Advice You - Finance

The National Association of Consumer Bankruptcy Attorneys has recently reported on early statistics, which confirm the concer

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

ns espoused by opponents of much of the recent Bankruptcy “Reform.” The report provides the first analysis of the over 60,000

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

Examples of combination products may in

consumers who have filed for bankruptcy protection since the enactment of the “Bankruptcy Abuse Prevention and Consumer Prot

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

ection Act” (“BAPCA”) (editors note: the use of the term ‘Consumer Protection’ in the title of this statute is nothing short

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

of Orwellian) in October of 2005. The full text of this report, entitled: Bankruptcy Reform's Impact: Where Are All the Deadb

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

Combination pro

eats, may be found at http://nacba.com/news/releases/022206.php.

In its report, the NACB concludes that the changes put in p

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

lace by Congress are not working as intended. Among other things, the report finds that of the 61,335 consumers seen so far b

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

y credit counseling firms nearly all (97%) are unable to repay any debts, and four out of five would-be filers were forced in

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

to dire financial straits by circumstances beyond their control, such as the loss of a job, catastrophic medical expenses or

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

the death of a spouse. It is almost certain that, due to the dramatic increase in administrative expenses and new hurtles to

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

ecovery of preferential transfers created in the new legislation, unsecured creditors are likely to be receiving less, not mo

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

Following aspects would a

re, in bankruptcy dividends and distributions.

And now, in a recent development, the National Association of Consumer Bankru

dd to the challenges in developing combination products:

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

ptcy Attorneys, together with the Connecticut Bar Association has brought suit to have portions of the law, relating to debt

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

counseling, declared unconstitutional. This, alas, is what comes of Congress’s having abdicated its legislative function and

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

having given a drafting pen and a free hand to the credit card industry. Unfortunately for that industry, the legislation it

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

wrought is sloppily drafted, and more importantly, will hurt consumers and not help the issuers of credit cards. Nobody is be

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

Professional from academic institutions, pharmaceutical industries, health care indust

nefited, and, in the opinion of this author, much of this legislation will ultimately be undone.

One does not ordinarily thi

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

nk of Otto von Bismarck (or any German leader, for that matter) as a wit. But his well-known and pithy quote to the effect of

.

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

: “If you love laws and sausages, you should never see either one made,” seems particularly apropos. One would hope that our

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

Companies that provide selfless information through particip

future legislators will, if they want to sell their votes, at least do the drafting themselves.

Warren Graham Copyright 200

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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