Actual - Legal

A department of the Federal Trade Commission is the Bureau of Consumer Protection, and its “mandate is

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

to protect consumers against unfair, deceptive, or fraudulent practices.” There are six division of th

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

Examples of combination products may in

e Bureau of Consumer Protection as follows:

Division of Advertising Practices: Consumers are p

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

otected from deceptive or unsubstantiated advertising. The focus is on advertising of the following pro

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

ducts: tobacco and alcohol, food and over-the-counter drugs, energy-related products, environmental pr

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

Combination pro

ducts, and infomercials.

Division of Enforcement: Consumers are protected by enforcing complia

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

nce with court orders in consumer protection cases, investigating and prosecuting civil actions to sto

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

fraudulent, unfair, or deceptive marketing and advertising practices, and enforcing consumer protectio

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

n laws.

The Division of Financial Practices: Many consumer credit statutes are enforced includ

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

ng the Consumer Leasing Act, the Credit Practices Rule, the Equal Credit Opportunity Act, and the Fair

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

Credit Billing Act. The text of these laws can be found on the Federal Trade Commission’s website www.

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

Following aspects would a

ftc.gov.

The Division of Marketing Practices: Enforces federal consumer protection laws by fil

dd to the challenges in developing combination products:

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

ng legal actions to stop scams and help victims of scams

The Division of Planning and Information
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
b>: Measures the impact of FTC activities to protect consumers, including the Identity Theft Program.
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
The Office of Consumer and Business Education: Establishes public education programs for consume
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
rs and industry about fraud, deception, and unfair practices using print, broadcast, and electronic med
ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
a.

It would be prudent for you or your attorney to visit the FTC’s website, read the regulations, and
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
set up systems to be sure you are in and stay in compliance. If the FTC determines that you are violat
.

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
ng any of its regulations, it has the authority to seize your assets pending investigation. If the FTC
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
gets a court judgment against you, the fines are significant and the FTC could shut down your business

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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Actual - Know the Consumer Protection Regulations

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