Advice Pool - Legal

• Three partners of a law firm were flying out of town to attend a convention. Halfway through the trip, one of the partners said to the seco

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

nd partner, “Oh no, I forgot to lock the office safe”. The third partner quickly responded, “Don’t worry all three of us are here”.

• Questi

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

Examples of combination products may in

n – “What’s wrong with telling a lawyer joke”? Answer – “Lawyers don’t think they’re funny and no one else thinks they’re jokes”.

• Question

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

– “What do honest attorneys and UFOs have in common”? Answer – “You always heat about them but no one has ever seen one”.

Chances are you ha

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

e heard numerous jokes pertaining to attorneys, and admittedly some are actually funny! However, while some can be taken lightly, others are

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

Combination pro

lmost gruesome. The love/hate relationship between attorneys and clients has been going on for a long time. Unfortunately, some attorneys pr

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

bably deserve to have a joke written about them but most are good, honest, and reputable people trying hard to make a difference in a person’s

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

life and society.

Although there are a number of negative perceptions associated with attorneys, the one that seems to keep hanging on is act

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

ally slightly misguided. Much of the public believes that all attorneys squeeze clients dry, charging them for every dime spent, often associ

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

ted with outlandish lawsuits. Believe it or not there are industry standards and state bar guidelines as to how attorneys charge clients and

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

re paid. The best way to avoid billing surprises is to agree in advance on how and what you are charged for and the expected timelines and ou

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

Following aspects would a

comes.

The media has played a huge role in our overall perception of lawyers from news reports involving attorneys to attorneys (fictional an

dd to the challenges in developing combination products:

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

reality). If you were to turn on any major news channel, the majority of issues being reported whether they involve attorneys or not are oft

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

n negative. We don’t hear news stories about attorneys doing their job, but we do hear of the isolated case of bad behavior. Therefore, the

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

ublic assumes that one story pertaining to a crooked attorney represents all attorneys, which is simply not the case.

We also have the percep

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

ion that many attorneys are hard nosed sharks. We love to hate this type of attorney but it’s also exactly the kind of representation we want

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

Professional from academic institutions, pharmaceutical industries, health care indust

on our side of the bargaining table! In a recent example Nancy Grace accused the mother of a missing child of holding back information. The

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

other committed suicide shortly after the hard hitting interview and the family partly blamed Grace. While Grace may have doggedly sought the

.

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

truth, it’s unlikely that her decided lack of sympathy caused the woman’s death. The public was horrified at the behavior, and yet if you nee

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

Companies that provide selfless information through particip

ed legal representation, would you want someone unsympathetic to the other side? Someone who would aggressively pursue justice on your behalf

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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