Actual - Writing and Speaking

It used to be that a four-line memorandum of agreement was all you needed to jump into a copywriting assignment.

Not so any more.

With lawsuits on the rise in Americ

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

a, copywriters – the true ghostwriter if ever there was one – have to be just as diligent in their written agreements as a contestant is on American Idol.

While it ma

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

Examples of combination products may in

y be tempting to only review the paragraphs outlining compensation, you could walk into some major problems if you ignore the rest of it.

The best way to be proactive

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

in your freelance business is to have a set of contracts you use regularly. There are short forms for flat fee compensation and for compensation with a bonus or royal

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

y tied to it. There’s also a long form that goes into more detail. All three should be in your arsenal.

And, if you can swing it, you should be the one drafting the f

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

Combination pro

reelance copywriting contract for your next project.

The compensation structure is important to be sure but so are other paragraphs. Clauses like revision terms and c

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

hange orders are equally critical. You’ll want to make sure to define how many revisions you’re willing to do for what you’re being paid. Are they major revisions or m

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

inor ones?

And what kind of additional compensation will you get if the direction of the project is changed after you’ve begun writing? Will you require a written cha

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

ge order – always a good idea to have every part of a project in writing and signed off on by you and your client – or will you permit the change order to be verbal?

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

The terms of the contract should also spell out just what is included in the project. It’s rare that a copywriting project involves just writing. What about phone call

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

s, brainstorming with staff members, and gathering testimonials?

While a flat fee agreement is the way most clients want to go these days, you may encounter a situati

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

Following aspects would a

on where you’ll want to get a bonus or commission tied with your compensation. You’ll need to be specific and precise in the wording of the bonus or commission languag

dd to the challenges in developing combination products:

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

and you’ll want to have some mention of a kill fee regarding that bonus or commission should the project never be mailed.

One of the trickiest paragraphs in a copywr

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

iter’s contract is the hold harmless and indemnification clause. If it’s written to benefit your client and the client is sued as a result of the copy you wrote, you c

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

ould end up having to pay a good bit of green on behalf of your client if the suit is lost over changes in the copy you couldn’t control once the contract was fully pa

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

id. Who knows how the client changed your words before it went into design and publication? Certainly not you – but you could be caught holding the bag.

Make sure you

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

Professional from academic institutions, pharmaceutical industries, health care indust

read and understand every word in a contract before signing. Don’t be afraid to look like a wimp or that your client will see you as someone who doesn’t understand som

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

ething. Chances are he never fully understood the contract he’s asking you to sign so you’re doing him a favor. Even if it’s one word that perplexes you, ask. That one

.

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

word could change the entire context of a sentence or paragraph. You wouldn’t turn in an assignment you didn’t fully understand – don’t sign a contract out of despera

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

Companies that provide selfless information through particip

tion and then find yourself stuck in a situation you didn’t intend.

Put yourself in the driver’s seat by drafting your own contracts for your next copywriting project

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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