Actual - Legal

Even if you lose your case for disability before the Social Security Judge and the Appeals Council you can take your

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

case to the US District Court. I have had success in overturning Social Security's adverse decisions in Federal Cou

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

Examples of combination products may in

t.

1. In a 2002 case I managed to obtain a reversal and remand in federal court when the Social Security Judge ign

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

red the rules regarding fibromyalgia and refused to consider it to be a significant impairment.

2. In a 2005 case

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

ew evidence developed after she lost her hearing before the Social Security Judge that claimant’s problems were due

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

Combination pro

o Ehlers Danlos Syndrome. When we presented this in federal court the case was remanded for a new hearing which we

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

on.

3. In a 2004 case the Social Security Judge refused to consider the claimant’s obesity. The Judge said the cl

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

imant should have followed weight loss programs. The Federal Court at our request reversed and said the claimant’s

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

besity had to be considered.

4. In a 2003 case the Social Security Judge refused to consider the testimony of the

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

laimant’s cleaning lady and other evidence. The Federal Court reversed saying all the evidence had to be considered

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

We won the new hearing.

5. There is a $255.00 filing fee for appealing a final denial by Social Security by the

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

Following aspects would a

ppeal Council to the US District Court . You have 60 days from the receipt of the Appeals Council decision to file

dd to the challenges in developing combination products:

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

his civil action in US District Court. If you have little assets you can ask the US District Court to waive the fi

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

ing fee.

6. It does take an experienced Social Security attorney to take a case to US District Court and win it.

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

f you have a case that has some strong merit, you may be able to interest such an attorney in filing your case in th

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

US District Court and winning it. Perhaps you have new evidence or the Social Security Judge ignored one of your i

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

Professional from academic institutions, pharmaceutical industries, health care indust

pairments or ignored some of your evidence as in the cases I have mentioned above. If so, then you may want to consi

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

er this type of appeal.

This may be considered AN ADVERTISEMENT or Advertising Material under the Rules of Professi

.

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

nal Conduct governing lawyers in Virginia. This note is designed for general information only. The information prese

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

Companies that provide selfless information through particip

ted in this note should not be construed to be formal legal advice nor the formation of a lawyer/client relationship

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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The IRS now allows an automatic extension of six months to file Form 1040. A taxpayer applies for the extension on Form 4868. In prior years, the extension was for four months, but a taxyer could apply for an additional two months extension by showing good cause. Obtaining an extension can reduce the possibility of being assessed the penalty for failure to file a timely return. An extension also allows the taxpayer more time to make many tax elections.

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