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Thomas Jefferson was an early and courageous champion of keeping government and churches institutionally separate. Few aspects of his public life characterized h

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

im more than this lifelong conviction.

Jefferson authored the famous Virginia Statute for Religious Freedom, and wrote repeatedly on the subject of faith, often

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

Examples of combination products may in

xpressing his skepticism and distrust of organized religion. In 1816, he bitterly wrote that the “dogmas of religion…have been quarreling, fighting, burning and

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

torturing one another, for abstractions unintelligible to themselves and to all others, and absolutely beyond the comprehension of the human mind.” In 1815, he wr

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

te of the “loathsome combination of Church and State.”

Jefferson clearly did not want to see government caught up in what he considered the irrational and often

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

Combination pro

violent turbulence systemic to organized religion. He believed that civil government should refrain from meddling in religious quarrels; and, likewise, competiti

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 (often adversarial) sectarian groups should not incorporate the arm of government into their arena.

However, despite the outrageous claims of his political opp

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

onents in the 1796 and 1800 presidential elections, Thomas Jefferson was no atheist. He most assuredly believed in God, and never retreated from his prominent me

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

tion of the Almighty in the most famous portion of the Declaration of Independence: “We hold these truths to be self-evident, that all men are created equal, that

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

they are endowed by their Creator with certain unalienable rights…” Underscoring this very religious sentiment (that our fundamental rights come from the Creato

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

, and not government), Jefferson asked later: “And can the liberties of a nation be thought secure when we have removed their only firm basis, a conviction in the

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

Following aspects would a

minds of the people that these liberties are of the gift of God?"

Believing an overall acknowledgment of God was critical, Jefferson nevertheless opposed religio

dd to the challenges in developing combination products:

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

us oaths and tests for public officials, and stood against the notion that a state, let alone the federal government, should establish a preferred religious denom

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

nation. Colonial Virginia, where Jefferson was born, had done this very thing. Prior to the American Revolution, Virginia recognized the Church of England as th

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

e official church of Virginia and required local communities to pay the salaries of their Anglican ministers. Jefferson’s contemporary, Patrick Henry, became fam

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

us by challenging this practice.

While Jefferson would’ve taken strong exception to the United States establishing a particular Christian (or Jewish or Muslim) d

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

Professional from academic institutions, pharmaceutical industries, health care indust

enomination as a national church and while he himself was not an active member of any mainline Christian congregation, it appears he nevertheless would have agree

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

with the assertion of our Pledge of Allegiance that America’s very identity, at least insofar as its commitment to the fundamental rights of the people is concer

.

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

ned, is based on God – or, in Jefferson’s words, “on the Laws of Nature and Nature’s God.”

Jefferson's death in 1826 - on the 50th anniversary of the signing of

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

Companies that provide selfless information through particip

he Declaration of Independence - brought to a close one of the most significant lives in American history, though his legacy, particularly on this issue, lives on

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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