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Many of you may have heard of the new law in California, the California Marketing Compliance Law (CMCL), that focuses on the marketing practices of p

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

harmaceutical companies and the controversy that it has caused in the drug industry. Even though the law went into effect almost a year ago many meet

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

Examples of combination products may in

ing planners are still unsure about what the law really is and how it affects them.

Why?

In September 2004, a bill was signed that added a n

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

ew section to the California Health and Safety Code – now known as CMCL. The goal of CMCL is “by limiting marketing practices to exclude inappropriat

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

e marketing or promotional activities ... the bill will have the effect of lowering prescription drug costs and easing public concerns about conflict

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

Combination pro

s of interest between doctors and drug company sales representatives.” SB 1765 Bill Analysis (April 12, 2004).

How?

CMCL mandates that drug

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

companies develop Comprehensive Compliance Programs (CCPs) in accordance with the Office of Inspector General’s pharmaceutical and marketing guidelin

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

es. The CCPs must include specific guidelines on annual spending for gifts, promotional items and materials and marketing activities, including any a

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

ctivities at medical conferences that target California doctors.

This not only includes companies headquartered in California, but any company that

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

does business in California.

What Now?

While there is still much debate over many aspects of the law including the effective date, how to im

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

plement the law and how to comply with it, most companies are erring on the conservative side. There has already been a decline on spending on confer

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

Following aspects would a

ence giveaways – no more expensive gifts or trips.

Companies are also being cautious at national conferences where California doctors are in attenda

dd to the challenges in developing combination products:

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

nce. The law is not clear on how it applies in this situation and how it applies to exhibitors, but experts agree that you should not assume that the

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

law does not apply if you are not actually in California. If you are exhibiting at a national conference, a safe bet is to find out how many Califor

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

nia doctors are in attendance at a national conference and assume that each one will receive one of your giveaways. That cost should be built into yo

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

ur budget for annual per-physician spending in California.

If you are planning a conference where California doctors will be in attendance, you can

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

Professional from academic institutions, pharmaceutical industries, health care indust

help your exhibitors comply with the new law by providing projected attendee demographic data before the conference, actual data shortly after the co

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

nference and use data-tracking on attendee name badges. Be sure that you are informed about the new law and pass that knowledge onto your exhibitors.

.

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

Coming to a State Near You

Do you still think this law does not apply to you? Several states including Maine, Vermont, Nevada, New Mexico,

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

Companies that provide selfless information through particip

Minnesota, West Virginia, and Washington D.C. are in the process of adopting similar legislation. So watch out – it could be affecting you very soon!

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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