FDA

Statement of American Cancer Society Cancer Action Network, American Heart Association, American Lung Association and Campaign for Tobacco-Free Kids

Washington, D.C. (March 3, 2009)— Our public health organizations strongly support the bipartisan legislation introduced today to provide the U.S. Food and Drug Administration (FDA) with effective authority to regulate tobacco products.

There are few steps Congress can take that will make a bigger difference for America’s health than to finally regulate tobacco products, the number one cause of preventable death and disease in the United States.    » read more »

Pharmaceutical Companies Allegedly Marketed the Drug Natrecor for a Use Not Approved by the Food and Drug Administration

February 19, 2009 -- WASHINGTON – The United States has intervened in two whistleblower suits filed in the Northern District of California against the drug manufacturer Scios Inc. and its parent company, Johnson & Johnson Inc., alleging that the companies marketed the cardiac drug Natrecor for a use not approved by the Food and Drug Administration (FDA) and caused false and fraudulent claims to be submitted to the federal health care programs, the Justice Department announced today. Such an unapproved use is also known as an "off-label" use because it is not included in the drug’s FDA approved product label.    » read more »

Washington, DC - 02/11/2009 - Erik Olson, director of chemical and food safety programs with Pew Health & Human Services Policy, issued the following statement at today’s House Oversight and Investigations Subcommittee Hearing on the recent peanut-related salmonella outbreak:

“The ongoing peanut product recall, widespread illnesses, and eight reported deaths highlight yet again that the nation’s food safety net has gaping holes that must be mended. As President Obama recently said, ‘At a bare minimum, we should be able to count on our government keeping our kids safe when they eat peanut butter.’    » read more »

February 11, 2009 -- Consumer Federation of America applauds Congressmen Dingell, Stupak and Pallone for their strong leadership on food safety. Their bill, the Food and Drug Administration Globalization Act, will do much to improve the FDA’s ability to assure the safety of the food supply. Consumers cannot afford an FDA that does not have the authorities and funding necessary to protect the public health.

The current Salmonella outbreak linked to peanut butter and peanut paste is only the latest example in an unfortunate series of nationwide foodborne disease outbreaks that demonstrate the problems that can occur without strong FDA authority and oversight.    » read more »

July 18, 2008 -- The U.S. Food and Drug Administration today issued a final regulation that makes early phase 1 clinical drug development safe and efficient by enabling a phased approach to complying with current good manufacturing practice (CGMP) statutes and FDA investigational requirements.    » read more »

XIENCE V, Only Drug Eluting Stent to Demonstrate Superiority Over Market-Leading Stent in Clinical Trials, Now Available in United States for Treatment of Coronary Artery Disease

Abbott Park, Illinois, July 2, 2008 -- Abbott (NYSE: ABT) today announced that the U.S. Food and Drug Administration (FDA) approved the XIENCE™ V Everolimus Eluting Coronary Stent System for the treatment of coronary artery disease. XIENCE V is the only drug eluting stent to have demonstrated superiority over Boston Scientific's TAXUS® paclitaxel-eluting coronary stent system in two randomized head-to-head clinical trials. XIENCE V will be launched in the United States immediately.    » read more »

06/17/2008 -- BOSTON – Senator John Kerry today urged the Food and Drug Administration (FDA) to explain the long delays in getting new generic prescription drugs out on the market.

People across Massachusetts and throughout the nation are facing rising costs for medications they depend on every day. For some, especially the elderly and low-income families, affordable generic drugs can be the difference between life and death.

The FDA is currently required to review a generic drug application within 180 days. However, the median approval time for a generic drug application now takes longer than 21 months - well beyond the 180 day requirement. These delays create a serious backlog of applications.    » read more »

Record-Breaking Agreement Requires Company to Submit Ads to FDA Prior to Airing

May 20, 2008 -- Chicago - Illinois Attorney General Lisa Madigan today announced a landmark financial settlement with Merck and Company, Inc., that also requires the pharmaceutical manufacturer to submit television drug advertisements to the U.S. Food and Drug Administration (FDA) for review before their broadcast.    » read more »

Boise – The State of Idaho will receive more than $1.1 million as a result of a consent judgment with Merck and Company, Inc., Attorney General Lawrence Wasden announced today. Wasden’s office filed a consent judgment resolving a three-year investigation by 30 states concerning the company’s deceptive promotion of the drug Vioxx.

The judgment, filed Tuesday in Fourth District Court in Ada County, will largely restrict Merck’s ability to deceptively promote any Merck product.    » read more »

Company was under investigation for marketing of anti-inflammatory drug

May 20, 2008 -- TALLAHASSEE, FL - Florida Attorney General Bill McCollum today filed a stipulated consent judgment with Merck and Company, Inc. resolving a three-year investigation that targeted the company’s promotion of the prescription drug Vioxx.

Merck Vioxx

The agreement provides $58 million to the 30 participating states, of which Florida’s share will be more than $3.5 million. The judgment, filed today in the Broward County Circuit Court and pending court approval, will largely restrict Merck’s ability to promote any Merck product in a manner that may be deceptive.    » read more »

May 20, 2008 -- SAN DIEGO -- California Attorney General Edmund G. Brown Jr. today announced a “groundbreaking settlement” with Merck & Co. which requires the pharmaceutical manufacturer to obtain Federal Drug Administration approval before running any television drug advertisements for new pain medications.

“Merck’s aggressive television advertising convinced hundreds of thousands of consumers to seek Vioxx prescriptions before the drug’s risk were fully understood,” Attorney General Brown said. “Today’s groundbreaking settlement prevents Merck from releasing new television drug advertisements without obtaining federal approval.”    » read more »

Tainted Heparin Linked To 81 Deaths; Blood Thinner Originating From China Contained Deadly Contaminant

April 22, 2008 -- WASHINGTON, DC--U.S. Senator Charles E. Schumer (D-NY) announced Tuesday he will introduce legislation this week establishing a modern track-and-trace system for all prescription drugs sold in the United States, a move he said would cut down on the contamination of popular patient medicines like the embattled blood thinner, heparin.

Heparin syringe: Photo by flaviab (CC)    » read more »

April 09, 2008 -- Following a federal recall of two dietary supplements, the Kentucky Department for Public Health (DPH) has issued a health advisory for consumers who may have ingested the products and could be at risk for illness.

The U.S. Food and Drug Administration on Friday reported that two products of the Total Body Formula dietary supplement line have been recalled due to health concerns: Total Body Formula in the flavors of Tropical Orange and Peach Nectar and Total Body Mega Formula in Orange/Tangerine flavor.    » read more »

March 28, 2008 -- The U.S. Food and Drug Administration (FDA) today announced it is seeking a $2.2 million penalty against a California hearing aid manufacturer for violations of federal law, including manufacturing standards violations and the failure to notify the FDA of a change in an outside supplier or vendor, which may have exposed recipients of the devices to unnecessary health risks.

The hearing aids pose a public health risk due to excessive moisture, exposing patients to the risk of device failure, possible surgery, and the potential for additional hearing loss.    » read more »

Distributor recalls dietary supplement products after reports of adverse reactions

March 27, 2008 -- The U.S. Food and Drug Administration (FDA) is advising consumers not to purchase or consume Total Body Formula in the flavors of Tropical Orange and Peach Nectar, or Total Body Mega Formula in the Orange/Tangerine flavor. The liquid dietary supplement products may cause severe adverse reactions, including significant hair loss, muscle cramps, diarrhea, joint pain and fatigue.    » read more »