Advice Pool - Legal

Hello,

Another loyal reader recently asked me an intriguing question. It's a question that I had to think about. Not because I did'n

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

t know the answer, but because of possible ethical issues. I email this individual and asked her why she wanted to know this ( yes, a

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

Examples of combination products may in

she). She replied, " I'm a student studing toxicology at a major university. My professor told the class that no one can fool a breat

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

h analyzer test". Well, I decided to answer the question, but with a disclaimer.

Drinking while driving is serious. You could kill

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

or severely injure a fellow citizen. So don't drink and drive. Matter of fact, don't violate the law at all!

Your professor is parti

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

Combination pro

ally correct, but their is a way to avoid the actual 'conviction in court'. The analyzer may be correct, but you could convince a judg

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

e that the test was wrong. First, in most states, the difference between a DWI and DUI or not the same in most states. In the former,

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

t's involving alcohol, while in the latter, it's involving over the counter medications, prescriptions, or any thing that will impair

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

your ability to operate a vehicle. Some states call both DUI.

First, let's deal with your professor. The simple spice called garlic c

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

ould trick a test. Not a liitle but a large amount. It certainly can reduce the total score on the analyzer. Say for instance that yo

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

ur state law caps a DWI at a score of 0.9. This means that if your score is 0.8 or below, you're not legally intoxicated. Garlic cons

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

Following aspects would a

umed a few minutes before a test can bring your score down a few points. If you're driving at 0.9 and ate garlic just before the test,

dd to the challenges in developing combination products:

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

you could clock in at 0.7, which means you tricked it.

Now the conviction part. If you were stopped in your vehicle and asked to tak

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

e a test, and you failed, you will be given a court date, as well as a night or more in jail. When you bond out and appear in court,

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

ou could have a defense if you can prove the test was wrong. How? If you were taking any legal presciption containing alcohol or said

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

you had consume something like , well I can't say that. But it's something easily available over the counter. My point is that a judg

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

Professional from academic institutions, pharmaceutical industries, health care indust

e has the power to rule based on intent. A DWI or DUI thrown out of court is not a conviction.

I must say this again If you have rea

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

d any of my articles I never suggest breaking the law. My focus is on those cops who violate the law. I see this article as a debatabl

.

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

e subject for the lady who asked the question. She can now go to class and debate her professor (smile) I have learned that life has

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

Companies that provide selfless information through particip

very few absolutes. Most things have an exception.

Finally, I write these articles for information, awareness, and safety. Drive safe

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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