Answers - Legal

Mediation and Arbitration are also referred to as Alternative Dispute Resolution. Mediation and Arbitration

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

can be used to assist parties reach a resolution without having to spend the time and money involved with g

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

Examples of combination products may in

oing to court.

“There are many businesses and individuals that come to me to act as an arbitrator or mediat

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

r for a few different reasons,” says Philip R. Brown, a litigation attorney in Honolulu, Hawaii. “Not only

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

am I an experienced litigation attorney, but rising court costs and the time a lawsuit takes both make Arbit

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

Combination pro

ation and Mediation very attractive to people who are looking for a way to reach a resolution.”

While both

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

Arbitration and Mediation resolve issues between two or more parties outside the court, they are different i

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

how the resolution is reached:

- Arbitration – During Arbitration, an experienced litigation attorney is a

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

ppointed as the arbitrator. Then, both sides present their issues and arguments, and the neutral arbitrator

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

makes a decision. The litigation attorney acting as the arbitrator decides on the resolution in a similar c

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

apacity to a judge. Arbitration can either be binding or non-binding. Binding Arbitration has the same res

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

Following aspects would a

ult as a legal judgment, while non-binding Arbitration is used merely as an advisory opinion.

- Mediation –

dd to the challenges in developing combination products:

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

Mediation is another alternative to traditional litigation in the courtroom, and it is less formal than an a

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

rbitration proceeding. During Mediation, parties are able to discuss possible solutions without the confine

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

of the litigation. With Mediation, a litigation attorney is appointed as the mediator and facilitates disc

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

ussion of the problem between the two parties. After the Mediation process of discussing the issue, negotia

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

Professional from academic institutions, pharmaceutical industries, health care indust

ions are made to reach a resolution, and the mediator offers their opinion about the best course of action.

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

Unlike Arbitration, Mediation is not legally binding.

If you are looking for a way to resolve a conflict w

.

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

th another person or business, but would like to avoid the hassles of a drawn out legal process in the court

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

Companies that provide selfless information through particip

room, you may want to consider Arbitration or Mediation from an experienced litigation attorney in your area

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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Answers - Mediation, Arbitration, and the Role of an Experienced Litigation Attorney

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