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Before the new law, consumers could pretty much choose which type of bankruptcy they want to file – chapter 7 or chapter 13 – within reasonable limits. The new law puts into use a “means test.” This te

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

st, administered by the bankruptcy attorney, will determine which bankruptcy the consumer is allowed to file.

The means test looks at your income and expenses in a particular way. With income, your at

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

Examples of combination products may in

torney will average your income from the last six months. He takes this average and measures it against your state’s median income. Your average income for the six months is used regardless of whether

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

you’ve lost your job recently or had a pay cut. Therefore, for some people, the average income might be higher than their actual income, which could hurt them in light of the new bankruptcy laws.

The

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

second part of the means test, expenses, examines your outgoing cash flow, minus your rent/mortgage payments, child support, past due taxes, car payments, and $1500 in private school tuition. The attor

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

Combination pro

ney then determines if you can pay out at least $100 per month to unsecured creditors.

What does means test really mean? If your average income is above the state median, you must file chapter 13 bank

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

ruptcy, unless your circumstances are extenuating. If your income is below the median but it is determined that you can pay the $100 per month to unsecured creditors, you also must file for chapter 13

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

bankruptcy. Ultimately, however, the judge decides whether your circumstances are extraordinary enough to warrant a chapter 7 filing. The next few years of bankruptcy filings under the new laws will sh

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

ed more light on what counts as an extraordinary circumstance.

The new laws include a residency provision. Some states, such as Florida, have more consumer-friendly bankruptcy jurisdictions than other

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

s. People would move to the favorable state and immediately file bankruptcy. Under the new laws, you must be a resident of the state in which you’re filing for two years.

Your personal possessions car

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

ry a higher value under the new laws. Attorneys used to advise people to list all their possessions and value them according to what they could get for them at a garage sale. Today, possessions must be

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

Following aspects would a

valued at full replacement value, taking into account its age and condition. Attorneys must then certify that the values are correct. What does this mean to the consumer? Ultimately, when your possess

dd to the challenges in developing combination products:

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

ions are worth more, you could end up paying creditors a higher amount.

Bankruptcy filing-related fees are expected to double under the new laws. Costs involved in filing bankruptcy ranged in the $700

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

-1500 area. Now, fees can be as high as $3000. This is because the new laws put an extra burden on the attorneys. They must certify the filer’s income, expenses, and assets, in addition to other burden

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

s that the new laws place on them.

While there are many other considerations under the new bankruptcy laws, these are some of the major provisions. What are some alternatives to filing bankruptcy?

On

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

e option is to do nothing, especially if you have very little in terms of property and assets. The government can’t take away any of your basic, necessary assets, such as clothing, food, social securit

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

Professional from academic institutions, pharmaceutical industries, health care indust

y, and ordinary furnishings. You also can’t go to jail for not paying your debts. If someone tries to sue you, they can’t collect because you have no assets to collect upon.

Another alternative is to

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

do your own negotiating with your creditors. For many, accepting a settlement of a lesser payment or payoff is more desirable than getting nothing in bankruptcy.

Regardless of whether you file bankrup

.

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

tcy or go with an alternative, keep a close eye on your credit scores. Make no mistake, your score will take a tremendous hit after filing. However, it’s not unusual to raise your score dramatically wi

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

Companies that provide selfless information through particip

thin a year or two with a solid score-boosting plan in place. Two years after your bankruptcy is discharged, you’d be surprised at how many credit options you’ll have available if your score is boosted

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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