

http://blog.vangal.com

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

Many innovations have been introduced in the field of advertising and this has made the whole process costly too. So, the idea is to promote your goods and do the thing in such a way that it does not cost you too much. You have to take care of your budget also.

Open your mind to see uncertainty as a state of possibility. Limitless possibilities. So often we view uncertainty with dread and anticipation of something negative happening to us. Imagine seeing the potential of limitless possibilities that might result in wonderful things happening. In other words, expect the best instead of expect the worst.

If you're thinking of getting into medical billing and sending claims in for oxygen, you better bone up on your GX records. In this installment, we cover the GX0 record, fields 14 through 19.

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Digg It - The Real Big Picture Around Options Backdating

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