Business Articles

I. BACKGOUND

The federal Mail or Telephone Order Rule spells out the ground rules for making promises abou

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

t shipments, notifying consumers about unexpected delays, and refunding consumers' money.

Enforced by the U

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

Examples of combination products may in

.S. Federal Trade Commission, the Rule applies to orders placed by phone, fax or the Internet. Compliance w

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

ith the Rule can have bottom line benefits for your company, because satisfied customers are repeat customer

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.

II. REQUIREMENTS

You must have a reasonable basis for stating that a product can be shipped within a c

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

Combination pro

rtain time.

If your advertising doesn't clearly and prominently state the shipment period, you must have a

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

reasonable basis for believing that you can ship within 30 days.

If you can't ship within the promised time

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

(or within 30 days if you made no promise), you must notify the customer of the delay, provide a revised sh

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

ipment date and explain his right to cancel and get a full and prompt refund.

For definite delays of up to

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

30 days, you may treat the customer's silence as agreeing to the delay, but for longer or indefinite delays

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

and second and subsequent delays - you must get the customer's written, electronic or verbal consent to the

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

Following aspects would a

delay.

If the customer doesn't give you his okay, you must promptly refund all the money the customer paid

dd to the challenges in developing combination products:

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

you without being asked by the customer.

Finally, you have the right to cancel orders that you can't fill

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

in a timely manner, but you must promptly notify the customer of your decision and make a prompt refund.

II

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

I. UNEXPECTED DEMAND

You can change your shipment promises up to the point the consumer places the order,

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

f you reasonably believe that you can ship by the new date.

The updated information overrides previous prom

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

Professional from academic institutions, pharmaceutical industries, health care indust

ises and reduces your need to send delay notices.

Be sure to tell your customer the new shipment date befor

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

e you take the order.

You must provide a delay option notice if you can't ship within the originally promis

.

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

ed time.

The Rule lets you use a variety of ways to provide the notice, including e-mail, fax or phone.

It

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

Companies that provide selfless information through particip

's a good idea to keep a record of what your notice states, when you provide it, and the customer's response

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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