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From: E-mailNewsService <biomednews1@aol.com>
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Subject: BMN PRESS RELEASE: FDA Testifies On Post-Market Drug Approval
Process & Drug Safety
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BMN PRESS RELEASE
Contact: John Stone
Director of E-mail News Service Sales
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FDA TESTIFIES ON POST-MARKET DRUG APPROVAL PROCESS & DRUG SAFETY
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COSTA MESA CA USA -- MEDICAL INDUSTRY E-MAIL NEWS SERVICE(TM) -- MAY 10 2005 -- On May 05 2005, Dr. Steven Galson, Acting Director of the FDA Center for Drug Evaluation & Research (CDER), testified before the House Committee on Government Reform, regarding the FDA?s post-market drug approval process and drug safety.

Dr. Galson revealed that the FDA plans to create a new Drug Safety Oversight Board (DSB), to provide independent oversight and advice on the management of important drug safety issues. It would also manage the dissemination of certain safety information through the FDA?s website to health care professionals and patients.

Under this proposal, the FDA "plans to enhance the independence of internal deliberations and decisions regarding risk/benefit analyses and consumer safety. The DSB will oversee the management of important drug safety issues within CDER. The DSB will include individuals from FDA, as well as medical experts from other HHS agencies and government departments" (NIH & Dept of Veterans Affairs).

He explained that, "Individuals on the Board who have conducted the primary review of data or served as deciding officials for any regulatory action under consideration, will be recused from voting on issues concerning those particular drugs. CDER?s Deputy Director will serve as the Chair of the DSB. The DSB also will consult with other medical experts and representatives of patient and consumer groups. CDER is updating its Manual of Policies & Procedures (MAPP) to reflect the organizational structure, roles and responsibilities of DSB in CDER."

Among other responsibilities described in the MAPP, the DSB and its staff will:

-- Identify, track and oversee the management of important drug safety issues.
-- Adjudicate organizational disputes concerning the management of drug safety issues.
-- Establish policies regarding management of drug safety issues in CDER.
-- Select drugs to be placed on Drug Watch and update their status (including deciding to remove drugs from Drug Watch) as appropriate.
-- Oversee the development of patient and professional information sheets in CDER.
-- Track important emerging safety issues and ensure that they are resolved in a timely manner.
-- Ensure that CDER decisions about a drug?s safety benefit from the input and perspective of experts within and outside FDA who have not conducted the primary review or served as a deciding official in the ongoing pre-market evaluation or post-market surveillance activities with respect to that drug.

The FDA also plans to increase the transparency of its decision-making process, "by establishing new and expanding existing communication channels to provide drug safety information to the public. These communications will help ensure that established and emerging drug safety data are quickly available in an easily accessible form. The increased openness will enable patients and their health care professionals to make better-informed decisions about individual treatment options."

One communication method the FDA is proposing is a new Drug Watch web page, "that will include emerging information about possible serious side effects or other safety risks for previously and newly approved drugs. This resource will contain valuable information that may affect patient selection or monitoring decisions. The web resource may also contain information about measures that patients and practitioners can take to prevent or mitigate harm. This information resource will significantly enhance public knowledge and understanding of safety issues, by discussing emerging or potential safety problems, sometimes even before FDA has reached a conclusion that would prompt a regulatory action."
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As the FDA's plans continue to gel and be announced, pharmaceutical companies and their trade associations can be expected to voice their opinions on the worth and impact of the FDA proposals. Many of those companies and associations will be issuing press releases via the "Medical Industry E-mail News Service(TM)," the leading distributor of press releases to the entire medical community.

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Please forward this press release to colleagues who may want to read it.
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EDITOR'S NOTE: The opinions, claims/statements in this press release are solely those of the author. The Medical Industry E-mail News Service(TM) & BMN Inc accept no legal liability/responsibility for its contents/transmission.

According to legal experts & federal requirements, this press release FULLY complies w/the CAN-SPAM Act, each of its provisions, & all applicable/current state/federal laws & regulations. This electronic newsletter & daily news transmittal service are Constitutionally-protected publications. Like the wire services, these are PAID transmittals of a news announcement & newsletter -- not an advertisement -- via the "Medical Industry E-Mail News Service(TM)." It's the world's 1st/largest, press release/newsletter distribution service focused exclusively on the medical product mfg industry.

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