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Disability, in the context of social security, is identified as a medical condition which hinders a person from performing a substantia

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

l gainful activity prevents him from obtaining sufficient income to support his family’s basic needs. Whether short termed or long term

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

Examples of combination products may in

d, incurring disability while working is very much possible. This may be due to various illnesses which may hinder the employees to per

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

orm their jobs for a certain period of time. Such experience will definitely cause the workers to loss their source of income during th

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

at time being.

In order to provide financial support to those disabled workers, the Federal government has developed the Social Securi

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

Combination pro

y and Supplemental Security Income disability programs. These two insurance benefits are indeed of great help for those people who fail

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

to get their own insurance policies from private insurance companies. Both these programs of the government are managed by the Social S

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

ecurity Administration which has the sole duty to determine whether a disabled applicant can be entitled of either benefits or not.

Ge

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

erally, the initial applications, which are filed in the SSA office for either benefit, will have big chances of being denied as well a

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 application for reconsideration. Hence, most persistent petitioners would result in filing a formal appeal of denial which they wo

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

ld brought up before an Administrative Law Judge who was given the authority to review all the denied petitions. And if in case the ALJ

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

Following aspects would a

still denied the claim, the case will be automatically brought to the Social Security National Appeals Council which will review the d

dd to the challenges in developing combination products:

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

cision of the ALJ. This appeals council has the power to reverse the decision of the ALJ. But then again, if the appeals council favors

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

the decision of the ALJ, the claimants would have nothing left to do but to result in filing a lawsuit against the SSA at a federal cou

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

rt.

The federal court hearings of a social security case involve the usual formal litigation procedure wherein the lawyer of the SSA w

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

ll try to defend their decision against the claimant’s lawsuit. Thus, if this legal endeavor still fails to succeed, the claimant may h

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

Professional from academic institutions, pharmaceutical industries, health care indust

ve the last try in the U.S. Supreme Court which will have the final ruling about the matter.

These stressful, time-consuming and compl

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

icated procedures of making appeals would not have happened if only the claimants have hired the services of a qualified social securit

.

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

attorney. A legal counsel who has the expertise and the sufficient skills in providing assistance and representation can increase the

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

Companies that provide selfless information through particip

etitioner’s chances of acquiring his benefits in such a short period of time without even going through these numerous appellate courts

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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