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The Compensation Committee is appointed by and serves in an advisory role to a company’s Board of Directors. It makes the import

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

ant final decisions on many executive compensation matters, including the types and particulars of the pay plans themselves, the

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

Examples of combination products may in

mount of compensation, and even the performance measures and specific targets upon which the executives will be judged for purpos

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 of calculating incentive awards. The following are the primary duties and responsibilities typically assigned to the Compensati

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

n Committee by the Board:

· Develop the compensation philosophy for the company and ensure that it is consistent with the compan

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

Combination pro

’s business strategy, mission and culture.

· Approve any compensation plans in which Officers and Directors are eligible to part

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

icipate, subject to the review of the full Board and shareholders, as appropriate.

· Recommend, provide oversight and approve aw

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

rds of stock options and other equity, perquisites and other benefits, and employment and change of control contracts, subject to

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

Board and shareholder approval, as required.

· Act as liaison between the CEO and Board on all compensation and human resource i

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

sues.

· Recommend and/or approve the CEO’s compensation to the Board, as well as the compensation for his/her direct reports as

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

whole.

· Recommend the compensation package for Board members, subject to approval by the entire Board.

· Recommend performanc

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

Following aspects would a

e criteria and specific annual and long-term performance targets for salary increases and/or awards under the various executive c

dd to the challenges in developing combination products:

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

mpensation programs.

· Review company’s performance in relationship to established targets and to peers, as appropriate.

· Appr

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

ve the company’s overall compensation budget and plan concepts. However, it is inappropriate for the Compensation Committee to be

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

ome involved with the specifics of compensation design or planning covering non-officer personnel, unless they carry over from 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

executive plans, or require Board or shareholder approval.

The Committee can and must provide the meaningful oversight within t

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

Professional from academic institutions, pharmaceutical industries, health care indust

he organization, by providing a “check and balance” on compensation matters, to ensure that the compensation paid is competitive

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

nd appropriate given the level of performance attained, and that such plans are consistent with the organization’s strategy and b

.

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

siness plan.

The Committee must also provide the transparency required in today’s more open and highly legislated business envir

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

Companies that provide selfless information through particip

nment; furthermore, it must ensure that compensation matters are conducted in a completely ethical and highly professional manner

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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