Main Subject - Business

Recent corporate financial scandals have highlighted the importance of business ethics and legal compliance. Yet a recent National Association of Corporate

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

Directors (NACD) survey of 280 corporate CEOs and directors found that "only one of three directors felt that they were highly effective in ensuring legal c

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

Examples of combination products may in

mpliance".

Ethics in Business

Most companies realize that they need to develop and implement a business ethics and compliance program.

An effectiv

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

e program can:

• Establish a code of conduct that reduces risk of criminal behavior

• Detect wrongdoing, foster quick investigations, minimize consequence

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

• Demonstrate company’s ethical/legal philosophy during an investigation

• Reduce fines if company is found guilty of wrongdoing

• Enhance company reput

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

Combination pro

tion and stature

Looking at the Options

But how do you build an effective program? Companies find themselves with three options to build the progra

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

m:

• Develop in-house from scratch

• Hire an external consultant

• Use a pre-written manual

And most of these companies learn a few lessons - sometimes

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

he hard way.

Making a Strong Company Policy

Developing a program from scratch can be very time consuming and costly. Also, the company might not ha

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

ve the knowledge or understanding of the complexity involved. But hiring an external consultant is not always a cost effective option either. So what’s left

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

Developing Your Business Ethics Program

By using a pre-written template or manual, many companies have found it easier to develop their business e

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

hics program. And to do this, they look for what a strong program needs.

A highly effective tool for creating, organizing and implementing a sound business

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

Following aspects would a

ethics and compliance program should provide:

• Sample policies and procedures

• Step-by-step instructions for the development of a program

• A business

dd to the challenges in developing combination products:

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

ethics training program outline with classroom materials and a detailed session leader’s guide

• Business ethics and compliance officer position descriptio

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

n

• Templates for employee involvement

• Sample code of conduct

Implementing Your Business Ethics Program

If the company board has committed to a

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

strong business ethics and compliance program, the next step is to put the manual in the hands of corporate executives responsible for implementation. Used

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

roperly under advice of legal counsel, this efficient tool will yield a solid program that the board can understand, endorse, and monitor for effectiveness.

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

Professional from academic institutions, pharmaceutical industries, health care indust

With step-by-step guidelines and accompanying examples of policies, procedures, training program, and employee survey, an effective tool provides an excel

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

ent road map for implementing an ethics and compliance initiative.

Maintaining a Culture of Ethics

Companies should make certain that their ethics

.

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

compliance manual provides fully editable MS Word files with sample policies, surveys, forms and training session outlines. Also, businesses should ensure t

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

Companies that provide selfless information through particip

eir ethics compliance system manual is fully endorsed by The National Association of Corporate Directors (NACD) as a tool to maintain a culture of integrity

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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