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    The Tax Increase Prevention and Reconciliation Act (TIPRA) recently signed by President Bush eliminates the $100,000 Modified Adjusted Gro
    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
    ss Income (MAGI) ceiling and the married taxpayer joint filing requirement for converting a traditional IRA into a Roth IRA, but not until
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    the year 2010. All other rules continue to apply, which means that the amount converted to a Roth IRA will still be taxed as income at th
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    individual’s highest tax rate. Under current law, single taxpayers with MAGI of more than $110,000 cannot contribute to a Roth IRA; or ma
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    rried taxpayers with joint income in excess of $160,000. However, by eliminating the income ceiling for conversions, the income limits on
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    ontributing to a Roth IRA have essentially been removed as well.

    In 2006 and 2007, individuals can contribute up to $4,000 per year to a
    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
    nondeductible traditional IRA ($5,000 if age 50 or older but under 70 1/2). In years 2008 – 2010, the amounts increase to $5,000 per year
    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
    $6,000 for investors age 50 or older but under 70 1/2). As a result, individuals under age 50 can contribute up to $23,000 during that fiv
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    e year stretch or up to $28,000 if 50 or older. If married, the same contribution limits apply to spouses who can also fund a separate non
    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
    eductible traditional IRA. (Reminder: IRS form 8606 must be filed each year a nondeductible traditional IRA contribution is made). Then in
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    2010, individuals can convert the nondeductible traditional IRA into a tax-free Roth account and have the choice of recognizing all of th
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    e conversion income in 2010 or averaging it over 2011 and 2012. At conversion, investors would only be taxed on the earnings that have acc
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    mulated in the nondeductible IRA. After 2010, individuals may continue to contribute to a nondeductible traditional IRA and immediately co
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    nvert to a Roth IRA, thereby effectively wiping out the income limitations on contributions. Investors initiating conversions after 2010 w
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    ll be responsible for recognizing the income during the year of conversion.

    There is one catch: Individuals who already have a traditiona
    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
    l IRA, including SEP and SIMPLE IRAs, cannot choose to only convert the nontaxable portion of the account. Even though investors are allow
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    d to have multiple traditional IRAs; for tax purposes, all traditional IRAs must be lumped together and treated as a single account. Indiv
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    iduals need to add up the total value of all traditional IRAs and also the total amount of nondeductible contributions to those IRAs to 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
    ermine what percentage of the conversion will be taxable.

    TIPRA has created a wonderful planning opportunity as the Roth IRA has not been
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    a useful savings vehicle for high income taxpayers. But with the passing of TIPRA, conversions to Roth IRAs will be available to everyone


    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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