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Effective June 1, 2005, the FTC’s Disposal Rule requires any business or individual that utilize

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

s credit report information to properly dispose of that information to protect against unauthori

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

Examples of combination products may in

zed access to or use of the information. The Rule can be found at www.ftc.gov/os/2004/11/041118

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

disposalfrn.pdf.

Examples of consumer reports include credit reports, credit scores, reports bu

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

sinesses or individuals receive with information relating to employment background, check writin

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

Combination pro

g history, insurance claims, residential or tenant history, or medical history.

Affected busine

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

ss include mortgage brokers, lenders, insurers, employers, debt collectors, and car dealers.

Fi

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

nancial institutions, including mortgage brokers, are subject to both the Disposal Rule and the

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

Gramm-Leach-Bliley (GLB) Safeguards Rule. The Safeguards Rule requires institutions to take ste

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

ps to protect sensitive customer information.

Financial institutions should incorporate practic

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

s dealing with the proper disposal of consumer information into the information security program

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

Following aspects would a

that the Safeguards Rule requires.

The Rule requires disposal practices that are reasonable an

dd to the challenges in developing combination products:

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

d appropriate to prevent the unauthorized access to, or use of, information in a consumer report

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

, such as burning, pulverizing, destroying, erasing, or shredding papers or electronic media so

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

that the information cannot be read or reconstructed.

It is also possible to conduct due dilige

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

nce and hire a third party for records destruction. Due diligence includes obtaining informatio

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

Professional from academic institutions, pharmaceutical industries, health care indust

n about the disposal company from several references, requiring that the disposal company be cer

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

tified by a recognized trade association, reviewing and evaluating the disposal company’s inform

.

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

ation security policies or procedures, or reviewing an independent audit of a disposal company’s

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

Companies that provide selfless information through particip

operations and its compliance with the Rule.

You should consult the following FTC publications

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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