E-Articles - Reference and Education

Parents of special needs students in the Atlanta Schools rejoiced this past week when Georgia Governor Sonny Perdue signed into law the Georgi

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

a Special Needs Scholarship bill. Formerly known as Senate Bill 10, the proposed voucher plan has been watched closely by parents and educator

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

Examples of combination products may in

s in Atlanta Schools.

The law will use state funds to offer vouchers to parents of children with special needs in order to provide them with

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

more appropriate school options. Atlanta Schools’ teacher, and parent of a child with autism, Linda Bryant Butler expressed her pleasure in a

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

recent article in the Atlanta Journal-Constitution, “…parents like me are ecstatic that we will now have a choice. If one school doesn’t work

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

Combination pro

for Xavier during his 12-year academic career, I know he won’t be trapped. He will have the choice to seek a better education elsewhere,” she

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

said.

Parents in Atlanta Schools and throughout the state will have the option of using vouchers to attend a different public school or a pri

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

vate school. In order for a child to be eligible, he or she must have a documented developmental disability (such as Autism or Tourette’s Synd

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

rome) and have attended public school for at least one year. Estimates are that the program will provide $4,000 worth of vouchers in the first

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

year, and that amount will increase to about $15,000 a year. Atlanta Schools’ educators are expressing some mixed feelings over the vouchers.

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

Proponents say that this is the only way Atlanta Schools can truly meet the needs of these exceptional learners. It simply isn’t possible to

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

Following aspects would a

have a specialist for every disability at every school. They also point out that Atlanta Schools’ teachers already struggle to meet the needs

dd to the challenges in developing combination products:

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

of students without developmental delays.

Opponents express concern over both the standards of private schools, and the removal of funds fro

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

m the public school sectors. Atlanta Schools receives government funding on a per pupil basis, and the loss of an additional $9,000 (the estim

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

ated average voucher payout) per student could weaken the abilities of the public schools.

Governor Perdue has stated that this law will give

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

parents more control over their children’s education, and that they “understand the needs of their child in the way only a parent can.”

Atla

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

Professional from academic institutions, pharmaceutical industries, health care indust

nta Schools have debated voucher programs, along with the rest of the nation, for years. But if the program is successful, Atlanta Schools may

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

find itself copied around the country.

Not all Atlanta Schools’ parents with special needs children will opt for the program. If a child is

.

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

successful at his current Atlanta School, no changes will be made. But if parents are interested in applying for the scholarship program they

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

Companies that provide selfless information through particip

should visit the Georgia Department of Education website at www.doe.k12.ga.us and click on the link for the Georgia Special Needs Scholarship.

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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