It may be the biggest thing in diaper rash treatment, a custom-made product to soothe a baby’s bottom at the eye-popping price of $1,600. This is no Desitin or Balmex, or any other brand found in stores. This cream is blended to order in a pharmacist’s lab. Does it work better than the common treatments? There is little evidence either way. But the sky-high prices commanded by such compounded medicines are drawing the ire of health insurance companies that must pick up the bill. They say the industry is profiteering at their expense. Compounded medicines are the Savile Row suits of the pharmacy, made to order when common treatments will not suffice. Pharmacists say it is the doctors who decide what to prescribe. But many pharmacies have standard formulations and some promise six-figure incomes to sales representatives who call on doctors. Besides the $1,600 ointment to treat diaper rash, there was the $8,500 cream to reduce scarring and the $2,300 salve to relieve pain recently billed to Catamaran, a pharmacy benefits manager. Alarmed that its spending on compounded drugs has quintupled in just two years, Catamaran has begun to review such claims more carefully. Pharmacy benefit managers owned by UnitedHealth and Blue Cross and Blue Shield plans are also reining in spending on compounded drugs, as are insurers like Harvard Pilgrim and various state workers’ compensation plans. Express Scripts, the largest pharmacy benefits manager, has said it will stop... |
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Showing posts with label Food and Drug Administration. Show all posts
Showing posts with label Food and Drug Administration. Show all posts
Sunday, August 17, 2014
Pharmacies Turn Drugs Into Profits, Pitting Insurers vs. Compounders
Tuesday, August 12, 2014
Colgate Total Ingredient Linked to Hormones, Cancer Spotlights FDA Process
Photographer: Daniel Acker/Bloomberg The chemical triclosan has been linked to cancer-cell growth and disrupted development in animals. Regulators are reviewing whether it’s safe to put in soap, cutting boards and toys. Consumer companies are phasing it out. Minnesota voted in May to ban it in many products. At the same time, millions of Americans are putting it in their mouths every day, by way of a top-selling toothpaste that uses the antibacterial chemical to head off gum disease -- Colgate-Palmolive Co.’s Total. Total is safe, Colgate says, citing the rigorous Food and Drug Administration process that led to the toothpaste’s 1997 approval as an over-the-counter drug. A closer look at that application process, however, reveals that some of the scientific findings Colgate put forward to establish triclosan’s safety in toothpaste weren’t black and white -- and weren’t, until this year, available to the public. Colgate’s Total application included 35 pages summarizing toxicology studies on triclosan, which the FDA withheld from view. The agency released the pages earlier this year in response to a lawsuit over a Freedom of Information Act request. Later, following inquiries from Bloomberg News, the FDA put the pages on its website. The pages show how even with one of the U.S.’s most stringent regulatory processes -- FDA approval of a new drug -- the government relies on company-backed science to show products are safe and... |
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Tuesday, July 29, 2014
Take Two: Just How Good Are Generic Meds Anyway?
A few days ago I wrote a post about generic painkillers and the fact that doctors themselves—who should know better—often don't use them. "If physicians aren't really sold on generics in their own personal lives," I asked, "does this mean they're not really sold on them in their professional lives too?" Well, perhaps I got it backwards. A friend sent me a link to a Forbes article from last year about the FDA retracting its approval of a generic version of Wellbutrin: The episode is bringing momentum to a movement that has been quietly building among many doctors and medical societies that are increasingly willing to ask a question that borders on heresy: Are generics really identical to the branded products they are meant to replicate? To a surprising degree, they say, the answer is no. |
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- FDA Issues Guidances for Industry on Social Media (workers-compensation.blogspot.com)
- FDA warns of compounded drug recall by Texas firm (workers-compensation.blogspot.com)
- Massachusetts Prohibited From Banning Zogenix (workers-compensation.blogspot.com)
- Leading Coal Industry Law Firm Withheld Evidence of Black Lung Disease (workers-compensation.blogspot.com)
- Its Déjà Vu All Over Again (workers-compensation.blogspot.com)
- FDA Warns Zithromax / Zmax Antibiotics Potential Risk of Fatal Heart Rhythms (workers-compensation.blogspot.com)
Wednesday, July 23, 2014
FDA warns of compounded drug recall by Texas firm
WASHINGTON — The Food and Drug Administration warned doctors Wednesday not to use compounded drugs from a Texas specialty pharmacy due to potential risks of contamination. The agency says FDA inspectors recently uncovered unsanitary conditions at Unique Pharmaceuticals’ plant in Temple, Texas. The inspections revealed production problems in several drug lots that were supposed to be sterile. “Using these products puts patients at an unacceptable risk for serious infection,” said Carol Bennett, an official in the FDA’s drug center. At the behest of regulators, Unique Pharmaceuticals has recalled all non-expired, sterile products distributed across the U.S., including a fluid used to clear mucus in patients with respiratory conditions. The company has also halted production of all other sterile drugs, which are generally solutions administered via injection or intravenous infusion. A spokesman for the company said it continues to produce other forms of drugs that do not require sterile conditions. “We are diligently working to address FDA’s concerns noted before the recall,” said David Shank, in a statement. “We have commissioned third-party independent experts to address those concerns and ensure the safety of our compounded preparations for our customers.” Shank added that the recall could contribute to shortages of medicines already in short supply. The FDA said in a statement it is not aware of any illnesses linked... |
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Thursday, June 26, 2014
FDA Issues Guidances for Industry on Social Media
Today's article shared from Thomas Abrams
Ongoing changes in technology transform medical products – and the ways that both patients and health care providers learn about those products. In today’s world, in addition to traditional sources of medical product information, patients and health care providers regularly get information about FDA-regulated medical products through social media and other Internet sources, and those technologies continue to evolve. But regardless of the Internet source used to communicate about medical products, the public health is best served by clear, accurate, truthful and non-misleading information about them.
That’s why the agency has proposed two draft guidances for industry with recommendations to help manufacturers and their representatives accurately communicate online about prescription drugs and medical devices.
These documents strive to ensure that the information provided by drug and device companies is accurate and will help patients to make well-informed decisions in consultation with their health care providers.
Our first guidance provides recommendations for the presentation of risk and benefit information for prescription drugs or medical devices using Internet/social media sources with character space limitations, such as Twitter and the paid search results links on Google and Yahoo. These recommendations address the presentation of both benefit information and risk information in this setting. We understand that...
[Click here to see the rest of this post]
That’s why the agency has proposed two draft guidances for industry with recommendations to help manufacturers and their representatives accurately communicate online about prescription drugs and medical devices.
These documents strive to ensure that the information provided by drug and device companies is accurate and will help patients to make well-informed decisions in consultation with their health care providers.
Our first guidance provides recommendations for the presentation of risk and benefit information for prescription drugs or medical devices using Internet/social media sources with character space limitations, such as Twitter and the paid search results links on Google and Yahoo. These recommendations address the presentation of both benefit information and risk information in this setting. We understand that...
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Related articles
F.D.A. Shift on Painkillers Was Years in the Making (workers-compensation.blogspot.com)
FDA Proposes Changes in Pain Medication Prescriptions (workers-compensation.blogspot.com)
Johnson & Johnson to Pay More Than $2.2 Billion to Resolve Criminal and Civil Investigatio (workers-compensation.blogspot.com)
As Robot-Assisted Surgery Expands, Are Patients And Providers Getting Enough Information? (workers-compensation.blogspot.com)
FDA Warns Zithromax / Zmax Antibiotics Potential Risk of Fatal Heart Rhythms (workers-compensation.blogspot.com)
F.D.A. Shift on Painkillers Was Years in the Making (workers-compensation.blogspot.com)
FDA Proposes Changes in Pain Medication Prescriptions (workers-compensation.blogspot.com)
Johnson & Johnson to Pay More Than $2.2 Billion to Resolve Criminal and Civil Investigatio (workers-compensation.blogspot.com)
As Robot-Assisted Surgery Expands, Are Patients And Providers Getting Enough Information? (workers-compensation.blogspot.com)
FDA Warns Zithromax / Zmax Antibiotics Potential Risk of Fatal Heart Rhythms (workers-compensation.blogspot.com)
Wednesday, March 5, 2014
Its Déjà Vu All Over Again
Today's post is shared from Judge David Langham and I would encourage to read his blog at: http://flojcc.blogspot.com/ David Langham is the Deputy Chief Judge of Compensation Claims for the Florida Office of Judges of Compensation Claims and Division of Administrative Hearings.
Zohydro is in the news yet again. This month the new medication will become available. Its manufacturer says it will market this only to a select few physicians whose experience with pain will assure their discretion and restraint in distributing this strong pain killer.
In November, I noted the approval of this new Opiod formulation, and in December, I wrote when over half the nation’s attorneys general wrote to the FDA urging that the approval receive greater scrutiny and perhaps reconsideration (Zohydro in the News Again).
Well, as Yogi Bera once said “its déjà vu all over again.” Zohydro is back in the news at the end of February. Now, an “activist” group is questioning the Food and Drug Administration (FDA)and has released a letter it sent to the FDA in late February. The group is called “Fed Up!” and their points are interesting.
They note that Zohydro is being marketed in the “midst of a severe drug addiction epidemic.” They note that Zohydro “will kill people as soon as it is released.” Dr. Andrew Kolodny calls it “a whopping dose of hydrocodone packed in...
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Florida Workers' Compensation FIlings Continue to Decrease- Addiction Specialists Wary of New Painkiller
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Thursday, February 20, 2014
Generic drug makers fight rule on health risk warnings
The proposed rule change by the Food and Drug Administration "would be nothing short of catastrophic," said Ralph G. Neas, president of the Generic Pharmaceutical Assn., an industry trade group. It could raise healthcare costs and "create dangerous confusion" for doctors and patients, he said.
At issue is a legal loophole created by Supreme Court rulings that drew a sharp distinction between brand-name drugs and lower-cost generics, which are the same products but usually are marketed under their chemical names.
In 2009, the high court confirmed drug makers could be sued if they failed to warn patients that a brand-name drug carried a serious potential health risk.
The decision upheld a $7-million jury verdict for Diana Levine, a Vermont violinist whose lower arm was amputated after she was injected with an anti-nausea drug made by Wyeth. The drug sometimes caused gangrene if injected into an artery.
But the Supreme Court majority flipped when confronted with a generic drug that also caused a horrible side effect.
Last year, a 5-4 ruling tossed out a $21-million verdict awarded by a lower court to Karen Bartlett, a New Hampshire woman who was disfigured, badly burned and nearly blinded after she had a rare,...
[Click here to see the rest of this post]
Saturday, February 15, 2014
Medicines Made in India Set Off Safety Worries
NEW DELHI — India, the second-largest exporter of over-the-counter and prescription drugs to the United States, is coming under increased scrutiny by American regulators for safety lapses, falsified drug test results and selling fake medicines.
Dr. Margaret A. Hamburg, the commissioner of the United States Food and Drug Administration, arrived in India this week to express her growing unease with the safety of Indian medicines because of “recent lapses in quality at a handful of pharmaceutical firms.”
India’s pharmaceutical industry supplies 40 percent of over-the-counter and generic prescription drugs consumed in the United States, so the increased scrutiny could have profound implications for American consumers.
F.D.A. investigators are blitzing Indian drug plants, financing the inspections with some of the roughly $300 million in annual fees from generic drug makers collected as part of a 2012 law requiring increased scrutiny of overseas plants. The agency inspected 160 Indian drug plants last year, three times as many as in 2009. The increased scrutiny has led to a flood of new penalties, including half of the warning letters the agency issued last year to drug makers.
Dr. Hamburg was met by Indian officials and executives who, shocked by recent F.D.A. export bans of generic versions of popular medicines — such as the acne drug Accutane,...
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Found on
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Sunday, January 5, 2014
Video: AAJ President Discusses Generic Drugs
Nearly 80 percent of all prescriptions in the U.S. are filled with the generic version of a drug. The price tag can be appealing, but taking a generic drug can also have dangerous consequences because generic drug manufacturers are not accountable for the safety of drugs they produce.Accountability is a key incentive to ensure drug companies monitor and adequately warn patients about the safety of drugs. Despite what many may think, the FDA does not test drugs, but instead relies on testing provided by the drug companies. FDA approval of a drug does not guarantee safety. In the above video, American Association for Justice President Burton LeBlanc talks about the accountability imbalance between generic drugs and name-brand drugs and how the lack of accountability can put consumers at risk. “What you may not know is that unlike brand-name manufacturers, generic drug manufacturers cannot be held accountable if their drugs injure or kill Americans. And we all know too well, if no one is accountable, no one is safe,” LeBlanc said. To view the video in its entirety, click here. Here’s where you can help. Join the growing number of over 20,000 consumers who have already signed a petition calling on the FDA to restore accountability. Safety is an issue that can’t be overlooked.
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Monday, December 16, 2013
FDA challenges safety, effectiveness of antibacterial soaps
In many medical treatment scenarios antibacterial soaps have been used and prescribed to treat injured workers. The US FDA has announced that new procedures to substantiate the allegations of the manufacturers as to the effectiveness and safety of these products. Today's post is shared from cidrap.umn.edu
[Click here to see the rest of this post]
The US Food and Drug Administration (FDA) today proposed a rule that would require companies that make antibacterial hand soaps and body washes to show that the products are safe for long-term use and are better than regular soap and water in preventing illness and the spread of infections.
Under the FDA's proposal, manufacturers that don't demonstrate the safety and effectiveness would be required to reformulate the products or relabel them to remain on the market, the agency said in a statement today. The FDA detailed its proposal in a 130-page report posted in the Federal Register and is taking comments on it over the next 180 days. Today's rule proposal doesn't apply to hand sanitizers, wipes, or antibacterial products used in healthcare settings. The FDA's proposed rules are part of a broader effort to weigh the benefit and risks of certain active ingredients in antibacterial products, including triclosan in liquid soaps and triclocarban in bar soaps. Scientists have raised concerns about a possible role of widespread antiseptic use in the development of antibiotic resistance. The FDA said in... |
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Friday, December 13, 2013
How Clinical Guidelines Can Fail Both Doctors and Patients
Guidelines came about after generations of physicians wanted to bring something more than “opinion and experience” to the patient’s bedside. In the late 1960s legislation for the U.S. Food and Drug Administration was amended to call for a demonstration of efficacy and an assessment of benefits and risk as prerequisite to the licensing of any pharmaceutical. Modern clinical science resulted, first slowly and now with an avalanche of clinical trials, each pouring forth outcome data galore. The Burden of Clinical Data Clinicians are expected to stay current with this wealth of information. The modern medical curriculum instructs all budding physicians on how to evaluate the quality and the clinical relevance of all such contributions to the body of clinical science. Because some (or perhaps many) find this exercise overwhelming, there are organizations—many academic and some without any discernible relationships with purveyors that could pose... |
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Jon L. Gelman of Wayne NJ is the author NJ Workers’ Compensation Law (West-Thompson) and co-author of the national treatise, Modern Workers’ Compensation Law (West-Thompson). For over 4 decades the Law Offices of Jon L Gelman 1.973.696.7900 jon@gelmans.com have been representing injured workers and their families who have suffered occupational accidents and illnesses.
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Thursday, December 5, 2013
FDA issues safety communication on HeartStart automated external defibrillators from Philips Healthcare
Certain HeartStart automated external defibrillator (AED) devices made by Philips Medical Systems, a division of Philips Healthcare, may be unable to deliver needed defibrillator shock in a cardiac emergency situation, the U.S. Food and Drug Administration said today in a new safety communication for users of these previously recalled devices.
The safety communication includes recommendations to better inspect and monitor the readiness of these devices, as well as steps to follow if someone must use a recalled device in an emergency situation.
“If the device indicates it has detected an error during a self-test the FDA advises users to keep recalled HeartStart AEDs in service until a replacement from Philips Healthcare or another AED manufacturer is obtained,” said Steve Silverman, director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health. “Despite current manufacturing and performance problems, the FDA considers the benefits of attempting to use an AED in a cardiac arrest emergency greater than the risk of not attempting to use the defibrillator.”
These devices were manufactured and distributed between 2005 and 2012 under the names HeartStart FRx, HeartStart HS1 Home, and HeartStart HS1 OnSite. Users, who may include consumers and first responders, should contact Philips Healthcare immediately for a replacement AED unit.
An AED is a device that automatically analyzes the heart rhythm in victims of sudden cardiac arrest and delivers an electrical shock to restore its normal rhythm. AEDs help save lives of cardiac arrest victims when they are working properly and used correctly. Each year, nearly 300,000 Americans collapse from sudden cardiac arrest. When normal heart rhythms are not restored quickly, sudden cardiac arrest can cause death.
In September 2012, Philips Healthcare initiated the recall of HeartStart FRx, HeartStart HS1 Home, and HeartStart HS1 OnSite AEDs due to the failure of an internal electrical component. The recall affected approximately 700,000 devices. In a Medical Device Safety Notice dated November 19, 2013, Philips provided consumers with updated information about the failure of an internal electrical component that could cause the AEDs to fail to deliver a shock. The notification also directed users to a Maintenance Advisory .
The FDA will continue to closely monitor all AED manufacturers’ quality system practices and manufacturing changes that have persistently contributed to recall and adverse events associated with AEDs.
In March 2013, the FDA issued a proposed order that if finalized would require manufacturers of AEDs and accessories to submit premarket approval applications that focus specifically on the critical requirements necessary to assure AEDs are safe and effective. The main objective of this proposed regulatory approach is to improve the reliability of AEDs so that they can continue to save lives.
For more information:
- FDA Medical Devices
- FDA Safety Communication: Philips HeartStart FRx, HeartStart HS1 Home, and HeartStart HS1 OnSite Automated External Defibrillators (AED)
- FDA issues proposal to improve the quality of automated external defibrillators
- Philips Maintenance Advisory
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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Jon L. Gelman of Wayne NJ is the author NJ Workers’ Compensation Law (West-Thompson) and co-author of the national treatise, Modern Workers’ Compensation Law (West-Thompson). For over 4 decades the Law Offices of Jon L Gelman 1.973.696.7900 jon@gelmans.com have been representing injured workers and their families who have suffered occupational accidents and illnesses.
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Wednesday, December 4, 2013
Rare Cancer Treatments, Cleared by F.D.A. but Not Subject to Scrutiny
When federal regulators permitted the sale of an unproved device that uses intense heat to combat cancer, they did so for a compelling reason, to give hope to some women desperately ill with cervical cancer.
Over the next two years, however, the few hospitals that purchased the $500,000 device did not take part in a study of patients that the manufacturer agreed to perform as a part of the machine’s approval. Cancer experts also said they were surprised that the Food and Drug Administration had approved the machine in the first place.
The reason: The group of woman for whom the F.D.A. approved the treatment — those with advanced cervical cancer who are too ill for chemotherapy — is so small. “I see, like, one patient like this a year,” said Dr. Junzo P. Chino, a cancer expert at Duke University.
A look at the F.D.A.’s decision to approve the device, which is called the BSD-2000, opens a window onto a little-known regulation known as the humanitarian device exemption.
The program, even its critics agree, is based on the best intentions. Because companies have little incentive to run costly trials for products used by small groups of patients, the exemption requires a producer only to show that a device is safe and has a “probable” benefit, rather than prove its effectiveness, the usual standard.
The rule, which is similar to one governing drugs for extremely rare diseases, also does not require the F.D.A., companies or...
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