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Top Articles - Is a SEP Plan Right For Your Business
A SEP is a special type of IRA. Under a SEP plan the employer creates an IRA account for each eligible employee, hence t
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
he name SEP-IRA. A SEP is funded solely with employer contributions. Employees do not make contributions to their SEP-I
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
A retirement account. Any money that goes into a SEP automatically belongs to the employee. Thus, the employee has the
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ight to take his SEP IRA account money with him whenever he stops working for the company.
Any size business can establi
Any size business can establi
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
h a SEP, but the SEP retirement plan is utilized mostly by the self-employed and the small business with few employees.
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
he SEP IRA rules dictate that if the business contributes for one employee, (i.e., the owner), then the business must con
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
tribute proportionately for all of the employees. With few exceptions, anyone who works for the business must be include
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
in the SEP. However, you can exclude from participating in the SEP plan anyone who:
• Has not worked for the company du
• Has not worked for the company du
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ing three out of the last five years.
• Has not reached age 21 during the year for which contributions are made.
• Rece
• Has not reached age 21 during the year for which contributions are made.
• Rece
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
ved less than $450 in compensation (subject to cost-of-living adjustments) during the year.
SEP IRA contributions to eac
SEP IRA contributions to eac
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
employee for 2004 cannot exceed the lesser of $41,000 or 25% of pay for W2 recipients (20% of income for sole proprietor
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
s). The SEP IRA contribution limit goes up to $42,000 for 2005, and is subject to cost-of-living adjustments for later y
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
ars. SEP-IRA rules do not provide for additional catch-up contributions for those 50 years old or over.
A growing numbe
A growing numbe
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
of self-employed individuals with no employees are abandoning the SEP-IRA for a newer type of retirement plan called the
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
Solo 401(k) or Self-Employed 401(k). The two main reasons for the switch are 1) they can generally contribute much more
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
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 a Solo 401(k) than they can under a SEP IRA, and 2) Loans are allowed under a Solo 401(k), whereas loans are prohibited
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
under a SEP-IRA.
Example: Henry, age 52, a realtor received $60,000 in compensation from self-employment income in 2004
Example: Henry, age 52, a realtor received $60,000 in compensation from self-employment income in 2004
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
For 2004, he could contribute a maximum of $27,152 in a Solo 401(k) versus a maximum of $11,152 under a SEP IRA.
Howev
Howev
.
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
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
r, the Solo 401(k) does not work for businesses with employees. Thus, if your company plans to hire employees or current
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
y has a few employees, the SEP IRA may be your best choice as a retirement plan that is inexpensive and simple to operate
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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