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Achieving and living the American Dream requires knowing the language we use here. Immigrants who don't learn English, and even our own citizens who don't have a good grasp of the language, never reach their full potential. People who know our language a

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

re more successful, earn more income, move into better neighborhoods with better schools and make better lives for their families. Their children, in turn, are more successful and the whole country benefits.

In years past, immigrants had to learn Englis

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

Examples of combination products may in

quickly to live and work here. There was almost nothing available to them in their own languages and certainly nothing provided by the government or most businesses. Because of the distance and cost involved in visiting their homeland, most never went "

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

ome" again. They were forced to cut all ties with their past and quickly became Americans.

It is very easy for immigrants now to keep ties with their homelands. Telephones, email and airplanes all make it easy to visit often. The Spanish speaking immigr

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

nts, especially, have little need to learn English. Businesses have made the decision to serve them in their own language because of their buying power and their sheer numbers.

Chinese is probably the only other language which has enough people here to

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

Combination pro

make it fairly easy for some people to live here and not learn English. People speaking other languages have a harder time and have to learn English quicker, more like immigrants a hundred years ago had to do.

Even with the ease for many immigrants to k

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

ep their own languages, the Pew Hispanic Center says that Latino immigrants recognize the importance of learning English. 92% of Latinos believe it is “very important” to teach English to the children of immigrant families. Only 2% believe it is not, com

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

ared to 27% of non-Latinos who feel that way. I wonder who the 27% is that thinks it is notimportant to teach English to immigrant children. Many people are very upset to hear Spanish spoken in so many places, how could they not want them to be taught E

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

glish?

Regardless of what language immigrants speak, as always, immigrant families know their children will lose their native language soon. Many families are working hard to keep their language alive in their homes. Children who grow up knowing more th

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

an one language usually do better in school and have better chances for employment too.

We should be proud and happy that more of our people know more than one language. A majority of Europeans know two or more languages, only about 10% of Americans do.

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

This puts us at a distinct disadvantage in the global marketplace. Just because people know another language along with English does not mean they are less American or haven't assimilated. Retaining one's native language and being bilingual does not mean

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

Following aspects would a

they can't also be good Americans.

English is what unites us in this country. Diverse people and cultures with one language made this nation. Assimilation into our society and culture happens much faster when there is a common language. We need more cla

dd to the challenges in developing combination products:

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

ses to teach English as a second language to immigrants. There are some available, but not always at convenient times or places, with childcare to allow mothers to take the class. If the businesses that serve the immigrants in their own languages would s

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

ponsor English classes instead, many problems would be solved at once.

Assimilation also happens much faster when the people are here legally. If the people here illegally are put on a path to citizenship, they will assimilate much faster. If you knew y

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

u were in a community or school or job temporarily, would you put much effort into getting to know all the rules and all the other members or try to become a leader? Probably not if you knew you were leaving, even if you didn't know exactly when.

If you

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

were in a permanent job, community or school, you would try to fit in and get to know everyone and be a full member. It is the same thing for the immigrants here now. We can't expect them to try to learn English, learn all the laws and culture if they ar

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

Professional from academic institutions, pharmaceutical industries, health care indust

leaving at any moment. Especially if they are scared they will be arrested and deported.

Thankfully, a large majority of Americans believe that the immigrants here illegally should be put on a "tough but fair path to citizenship". They approve of the r

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

equirement of stringent background checks, fines, back taxes paid, along with fluency in English, obeying all the laws, staying employed and keeping their children in school. This large majority restores my faith in the humanity and compassion of America

.

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

s. The very vocal minority sometimes make me forget that.

Congress keeps ignoring this problem, while more and more of these immigrants are crossing our border, replacing the ones who are deported. Immigration reform and a humane, compassionate, respons

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

Companies that provide selfless information through particip

ble way to allow these people to stay legally are long overdue.

Hopefully, the large majority of Americans who believe this will become a very vocal majority and talk louder than the vocal minority. And it is time Congress listens to the majority.

####

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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