Answers - Legal

I read an interesting statistic recently that was published in a well-known online newspaper. According to the article, one out of three otherwise-healthy adults will experience a long term state

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

of disability (due to an accident or illness and lasting a month or longer, with the possibility of being permanent) prior to age sixty.

Upon reading this statistic, I immediately perked up since

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

Examples of combination products may in

one out of three odds is fairly high. However, I had little trouble believing the statistic: as a former disability claims examiner, it was once my job to do nothing but evaluate the records of in

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

ividuals both young and old who had been severely affected by an injury or illness. Most individuals, however, unless they've known someone whose ability to work was profoundly diminished by an im

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

airment, never consider the possibility that they might, at some point, become disabled. Unfortunately, the limiting effects of an accident or disease are closer than many of us would care to know

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

Combination pro

So, what does an individual who can no longer work do? Answer: they file for benefits. The next obvious question question, of course, is what kind of benefits? Answer: everything you may possibl

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

be eligible for, incuding workers compensation benefits, short term disability benefits, long term disability benefits, and, last but not least, federal disability benefits.

Federal disability b

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

nefits are provided by two programs, both of which are administered by the social security administration. The first program is established under title 2 of the social security act and it is known

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

by many abbrevations and acronyms such as RSDI (retirement, survivors, and disability insurance), DIB (disability insurance benefits), and SSDI (social security disability insurance benefits). How

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

ver, most individuals simply refer to this program as social security disability, or SSD.

The second disability program that

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

s administered by the social security administration is established under title 16 of the social security act and is known as SSI, which stands for supplemental security income.

How are these two

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

Following aspects would a

disability programs different? They differ in a number of ways, both in terms of basic eligibility requirements and in terms of intended purpose.

SSI disability is fundamentally a needs-based pro

dd to the challenges in developing combination products:

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

ram. As such, there are certain limiting prerequisites to filing for SSI. The first prerequisite is that a potential SSI claimant cannot have countable assets that exceed two thousand dollars. Wha

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

are countable assets? They include money in bank accounts, real estate property other than one's home residence, and almost any asset upon which an individual does not rely for the most basic nee

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

s, and which can be liquidated fairly easily.

SSI benefits are intended for minor-age children who are disabled and for disabled adults who are not covered for SSD, as a result of insufficient co

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

tributions to the disability system via payroll deductions.

SSD, or social security disability, is different. It is not a nee

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

Professional from academic institutions, pharmaceutical industries, health care indust

s-based program and is treated by the federal government as a form of insurance. In fact, whether or not an individual can apply for SSD depends soley on their insured status. In other words, has

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

he individual worked long enough to earn the minimum number of credits needed to be insured for SSD? Individuals who are insured for SSD benefits are allowed to file for SSD benefits. Individuals

.

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

ho are not insured for SSD may have a disability application taken in the SSI program, assuming that they do not possess assets in excess of the two thousand dollar limit.

SSD and SSI benefits, h

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

Companies that provide selfless information through particip

wever, are both administered by the same federal agency, the social security administration. For this reason, disability claims in either program are handled and processed in an identical fashion

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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Answers - Basic Facts about the Federal Disability Programs - SSD and SSI

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