Top Adding - Legal

Backup tapes are important. Aside from the fact that backup tapes can save a company's data in the event of a software

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

failure, hard drive failure, or a database corruption... backing up a company's data on a regular basis should be a p

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

Examples of combination products may in

art of every IT department's disaster recovery plan.

As part of that plan, IT departments should test and validate th

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

at the backups are in fact backing up data and is able to be restored. Most companies assume that once the backup is r

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

unning everything will be safe. However, not many IT departments routinely check the error logs to discover problems.

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

Combination pro

And only when a disaster occurs do they realized that the scheduled backups have not been collecting all of the data.

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

From an IT point of view, the above is one of the hurdles they deal with on a daily basis. From a legal point of view

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

those backup tapes are even more valuable. Those tapes represent a snapshot in time for that company.

In a recent ca

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

se, AAB Joint Venture v. United States, 2007 WL 646157 (Fed. Cl. Feb. 28, 2007), the

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

court heard an argument regarding the a period of time (data) for which that data was not available. The defendant cl

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

aimed that it had provided all e-mails related to the case. However, the court was not persuaded by defendant’s argume

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

Following aspects would a

nts, and agreed that defendant’s overall production of emails had been far from adequate. The court also said that, w

dd to the challenges in developing combination products:

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

hile cost was an issue for the court to consider in addressing a motion to compel, it was not the only consideration.

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

The court continued with the following statement:

Here, because the Court finds that defendant had a dut

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

to preserve evidence, as set forth below, the Court cannot relieve Defendant of its duty to produce those documents m

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

erely because Defendant has chosen a means to preserve the evidence which makes ultimate production of relevant docume

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

Professional from academic institutions, pharmaceutical industries, health care indust

nts expensive. Accordingly, the Court concludes that Defendant has not adequately responded to Plaintiff's requests f

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

or production of electronic documents and that supplementation of its response to Plaintiff's requests is necessary.

.

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

As the field of Computer Forensics and E-Discovery becomes more mainstream in litigation, more companie

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

Companies that provide selfless information through particip

s may find they need to take a look at what exactly is in the disaster recovery plan for both data loss and litigation

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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