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“The notorious Smoot-Hawley Tariff Act of 1930 – a policy blunder of monumental proportions that played a key role in sparking a global trade war and the Great Depression

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

.” Stephen Roach, Managing Director Morgan Stanley Investment Bank March 30, 2007

When the US economy contracted after the collapse of the 1929 stock market bubble, the

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

Examples of combination products may in

US Congress acted. And as it often happens in history, the action backfired. Instead of protecting the US economy and US markets, the Smoot-Hawley Tariff Act of 1930 plun

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

ged the US and the world into the Great Depression of the 1930s.

The road to hell is paved with good intentions. That was true in 1930 and is true today in 2007. The US

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

ongress, looking for someone to blame for America’s mounting economic problems—increasing trade deficits, loss of jobs, declining competitiveness, etc.—is now blaming Chi

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

Combination pro

na. And, once again, instead of protecting America’s economy, the US Congress is about to pull the lynchpin on the global economy.

Accusing China of currency manipulatio

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

is more self-serving than blaming nature for global warming—and that’s pretty damn self-serving. Currency manipulation is, in fact, the domain of the US. Without the US,

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

currency manipulation would not even be possible.

After WWII, the US dollar was the foundation of the global financial system. America owned 75% of the world’s monetary

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

gold and that gold backed the US dollar. Currency manipulation was impossible because the US dollar was tied to gold and all currencies were tied to the US dollar.

Betwe

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

en 1949 and 1971, because the US had a positive balance of trade its gold supplies should have increased. Instead, they disappeared. In two decades, the US overspent its

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

ntire hoard of gold and in 1971 announced that the US dollar was no longer convertible to gold and that it would keep what gold it had instead of paying what it owed.

In

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

Following aspects would a

1973, the US officially went off the gold standard and plunged the world into monetary chaos. For the first time in history, the world’s reserve currency, the basis of w

dd to the challenges in developing combination products:

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

rld trade, was not backed by gold or silver. Money was no longer intrinsically valuable. Money now was only a piece of paper, an IOU.

The next year the foreign exchange

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

markets began to grow exponentially as speculators now determined the relative value of currencies. No longer needing to transfer gold (which it no longer had) to balance

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

its trade deficits, the last positive US trade balance was in 1975. In 2007, the US trade deficit is heading for $700 billion as the US can now pay its creditors—mainly C

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

hina—with paper money instead of gold.

The US has now chosen China to be its whipping boy, the reason for America’s economic troubles. So be it. Blaming China will play

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

Professional from academic institutions, pharmaceutical industries, health care indust

ell in the US where R no longer stands for responsibility. It will also lead the world into economic chaos.

The Smoot-Hawley Tariff Act of 1930 played a critical role in

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

causing the Great Depression in the 1930s; and, whatever Congressional action is enacted to “protect” American markets in 2007 will do the same.

America is in trouble a

.

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

d it’s looking for someone to blame. Last year it was illegal immigrants crossing its borders from Mexico. This year it’s China. But if America wants to know who’s respon

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

Companies that provide selfless information through particip

sible, it need look no further than into a mirror.

But America doesn’t want to know who is responsible. America wants someone to blame—and it wants to blame someone else

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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