Top Adding - Legal

What if a state employee came to your door and asked you to sign a lease that required you to pay THEM to use your own deeded shor

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

eline property?

Well that is exactly what is happening on Lake Erie in Ohio. The Ohio Department of Natural Resources (Coastal M

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

Examples of combination products may in

nagement Program) is asking lakefront owners on Lake Erie to sign a 50 year lease that requires payment to the Ohio DNR for use of

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

the shoreline that in most cases, is deeded to the owners on their property titles. This should be a wake up call for all my fel

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

ow lakefront owners in other states. The Michigan Supreme Court has already proclaimed that the public has the right to walk on l

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

Combination pro

akefront owner's private beaches because they are held in the "public trust". Will your state follow?

Each respective state hold

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

in trust the land below the water on all navigable lakes. They hold it in trust for the rights of the public pursuant to the Pub

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

lic Trust Doctrine. The public's rights are usually paramount to private rights when it comes to littoral and riparian rights, bu

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

when it comes to using that theory to interfere with the land of lakefront owners with deeded titles, something must be done abou

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

t it.

Besides asking Lake Erie lakefront owners for money to use the shoreline they already have deeds to use, the Ohio DNR is al

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

o asking them to essentially sign away certain property rights by signing a submerged land lease agreement for 50 years. Wait, th

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

Following aspects would a

ere is more, they are also requiring the owners to continue to pay the taxes on that lakeshore. They should not be "double taxed"

dd to the challenges in developing combination products:

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

this way.

What is the motivation for all of this you ask? The Ohio DNR Coastal Management Program is doing it under the guise o

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

f public interest. I find it hard to believe that they can confidently say they are giving the public any more rights than it alr

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

ady has by making lakefront owners sign leases. Do you really think a person is going to trespass through your private property t

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

o get to the state held strip of land next to the water to picnic and launch a boat? I hardly think so. They need to think of ot

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

Professional from academic institutions, pharmaceutical industries, health care indust

er ways to provide public access. How about purchasing a few homes from lakefront owners who are willing to sell and making publi

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

c access out that land?

I think the Ohio DNR is surely neglecting private lakeshore owners and is going too far in the interest o

.

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

the public. There needs to be state legislation in place that protects the rights of lakeshore property owners, especially when

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

Companies that provide selfless information through particip

it comes to land grabs. The Ohio Lakefront Group has filed a class action suit in Lake County, Ohio. The matter is still ongoing

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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