BREAKING NEWS
April 4, 2012
FDA Publishes Guidance Document on Benefit-Risk Analysis for Medical Device Approvals
The FDA, to further its Transparency Initiative launched in 2009, published its first ever guidance document on benefit-risk analysis for medical devices. This document is the first to attempt an explanation of the sometimes nebulous benefit-risk analysis that forms the cornerstone of FDA approval. The self-proclaimed purpose of the guidelines, which will take effect on May 1, is to “improve the predictability, consistency, and transparency of the premarket review process.”
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM296379.pdf
March 3, 2011: Judge Lets Health Reform Law Stand Pending Appeal
By Emily P. Walker, Washington Correspondent,
MedPage Today
Published: March 03, 2011
WASHINGTON -- Federal district court judge Roger Vinson has issued a stay against his January ruling that voided the healthcare reform law, but he has also directed the Obama administration to appeal the earlier decision to a higher court within seven days.
On Jan. 31, Vinson, of the Northern District of Florida, in Pensacola, ruled that it's unconstitutional to require people to purchase health insurance. And because that so-called "individual mandate" provision in the law cannot be removed from the rest of the Affordable Care Act (ACA) "the entire Act must be declared void."
The Obama administration asked Vinson last week to "clarify" his ruling, asking that he make it clear that the 26 states that challenged the ACA are still required to comply with it while the case makes its way through the appeals process.
Since Vinson's ruling, a number of states have said they'd halt implementation of the law, while at least eight of the states included in the lawsuit said they would continue implementing the law until all appellate decisions were final. A judge in one of the states included in the lawsuit, Michigan, had ruled separately that the individual mandate is constitutional.
Vinson said he thought he was being crystal clear in his ruling.
"While I believe that my order was as clear and unambiguous as it could be, it is possible that the defendants may have perhaps been confused or misunderstood its import," Vinson wrote. "Accordingly, I will attempt to synopsize the 78-page order and clarify its intended effect."
Vinson went on to say he did intend his original ruling to have an immediate "injunction-like effect," resulting in a halt to implementation of the Affordable Care Act (ACA).
He said that if the Obama administration was unable to comply with his injunction, it could have immediately sought a stay of the ruling.
"It was not expected that they would effectively ignore the order and declaratory judgment for two and one-half weeks, continue to implement the Act, and only then file a belated motion to 'clarify,' he wrote.
However, he went on to determine that the administration's "motion to clarify" was essentially a stay request.
"At this point in time, and in light of all this uncertainty, it would be difficult to deny the defendants a stay pending appeal," Vinson said.
However, the stay is contingent upon the administration filing an appeal of his original decision within seven days, either in an appeals court, or directly with the Supreme Court.
The Supreme Court is expected to be the final arbiter on the constitutionality of the Affordable Care Act.
To date, Vinson and another judge have ruled parts of the law unconstitutional; three judges have upheld the ACA's constitutionality; and 13 courts have thrown out the case on various grounds.
http://www.medpagetoday.com/Washington-Watch/Reform/25177?utm_source=breaking-news&utm_medium=email&utm_campaign=breaking-news
February 24, 2011: Salix Sees Regulatory Delay In Widening Use Of Xifaxan.
Salix Pharmaceuticals Inc. (SLXP) expects the U.S. Food and Drug Administration to decline to approve the company's bid to widen the uses for its gastrointestinal antibiotic Xifaxan because the regulator wants more information.
Xifaxan is currently approved to treat travelers' diarrhea and to reduce the risk of recurrence of hepatic encephalopathy. Last year, the company applied for FDA approval to market the drug to treat non-constipation irritable bowel syndrome and IBS-related bloating. The company had hoped for FDA approval by a target date of March 7.
But Salix said Thursday that based on a telephone conversation with FDA officials Wednesday evening, the company now expects the agency to send a so-called "complete response letter" by March 7. The agency sends such letters when it's not ready to approve drug applications.
Analysts said it's now possible the FDA would delay final approval of the application for as much as two to three years. The company may have to run an additional clinical trial to generate the retreatment data.
http://online.wsj.com/article/BT-CO-20110224-714943.html
Oct 8, 2010: Diet drug Meridia pulled over heart attack, stroke issues.
Abbott Laboratories has withdrawn its popular weight-loss drug Meridia, also known as sibutramine, because it increases the risk for heart attacks and strokes, the Food and Drug Administration announced Friday.
The FDA requested the withdrawal after reviewing data from a study called the Sibutramine Cardiovascular Outcomes Trial, which found a 16 percent increase in the risk of serious heart problems, including non-fatal heart attacks, non-fatal strokes, the need to be revived after cardiac arrest, and death. Those taking the drug were able to lose only a small amount of weight, the study found.
Meanwhile, the FDA also warned consumers Friday not to use a supposedly "herbal" weight-loss product sold over the Internet because it contains sibutramine. The product is called "Slimming Beauty Bitter Orange Slimming Capsules." Sibutramine is not listed on the product's label and "could harm consumers," especially those with heart conditions, the FDA said in its warning.
http://voices.washingtonpost.com/checkup/2010/10/weight-loss_drug_withdrawn.html?wprss=checkup
Sept 14, 2010: FDA staff questions Meridia safety.
As the advisory panel showdown over Abbott Labs' weight loss drug Meridia nears, FDA scientists have released their assessment of the safety data. They are worried about the deaths of Meridia patients--especially those who don't have the cardiovascular risks that, according to the drug's label, contraindicate its use. A review of death reports reported by NPR noted that "young people without known risk factors (aside from obesity) have died" soon after starting Meridia therapy.The FDA is asking the advisory panel to weigh in on ways Meridia's use might be made safer--and to determine whether the drug should stay on the market at all. European regulators have already pulled it. We'll see what the FDA's experts decide.
http://www.fiercepharma.com/story/fda-staff-questions-meridia-safety/2010-09-14?utm_medium=nl&utm_source=internal
June 26, 2010: Study Shows Bariatric Surgery Reduces Women’s Cancer Risk
14 percent of cancer deaths in American men and 20 percent in women may be due to overweight or obesity. Therefore, if obesity contributes to death and disease, it would stand to reason that weight-loss would cut the risk, and research increasingly bears out this assumption. The latest evidence comes from a Swedish study that shows obese women who had bariatric surgery had a 42 percent reduction in cancer risk, compared with conventional obesity management. However, the exact reason why the surgery had a beneficial effect remains unclear, as the researchers could find no direct link with either weight loss or a reduction in food intake.
http://www.healthnews.com/nutrition-diet/weight-loss/study-shows-bariatric-surgery-reduces-women-s-cancer-risk-3355.html
June 21, 2010: FDA Marks First Anniversary of Tobacco Control Act
One year ago, President Obama signed the historic Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act).
Under the Tobacco Control Act, the U.S. Food and Drug Administration obtained authority to regulate tobacco products, with a special emphasis on preventing their use by children and youth and reducing the impact of tobacco on public health. The Act authorizes the FDA, among other things, to set tobacco product standards, require product listing and registration, revise health warning labels, create manufacturing standards, and review products intended to modify the risk of tobacco use.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm216406.htm
http://www.fda.gov/downloads/TobaccoProducts/NewsEvents/UCM216374.pdf
May 24, 2010: FDA and NIH launched a new Web site
When fully developed, it will provide a mechanism for the reporting of pre- and post-market safety data to the federal government. Currently the Web site can be used to report safety problems related to foods, including animal feed, and animal drugs, as well as adverse events occurring on human gene transfer trials.
http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm212845.htm
April 30, 2010: Recall of McNeil Liquid Products for Infants and Children
Working in consultation with the United States FDA, McNeil Consumer Healthcare began implementing a voluntary recall of infant and children’s liquid products due to manufacturing deficiencies which may affect quality, purity or potency. The products include certain liquid infant’s and children’s Tylenol®, Motrin®, Zyrtec®, and Benadryl® products. For a complete list of recalled products, please see http://www.mcneilproductrecall.com/.
http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm211439.htm
Friday March 12, 2010: A Boxed Warning was Added to Clopidogrel Drug Label
WASHINGTON -- The FDA indicated that prescribing information for clopidogrel (Plavix) now includes a warning that the drug can be less effective in poor metabolizers.
For more information, please use the link below:
http://www.medpagetoday.com/InfectiousDisease/PublicHealth/tb/18982?utm_source=breaking-news&utm_medium=email&utm_campaign=breaking-news
February 23, 2010: Gastrointestinal Drugs Advisory Committee Meeting Announcement
The committee will discuss the new drug application (NDA) 22-554 for XIFAXAN (rifaximin), manufactured by Salix Pharmaceuticals, for use in the maintenance of remission of hepatic encephalopathy.
Please see the link, below, for more information on this development.
FEBRUARY 22, 2010: The FDA will Assess Cardiovascular Risks Associated with Diabetic Patients Taking Avandia.
See the link below for more information.
LATEST NEWS RELATING TO DRUGS THAT ARE UNDER INVESTIGATION
The FDA released its quarterly list of drugs under review for potential safety issues. This provides information about potential drug saftey issues, but not a causal relationship between the drug and the listed risk. This information is posted via the FDA from the Adverse Reporting System (AERS). The most recent report is from may be viewed using the link, below:
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm082193.htm
MedWatch: The FDA Safety Information and Adverse Event Reporting Program:
http://www.fda.gov/Safety/MedWatch/default.htm