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Mistakes happen. Every person, company, organization, or government, will one day face the reality of having made a bone-head mistake, that requires you h

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

aving to handle the problem with the public and the press. Unfortunately, most mistakes are not addressed properly... which leads to even more problems, r

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

Examples of combination products may in

gulatory intervention, lawsuits, or just plain embarrassment for your lack of planning or incompetence. Here are five simple tactics that anyone can (and

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

should) use to make the best out of a bad situation...

1. ACT IMMEDIATELY... Speed is your ally. Delay is your worst enemy. Attempting to sweep the probl

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

m under the rug... or stonewall the media... is an invitation to disaster. Nothing can stir up a media feeding frenzy faster than a hint of foot dragging

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

Combination pro

n your response. The delay is perceived as you "having something to hide" and it makes reporters, regulators, and the public more curious. The words 'no

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

comment' are a bright red flag that will result in the worst opinions and conclusions about you. Immediate action on your part is perceived as honesty, fo

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

thrightness, and decisiveness. Even if the mistake is a huge one... quick action will help diffuse the problem.

2. ADMIT YOUR MISTAKE... this is not time

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

for hedging or mealy-mouthed excuses or passing the buck. Take the problem head-on. President Truman was famous for his desk sign which said "The Buck St

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

ops Here". Every CEO should have one on his/her desk... and pay attention to it. Direct action by top management will be seen as the sign of strong leader

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

hip and responsibility. It may ward off legal actions or regulatory intrusions. It's savvy PR... and good business.

3. APOLOGIZE FOR YOUR MISTAKE... say

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

Following aspects would a

the words. "We regret and apologize for this error.". Those, or similar, words will take a lot of heat away from the situation instantly. The public is

dd to the challenges in developing combination products:

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

generally forgiving of honest errors in judgement... IF you admit the error quickly. Wait too long to make an honest apology and you will be perceived as

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

cting out of pressure or hind-sight. Delay your apology and you aggravate the situation unnecessarily.

4. OUTLINE, IN SPECIFIC TERMS, WHAT YOU ARE DOING

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

ODAY TO RECTIFY YOUR MISTAKE. Nothing will put you on the right side of the issue any faster than outlining a specific plan-of-action to make amends for y

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

our errors. Again this is seen as honesty and decisiveness. Reporters will often start reporting the responsible way in which you addressed the problem..

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

Professional from academic institutions, pharmaceutical industries, health care indust

instead of beating you to death with the problem itself. Responsiveness and taking responsibility with a quick plan of action are the order of the day.

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

. OUTLINE, IN SPECIFIC TERMS, STEPS YOU ARE TAKING TODAY TO INSURE THIS MISTAKE NEVER HAPPENS AGAIN. This is where you set yourself apart from most probl

.

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

em reconciliation methods. It's this last step, combined with the first four above, that sets you head and shoulders above the pack.

So, there you have it

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

Companies that provide selfless information through particip

.. a simple forumla to turn publicity nightmares into advantages. Every corporate and government executive should stencil this formula on his/her forehead

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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