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Charlotte Schools have a long history of dealing with segregation issues in public education. While current testing standards focus on the ever-pr

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

esent racial gap, notable efforts to address the issue were first started in Charlotte Schools in 1969. The Civil Rights movement brought the inequ

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

Examples of combination products may in

alities in educational opportunities of children to the forefront with a 1971 US Supreme Court ruling that imposed a 30-year term of mandatory busi

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

g.

The effects of busing were immediate. Charlotte Schools achieved integration numbers that earned the district nationwide acclaim throughout the

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

‘70s and ‘80s. Far from being the end of the story, parents of students in the Charlotte Schools had concerns. Many parents wanted the option to

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

Combination pro

end their child to their neighborhood school, rather than having them ride an hour across town. The Charlotte Schools’ magnet program also fell und

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

er attack as parents fought the limited number of slots allotted for white and non-white students.

While busing sought to bring inner city minorit

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

y children to more affluent school districts, the magnet system sought to attract middle class families and above to poverty ridden Charlotte Schoo

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

s. The Charlotte Schools offer magnet programs for gifted and talented, language immersion, math and science, global studies, and many more.

Charl

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

otte Schools’ magnet programs are free, public, and based on a lottery system. Dissatisfaction with the magnet methods came to a head in 1997 when

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

family sued Charlotte Schools because their child was denied admission to a magnet where all the non-white slots had been filled. In 1999 a judge

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

Following aspects would a

declared that Charlotte Schools had already achieved integration, and repealed the mandatory busing statute. While that motion was soon overturned,

dd to the challenges in developing combination products:

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

it was reinstated in 2002, and Charlotte Schools have been “colorblind” ever since.

Where does this leave the Charlotte Schools in 2007? With man

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

of the same issues. While many Charlotte Schools are well rated and successful on state testing measures, those that aren’t still tend to be in hi

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

gh-poverty areas. And the national racial gap that shows African-American students and other minorities (except Asian-Americans) lagging far behind

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

white students in state test scores is still huge.

Despite the innovative programs offered by many magnets in Charlotte Schools, both white and bl

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

Professional from academic institutions, pharmaceutical industries, health care indust

ack parents struggle with the issue of where to send their children. Middle class families have to decide if a gifted program in a high poverty sch

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

ool will be better that the regular classes at their neighborhood school. Will a child’s education fall behind from attending one of Charlotte Scho

.

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

ls’ lower rated facilities? Or can the strength of the magnet rise above the discipline and behavior issues that often haunt at-risk schools? Succe

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

Companies that provide selfless information through particip

ss of the magnet program in Charlotte Schools may prove to have as strong and long-lasting implications as the busing programs of the ‘70s and ‘80s

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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