FDA to Receive More Money from Drug Manufacturers, But Denies “Undue Influence”

The proposed budget of the US Food and Drug Administration (FDA) is worrying the Democrats. They are concerned that FDA’s annual increases in industry user fees—$828 million from manufacturers of medical and food products, including hundreds of millions drug manufacturers pay annually to help speed the review of new medicines—might compromise the agency’s independence.

Nineteen Members of Congress Ask FDA for Official Warning About Mercury in Dental Filling Amalgams

A bipartisan letter authored by Rep. Diane Watson (D-CA) and Rep. Dan Burton (R-IN), and co-signed by congresswomen and men from twelve states, has been sent to the FDA urging them to require clear warnings about mercury toxicity to every dental patient, and to establish specific protections for children and young women.

Vermont Acts to Make Drug Makers’ Gifts Public

Under a new Vermont law, drug and device manufacturers will have to publicly disclose all gifts (in direct payments, speaking and consulting fees, grants, food, lodging and transportation, and books) they make to healthcare providers. The law will require specific disclosure of doctors’ names, dollar amounts, and the medical products to which the spending is… Continue reading Vermont Acts to Make Drug Makers’ Gifts Public

FDA Calls Cheerios an “Unapproved Drug”

The US Food and Drug Administration (FDA) issued a warning letter to cereal manufacturer General Mills for claiming on its cereal box that Cheerios can help lower cholesterol, and saying on their website that “diets rich in whole grain foods can reduce the risk of heart disease.” The letter, dated May 5, called the above… Continue reading FDA Calls Cheerios an “Unapproved Drug”

AAHF Asks Senate Finance Committee to Prioritize Privacy, Transparency, and Independent Research

Last week, AAHF contacted the Senate Finance Committee, which is working on proposals to improve patient care and reduce healthcare costs. We asked committee members to look at two sections in particular: Health Information Technology (HealthIT), and Comparative Effectiveness Research (CER).

Senate HELP Committee Approves Margaret Hamburg as New FDA Commissioner

Sen. Mike Enzi (R-WY) announced that the Senate HELP Committee has approved President Obama’s nomination of Dr. Margaret A. Hamburg, a former New York City health commissioner, as the next commissioner of the Food and Drug Administration. The approval process now moves to the full Senate.

Hydroxycut Recall—The FDA’s double standard

On May 1, consumers were urged by the FDA to immediately stop using fourteen Hydroxycut weight loss products. The manufacturer recalled Hydroxicut after the FDA received 23 reports of liver damage under the Adverse Event Reporting system that now includes dietary supplements—several reports of jaundice, one incident that required a liver transplant, and one death.

Electronic Medical Records Coordinator Says Program Faces “Huge Challenges”

Dr. David Blumenthal has been named the National Coordinator for Health Information Technology as part of the economic stimulus package allocating more than $20 billion for a massive move to electronic medical records (EMRs). Dr. Blumenthal recently published a paper in the New England Journal of Medicine noting, as he starts his Washington job, that… Continue reading Electronic Medical Records Coordinator Says Program Faces “Huge Challenges”