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In April of 2004, the NOW Legal Defense and Education fund changed their name to

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

Legal Momentum. The name change was a grand success. LM's Vice President of Comm

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

Examples of combination products may in

unications, Maureen McFadden, shares these four tips to ensure the same success f

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

or your nonprofit:

1. Dedicate Yourself. Dedicate yourself to

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

a long-term process for the name change. Be prepared for the process to become em

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

Combination pro

otionally exhausting at certain points (names, like design, trigger emotional res

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

ponse).

2. Include Staff, Board Members and Stakeholders. Be

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

inclusive in a way that contributes to the name change process. Beware -- when th

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

going gets rough, the knee-jerk response is to pull back and become very secreti

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

ve. But this is the point at which it's especially critical to keep the dialogue

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

going.

3. Research Other Name Changes. McFadden recalls one o

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

Following aspects would a

f the most useful steps in LM's name change process was to survey other nonprofit

dd to the challenges in developing combination products:

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

organizations that had recently changed their names. She asked:

Why did

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

you do it?

What kind of problems did you run into?

What steps o

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

r techniques were particularly successful?

4. Stay Focus

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

ed On Why You Decided to Change the Name. You'll find that you (and you

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

Professional from academic institutions, pharmaceutical industries, health care indust

colleagues and external audiences) are more attached to your organizations curre

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

nt name than you knew. According to McFadden, "the moving on is emotional, the ac

.

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

ceptance is intellectual."

The antidote? McFadden advises you to "stay focused o

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

Companies that provide selfless information through particip

n why you implemented the change and what it will help your organization achieve.

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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