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What does FICA stand for?

FICA stands for the Federal Insurance Contributions Act. The history of the act reverts back to the year 1935, when the government implemented the social s

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

ecurity program. A provision to include social security taxes was included in this act. However, due to concerns over the constitutionality of the 1935 act, there were amendments mad

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

Examples of combination products may in

e and the provision for collecting social security taxes was moved to the Internal Revenue Code in 1939. At this time it was renamed the Federal Insurance Contributions Act.

What is

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

FICA exactly?

The Federal Insurance Contributions Act authorizes the IRS to collect taxes for the benefit of the social security program. Intuitively, we might think of these taxes

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

s social security taxes, but more commonly they are referred to as FICA taxes. These FICA taxes serve as deposits into the federal social insurance program we think of today as Social

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

Combination pro

Security.

According to FICA, you must contribute 12.4 percent of your earned income up to the predetermined limit of contributions, and another 2.9 percent must be contributed to Med

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

icare. It is important to note that there is no earnings limit on the Medicare portion of the tax, and thus in practice one is taxed 2.9 percent of all earned income, regardless of yo

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

r total income level.

For those working for hourly wages the tax levels are different. Hourly employees contribute 6.2 percent for Social Security and 1.45 percent for Medicare. Hop

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

efully you noticed that this is just half of the standard rates. There is good reason for this as your employer is required to pay the other half of the rate for Social Security and M

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

edicare contributions. In other words, for those working at hourly wages, the employer must match the employee contributions.

How would you spend your FICA?

Let’s imagine we live in

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

a perfect world, and we don’t have to pay taxes. That means no more contributions to FICA. Now, after the excitement settles down we must decide what to do with our extra income. Le

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

Following aspects would a

t’s pretend we work a part time job, because we are still studying to get our degree in economics. Fortunately, we have a decent job paying $11 bucks an hour assisting an up and comin

dd to the challenges in developing combination products:

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

g lawyer. Typically, we put in a 25 hour work week, meaning we make about $275 a week. That is exactly $1100 dollars every month. If we made $1100 every month, the FICA taxes we wou

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

ld normally contribute would break down like this:

Social Security: $1100 X 6.2% = $68.20
Medicare: $1100 X 1.45% = $15.95

$84.15

So by not having to pay taxes

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

particularly FICA, we would increase our cash flow by $84.15 each month. Now the fun begins. What are the ways we could spend our hard earned cash. I know what I would do. I would

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

begin by signing a lease agreement with TiVO for one of their popular digital video recording options. With this contract, I allocate $12.95 of my savings each month to the TiVO serv

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

Professional from academic institutions, pharmaceutical industries, health care indust

ice. To complement my new DVR, I would go ahead and splurge on the best cable TV service in the area. I estimate the cost would come in around $50 a month. As a college student I wou

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

d likely be coerced into filling the music void in my life by signing up for an all you can consume digital music subscription service, running approximately $9.95 a month. Just like

.

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

that I am only left with about $10 a month, which could easily be spent seeing a one or two movies every month.

Snap Back to Reality

Well, unfortunately life is not that easy. We do

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

Companies that provide selfless information through particip

have to pay FICA, and the contributions we make go a long way in improving the living conditions of others. So for now, plan on paying those FICA taxes, or should I say contributions

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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Have you ever thought about how your retail organization handles the distribution and record keeping for its mechanical keys? If you have, what did you conclude? That the current system is a cornerstone of your security program or a liability? If you're like most, you might have reached the decision that it was just too stressful to think about and simply stopped thinking about it.

While your general bookkeeping education and experience can offer you the opportunity to reach into many types of business, specializing in one or more types of businesses or industries will allow you to work within areas that are of interest to you and perhaps are passionate about.

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