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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

Today's post was shared by The New York Times and comes from www.nytimes.com



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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Tuesday, August 12, 2014

Colgate Total Ingredient Linked to Hormones, Cancer Spotlights FDA Process

Today's post was shared by Steven Greenhouse and comes from www.bloomberg.com




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?

Today's post was shared by Mother Jones and comes from www.motherjones.com

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.
If you’re a layperson, this is the way you probably think of generics: They’re the exact same products in different packaging; generics companies can sell such medications for a fraction of the cost of the originals because they don’t have to spend huge sums on drug development and marketing....But generic drugs diverge from the originals far more than most of us believe.
....The FDA’s rules effectively acknowledge that. The agency’s definition of bioequivalence is surprisingly broad: A generic’s maximum concentration of active ingredient in the blood must not fall more than 20% below or 25% above that of the brand name....
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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...

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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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Thursday, February 20, 2014

Generic drug makers fight rule on health risk warnings

Drug safety is a concern of all injuured workers. Better regulation will improved the ultimate medical delivery system of a workers' compensation program. Today's post was shared by FairWarning and comes from www.latimes.com

Companies that make generic drugs, the medications most Americans buy, are fighting to kill a proposed federal regulation that would require them for the first time to warn patients of all the known health risks of each drug they sell.

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,...

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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



Related articles
India to flag market access of drugs and spices with US (vancouverdesi.com)
Indian Regulators to Shadow U.S. FDA on Plant Inspections (bloomberg.com)
A California Lesson: How to Kill Workers' Compensation Pill By Pill (workers-compensation.blogspot.com)
Prescription-Drug Coupons - No Such Thing as a Free Lunch (workers-compensation.blogspot.com)


Sunday, January 5, 2014

Video: AAJ President Discusses Generic Drugs

Today's post was shared by Take Justice Back and comes from www.takejusticeback.com


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

 Liquid hand soap 
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

Today's post was shared by The Health Care Blog and comes from thehealthcareblog.com



Any confusion over the recent news of cholesterol guidelines in the U.S. is perfectly understandable. On the one hand, the guidelines suggest that nearly half the population should use statins to stave off heart attacks and strokes. On the other, use of the drugs is not with potential side effects and, to many, will offer no substantive benefits. The controversy highlights a problem mired in an outdated way of thinking about health care and the doctor-patient relationship.
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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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  disclaimer icon 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 disclaimer icon.
 
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:
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.

Wednesday, December 4, 2013

Rare Cancer Treatments, Cleared by F.D.A. but Not Subject to Scrutiny

Today's post was shared by The New York Times and comes from www.nytimes.com

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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