FDA

March 18, 2010 -- The U.S. Food and Drug Administration issued a final rule containing a broad set of federal requirements designed to significantly curb access to and the appeal of cigarettes and smokeless tobacco products to children and adolescents in the United States. Published March 19, 2010, the new rule becomes effective June 22, 2010, and has the force and effect of law.

Titled Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents, the new rule restricts the sale, distribution, and promotion of these products to make them less accessible and less attractive to kids.    » read more »

January 15, 2010 -- Washington, DC -- Congresswoman Rosa DeLauro (CT-3) released the following statement today in response to the expanded recall of Tylenol products.

A report by the Food and Drug Administration shows that McNeil Healthcare, LLC, the Johnson & Johnson division that manufactures Tylenol, received complaints about an uncharacteristic musty odor emanating from Tylenol Arthritis Relief Caplets in 2008. After multiple consumer complaints of stomach problems, a recall was initiated in September of 2009. The FDA investigated, and has determined that the quality control testing at McNeil failed, as did the company’s response and notification of the public.    » read more »

8 December 2009 -- WASHINGTON – Today, Congressman Mike Quigley (D-IL) released a letter he sent to the Food and Drug Administration (FDA) urging them to reexamine outdated and discriminatory restrictions on blood donation by gay men.

The FDA’s current policy permanently bans men who have had sex with men from donating blood, while still permitting heterosexual individuals who have had sex with an HIV-positive partner to donate samples after a one-year deferral period. The issue has been the subject of an ongoing debate that has come to the forefront once again with President Obama’s appointment of a new FDA Commissioner, Dr. Margaret Hamburg.    » read more »

Prescription drug legislation would put downward pressure on health care costs, save billions of dollars for taxpayers and consumers

December 8, 2009 -- WASHINGTON, D.C. – Senator Jim Webb (D-VA) today joined a bipartisan group of nineteen Senators in proposing an amendment to the health care reform bill to lower prescription drug costs and save the federal government nearly $20 billion over the next ten years.

Originally introduced earlier this year as the Pharmaceutical Market Access and Drug Safety Act, and supported at that time by Senator Webb, the measure would allow American consumers to safely import lower-priced, Food and Drug Administration-approved drugs from other approved countries. The Senate is expected to consider the amendment in the coming days.    » read more »

Requests GAO Audit on Reducing Illnesses and Death Due to Contaminated Raw Oysters; Audit Would Determine Effectiveness of ISSC Risk Management Plan in Reducing Deaths Due to Raw Oysters Contaminated with Vibrio Vulnificus

November 17, 2009 -- Washington, DC -- Congresswoman Rosa L. DeLauro (D-CT) today sent a letter to the Government Accountability Office (GAO) requesting an audit of the Interstate Shellfish Sanitation Conference’s (ISSC) risk management plan for Vibrio vulnificus (Vv).

The audit would determine whether the risk management plan being used by the oyster industry, and promoted by the ISSC, is effective in reducing illnesses and death due to oysters contaminated with the Vv bacteria.    » read more »

November 16, 2009 -- Genzyme Corporation (Nasdaq: GENZ) announced today that it has received a complete response letter from the FDA regarding its application to market Lumizyme™ (alglucosidase alfa) for the treatment of Pompe disease. In its letter, the agency stated that satisfactory resolution of deficiencies related to the Allston Landing manufacturing plant are required before the Lumizyme application can be approved.

Genzyme believes the other elements of the Lumizyme review, such as the Risk Evaluation and Mitigation Strategy (REMS), the product label, and post-marketing requirements, have been satisfactorily addressed.    » read more »

Chemical Has Been Shown To Lead To Developmental Problems And Cancers

November 16, 2009 -- On the heels of a new Consumer Reports’ study showing that the toxic chemical bisphenol-A is now in a wider range of products used and consumed by children and in higher concentrations than previously thought, U.S. Senator Charles E. Schumer today unveiled his legislation that bans BPA in food and beverage containers marketed to kids aged three and under.    » read more »

Protects Families and Assists Farmers

November 16, 2009 -- Washington, D.C. –Today the Senate took another step closer to passing legislation that will give the Food and Drug Administration (FDA) the resources it needs to ensure the safety of our nation’s food supply. The Senate Agriculture Committee released the chairman’s draft of the Food Safety Modernization Act, which includes Senator Jeff Merkley’s provisions to improve traceability of contaminated processed foods and protect the organic farming and sustainable agriculture industries.    » read more »

Washington, DC - 11/12/2009 - New polls of voters in selected states – Nevada, New Hampshire, North Carolina and Ohio – show overwhelming support for measures that would give the Food and Drug Administration (FDA) new authority to ensure the food Americans eat does not make them sick, according to a new poll commissioned by the Pew Health Group and conducted by a respected bipartisan team of pollsters at Hart Research (Democratic) and Public Opinion Strategies (Republican).

The polls, conducted in October, demonstrated an overwhelming majority of voters support food safety legislation that would give the FDA these new powers.    » read more »

Nov 13, 2009 -- BATON ROUGE – Louisiana Governor Bobby Jindal and Louisiana Department of Health and Hospitals Secretary Alan Levine today applauded the U.S. Food and Drug Administration’s (FDA) decision to delay a proposed plan banning the interstate sale of untreated raw Gulf oysters in warm months. Both the Governor and Secretary had previously expressed their concerns with the proposal directly to the FDA, which has now agreed to commission a study on both the economic impact of any decision for the oyster industry and how to decrease the incidence of vibrio vulnificus infection.

Governor Jindal sent a letter to FDA Commissioner Margaret Hamburg on Tuesday, outlining the effects of its proposed regulations on the state’s oyster industry.    » read more »

FDA to Study Consequences of Proposal

November 13, 2009 -- WASHINGTON— U.S. Congressman Charlie Melancon (LA-03) announced today that the Food and Drug Administration has halted movement on a proposed ban of the sale of fresh Gulf oysters during warm weather months, pending the results of a feasibility study.

After Congressman Melancon and U.S. Senator Mary Landrieu organized a meeting earlier this week with Gulf Coast members of Congress and senior officials at the FDA, the agency decided to study the possible effects of the ban before moving forward.    » read more »

Chemical Used in Countless Products Including Baby Bottles, Canned Formula and Canned Food

November 13, 2009 -- On the heels of a new Consumer Reports’ study showing that the toxic chemical bisphenol-A is now in a wider range of products used and consumed by children and in higher concentrations than previously thought, U.S. Senator Charles E. Schumer today unveiled his legislation that bans BPA in food and beverage containers marketed to kids aged three and under.    » read more »

Senator Landrieu gets commitment from FDA Commissioner Dr. Hamburg in phone call today.

11/13/2009 -- WASHINGTON -- Senator Mary L. Landrieu, D-La., today announced that the U.S. Food and Drug Administration (FDA) has agreed to halt a proposed plan to ban Gulf Coast oysters that are not subject to post-harvest processing. Sen. Landrieu received the news in a phone call with FDA Commissioner Dr. Peggy Hamburg earlier today.

Sen. Landrieu has been a staunch opponent of the FDA regulation, and has organized several calls and meetings urging top FDA officials to reconsider their proposed action.    » read more »

Pre-Market Testing Was Flawed, Public Citizen says

Nov. 11, 2009 -- WASHINGTON, D.C. - Medicare should deny reimbursement for a medical device for depression that the Food and Drug Administration (FDA) approved despite unconvincing test results, Public Citizen said today in a letter sent to Medicare officials.

“The scant evidence presented for approval of this device does not come close to matching the type of data typically required for approval of anti-depressant drugs” said Dr. Peter Lurie, deputy director of Public Citizen’s Health Research Group. “Medicare should not approve coverage of this unproven device because it could divert patients from more effective therapies.”    » read more »

10 November 2009, London UK & Philadelphia US -- GlaxoSmithKline (GSK) today announced that the US Food and Drug Administration (FDA) has approved a supplemental biologics license application (sBLA) for its unadjuvanted influenza A (H1N1) pandemic vaccine. The approval of the sBLA, which was filed as a strain change supplement to GSK’s FluLaval seasonal flu vaccine, allows the company to manufacture a flu vaccine for use in adults to prevent influenza caused by the 2009 pandemic H1N1 influenza A strain.    » read more »