Actual - Legal

In order to understand the thought process in the legal system it is important to understand how the individuals involved interpret things. When it comes to the treatment of statutory rape offenders, for example, this is but one attitude that can be fo

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

und in such places as the LawEnforcement NetBase(1):

"These offenders [referring to statutory rapists in consensual situations] tend to function fairly well aside of their recent abusive or sexually assaultive behavior. They tend not to present w

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

Examples of combination products may in

ith personality disorders or other mental health disorders, and tend not to have abusive backgrounds or difficulty with employment or in relationships in general."

Maybe it's because consensual sexual relations are normal? In other words, those in the

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

legal system are predisposed to prejudice based on the existence of the law and are, to a good degree, unable to think objectively about it due to their occupational position. Let me show you yet another example of how this occurs everyday by offering

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

a snippet of conversation given to me by a MoralOutrage.Net member:

Police Officer: "What he did to you was horrible."
Young Girl: "He didn't do anything to me."
Police Officer: "He victimized you and took advantage of you."

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

Combination pro

Young Girl: "He didn't victimize me, I wanted to have sex with him."
Police Officer: "That's what he wants you to believe."
Young Girl: "I had sex because I wanted it, not because anybody made me think I wanted it."

Ca

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

you see the circular reasoning? The law states that minors are unable to legally consent therefore those in the legal system simply dismiss the logic that teens can and do consent. Their logic is based on the law instead of the laws being based on log

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

ic. I can find no better example of this legal bigotry than from Georgia's own top Republican senator, Eric Johnson, of Savannah. Every one familiar with the Genarlow Wilson case understands the absurdity of his case. He was 17 when he was convicted of

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

having consensual oral sex with a 15 year old. Many appeals to logic and common sense have gone through the courts but they have been consistently opposed by Rep. Eric Johnson. His opposition to common sense and his stupidity (and I use that word in 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

s fullest force) can be viewed in this CNN transcript excerpt(2):

******

EDDIE BARKER, DOUGLASVILLE PROSECUTOR: From what we’ve seen on the videotape and heard from the victim ourself, we do not believe there was any physical force used.

[

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

CNN CORRESPONDENT RICK] SANCHEZ: No physical force? Doesn’t matter. Nor does it matter that it was consensual sex between two teens. Ten years, mandatory, no way around it. The law that ensnared Genarlow is so illogical that if he’d had intercourse with

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

Following aspects would a

the 15-year-old instead of oral sex, his punishment would only have been a misdemeanor. Back to the Georgia legislature, which recently changed the law but didn’t change Genarlow Wilson’s punishment. Why not?

State Senator Eric Johnson took the floor.
dd to the challenges in developing combination products:

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

ERIC JOHNSON, GEORGIA STATE SENATOR: Mr. Wilson participated in multiple sexual acts with a minor while she was unconscious.
SANCHEZ: Wrong. The girl was not unconscious. The senator also said she was raped. That’s not even what
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
the prosecutor thought. So we called the senator and asked for an interview.
(on camera) Do you feel bad about the fact that you characterized this as a rape when you were talking yesterday in the Senate?
JOHNSON: No.
SANCHEZ
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
: You don’t have any problem with that?
JOHNSON: No.
SANCHEZ: Because it wasn’t a rape.
JOHNSON: It’s a rape in my mind.
SANCHEZ (voice-over): Here’s what it was in the minds of the jurors. We know; we talked
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
to them.
MARIE MANIGAULT, JURY FOREPERSON: When we viewed the tape, there was absolutely nothing in there that showed us that he in any way encouraged this person, even invited the person to come.
SANCHEZ: So for now, the Georgia
ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
legislature has done nothing, leaving Genarlow Wilson behind these walls, hoping some day for justice.
*****

While Rep. Johnson serves as a worst case example, attitudes such as his are all too common. People like him can not be reasoned with, they
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
can only be voted out of office. Others however will respond to logic. Matt Towery, for example, is among those individuals who have stood up for integrity in the Georgia legislature and said, "The law is broken."

Understanding the mindset that creat
.

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
d such laws is, without a doubt, a difficult thing. It is none the less important to understand that mindset in order to know how to make your appeals to logic so that the laws may be changed. Statutory rape laws, as has been shown countless times, def
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
initely pave the road as an antithesis to freedom by destroying common sense. Maybe, with the work and help of the level-headed, common sense will once again become common and the minds of our legal system can be reshaped by the people - for the people

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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Actual - Reshaping Minds In The Legal System

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