FDA

March 19, 2008 -- WASHINGTON, DC— Today, Senator Edward M. Kennedy, Chairman of the Health, Education, Labor and Pensions Committee, released the following statement in response to the FDA’s announcement that they have identified the contaminant in the blood thinner heparin, a chemical compound called oversulfated chondroitin sulfate. Senator Kennedy will be sending letters to the FDA and industry later today.    » read more »

Agency on path to establish offices in China

March 14, 2008 -- In an important development, the U.S. Food and Drug Administration has received approval from the U.S. State Department to establish eight full time permanent FDA positions at U.S. diplomatic posts in the People's Republic of China, pending authorization from the Chinese government.    » read more »

Ongoing safety review of Botox, Botox Cosmetic and Myobloc taking place

February 8, 2008 -- The U.S. Food and Drug Administration (FDA) today notified the public that Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B) have been linked in some cases to adverse reactions, including respiratory failure and death, following treatment of a variety of conditions using a wide range of doses.    » read more »

FDA advises health care practitioners to switch suppliers and limit use of drug until problem identified

February 11, 2008 -- The U.S. Food and Drug Administration (FDA) announced today that Baxter Healthcare Corporation has temporarily stopped manufacturing multiple-dose vials of the injectable blood-thinning drug heparin due to reports of serious allergic reactions and hypotension (low blood pressure) in patients who receive high "bolus" doses of the drug.    » read more »

Feb. 8, 2008 -- Statement of Sidney Wolfe, MD, Director of the Health Research Group at Public Citizen:    » read more »

February 05, 2008 -- Reps. Henry A. Waxman, John D. Dingell, Bart Stupak, and Frank Pallone, Jr., called on members of one of FDA’s own advisory committees to provide Congress with its assessment of the resources needed to remedy the crisis at the agency stemming from years of chronic underfunding.    » read more »

February 4, 2008 -- The U.S. Food and Drug Administration (FDA), part of the U.S. Department of Health and Human Services, is requesting nearly $2.4 billion to protect and promote public health as part of the President's fiscal year (FY) 2009 budget—a 5.7 percent increase over the budget that the FDA received for the current fiscal year.

The FY 2009 request, which covers the period of Oct. 1, 2008 through Sept. 30, 2009, includes $1.77 billion in budget authority and $628 million in industry user fees.    » read more »

Additional Clinical Trial Sites To Be Added -- Fast Track Status With FDA

CORAL GABLES, FL - January 25, 2008 -- Catalyst Pharmaceutical Partners, Inc. (Nasdaq: CPRX), a biopharmaceutical company that acquires, in-licenses, develops and commercializes prescription drugs for the treatment of drug addiction, today announced that it has initiated enrollment of patients for its 180- patient, U.S. Phase II clinical trial evaluating the use of CPP-109 in treating patients with cocaine addiction.    » read more »

Public Citizen Petitions FDA for ‘Black Box’ Labels, Physician and Patient Warnings; Cites Deaths Linked to Use of the Drugs

Jan. 24, 2008 -- WASHINGTON, D.C. – The Food and Drug Administration (FDA) should immediately increase its warnings and directly warn patients and doctors about the use of botulinum toxin – available as Botox and Myobloc – because of serious adverse reactions, including deaths, linked to the drug, Public Citizen said in a petition filed Thursday with the agency.    » read more »

January 23, 2008 -- Today Representatives Henry A. Waxman, John D. Dingell, Frank Pallone, Jr., Rosa L. DeLauro, and Edward Markey, and Senators Edward M. Kennedy, Patrick J. Leahy, and Christopher J. Dodd, questioned the basis for a new Food and Drug Administration (FDA) proposal that was apparently designed to shield pharmaceutical and device companies from liability for injuries sustained by American consumers as a result of unsafe products.    » read more »

January 23, 2008 -- BURLINGTON – The Vermont Department of Health is warning consumers about a product recall of all canned green beans and garbanzo beans distributed by New Era Canning Company during the past five years, due to possible Clostridium botulinum (C. botulinum) contamination.

The products were distributed nationwide.

No one, to date, has been reported ill. The recall is the result of a routine Food and Drug Administration (FDA) inspection.    » read more »

Statement from CFA’s Carol Tucker Foreman

January 15, 2008 -- The Bush Administration, after days of internal debate, has rejected public opposition and the pleas of the food industry and consumer groups and approved putting milk and meat from cloned animals in our food.

Milk and meat from cloned animals and their offspring will enter the food supply. They can do so immediately. The products will not be labeled as such and American consumers will have no way to avoid consuming them.    » read more »

Statement by Margaret Mellon, Union of Concerned Scientists

WASHINGTON (January 15, 2008) – The Food and Drug Administration (FDA) today released a report concluding that meat and milk from cloned animals and their offspring pose no public health threat. At the same time, the U.S. Department of Agriculture announced that it would ask producers of clones to continue to abide by a “voluntary moratorium” and keep their products off the market.

Below is a statement by Margaret Mellon, Director of the Food and Environment Program at the Union of Concerned Scientists:    » read more »

15 January 2008 -- A final report from the U.S. Food and Drug Administration concludes that meat and milk from cloned cows, pigs, goats and their offspring are safe for American consumers to eat and drink. Opponents, including a number of consumer and animal rights groups, say the FDA was heavily influenced by the biotechnology industry, and failed to consider possible side effects of cloning.    » read more »

Statement by Sidney Wolfe, M.D., Director of Public Citizen’s Health Research Group

Jan. 14, 2008 -- Users of the prescription cholesterol medicine Zetia and Vytorin received some troubling news from the makers of the drug today: Although the pills they’re taking lower their cholesterol, there is no evidence that they reduce the risk of heart attacks and strokes, and may, in fact, be putting them at risk.    » read more »