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Senate to follow

The House today passed significant reforms to the Food and Drug Administration’s drug safety review system. Part of a comprehensive FDA bill, the bill was a compromise between Senate and House legislation that passed overwhelmingly earlier this year. The bill, which includes strong consumer protections, will be voted on in the Senate tomorrow.

Statement by CALPIRG’s Federal Health Care Advocate Paul Brown:

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SEATTLE — In a study of more than 100,000 patients treated for depression, suicide attempts declined during the first month of treatment—whether that treatment consisted of medication, psychotherapy, or both. The findings, published by Group Health researchers in the July American Journal of Psychiatry, show a similar pattern for populations of adolescents and young adults (up to age 24) as for older adults.

The study sheds new light on the “black box” advisory that the U.S. Food and Drug Administration (FDA) placed in 2004 and has revised since then, said Greg Simon, MD, MPH, the Group Health psychiatrist who led the study. The advisory—which has concerned many patients, families, and care providers—warns that suicidal behavior may emerge soon after people younger than 25 start treatment with newer antidepressant medications called selective serotonin reuptake inhibitors (SSRIs). It was spurred by randomized placebo-controlled trials showing that starting to take an SSRI can make thoughts of suicide more common among some teens and young adults.

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Cephalon has reported an increase of revenue for 2005 of 19 per cent to $1.2 billion. The firm’s total sales hit $1.16 billion, a rise of 18 per cent on 2004 levels, with the biggest seller being the narcolepsy drug Provigil (modafinil) with sales of $512.8 million. However, despite these figures the company made a loss for the year of $175 million, compared with a loss of $74 million in 2004.

Cephalon chairman and chief executive Frank Baldino said: “Cephalon delivered strong top- and bottom-line growth in 2005. “We also completed a series of acquisitions and collaborations that created a fully integrated oncology business and expanded our business geographically.” He added: “We continued to make progress in our plan to launch five new drugs. Finally, we eliminated uncertainty and added significant upside for our business by settling our litigation over Provigil. As a result, we enter 2006 in a position of strength, poised to deliver our best performance ever.”

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Statement by Mike Russo, Health Care Advocate and Staff Attorney for CALPIRG:

“CALPIRG applauds the Assembly’s passage today of the comprehensive health care reform bill, ABX1-1. The reform will greatly expand coverage, contain the surging costs of health care, and give consumers a fair shake when buying insurance.The bill:

Creates a large purchasing pool to let many Californians who currently lack access to group coverage gain access to the risk-sharing and bargaining power a pool provides.
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Your health and Migraines … therapeutics that associates many diseases on … Alexandria, VA 22314. Phone: (703) 349-1929. http://www.migraines.org …

Publication-Medical Home@AAP-Mental Health Publications
ALEXANDRIA, Va. (September 13, 2004) As the Food and Drug Administration … Health Benchmarking Project report, by Dougherty Management Associates, tracks …

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Washington — With congressional debate on an upcoming 10.1% Medicare cut to physicians stretching into the final weeks of the year, physicians’ decisions on whether to participate in the program in 2008 took on added degrees of importance and complexity.

The year-end deadline for physicians to change their participation status is important because it likely will determine how doctors will be able to bill the program and receive payment for all of 2008. If physicians do not inform their Medicare carriers in writing of their intent to change their status before Jan. 1, they will be locked into their current choices for the next 12 months — possibly under a newly reduced fee schedule.

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ROCKVILLE, Md., Oct. 3 — The FDA has clarified reports by some major media suggesting that the agency has plans for new regulations on over-the-counter cough and cold medications for children.

In an unusual press release, the agency pointed out that the recommendations it posted on its Website, as part of a 356-page briefing document, were merely unvarnished views of staffers. They were drafted in preparation for deliberations a couple of weeks hence by the FDA’s Nonprescription Drug Advisory Committee on over-the-counter cough and cold medications.

Contrary to the impression conveyed by the press reports, the FDA said, nothing had happened yet. The staff recommendations to discourage decongestant use by children younger than two years old, and antihistamines by those younger than six, were essentially talking points for a meeting that hasn’t happened.

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The NBC affiliate KSBW has a brief item on a medical marijuana lawsuit that is interesting just because of the legal angle that is being explored:

SANTA CRUZ, Calif. — The city and county of Santa Cruz, along with the Women’s Alliance for Medical Marijuana, are suing the federal government over the use of pot to help ease chronic pain.

The groups are asking the courts to reconsider an earlier decision denying their motion for a preliminary injunction, Action News reported.

They argue that the 10th Amendment protects a state’s right to govern itself.

The case is expected to be heard by the U.S. District Court as soon as next week.

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PITTSBURGH, October 02, 2007 /PRNewswire-FirstCall/ — Mylan Inc. today announced the appointment of Rajiv Malik as Executive Vice President in charge of Global Technical Operations. Mr. Malik has served in a similar capacity for Mylan since the Company acquired a controlling stake in Matrix Laboratories Limited (Matrix), where he is Chief Executive Officer, in January 2007.

As Head of Global Technical Operations, Mr. Malik will oversee the Company’s global research and development (R&D) centers and manufacturing and distribution units, with responsibility for enhancing and rationalizing Mylan’s global supply chain and expanded product pipeline, as well as leveraging Matrix, one of the world’s largest suppliers of active pharmaceutical ingredients, across the enlarged company.

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