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California has just passed a law that’s designed to lower the amount of greenhouse gas pollution the state puts out. The idea is to stop, or at least slow down, the effects of global warming. It’s a little complicated, but here

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

are the details as I see them: --Businesses in the state need to cut their greenhouse gas emissions back to 1990 levels by 2020. --Industries that are traditionally heavy-polluters, like refineries, power plants, and cement m

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

Examples of combination products may in

akers, will be required to report on their progress in lowering emissions. --A state agency, the California Air Resources Board, will be in charge of implementing and enforcing the new regulations.

The law is a little vague as

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

to how the board will enforce theses regulations, and how to handle industries that cannot meet the new standards. The bill calls for “market solutions” to be used in these situations, but doesn’t detail those solutions.

What d

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

oes it mean? Gov. Arnold and Dems in the legislature hail this as a chance for California to lead the country in setting hard limits on this type of pollution. Many Republicans and business people say this will cause higher pric

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

Combination pro

es and job losses for our state. The Competitive Enterprise Institute released a statement with my favorite headline: “California Votes to Join the Third World.”

What’s the truth? Honestly, there’s no way we can know. Both sid

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

es are driven by certain beliefs, many of which have shaky foundations. Supporters of the bill believe: --That global warming is an absolute fact, caused largely by human pollution. --Further, they believe that if governments

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

put hard limits put on industrial pollution, companies will develop technology that will make those industries cleaner. --The new technologies will result in more, better jobs, and that those jobs will offset any job losses tha

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

t industry suffers. --Supporters are also betting that the whole country will adopt hard pollution limits, so there will be no advantage in companies leaving the state.

Opponents of the bill have a whole different set of assum

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

ptions: --They aren’t at all convinced that humans have a decisive part in global warming. Most people in this group say that if the climate is warming, it’s part of the natural cycle the earth has gone through many times. --I

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

f the technology to make these industries cleaner does not come along, companies will need to find another way to cut pollution levels back to 1990 levels. Some companies would have to cut production, resulting in higher prices.

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

Following aspects would a

Others would simply leave the state, with potentially thousands losing their jobs. Either of these scenarios would devastate California’s economy. --If other states, or the nation as a whole, does not enact similar standards,

dd to the challenges in developing combination products:

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

the state likely will see more companies leave for states with looser pollution regulations.

Which side is right? My crystal ball is in the shop, so I can’t see the future. But both sides have legitimate points—the problem is

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

that one of them will be proven wrong. California chose the side it thought was right, and for the sake of our economic well-being, all of us who live here have to hope they are correct.

What kind of business opportunities might

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

come about because of this bill? Four opportunities are likely to come about in the next few years: --Companies will come up with cleaner, more efficient processes for heavy polluters to do their business. Companies are someti

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

mes reluctant to change their familiar, proven methods of manufacturing, but these new standards may leave them little choice. --It seems likely that some companies will turn to alternative energy sources, and those involved in

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

Professional from academic institutions, pharmaceutical industries, health care indust

producing that energy stand to benefit. --Manufacturers that find themselves dramatically lower their emissions could profit by selling their “clean air” credits to companies who pollute too much. The Air Resources Board will p

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

robably set up a system where heavy polluters can buy these credits from non-polluting companies. This could be a potential windfall for clean companies. --Companies will need people who have studied the new law, and its effects

.

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

, in detail. These people will profit by showing companies how to navigate the maze of new regulations that is sure to result from the new law.

The full impact of this legislation won’t be felt for several years. But California

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

Companies that provide selfless information through particip

companies cannot afford to wait. The companies that will profit in the new California landscape will be those that can adapt quickly, find new ways to do things, and figure out exactly what the regulations mean to their business

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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