Useful Advices - Business

Businesses routinely maintain copies of correspondence and memos. Far to often, however, they do not extend this practice to ema

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

il correspondence. Email correspondence is no different then your normal paperwork. You must keep copies of all of it to protect

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

Examples of combination products may in

your business in any litigation.

Currently, only banks and broker-dealers are obliged to retain e-mail and instant messaging d

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

cuments for three years under U.S. Securities and Exchange Commission rules. Beginning July 2006, all public companies will also

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

be required to do so under the Sarbanes-Oxley Act.

Notwithstanding these laws, your custom and practice should be to maintain

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

Combination pro

opies of all email correspondence. Email is considered evidence and courts are hammering businesses that do not maintain email r

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

ecords. Judges are often ruling that the failure to maintain and produce email records means the business in question is hiding

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

key evidence.

In the recent Perelman v. Morgan Stanley litigation, a judge’s ruling on the failure of Morgan Stanley to produce

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

email was key factor in the issuance of a $1.45 billion verdict. Based on the failure to produce email records, Judge Elizabeth

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

Maass issued a pretrial ruling that effectively found Morgan Stanley conspired to defraud Perelman in a 1998 deal. Morgan Stanle

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

is not the only business defendant to have this problem.

In the summer of 2004, UBS bank was found by a judge to have “willful

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

Following aspects would a

ly destroyed” email evidence in a discrimination case. UBS was ordered to pay costs and a jury returned a $29 million verdict.

dd to the challenges in developing combination products:

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

Email Policy

To protect your business, you must have a procedure in place to maintain email communications generated through th

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

business. Failure to keep these records can lead to rulings in litigation that your business willfully destroyed evidence. If t

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

his occurs, the judge may issue significant monetary sanctions, automatically find you liable or take other harsh steps that ass

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

re a victory for the Plaintiff. As if such developments are not bad enough, there exists a second risk associated with email com

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

Professional from academic institutions, pharmaceutical industries, health care indust

munications.

Maintaining email communications, however, can have a downside. The problem arises, of course, when a communicatio

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

n contains statements that are damaging to your business. Yes, the proverbial catch-22 situation.

To avoid such disasters, your

.

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

business must develop a clear policy on email communications and train all employees to comply with that policy. Employees must

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

Companies that provide selfless information through particip

understand the business environment is not one in which jokes, flippant remarks and so on should be made in email communications

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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You may have heard about how business coaches can come in and meet with the management of a business and lead it success, and perhaps you even considered hiring a business coach yourself. Thankfully, we live in a digitized and connected world, so now you can sign up for online business coaching and attend classes, meet with your mentor, and improve your business from wherever you connect to the Internet.

There is a world of difference between efficiency and effectiveness, and it's in that world that successful marketers flourish. They are well aware of the power and omni-presence of the 80/20 rule.

Business people are aware that companies are moving some jobs overseas in an effort to save money and in some cases improve levels of service. What most fail to recognize, however, is that this 'outsourcing' trend has already moved beyond typical customer service levels positions and is now about to take jobs away from managers and professionals in industries and businesses never considered previously.

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