Cases - Business

TRUTH IN ADVERTISING

Below is an excerpt from our Business Kit "Advertising Works" --this is information that anybody who i

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 advertising should know:

Any advertising is serious business. It reflects you, your business, product and/or service. There are laws gove

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

Examples of combination products may in

ning "truth in advertising" which are designed to prevent people from making false claims in advertising. If you have specific questions abou

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

these laws requiring answers you are advised to consult an attorney. If you can not afford to retain the services of an attorney then follo

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

w these simple rules of thumb:

FALSE ADVERTISING-Whatever you say or promise in your advertisement you better be ab

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

Combination pro

e to deliver! If you can't, then you may be frauding your audience with false advertising which is illegal. No amount of financial success i

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

worth this type of legal problem.

WARRANTIES-There is basically two kinds of legal promises or warranties: Expresse

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

d and implied. An express warranty, for example, is one in which you offer a 30 day money back guarantee if the customer is not satisfied. I

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

the customer returns the product in salable condition within (30 days) and requests a refund, you MUST be prepared to refund ALL the money p

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

omptly. An implied warranty or promise is a natural expectation that anybody would have when they purchase a new product...that it is new, f

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

ee from defect and constructed in a manner represented by the advertising surrounding the sale. When you buy a new car, you "expect" that it

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

Following aspects would a

will run like a new car should. In other words, it is naturally implied to be from free defect. This doesn't need to be said to the person b

dd to the challenges in developing combination products:

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

ying the car because it is a natural expectation of the transaction.

CHAIN LETTERS-Chain letter programs are illegal

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

Any "scheme" where money is exchanged and no products or services are delivered is against the law. Not only is it a violation of advertis

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

ing law, it is an offense against postal regulations. To avoid legal problems do not participate in chain letters.

BAIT & SW

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

TCH-Bait and switch programs are illegal. Any “scheme” where you mislead people by “baiting them” with an advertisement to sell an

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

Professional from academic institutions, pharmaceutical industries, health care indust

ffering at a specified price with no intention of delivering the offering but rather to “switch them” into another higher priced offering is

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

false and misleading advertising. To avoid legal problems do not participate in bait and switch schemes.

THE GOLDEN RULE.
.

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
ong>..Follow the golden rule “Do unto others, as you would have others do unto you”…this will keep you from breaking most of the advertising
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
aws. Honesty is the best policy. If you can't be honest, don't advertise!

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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Cases - Truth In Advertising Law - Information Every Advertiser Should Know

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