Life Sciences Legal Update : Life Sciences Lawyers & Attorneys : Reed Smith Law Firm : Healthcare, Food and Drug Law, Biotechnology, Privacy, Product Liability

This post was written by Ruth N. Holzman, Arnie Grant, Paul J. Jaskot, Michael Sanders, Donald C. Reinke, Nanette W. Mantell and Richard Scudellari.

Small biotech companies will need to move quickly in order to take advantage of a new tax credit, known as the “qualifying therapeutic discovery project credit,” enacted as part of the Patient Protection and Affordable Care Act of 2010. The new credit, contained in section 48D of the Internal Revenue Code, is equal to 50 percent of eligible costs incurred by small biotech companies in developing new therapies to prevent, diagnose and treat acute and chronic diseases. Some taxpayers may be eligible to elect to receive a cash grant in lieu of the Credit (Cash Grant). The Credit/Cash Grant program is limited to $1 billion and is only available for taxable years beginning in 2009 and 2010.

The Secretary of the Treasury has until May 22, 2010 to establish a program to consider and award certifications to qualifying therapeutic discovery project sponsors. Because it will be a competitive application process, eligible biotech companies will need to move quickly and submit their applications promptly once the Treasury Department issues guidance on the program. Since the Credit/Cash Grant program includes eligible costs incurred in 2009, biotech companies should review their 2009 costs now so that they have the data to complete their applications as soon as program details are released.

To learn more about the qualifying therapeutic discovery project credit, read our full alert.

For more information, please contact one of the authors: Ruth N. Holzman, Arnie Grant, Paul J. Jaskot, Michael Sanders, Donald C. Reinke, Nanette W. Mantell and Richard Scudellari.

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This post was written by Carol C. Loepere, Elizabeth Carder-Thompson, and Debra A. McCurdy.

On March 23, 2010, President Obama signed into law the Patient Protection and Affordable Care Act (PPACA), a sweeping measure designed to expand access to health insurance, reduce health care spending (particularly in the Medicare program); expand federal fraud and abuse authorities and transparency requirements; impose new taxes and fees on health industry sectors; and institute a variety of other health policy reforms. The President also signed a second bill into law on March 30, 2010, the Health Care and Education Reconciliation Act of 2010 (Reconciliation Act), which includes a series of “fixes” to the PPACA, including substantive changes to the PPACA’s provisions regarding Medicare prescription drug coverage, Medicare Advantage and fee-for-service payments, Stark law self-referral policy, and Medicaid matching payments, among many others. Within the thousands of pages of the new laws are numerous provisions that will have a direct and material impact on nearly every component of the health care delivery and financing systems in the United States, including health insurers, health care providers, and manufacturers of pharmaceuticals and medical devices, as well as employers, taxpayers, and patients. Moreover, the impact of some of these provisions will be felt immediately, as certain provisions are effective upon enactment, and some have January 1, 2010 effective dates. Reed Smith has prepared a major Alert concentrating on those PPACA provisions we believe are of most interest to health care providers and medical device and pharmaceutical manufacturers.

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This post was written by Paul Sheives, Areta Kupchyk and Kevin Madagan.

FDA has released a proposed rule that would amend the regulations affecting direct-to-consumer (“DTC”) advertisement regulations to implement a provision of the Food and Drug Administration Amendments Act of 2007. The change in regulations would require DTC television or broadcast advertisements of prescription drugs to place the “major statement” in a “clear, conspicuous and neutral manner.” Under the regulation, FDA would use the following standards to determine whether the information meetings the clear, conspicuous and neutral requirement: 1) information is presented in language that is readily understandable by consumers; 2) audio information is understandable in terms of the volume, articulation, and pacing used; 3) textual information is placed appropriately and is presented against a contrasting background for sufficient duration and in a size and style of font that allows the information to be read easily; and 4) the advertisement does not include distracting representations (including statements, text, images, or sounds or any combination thereof) that detract from the communication of the major statement.

To learn more about FDA's proposed rule on DTC advertising, please read our full alert.

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This post was written by James R. Tandler, Angelo Ciavarella and Jeffrey E. Kaylor.

On March 23, 2010, President Obama signed the Patient Protection and Affordable Care Act of 2010 (PPACA) into law. The PPACA, which is designed to overhaul the United States health care system, regulates all aspects and players in the health care arena, including individuals, employers and health insurers. On March 30, 2010, President Obama signed the Health Care and Education Reconciliation Act of 2010 (Reconciliation Act), which amends certain aspects of the PPACA. This legislation is funded, in part, by increased taxes. To view a summary of certain of the tax-related provisions included in the PPACA as currently adopted and as amended by the Reconciliation Act, please read our full alert.

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