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The federal government announced recently that it was creating a new law enforcement task force that will be charged with cracking down on violators of U.S. trade and travel sanctions against the island nation of C

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

uba. As part of the task force, personnel from the Departments of Commerce, Homeland Security, and the Treasury, as well as agents from the FBI, will focus on individuals and businesses engaged in commercial activi

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

Examples of combination products may in

ty, travel, and the transfer of currency to Cuba.

The sanctions, which have been in effect for more than forty years, and which will remain in place until free and fair elections are held, are supposed to isolate

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

the Castro dictatorship politically, economically, and socially. The reality, though, is that they do little more than hurt the Cuban people while the Castro brothers maintain their firm grip on power.

Historicall

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

, economic sanctions have done little to change the behavioral patterns of bad governments and ruthless dictators. Nicholas Kristof of the New York Times wrote in 2003 that "The United States imposed 85 new unilate

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

Combination pro

ral economic sanctions on foreign nations from 1996 to 2001. But sanctions, which cost U.S. companies up to $19 billion in 1995 alone, aren't a policy; they're a feel-good substitute for one."

On most issues facin

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

g America today, I find myself on the opposite end of the political spectrum from Mr. Kristof. However, the question of economic sanctions provides a rare opportunity for us to agree on a policy matter. There have

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

been very few instances where economic sanctions have hurt those in power. They almost always fail to achieve the policy aims of the nation imposing them and usually end up hurting the very people they are meant to

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

help.

For economic sanctions to work against a particular state there has to be global consensus for their implementation. Sanctions imposed and enforced by one nation alone rarely have the desired effect because

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

the sanctioned nation simply finds other trading partners to conduct economic activity. Too often, business opportunities and investment programs prevent countries from signing on to a sanctions regime, even though

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

they may find the target country's behavior objectionable.

Take for instance the recent discussions in the United Nations Security Council over Iran's uranium enrichment activities. Despite a clear threat to regi

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

Following aspects would a

onal peace and stability should Iran acquire nuclear weapons, Russia, France and China have thus far refused to go along with sanctions that would limit Iran's access to nuclear technology. All three nations have b

dd to the challenges in developing combination products:

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

siness interests in Iran and all three stand to lose money if sanctions are imposed. Even if the United States unilaterally imposed sanctions to supplement restrictions already in place, the effect on Iran's radica

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

l regime would be negligible at best.

In the case of Cuba, sanctions currently in place against the Castro regime are largely American, and as such are summarily ignored by most other nations. While Castro has cer

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

tainly been deprived of American dollars, there has been no shortage of willing trade partners or arms suppliers for the communist dictatorship. Cuba has indeed experienced significant economic troubles since the c

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

ollapse of the Soviet Union, but those fiscal woes are the result of losing the island nation's long-time economic and political sponsor and not the result of American economic sanctions.

Truth be told, sanctions

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

Professional from academic institutions, pharmaceutical industries, health care indust

mposed by the United States against Cuba hurt American businesses, Cuban-Americans with relatives living under the Castro dictatorship, and ordinary Cuban citizens. Fidel and Raul Castro have used U.S. economic san

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

ctions as a scapegoat for the island's depressed economic state without consequence.

The United States should aggressively promote democratic values and the promise of a better life without the Castros, especially

.

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

through the large Cuban population in southern Florida. The end of communist rule in Cuba is a matter of "when" and not "if." Eventually the regime will fall, much like the former Soviet Union did. In the meantime

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

Companies that provide selfless information through particip

, other methods for promoting regime change should be explored and pursued, and economic sanctions that have done more to hurt the Cuban people than the Castro government over the past four decades should be lifted

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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