FDA

May 26, 2009 -- PROVIDENCE, RI – In an effort to help Americans better protect themselves from the sun’s harmful rays, U.S. Senator Jack Reed (D-RI) is championing legislation requiring the Food and Drug Administration (FDA) to strengthen labeling and testing standards for sunscreen products.    » read more »

May 26, 2009 -- CHICAGO, IL – The ability of the Food and Drug Administration (FDA) to protect the safety of the nation’s food supply for American families will dramatically improve if Congress passes the FDA Food Safety Modernization Act, U.S. Senator Dick Durbin (D-IL) said today. Durbin’s legislation would give the FDA new authorities, tools and resources to comprehensively reform the nation’s food safety systems.    » read more »

Applications Based on Data from Nearly 1,500 Patients in Two of the Largest Studies Ever Conducted in Chronic Lymphocytic Leukemia

SOUTH SAN FRANCISCO, Calif. and CAMBRIDGE, Mass. – May 19, 2009 – Genentech, Inc. and Biogen Idec (Nasdaq: BIIB) today announced that the companies submitted two supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration (FDA) for Rituxan® (rituximab) plus standard chemotherapy for people with previously untreated or treated chronic lymphocytic leukemia (CLL).

The companies will request a priority review, and if granted, anticipate the FDA will make a decision within six months.    » read more »

May 21, 2009 -- Genzyme Corporation (Nasdaq: GENZ) announced today that it has submitted the final documentation to address all items in the FDA’s complete response letter for Lumizyme™ (alglucosidase alfa), produced at the 2,000 L bioreactor scale.

The submission included clinical data requested by the FDA from Genzyme’s Pompe Registry. The FDA has agreed that these data can fulfill the requirements for a verification study to demonstrate the clinical benefit of Lumizyme. Also included in the submission were the Risk Evaluation and Mitigation Strategy (REMS) and the final label for the product.    » read more »

May 22, 2009 -- In an effort to help Americans better protect themselves from the sun’s harmful rays, U.S. Senators Chris Dodd (D-CT) and Jack Reed (D-RI) are teaming up with dermatologists and consumer rights advocates to introduce legislation requiring the Food and Drug Administration (FDA) to strengthen labeling and testing standards for sunscreen products.

The FDA has not updated its sunscreen labeling standards to include UVA protection, despite working on it for over 30 years. The current standards only require testing and labeling for UVB rays, known for causing sunburns and increasing the chance of skin cancer. However, they do not require standards for UVA rays, which are a major cause of skin cancer and premature aging.    » read more »

May 19, 2009 -- WASHINGTON, D.C. – U.S. Senator Sherrod Brown (D-OH), a member of the Senate Health, Education, Labor & Pensions (HELP) Committee, issued the following statement in response to the start of the committee’s mark-up of the “Family Smoking Prevention and Tobacco Control Act”:

“Fifteen years ago, I sat on the House Energy and Commerce Committee and listened as seven tobacco company CEOs raised their right hands to defend their practices and swear, under oath, that cigarettes and nicotine were not addictive.    » read more »

March 24, 2009 -- Planned Parenthood Federation of America (PPFA) applauded today’s ruling by the U.S. District Court for the Eastern District of New York ordering the Federal Drug Administration (FDA) to expand access to emergency contraception (EC), also known as Plan B.

“Today’s federal court ruling puts women’s health ahead of politics,” said Cecile Richards, president of Planned Parenthood Federation of America. “We must do everything we can to reduce the number of unintended pregnancies and protect the health and safety of all women.”    » read more »

Decision Underscores Need for Reform at FDA

March 23, 2009 -- A federal district court today ruled the Food and Drug Administration (FDA) violated its own rules when it restricted over-the-counter sales of the emergency contraceptive Plan B to women over 18. The New York City-based court ordered the FDA to reconsider its decisions regarding over-the-counter access and age restrictions and to extend over-the-counter access to 17 year olds within 30 days.    » read more »

March 14, 2009 -- WASHINGTON – In his weekly address, President Barack Obama announced the appointments of Dr. Margaret Hamburg as Commissioner of the Food and Drug Administration, and Dr. Joshua Sharfstein as the Principal Deputy Commissioner, as well as the creation of a new Food Safety Working Group.

This Food Safety Working Group will be chaired by the Secretaries of Health and Human Services and the Department of Agriculture and it will coordinate with other agencies and senior officials to advise the President on improving coordination throughout the government, examining and upgrading food safety laws, and enforcing laws that will keep the American people safe.    » read more »

March 11, 2009 -- Consumer Federation of America welcomes the appointment of Dr. Margaret Hamburg and Dr. Joshua Sharfstein as commissioner and principal deputy commissioner of the U.S. Food and Drug Administration. Their resumes are extremely impressive and both are familiar with the FDA’s failure to protect the public from foodborne illness.    » read more »

Statement of Sidney Wolfe, M.D., Director, Health Research Group at Public Citizen

March 10, 2009 -- On Monday, the Food and Drug Administration (FDA) belatedly announced a Class I recall of the Shiley 3.0 PED tracheostomy tube, highlighting the painfully slow and lethargic way that the agency responds to emerging problems with medical devices. This delayed and therefore negligent FDA announcement comes three months after the agency was first aware of problems with the device and two months after the company had warned its customers and begun a recall.    » read more »

Statement of Peter Lurie, M.D., M.P.H., Deputy Director, Public Citizen’s Health Research Group

March 9, 2009 -- Friday’s approval of SyntheMed’s REPEL-CV, which is designed to reduce post-surgical scarring in children following open-heart surgery, once again demonstrates the Food and Drug Administration’s (FDA) low standard for approving medical devices. On the heels of the FDA’s approval of ReGen’s Menaflex implant, this approval further shows the agency’s willingness to approve a device that has failed to demonstrate any clinical benefit.    » read more »

ill Would Allow Patients Hurt by Faulty Medical Devices To Hold Manufacturers Accountable

March 5, 2009 -- WASHINGTON, D.C. - Congress should quickly pass legislation introduced today that would restore the rights of patients injured by defective or poorly labeled medical devices to hold manufacturers accountable in court, Public Citizen said today.

The Medical Device Safety Act is sponsored by Sen. Edward Kennedy (D-Mass.) and Reps. Henry Waxman (D-Calif.) and Frank Pallone (D-N.J.). Public Citizen and nine other public interest groups sent letters to Kennedy, Waxman and Pallone urging prompt action on the bills.    » read more »

March 4, 2009 -- Statement of Charles D. Connor, American Lung Association President and CEO:

Today in Washington, the Congress has moved one big step closer to ending the grip Big Tobacco has on our nation’s health. The U.S. House of Representatives’ Energy and Commerce Committee sent the Family Smoking Prevention and Tobacco Control Act (HR 1256) to the full House for its consideration. Passage of this important bill will provide the U.S. Food and Drug Administration (FDA) urgently needed regulatory control over the tobacco industry.    » read more »

Statement of Brian Wolfman, Director, Litigation Group at Public Citizen

March 4, 2009 -- "We are extremely gratified that the U.S. Supreme Court today in Wyeth v. Levine upheld the traditional right of patients harmed by defective and mislabeled drugs to sue drug companies to recover compensation for their injuries.

Drug companies are not perfect, and they sometimes fail to identify and inform doctors and the Food and Drug Administration (FDA) of problems with their products or their products’ labels. Nor is the FDA perfect. It is overworked and underfunded, and it depends almost entirely on drug companies for information about the safety and effectiveness of drugs.    » read more »