Advice You - Business

The subject is constantly in the news and may decide the next national elections - the infamous jobless recovery. More than 8 million American

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

s are out of work with another 4 million underemployed or no longer looking for work. Good manufacturing, technical and services jobs are bein

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

Examples of combination products may in

g shipped to India, Asia, and other developing countries. The mood of the middle and working class becomes more pessimistic, the outlook for

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

heir immediate future more grim.

Politicians debate solutions: abrogating current trade treaties, providing protection for various industries,

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

investment in retraining programs, wishful thinking that lower taxes will turn everything around, the promise of a labor shortage within 15

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

Combination pro

ears.

Meanwhile, the population grows, demanding the creation of 150,000 new jobs per month just to stay even. Where are the more than 2 mill

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

ion 2004 jobs promised by the Council of Economic Advisers?

They will come when the government truly invests in the social and financial welf

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

re of the working public. Historically, the U.S. has looked at employment only in times of crisis - recession or alarming unemployment figure

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

s. Rather than "quick fixes," we need a national long- range policy on employment which addresses the issue, in good times and bad, with susta

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

ned interest, analysis, and support.

Here are seven proposals:

1. Create a National Office of Employment to develop long term strategies and

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

oversight of the U.S. labor market in order to track trends, analyze data, research emerging problems, and prepare early interventions.

2. I

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

Following aspects would a

dentify growing and potential industries and the skills they will need in future staff.

3. Design a plan which allows for the rapid retargetin

dd to the challenges in developing combination products:

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

of training courses as Community Colleges and vocational schools are traditionally 5 to 15 years behind current needs.

4. Provide substanti

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

al tax incentives for businesses to hire in the U.S. rather than shipping their jobs to low income countries.

5. Devise "red-tape-less" progr

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

ms to reward employers with significant tax credits for hiring the long-term employed and new trainees.

6. Overhaul the processes of State Un

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

employment Offices by implementing coordinated support programs in which workers participate as part of receiving unemployment benefits and e

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

Professional from academic institutions, pharmaceutical industries, health care indust

ployers participate as a means of meeting their future needs for staff.

7. Provide incentives for employers to hire more part-time workers. S

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

imultaneously, America must reframe its social policy to promote a new work ethic of reduced work hours, along with increased leisure and volu

.

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

teer activities, to allow more workers to be employed, albeit for fewer hours. Due to the negative emotional effects of living without work,

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

Companies that provide selfless information through particip

our society needs to stress high employment rather than high productivity which often translates into fewer workers, working harder and longer

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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