FDA

FDA issues warning to consumers to avoid purchasing flu drugs online; WHO says counterfeit drugs are a $35 to $40 billion a year industry

October 16, 2009 -- Huntington, NY – On Friday, Rep. Steve Israel (D-Huntington) called for Congress to act on his legislation, the Counterfeit Drug Enforcement Act of 2009 (H.R.2726) – also known as Tim Fagan’s Law, amid warnings about counterfeit drugs related to the H1N1 virus. Websites selling fake Tamiflu and other purported flu treatments are proliferating and preying on fears of the H1N1 virus.    » read more »

Contaminated Food Kills 5,700 Americans Each Year – Nation’s Food Safety Laws Have Not Been Overhauled In A Century

October 14, 2009 -- Washington, DC - U.S. Senator Kirsten Gillibrand, the first New York senator to sit on the Senate Agriculture Committee in nearly 40 years, today announced a comprehensive plan to overhaul the nation's food safety laws by improving inspection, recall response, and public education. A cornerstone of Senator Gillibrand's plan is new legislation to mandate E. coli inspections of ground beef.    » read more »

Washington, Oct 8 - Congressman Silvestre Reyes (D-TX) yesterday voted to pass legislation that will enhance food safety, boost rural economies, protect Americans against price fluctuations for necessities, and help feed struggling families. The Agriculture Appropriations Act for Fiscal Year 2010 passed the U.S. House of Representatives by a vote of 263 to 162. The bill provides funding for the Department of Agriculture (USDA), the Food and Drug Administration (FDA), the Commodity Futures Trading Commission (CFTC) and the Farm Credit Administration (FCA).    » read more »

Bill contains Cheyney University project sponsored by Congressman Sestak to support workforce development in his District

October 7, 2009 -- Washington, DC – Congressman Joe Sestak (PA-07) voted to pass the Conference Report of the Fiscal Year 2010 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act.    » read more »

Washington, Oct 7 - Congressman Dennis Kucinich (D-OH) secured a legislative victory for organic farmers and consumers by ensuring that the US Department of Agriculture will collect and share economic data that is essential to help the organics industry compete with agribusiness. The $500,000 for the Organic Production and Market Data Initiative was secured as part of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriation Act.

“Organic foods and products should be able to, at a minimum, compete equally with foods and products made with pesticides, chemical fertilizers, and genetic manipulation,” said Kucinich.    » read more »

27 million doses shipped to US market by Novartis - providing more seasonal flu vaccine earlier than in any previous year

Basel, October 6, 2009 - Novartis announced today that the company has completed its entire shipment of seasonal influenza vaccine to the United States for the 2009/2010 season. As previously anticipated, the company delivered 27 million doses of Fluvirin® influenza virus vaccine, which has been approved by the U.S. Food and Drug Administration (FDA).

Novartis completed this season's shipment earlier than in previous years, in anticipation of demand for earlier vaccination with seasonal influenza vaccine created by the current global A(H1N1) influenza pandemic.    » read more »

October 6, 2009 -- CAMBRIDGE, Mass. – Genzyme Corporation (Nasdaq: GENZ) announced today that the FDA provided a complete response letter regarding the company's supplemental New Drug Application for Clolar® (clofarabine) in previously untreated older adult patients with acute myeloid leukemia (AML) and at least one unfavorable baseline prognostic factor. The agency recommended a randomized, controlled clinical study be conducted for label expansion of Clolar in this indication.    » read more »

Agencies Unite on Outreach to Produce Industry

WASHINGTON, October 5, 2009 -- USDA's fresh produce chief will join FDA to develop new food safety rules, as part of a cooperative initiative between FDA and the U.S. Department of Agriculture (USDA). Today's announcement comes amid beefed up outreach efforts with key agriculture and safe food stakeholders to better share and exchange produce safety "best practices" and ideas.    » read more »

Sept. 30, 2009 -- WASHINGTON, D.C. – Today, eleven public health and consumer advocacy organizations filed a friend of the court (amicus) brief asking a federal court to reject a lawsuit by R.J. Reynolds, Lorillard and other tobacco companies that seeks to block key provisions of the new federal law regulating tobacco products. The immediate issue before the court is the industry’s challenge of a provision that requires FDA approval before tobacco companies can make claims about “modified risk tobacco products.”

The tobacco companies have also challenged other marketing restrictions in the Family Smoking Prevention and Tobacco Control Act, which authorizes the U.S. Food and Drug Administration (FDA) to regulate the manufacturing, marketing and sale of tobacco products.    » read more »

9/30/09 -- WASHINGTON – Today, the Senate and House conference committee approved the FY2010 Agriculture Appropriations bill including $3.376 billion for food and drug safety. The bill provides funding for the Food and Drug Administration (FDA) and the Food Safety and Inspection Service (FSIS). Under the bill, funding for these two agencies would increase $353 million over last year's level. Kohl is the Chairman of the Senate Agriculture Appropriations Subcommittee.    » read more »

Receives Fast Track Designation from FDA for PEGylated Interferon Beta-1a for Relapsing Multiple Sclerosis

CAMBRIDGE, Mass., Jul 08, 2009 -- Biogen Idec (NASDAQ: BIIB) today announced the U.S. Food and Drug Administration (FDA) has granted PEGylated interferon beta-1a (BIIB017) Fast Track designation for relapsing multiple sclerosis (RMS). Biogen Idec is currently enrolling patients in a global Phase III study evaluating the efficacy and safety of either bi-weekly or once-monthly injections of PEGylated interferon beta-1a in this patient population.    » read more »

June 22, 2009 -- (Washington, D.C.) – Today, U.S. Senator Patty Murray (D-WA) applauded President Obama for signing into law the Family Smoking Prevention and Tobacco Control Act. Senator Murray voted for the bill on June 11th, which passed the Senate 79-17. This law provides the Food and Drug Administration (FDA) with the authority to regulate tobacco products, protect families and consumers, and help smokers overcome their addiction.    » read more »

Remarks By The President At The Signing Of The Family Smoking Prevention And Tobacco Control Act

June 22, 2009 -- Rose Garden -- THE PRESIDENT: Please, everybody, have a seat -- have a seat. I am thrilled to be here for what is I think an extraordinary accomplishment by this Congress, a bill we're about to sign into law.    » read more »

American Lung Association Poised to Help Smokers Quit

June 22, 2009 -- Statement of Stephen J. Nolan, American Lung Association National Board Chair:

Today, President Obama signed the Family Smoking Prevention and Tobacco Control Act (HR 1256) marking a historic day in our fight against lung disease. Finally, after a two-decade long battle, the American Lung Association can join our public health partners in heralding in the day when tobacco companies can no longer prey on America’s kids with deceitful advertising and candy flavored cigarettes.    » read more »

“Family Smoking Prevention and Tobacco Control Act” promotes disease prevention and healthy lifestyles

June 22, 2009 -- Statement of J. James Rohack, MD, AMA President:

“As long-time advocates for strong regulation of the tobacco industry, the AMA is honored to stand with President Obama today as he signs the historic tobacco law. Today’s historic bill signing is a victory for public health over Big Tobacco.    » read more »