Advice You - Business

1. They don't have an experienced contract lawyer evaluate their contract.

Do not entrust your physician employment contract to your local genera

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

l practitioner. While there are some similarities to general contracts and physician contracts, you should have an attorney who has extensive experience reviewing physician contrac

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

Examples of combination products may in

ts. There are more differences than similarities and an experienced lawyer will be able to spot them and correct them before they cause harm.

You wouldn't want a

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

family practitioner performing coronary artery bypass surgery on you unless that physician has had years of training and fellowship in that field of medicine. The same holds true f

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

or lawyers.

2. A young doctor is money-conscious and is afraid to spend money to hire a lawyer.

The common thinking is that if they can save a few dollars by not

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

Combination pro

having to pay a lawyer, then they're ahead of the game. Wrong. That's what you call 'penny-wise and pound foolish'. By spending money for a good lawyer now you will be protecting

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

yourself for years to come knowing that you have fought for everything you can possibly get in your contract.

Remember, your contract will guide you for many years. If you make mi

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

stakes at the begining by not knowing and not being an informed consumer, you will regret it for years to come. Believe me, I've seen physicians kick themselves for not having thei

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

r contracts reviewed by an experienced lawyer before signing it.

3. The young doctor is afraid to make waves with his new group or hospital.

You've just been hir

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

ed. "You got the job!" But, once you see the contract you realize that all is not rosy. However, with good counsel, you can learn to negotiate, and you can have your lawyer be the

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

bad guy and negotiate for you.

It never hurts to say, "My lawyer felt this was inappropriate...", "My lawyer advised me to have this re-worded...", "My lawyer felt this was unfair

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

Following aspects would a

and needs to be removed." Let your lawyer be the bad guy. Do you think the groups' lawyer is looking out for your interests? Never.

4. The group wants to give you as litt

dd to the challenges in developing combination products:

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

le as possible.

You have little to compare your contract to. All you know is that when you leave residency you'll be making a tremendous jump in salary as an attending p

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

hysician. That's good, but that's only part of the equation. You need to know much more.

How do you learn more? By reading books written by attorneys who have experience in this a

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

rea. Learn all you can about your contract and physician employment contracts. Have your attorney give you a crash course on contracts and negotiation. I guarantee you it'll be the

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

best money you ever spend. An experienced lawyer should know what the going rate is for your specialty in your geographic area. He (or she) should know whether the other benefits

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

Professional from academic institutions, pharmaceutical industries, health care indust

you're getting are consistent with other competing groups. You must ask lots of questions.

5. The young doctor fails to do research about the group or hospital he is joini

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

ng.

This is vital. You must investigate your group. Ask your colleagues about their reputation, their ethics, their surgical or non-surgical abilities. Speak to members w

.

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

ho have left the group if possible. The more information you have about the group, the better informed you'll be, and you'll be able to make judgment calls knowing full well what y

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

Companies that provide selfless information through particip

our options are.

CONCLUSION

Be informed, do your research, read your contract, and then hire an experienced contract lawyer who specializes in doctors contracts.

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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