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FOR IMMEDIATE RELEASE

November 6, 2002

Contact: Richard Sellers

703/524-0810; rsellers@afia.org

AFIA ASSEMBLES INDUSTRY TEAM TO RESPOND TO

FDA BSE FEED RULE PROPOSAL


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The new label warns that LARIAM may cause psychiatric symptoms in a number of patients. Roche letter to pharmacists Roche letter to doctors


Infections

Press Release

Update: Listeriosis Outbreak Investigation

Update October 3, 2002 Contact: CDC, Media Relations (404) 639" 3286


Infections

October 4, 2002 Contact: CDC Media Relations 404-639-3286

Press Release

E.coli O157:H7 Outbreak Investigations

O157:H7 infections.


FOR IMMEDIATE RELEASE:

Monday, October 7 , 2002

CONTACT: Ken Johnson or Arturo Silva

202.225.5735

Greenwood Announces Hearing

On The ImClone Erbitux Story

WASHINGTON (October 7) -- House Energy and Commerce Oversight and Investigations Subcommittee Chairman James Greenwood (R-PA) has scheduled a hearing for Thursday (October 10 at 10:00 a.m. in room 2123 of the Rayburn House Office Building) entitled, "An Inquiry into the ImClone Cancer-Drug Story."


In a Sept. 25 letter to the Senate Finance Committee leader, CMS Administrator Tom Scully is requesting action on the administration's top legislative priorities: contractor reform, competitive bidding for durable medical equipment, and Medicare benefit improvements. Scully advises, however, that many provisions in the Senate's original regulatory reform bill, which was introduced last year, could be counterproductive as CMS has already implemented such changes.


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Subject: HHS Regulatory Reform Committee Final Meeting -- 11/21/02

Please be advised that the final meeting of the Department of Health and Human Services (HHS) Secretary's Advisory Committee on Regulatory Reform which had originally been scheduled for October 1-2, 2002 has been rescheduled as follows:

Times: 8:00 am - 6:00 pm

Location: Washington, DC

The exact location and agenda for the meeting will be posted on the Regulatory Reform web-site at www.regreform.hhs.gov before the meeting.


of BLAs

On May 14, 1996 (61 FR 24227), FDA issued a final rule to amend the licensing regulations by eliminating the ELA requirement for specified biotechnology and synthetic biological products regulated under the Public Health Service (PHS) Act. Upon approval, manufacturers of these products would receive a single biologics license instead of product and establishment licenses (21 CFR 601.2(c)).


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October 4, 2002

The Honorable Max Baucus

Chairman

Senate Finance Committee

United States Senate

Washington, D.C. 20510

The Honorable Charles Grassley

Ranking Member

Senate Finance Committee

United States Senate

Washington, D.C. 20510

Dear Senator Baucus and Senator Grassley:

On behalf of the nation's Governors, we very much appreciate your willingness to include a modified Rockefeller-Nelson-Collins state fiscal relief provision in your Medicare provider give-backs package.


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