Advice You - Finance

Chapter 13 is a bankruptcy law under which a petition can be filed by an individual or company. Chapter 13 dictates that

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

the debtors repay the debt amount from their monthly earnings in installments. The court decides the time within which

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

Examples of combination products may in

the decided amount has to be repaid to the creditors. Most of these will be for a maximum period of five years.

Employe

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

s and firms who have a steady income, in spite of all the debts incurred, can file a bankruptcy under this law. Since th

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

is law does not require any assets to be secured as liens, most people prefer this to the Chapter 7 law. This allows the

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

Combination pro

debtor to keep a mortgaged home or car even while he’s paying his creditors from the monthly salary.

As in the case wit

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

h Chapter 7 law, the automatic stay injunction is sent to all the creditors soon after filing the case and receiving the

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

case number.

The debtor has to provide the details regarding the method of repayment. This might mean paying the credi

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

tors with the entire net income, other than absolutely necessary for basic needs, for about 3 to 6 years. The court wil

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

decide the amount that will be required for such basic needs. If some of the assets are not completely exempted, then t

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

hat amount also has to be repaid within the given time slot.

As in the case of the Chapter 7 law, the individual gets t

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

Following aspects would a

o meet the trustee to provide the trustee with the details of income and the proposed plan to pay back the creditors wit

dd to the challenges in developing combination products:

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

in a given time frame. The trustee needs to make sure that the case is not fraudulent and that the plan provided by the

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

individual will meet the creditors debt within the specified time limit.

The creditors can object to the plan provided

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

y the individual before the final hearing in the court or even before the meeting with the trustee. Creditors can file 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

heir claim within 90 days after the individual’s meeting with the trustee.

The payments can start 30 days after filing

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

Professional from academic institutions, pharmaceutical industries, health care indust

he case till the end of the plan term. All the details will be taken care of by the attorney. However, the payments mus

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

t be made without fail to avoid the dismissal of the case in court. Current payments must also be taken care of simultan

.

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

ously to avoid leaving the case pending. This might result in the asset being taken away after the specified term finish

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

Companies that provide selfless information through particip

es. A discharge order at the end of the term has to be sent by the court to confirm the absolute discharge from the case

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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