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A friend of mine, a responsible sort who had always paid his bills on time, recently fell on hard times. The corporation that had benefited from the diligence and devotion with which he customarily performed his duties day in and day

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

out for 10 years laid off hundreds of employees, and my friend – we’ll call him X – found himself downsized.

X had a son and daughter attending UCLA, and the combined income of X and his wife was what had kept the family solvent. W

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

Examples of combination products may in

ith only his wife’s income keeping the family afloat, they were forced to delve into their savings. X, a JPL physicist, had no idea that his shining credentials would actually work against him in the job market. Time and time again h

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

e was told that he was overqualified. Weeks stretched into months, and before he knew it, the savings and the nest egg were exhausted. He was still unemployed.

Humiliated, X nevertheless called his creditors and explained his situat

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

ion, expressing his desire to defer payments on his monthly bills until he was back on his feet. For a few creditors he was able to send a nominal monthly fee, but there were some bills he simply could not pay. Many of the creditors

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

Combination pro

he contacted were not sympathetic to X’s plight. He began to receive calls from collection agencies.

He received calls off and on throughout the day. He tried explaining his situation, but the collection agency representatives had a

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

single item on their agenda: to get X to pay his bills. X told me that the attitude of his callers ran the gamut: cajoling, patronizing, harsh, mean-spirited. Some of the callers probably crossed the line into harassment. His stres

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

s level rose exponentially. He might have sought consumer credit counseling services were it not for the fact that paying for such services was simply not an option.

“What did you do?" I asked him.

“Nothing. I figured I’d have a p

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

retty hard time proving that a caller’s tone was abusive. It wasn’t what they said. It was the way they said it. I tried explaining that I was an upright citizen who had always been responsible when it came to paying my bills. That w

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

ent in one ear and out the other."

I told X’s story because there are those who think people with less than perfect credit histories are irresponsible, are somehow trying to scam their way out of paying bills, or are financially cha

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

lenged individuals who couldn’t balance a check book. Sure, there are some people with tainted credit histories who fall into this category. But often circumstances we have no control over wash over us, and we may quite unexpectedly

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

Following aspects would a

find ourselves in dire and desperate straights. X was one such person.

What X didn’t know – what a lot of people don’t know – is that there’s something called The Fair Debt Collection Practices Act. This is a federal law that was i

dd to the challenges in developing combination products:

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

nstituted to protect consumers from collection agencies and bill collectors who, in their zealousness, break the law and cross the line into harassment.

Three Words That Will Stop Calls From Collection Agencies

X d

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

idn't really need to pay for consumer credit counseling. All he needed to do was write a short letter that can be summed up in three words: Cease and desist. Actually, you’ll fluff the letter up a little, as follows:

"Please be adv

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

ised that this letter is your notification, under provision of public laws known as the Fair Debt Collection Practices Act (public laws 95-109 and 99-361) that your services are no longer required. I will not acknowledge or respond t

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

o any collection agency and am exercising my right to communicate only with the original creditor (name the creditor) therefore, your organization must immediately DESIST and CEASE all efforts to collect this debt."

Feel free to use

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

Professional from academic institutions, pharmaceutical industries, health care indust

any portion, or all, of the letter above. When I told my friend how simple it was to get collection agencies off your back, he couldn’t believe it. “If only I’d known," he said sadly, shaking his head.

The reason I know about this

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

is because I fell on financial hard times myself and learned the answers the hard way. In effect, I became my own consumer credit counseling service, learning everything I could about bad credit, how to improve and repair it, credit

.

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

reports, bankruptcy, FICO scores, and even segregated credit files. My story is similar to X’s, which I present in all its gory, gaudy detail on my blog.

If I learned anything from my own unhappy experience, it’s that just because

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

Companies that provide selfless information through particip

you find yourself in a precarious financial situation, you’re not powerless. The Fair Debt Collection Practices Act gives you the ability to protect yourself from abuse, harassment, and humiliation at the hands of collection agencies

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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Are low cost and high skills enough to determine which country to outsource a business or project? What if all countries offer them? What will be the determining factor? The article provides an interesting insight on the advantage of the Philippines over other Asian countries when it comes to Business Process Outsourcing.

Boozy brawls, festive flirting and festering finger-food are creating a legal minefield for employers, making the office bash one of the most risky corporate events of the year. But rather than scrap the party all together, here are the Top Ten Tips to help bosses host a safe celebration.

Many people ask me whether there is actually an alternative to bankruptcy. Well actually it might surprise you, but the answer is yes! There are many substitutes for bankruptcy and not all of these are suitable for everybody, it is necessary to look at each method in detail before making a decision.

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