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Digg It - New Bankruptcy Law - Five Essential Things to Know
Last April, Congress passed the Bankruptcy Abuse and Consumer Protection Act, the most sweeping reform of our nation’s bankruptcy laws
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
in more than twenty-five years. Proponents of the bill argue that most consumers who file for bankruptcy do so simply because they do
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
not wish to pay their bills. That is an arguable point, as studies show that most bankruptcy filers have suffered illness, injury or j
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ob loss. Regardless of the reasons, Congress has made the changes, and millions of Americans will be affected when the new law takes e
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
fect on October 15.
Here is a short list of the changes and how consumers will be affected.
Goodbye, Chapter 7 – Until now, most
Here is a short list of the changes and how consumers will be affected.
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
consumers have been permitted to file under Chapter 7 of the Federal bankruptcy code. Chapter 7 permits the court to wipe away most co
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
nsumer debt, allowing the debtor to make a fresh start. The new law establishes a “means test.” Anyone with income that exceeds the m
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
edian income for his or her state will have to file under the stricter Chapter 13 instead, which requires a repayment schedule of up to
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
five years.
Attorney problems – The more complicated Chapter 13 filings will make it necessary for filers to hire an attorne
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
y. Most attorneys who practice bankruptcy law are already reporting dramatically increased business; some are even turning clients awa
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
y. If you need an attorney, hire one now, as they are soon going to be very busy
More attorney problems - The law also leave
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
s lawyers legally responsible for the accuracy of the information filed on their clients’ behalf. This has led most lawyers to increas
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
their fees. Some, including those who do bankruptcy work on a pro bono, or free, basis, have decided to forego bankruptcy work altoge
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
ther. In short, it will soon be more difficult and more expensive to hire an attorney.
Mandatory credit counseling – Congres
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
s has required that debtors obtain credit counseling from an approved agency within six months of filing for bankruptcy. As of now, th
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
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
is requirement is largely undefined, with rules, regulations, and qualifications for counselors still up in the air.
Expect
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
to may more bills – Some obligations, such as student loans or taxes, must be paid in full even after a bankruptcy filing. The new law
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
lengthens the list of debts that cannot be forgiven.
The new legislation, rightly or wrongly, makes it more difficult, more time
The new legislation, rightly or wrongly, makes it more difficult, more time
.
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
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
consuming and more expensive for a debtor to file for bankruptcy. Consumers who are considering doing so should act now, as the regul
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
ations will soon become stricter. Bankruptcy should always be a last resort option, but if you cannot avoid it, you should act quickly
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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