Food And Drug Administration-Reduced Calorie Diet-Obese Adults-Diet Drugs-Diet Pills

Qsymia - fat profits?

Fen-Phen problems weigh heavy: Docs wary of diet pills
Despite the Food and Drug Administration's approval of two new diet drugs, Mississippi doctors are wary of prescribing them.
Belviq and Qsymia (pronounced kyoo-SIM-ee-uh and formerly known as Qnexa) are the first diet drugs in more than a decade to be approved by the FDA. However, "it's a general rule that most doctors don't use a new drug until there's a year experience with it," said Dr. Richard deShazo, professor of medicine and pediatrics at the University of Mississippi Medical Center.
Belviq and Qsymia work by suppressing appetite. Both drugs cater only to people who are obese (with a body mass index, or BMI, of 30 or above) or who are overweight (with a BMI of 27 or above) and also have at least one weight-related health condition such as Type 2 diabetes, high blood pressure or high cholesterol.
According to the Centers for Disease Control and Prevention, more than one-third of U.S. adults are obese. In Mississippi, seven of 10 adults are overweight or obese.
Qsymia, considered the more effective drug, is a combination of two FDA-approved drugs, phentermine and topiramate. Phentermine is used for short-term weight loss in overweight or obese adults who are exercising and eating a reduced calorie diet. Topiramate is used to treat certain types of seizures in people who have epilepsy and to prevent migraine headaches.
"Qsymia, used responsibly in combination with a healthy lifestyle that includes a reduced-calorie diet and exercise, provides another treatment option for chronic weight management in Americans who are obese or who are overweight and have at least one weight-related comorbid condition," said Dr. Janet Woodock, director of the FDA's Center for Drug Evaluation and Research.
Clinical trial results show patients on Qsymia went from an average 227 pounds to 204 pounds. On Belviq, the average weight dropped from 220 to 207, said Dr. Randy Easterling of River Region Health Center in Vicksburg.
"However, (Qsymia) is not effective without people changing their lifestyle," Easterling said. "I've told my patients if there was a pill that would make you skinny, nobody would be fat."
http://www.clarionledger.com/article/20120728/ACTIVELIVING10/207280314/Fen-Phen-problems-weigh-heavy-Docs-wary-diet-pills?odyssey=mod%7Cnewswell%7Ctext%7CHome%7Cp read more..

Food And Drug Administration-Active Ingredient-Bevacizumab-Cancer Drug-Avastin

Fake Avastin (Bevacizumab) Found In USA

Fake cancer drug, Avastin (bevacizumab) has been distributed in the USA, according to statement issued by Roche, Genentech and the FDA (Food and Drug Administration) today. Roche warns that the counterfeit medication does not have the active ingredient - bevacizumab - and should not be used or taken. Roche says it was told about the fake Avastin from a non-US health authorities... read more..

source:http://www.medicalnewstoday.com

Food And Drug Administration-Television Advertisement-Prescription Drugs-Warning Letter

A Loophole (?) in New FDA Guidance on Pre-Dissemination Review of TV Direct-to-Consumer Ads

On September 27, 2007, President Bush signed into law the Food and Drug Administration Amendments Act of 2007 (FDAAA), which gives FDA the authority to ". . . require the submission of any television advertisement for a drug . . . not later than 45 days before dissemination of the television advertisement." The notice of issuance of "Draft Guidance for Industry Direct-to-Consumer Television Advertisements — FDAAA DTC Television Ad Pre-Dissemination Review Program" was published today in the Federal register (see "Draft FDA Guidance on PreDissemination Review of TV Direct-to-Consumer Ads").
Before I get to the "loophole," here's a summary of the guidance.
Up until now, the FDA allowed the VOLUNTARY submission of TV ads for review prior to airing, but did not require it. The draft guidance details which type of TV ads REQUIRE approval prior to "dissemination," how long it will take FDA to review these ads and get back to the sponsor (45 days), and what the sponsor can do if the FDA does NOT meet the 45-day deadline. Of course, it also mentions CRIMINAL and CIVIL MONETARY penalties that may be sought by the FDA for violations.
Which Ads Will Require "Pre-dissemination" Review?
The Agency intends to require sponsors to submit TV ads for pre-dissemination review in the following categories:

• Category 1: The initial TV ad for any prescription drug or the initial TV ad for a new or expanded approved indication for any prescription drug 
• Category 2: All TV ads for prescription drugs subject to a Risk Evaluation and Mitigation Strategy (REMS) with elements to assure safe use (see section 505-1(f) of the FD&C Act) 
• Category 3: All TV ads for Schedule II controlled substances 
• Category 4: The first TV ad for a prescription drug following a safety labeling update that affects the Boxed Warning, Contraindications, or Warnings & Precautions section of its labeling 
• Category 5: The first TV ad for a prescription drug following the receipt by the sponsor of an enforcement letter (i.e. a Warning or untitled letter) for that product that either cites a TV ad or causes a TV ad to be discontinued because the TV ad contained violations similar to the ones cited in the enforcement letter  
• Category 6: Any TV ad that is otherwise identified by FDA as subject to the pre-dissemination review provision

"Specifically, these categories allow the Agency to review and provide comments on TV ads for prescription drugs with particularly serious risks," says the FDA
Regarding the 45-Day Review Period, FDA says:
"Once the 45-day review time has elapsed, there is no specific legal consequence resulting from disseminating the proposed TV ad without waiting for FDA’s comments. However, once an ad is disseminated, the sponsor is at risk of enforcement action if the ad violates the FD&C Act and implementing FDA regulations."
That is, if the FDA misses its deadline, the situation reverts back to what is the current practice -- air the commercial and perhaps suffer the consequences, which could be nothing more than a warning letter, but may also require the sponsor to air a correction.
What Exactly Will the FDA Review?
In the past, FDA has primarily reviewed TV Ad storyboards, which are graphical representations of key scenes in the ad with dialog included. Storyboards are blueprints for production and are created BEFORE any video production has begun. Now, however, FDA requires a video of the TV ad to be submitted to fulfill the submission requirements. Only after the video is submitted will the 45-day review clock start running.
"FDA cannot provide final comments on the acceptability of a TV ad without viewing a final recorded version in its entirety. FDA understands that some sponsors may wish to receive comments from the Agency before producing a final recorded version of the ad. In such situations, sponsors can submit a pre-dissemination review packag read more..

Food And Drug Administration-Drug Shortages-Crisis-Usa

US drug shortages could continue for years : The Lancet

Sharmila Devi Recent shortages of critical drugs in the USA have hampered patient care and attracted much media attention. Sharmila Devi examines the problems with America's drug supply.Severe shortages of drugs such as sterile injectables that have forced physicians in the USA to practise medicine from crisis to crisis are likely to continue for several more years, say regulators and health-care providers.Around 280 drugs, almost all manufactured in the USA, remain in short supply because of factors including a dwindling number of makers of some drugs, deteriorating conditions in factories, and low prices for generics leading to a lack of investment to upgrade plants.The shortages have led to delays in surgery and cancer treatments, left patients in pain, and forced hospitals to prescribe less effective treatment, said a review by the Associated Press late last year. At least 15 deaths in 15 months were blamed on the shortages, according to data compiled by the Institute for Safe Medication Practices, a patient safety group, and the true number might be higher because many deaths and injuries caused by shortages go unreported.“We don't have any expectation the issue will be resolved soon”, Sandra Kweder, deputy director of the Food and Drug Administration's Office of New Drugs, told The Lancet. “It will be several years before companies building new plants get them up and running.” via thelancet.com Posted via email from Jack's posterous read more..