Main Subject - Business

The telemarketing no call list is something that you most definitely need to be familiar with and aware of if you engage in telemarketing as part of your marketing and sales program, if you outsource telemarket

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

ing duties, or if you provide telemarketing services for other companies.

Historically, telemarketing has been deemed as an annoyance by many due to unscrupulous practices of telemarketers who solicit business

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

Examples of combination products may in

through telemarketing, making unwanted calls, sometimes at unreasonable hours, and basically being a nuisance to the people they call.

In addition to the standard annoyances, the telemarketing industry has al

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

o developed a bad reputation due to deceptive and fraudulent practices of some telemarketers.

The federal government has taken some initiatives to prevent telemarketing fraud, to improve telemarketing practices

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

, and ultimately to eliminate unnecessary aggravation to consumers.

The telemarketing no call list (also called the "National Do Not Call Registry"), established in a joint effort between the Federal Communica

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

Combination pro

ions Commission (FCC) and the Federal Trade Commission (FTC) is central to federal efforts to regulate the telemarketing industry.

The main laws that apply to telemarketing practices are the Telephone Consumer

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

Protection Act (TCPA) and the Telemarketing and Consumer Fraud Abuse Prevention Act (TCFAPA) enforced by the FCC and the FTC respectively.

If you engage in telemarketing in any form or fashion, you should fam

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

iliarize yourself with these two Acts and the regulations associated with them.

To learn more about the telemarketing laws and regulations visit the following websites:

Federal Communications Commission: http

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

//www.fcc.gov/cgb/policy/telemarketing.html

Federal Trade Commission: http://www.ftc.gov/bcp/rulemaking/tsr/

Some states have rules and regulations regarding telemarketing and they may have their own telemarket

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

ing no call list.

In regard to telemarketing laws and rules, the federal laws supersede state and local laws meaning that if the federal laws are stricter than the state or local laws, the provisions of the fe

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

eral laws are applicable.

The main website for the National Do Not Call Registry where telemarketers are supposed to register and obtain access to the telemarketing no call list can be found at the following we

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

Following aspects would a

bsite:

National Do Not Call Registry https://www.donotcall.gov/

Telemarketers are supposed to subscribe to the National Do Not Call Registry and are supposed to check the telemarketing no call list at least on

dd to the challenges in developing combination products:

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

ce every thirty-one days for the purpose of updating their call lists and removing phone numbers for consumers who have requested to have their numbers listed as numbers that telemarketers are not allowed to ca

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

l.

Paying attention to the federal laws, regulations and rules regarding telemarketing and addressing them appropriately is the first step to devising an effective (and legal) telemarketing program.

If you ar

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

e calling numbers that are listed in the Do Not Call Registry you are wasting your time and you are likely to get reported to one or both of the federal agencies that enforce telemarketing laws.

It is in your

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

best interest -monetarily, ethically and professionally - to comply with the laws governing the telemarketing industry.

In addition to the federal laws and regulations that apply to everyone in the United Stat

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

Professional from academic institutions, pharmaceutical industries, health care indust

es, be sure to check into your local and state rules regarding telemarketing as well.

If they are more restrictive than the federal laws, make sure that you comply with their provisions as well.

If you are pro

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

viding telemarketing services as an outsource provider, your compliance with local, state and federal telemarketing rules can actually serve as a competitive advantage setting you apart from other providers who

.

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

engage in unethical, unprofessional or illegal telemarketing practices.

If your company outsources telemarketing services, be sure to check into your provider's business and compliance practices.

If you run an

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

Companies that provide selfless information through particip

in-house telemarketing program, educate yourself about the laws, rules and regulations that are applicable to your company and abide by them. Compliance is a winning proposition when it comes to telemarketing

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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