<s docid="LA111090-0112" num="10"> President Bush Friday vetoed legislation intended to prevent drug manufacturers from realizing unintended windfall profits from drugs developed under a law designed to stimulate research into therapies for rare disorders.</s>

<s docid="LA111090-0112" num="16"> In a statement, Bush said he had "serious concerns" that the amendments would have removed incentives for drug companies to develop new drugs.</s>

<s docid="LA111090-0112" num="30"> The true orphan drugs are drugs of little commercial value.</s>

<s docid="LA111090-0112" num="31"> The incentives were a way to entice companies to make them.</s>

<s docid="LA111090-0112" num="32"> The bill was not written for the blockbusters.</s>

<s docid="LA111090-0112" num="33"> The amendments were designed to correct the abuses".</s>

<s docid="FBIS3-59753" num="31"> As the mid- and long-term strategies for strengthening the system of health science research, this report cites the following as necessary in order to establish a foundation: 1) revamping the research system; 2) increasing the budget for research expenses and making effective use of the strength of the private sector; 3) cultivating, securing, and employing excellent researchers; and 4) strengthening the research support system.</s>

<s docid="FBIS3-59753" num="32"> For breakthroughs, the report stresses the importance of: 1) setting priority themes and implementing research based on project formats; 2) facilitating research exchange among industry, government, and universities; and 3) facilitating research exchange with overseas organizations.</s>

<s docid="LA041289-0054" num="46"> The federal commission's 54 recommendations to Congress include establishment of a federal office to oversee issues concerning rare diseases, increased research funding and efforts to ensure that insurance plans don't discriminate against people with rare diseases.</s>

<s docid="LA041289-0054" num="50"> The Orphan Drug Act established incentives for pharmaceutical companies to develop products to treat rare diseases.</s>

<s docid="LA011089-0045" num="57"> To encourage companies to come up with drugs to treat relatively rare diseases, Congress awards so-called "orphan drug status," a seven-year exclusive franchise, to the first manufacturer of such drugs.</s>

<s docid="FT941-10753" num="18"> A recent Japanese law gives priority for orphan drugs treating diseases affecting no more than 50,000 people.</s>

<s docid="FT941-10753" num="19"> In theory, orphan drugs are given: Priority during the ministry of health's review of the drug's safety and efficacy.</s>

<s docid="FT941-10753" num="20"> Exclusive marketing rights for 10 years against six years for other drugs.</s>

<s docid="FT941-10753" num="21"> Government R&D subsidies.</s>

<s docid="FT941-10753" num="22"> Tax exemptions on development costs.</s>

<s docid="FT941-10753" num="23"> Even in the US, the review procedure was markedly accelerated by choosing such a limited indication.</s>

<s docid="FR940830-2-00058" num="25"> SUPPLEMENTARY INFORMATION: FDA is announcing its intention to accept and consider an application for the award of a grant with time constraints to ADD, Baltimore, MD.</s>

<s docid="FR940830-2-00058" num="26"> FDA's authority to enter into grants for the development of drugs for rare diseases and conditions is set out in Section 5 of the Orphan Drug Act (21 U.S.C. 360ee).</s>

<s docid="FT921-13615" num="44"> Orphan drug makers receive tax benefits and a seven-year monopoly on the drug once it comes to market.</s>

