Answers - Real Estate

In an effort to keep the home buying public up to date about receiving an un-advertis

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

ed home buyer rebate the next time they buy, I have discovered that Kentucky now allo

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

Examples of combination products may in

ws buyer rebates and incentives by agents under the following terms of Kentucky Real

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

Estate Law:

Kentucky Real Estate Professional and the Law

NOTICE: On July 15, 200

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

, the Kentucky Real Estate Commission and the United States Department of Justice fil

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

Combination pro

ed an Amended Final Judgment in federal district court. On July 13, 2005, the Commis

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

sion filed emergency regulations. Because of this Amended Final Judgment and these e

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

mergency regulations, Kentucky real estate licensees may now offer any inducement or

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

ebate, so long as it is disclosed in writing to the client or customer. Therefore, a

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

ny portion of this book that references the inducement and rebate prohibitions found

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

in the old versions of KRS 324.160(4)(m), 201 KAR 11:011, Section 1(5) and/or 201 KAR

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

Following aspects would a

11.121, Section 1(2) is now obsolete. Please refer to the Commission's website at w

dd to the challenges in developing combination products:

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

w.krec.ky.gov for additional information on the Judgement and the new laws allowing i

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

nducements and rebates by Kentucky licensees. Please refer to the box at the top of

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

this Legal Information Section for additional information on the Judgment and the new

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

laws allowing inducements and rebates by Kentucky licensees.

Previously, I had ment

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

Professional from academic institutions, pharmaceutical industries, health care indust

oned in other articles that the states of AK, ID, IA, KS, KY, LA, MS, NJ, OK, OR, TN

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

and WV had restrictive laws regarding incentives and rebates. As I further research

.

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

these state laws, I have found things changing as the DOJ (Department of Justice) inv

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

Companies that provide selfless information through particip

estigates and sues these states for their restrictive behavior regarding this subject

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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