Suggest - Relationships

Nedra, one of my clients, was quite upset when she received an email from her friend, Roxanne, ending their friendship. The email was quite blaming, telling Nedra th

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

at she was narcissistic, selfish, and uncaring. Roxanne complained that Nedra just talked about herself and was never there for Roxanne. “You don’t listen to me. You

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

Examples of combination products may in

don’t care about me. You are never there for me when I need you.”

Nedra was stunned. In her experience, this was not going on at all. “I just can’t understand how

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

she could see me this way!” she told me in our counseling session.

Nedra’s inclination was to write it off as projection. In her mind, this had nothing to do with h

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

er.

“Nedra,” I said to her, “Let’s see if we can find the lesson here. There is always something to learn from a situation like this. While this might indeed be a p

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

Combination pro

rojection, there is some way in which it has something to do with you. I’m wondering how you might have abandoned yourself in your friendship with Roxanne.”

“Well,

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

often I didn’t speak up for myself. Roxanne wasn’t really open, so I would go along with things to avoid conflict.”

“So you didn’t really take care of yourself in t

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

his friendship?”

“I guess I didn’t. I let a lot of things go. And recently I started to feel distant from her. I think I could feel that she wanted me to take care

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

of her feelings so I started to pull away. She is not open to learning and, while she talks a good talk about taking responsibility for her feelings, she doesn’t rea

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

lly do it.”

“But it sounds like you didn’t take care of your feelings either – that you ignored your own feelings to avoid conflict with her. So I would like you to

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

try something with this email you received from her. I would like you to pretend that your Inner Child – your feeling self - wrote it to your Adult. Pretend that it

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

Following aspects would a

is your Inner Child who is saying, ‘You don’t listen to me. You don’t care about me. You are never there for me when I need you.’ Does this make sense to you?”

“Oh

dd to the challenges in developing combination products:

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

yes! I can see this! I never would have thought of it this way, but I can see that she was not taking care of her feelings so she is blaming toward me for not taking

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

care of her, and I was not taking care of my feelings so I was pulling away from her. In a way, her letter to me is a gift to me!”

“Right. You can see that you nee

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

d to be going within more, paying more attention to your own feelings. It sounds like, at least in this relationship, your focus was outward instead of within.”

“Ye

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

s, I often do this. And I can see that it never works out well. I have done the same thing in my relationships with men, and the relationships have never worked out.

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

Professional from academic institutions, pharmaceutical industries, health care indust

Okay, I’m going to start to pay more attention to my own feelings. But I’m wondering what I should do about the email? I have no idea what to say to her. I feel tha

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

t I don’t want to respond to her at all.”

“Yes, I think that is appropriate. I don’t see that there is anything to say. You can send her your love and your prayers

.

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

and let it go. She has made it clear that she is ending the relationship and that she is not open to learning or exploring with you. So there is nothing for you to s

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

Companies that provide selfless information through particip

ay or do. How does that feel?”

“I actually feel relieved! I’m excited to have learned this from the letter. All my resentment is gone and I feel complete with this.

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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