Actual - Real Estate

Sixty-nine percent of Americans are homeowners, and they are under siege. A number of "unfriendly" policies, proposals and court decisions within the past year have produced an atmosphere which is arguably antithetical to the American dream of carving out a slice of

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

the apple pie and plopping a single family residence on it.

The assault weapons have catchy titles, such as inclusionary zoning, smart growth, density bonus incentives, eminent domain and mortgage interest tax reform. It could be said that corporations and develop

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

Examples of combination products may in

ers attack from one side while politicians and government officials, acting in the interest of the less well-off, attack from the other.

In the tug-of-war between the "have a lots" and the "have a littles," the flag shifts back and forth in an effort to balance int

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

rests, and those in the middle are swept along for the ride.

This argument is more than a refrain of "the gap between the rich and the poor" tune as sung in Kevin Phillips' Wealth and Democracy, Lester Thurow's Fortune Favors the Bold or Lawrence Mish

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

el's The State of Working America. The "middle" encompasses more than the middle-class. Most homeowners are at risk.

"Eminent domain" refers to the government's right--with fair compensation--to seize private property for public use, such as when residences

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

Combination pro

ould be bulldozed to make room for much-needed freeway. But in this "property assault era," the U.S. Supreme Court has ruled that the word "public" can be synonymous with the word "private." Do you remember what the definition of "is" is?

Any private property that

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

can produce greater tax revenues in the hands of a more enterprising private property owner, such as a corporation that plans to build a shopping mall or high rise, could be plucked away for so-called public benefit. Attorney Dana Berliner said of the ruling, "This

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

s a dark day for American homeowners."

An "attempted assault" emerged recently from President Bush's tax-reform panel, which proposed replacing the mortgage interest deduction with a meager tax credit equal to 15 percent of the homeowner's mortgage interest. Accord

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

ing to Al Mansell of the National Association of Realtors, this could translate into a 15% decline in home prices in some parts of the country; and therefore, a significant loss of equity for homeowners. Fortunately, Congress is not expected to countenance the recom

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

endation.

Because measures related to eminent domain and mortgage interest tax deductions are criticized by a vocal majority, they are unlikely to become permanent policy. However, inclusionary zoning, smart growth and density bonus incentives are another matter al

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

together.

"Smart growth" (SG) is supposed to be smart, but it can be short-sighted. SG advocates generally promote taller structures near mass transit lines, greater use of the existing infrastructure, conversion of obsolete and distressed commercial and industrial

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

Following aspects would a

buildings into mixed-use properties and preservation of the countryside from urban sprawl. While these goals are noble and often sound, the impact of high density building upon existing residents must be factored into the equation.

"Smart growth" could be likened

dd to the challenges in developing combination products:

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

to a finely constructed ship. Without fuel, a place to dock and an unobstructed sailing path, the boat is useless. "Smart growth" proponents must consider the capabilities of the existing infrastructure to fuel new growth; they are often not upgraded to handle addit

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

ional customers. They must factor in the parking and traffic situation--especially along mass transit lines which may already be congested—and the current density figures for the target area. Los Angeles, for example, is the densest city in the country with just ove

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

7000 people per square mile. The plan which means smooth sailing in Oklahoma City may stall in L.A.

Directives or incentives aimed at providing affordable housing for low or moderate income residents are touched upon in most "smart growth" plans, but they are inte

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

gral to "below market rate" (BMR) housing programs, such as inclusionary zoning and density bonuses. BMR initiatives ignore market forces--such as the law of supply and demand and the natural "trading up" homeownership process--by requiring or incentivizing builders

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

Professional from academic institutions, pharmaceutical industries, health care indust

to set aside a portion of their sale or rental units at below market rates for those deemed unable to afford current prices.

In addition to density increases, government may permit BMR developers to erect taller structures, skirt parking and open space requirements

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

and dot single family neighborhoods with townhouses. Homeowners—from the "struggling" to the affluent--may, in turn, feel assaulted by the resulting traffic congestion, parking problems, loss of backyard privacy and inferior quality of life on previously serene str

.

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

ets. It could be likened to a cramped elevator; as passengers flood through the doors, claustrophobia increases as well as a fear that the community will exceed its capacity and plummet to its figurative death.

BMR programs exist in at least 134 cities, towns and c

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

Companies that provide selfless information through particip

ounties in America, and in the following states: California, Colorado, Illinois, Maryland, Massachusetts, New York, Vermont and Wisconsin.

We cannot stop growth, but we must be intelligent about it. Above all, we must not take homeowner assault with a grain of salt

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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