Actual - Legal

I love “Judge Judy”! Her ability to cut through the malarkey and skewer the wrongdoers is just amazing. Among the little life less

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

ons that get repeated again and again is, “Get it in writing!”

Most of her customers have gotten the message that there is such a

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

Examples of combination products may in

thing as an oral contract, and many show up having managed to extract a written agreement from their opponent. But people tend t

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

get tripped up when there is a written agreement and an oral agreement, and the two conflict. “But he said,” or “but he promised,

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

” is the refrain heard often on the show.

Here’s the rule: When a written agreement exists, it entirely takes the place of any or

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

Combination pro

l agreements made either prior to the written agreement or subsequent to it. Period. It’s called the parol evidence rule, and it’s

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

written in stone.

Real estate agents know this rule only too well; many have horror stories of agreements reached between buyer

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

and seller that haven’t been honored and that are unenforceable, either because the agreement wasn’t memorialized in the purchase

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

nd sales agreement or because it was inadequately memorialized. One agent reported that a written agreement was made to sell a par

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

ticular house “with appliances,” only to discover that the expensive appliances, worth many thousands of dollars, that the buyers

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

ad viewed when they toured the house had been removed and replaced by inexpensive, used appliances. In another instance, the same

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

Following aspects would a

real estate agent got an irate call from his new buyer, telling him that when they moved into their new home, all the electrical f

dd to the challenges in developing combination products:

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

ixtures had been removed—not just the chandelier in the dining room, but all the faceplates and light switches in the room. All th

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

y had were bare wires sticking out of holes in the walls. Now the second instance might be more easily actionable than the first—i

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

t’s reasonable to assume that your basic electrical setup isn’t going to be carted away by the seller—but the real estate agent qu

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

ckly learned to add to his purchase and sales agreements the words, “as seen by the buyers on [January 7, 2007],” (Polaroid photos

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

Professional from academic institutions, pharmaceutical industries, health care indust

attached to the P&S wouldn’t have hurt, either.)

One common occurrence is that two parties will reach an agreement, sign a docum

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

ent to that effect, and then keep talking. Often one party will make additional promises to the other, and then renege. In this in

.

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

tance the injured party is out of luck unless he or she has thought to create a written addendum to the original agreement, signed

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

Companies that provide selfless information through particip

and dated by both parties.

The lesson? Get it in writing. And if the agreement changes for some reason, get that in writing, too

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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