Answers - Legal

As we start off the 2007 year, many in the web community probably have questions about what developments we can expect in web law in 2007. Well, the iss

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

ues already appear to be coming together.

Internet Law in 2007

The beauty of the web is it is still a relatively new communication platform and is evo

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

Examples of combination products may in

ving on a daily basis. From a legal standpoint, this raises all kinds of issues and problems. The law prefers stability. It is also generally slow to re

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

act to new issues. Since the net is evolving on a daily basis, this puts the legal issues regarding it in some what of a time warp. Simply put, the law

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 a couple years behind on issues such as phishing, privacy and so on. Still, 2007 is cranking up to be an interesting year.

One of the major areas whe

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

Combination pro

re we should see more legal wrangling in 2007 is privacy rights. While you might immediately jump to the conclusion I am talking about how the governmen

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

invades our privacy, I am not. Instead, the issue of how companies use our private information is going to come front and center again. Specifically, t

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

he security used by companies in protecting our information is laughable. It seems a day does not pass without a company announcing it has been hacked a

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

d private information exposed. Frankly, it is a miracle that identity theft is not a bigger problem. Regardless, you should expect Congress and lawsuits

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

to carve out clearer rules on this issue.

In some ways, 2007 will be the same as 2006, 2005 and so on in one are – copyright. If you work on the web,

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

ou are probably sick of hearing about copyright by now. I am! Still, the issue continues to rear its head as new web innovations arise. The obvious issu

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

Following aspects would a

arising now is YouTube and similar sites. Specifically, what happens when people post content that they do not own the copyright on? Well, things are g

dd to the challenges in developing combination products:

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

oing to get interesting to say the least. Unlike Napster, YouTube is now backed by big money Google, and has the deep pockets to fight copyright claims

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

y the music industry, etc. This doesn’t necessarily mean it will win, but it should be an interesting fight!

A second area of copyright law as applied

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

to the web is also starting to show some strength. It is in the field of search engine optimization, to wit, the great game of trying to obtain organic

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

ankings for your site on Google, Yahoo, MSN and so on. Google is at the center of the issue. It has implemented a duplicate content filter that basicall

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

Professional from academic institutions, pharmaceutical industries, health care indust

y eliminates certain pages from the rankings if they have the same content as other sites. This is becoming aggravating for certain sites when their con

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

ent is stolen, used on another site and then the offending site is used in the rankings. It is blatant copyright infringement and you can expect to see

.

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

larger sites taking legal action to protect their turf.

Since the web evolves a breakneck speed, you can expect there to be many more legal areas poppi

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

Companies that provide selfless information through particip

g up in 2007. SPAM may very well be one of them given the monumental failure of the CAN-SPAM Act. As to other areas, we will just have to wait and watch

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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