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The Anti-Discrimination Board plays a great role in the employees’ lives. It insures the proper behavior at the workplace. In this article I will talk about sexual harassment and the r

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

ole ADB plays in it.

According to the Anti-Discrimination Board, sexual harassment is any form of sexually related behaviour that is not wanted, not asked for and not returned. It i

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

Examples of combination products may in

behaviour that humiliates, offends or intimidates someone. Sexual harassment can directed by a man towards a woman, a man towards a man, a woman towards a man or a woman towards a

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

woman. It can take various forms and involve, among others: unwelcome touching, hugging or kissing sexually explicit pictures, screen savers or posters unwanted invitations to go ou

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

on dates or requests for sex intrusive questions about an employee's private life or body behaviour which would also be an offence under the criminal law, such obscene communicatio

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

Combination pro

ns.

Policy and Procedure

Scott's sexual harassment policy is open to interpretation by managers and employees. Scott should have allowed for measures to provide ongoing tracking of

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

policy effectiveness, and requested an external audit of the document by legal counsel and/or specialists before introduction. He should have been more critical of his policy, and c

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

ited its weaknesses. Min's failure to act on Lee's initial complaint demonstrates that Scott's employee education programme on sexual harassment was ineffective. As a senior manager

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

Scott must ensure that the policy receives ongoing communication and promotion among all staff. Scott's informal structure of dealing with sexual harassment did not allow employees

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

to feel safe about talking to management if harassed. His practice of trying to resolve all conflicts before the weekend was a superficial solution. His policy did not promote a cul

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

ure of openness. Citing a fear of an unfair dismissal lawsuit, Scott wasn't prepared to make an effective decision about Warren after the employee confessed to the sexually harassm

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

Following aspects would a

nt accusations. Scott's inability to understand his own company's employee termination rights placed the organisation in jeopardy of being held legally responsible for sexual harass

dd to the challenges in developing combination products:

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

ment. He should have sought additional information by consulting the company's lawyers or the Anti-Discrimination Board before making a decision about Warren. He was unprepared to

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

ddress sexual harassment complaints. He should have assured confidentiality, insisted that Lee was not at any risk in naming names, and taken timely action to address the complaint.

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

Instead, he showed very little empathy toward the complainant. It is assumed that Min did not provide ongoing promotion of the policy or discussed sexual harassment with his staff,

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

o ensure they understood the company's policy toward unacceptable behaviour and sexual harassment. Had he done this, Lee may have come forward sooner. Min's reaction toward Lee indi

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

Professional from academic institutions, pharmaceutical industries, health care indust

cates he did not take the policy or complaints of sexual harassment seriously. Min failed to identify sexual harassment as unsuitable workplace behaviour and didn't view the complai

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

t seriously. Had he done so, he would have understood that it was causing Lee distress and affecting her performance, and responded.

Min exhibited avoidance behaviour by not recogni

.

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

sing sexual harassment was occuring and he was unprepared and inexperienced to address it. Had he also noted his bias toward Warren, he may have been able to apply better judgment t

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

Companies that provide selfless information through particip

address the conflict. He also failed to monitor the situation as requested by Scott, and allowed the sexual harassment to continue unabated for five months until Warren's dismissal

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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