De Blasio’s Plans to Reduce Worker Health Costs Have a Carrot and a Stick

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

When Mayor Bill de Blasio announced his first labor agreements with New York City unions this spring, he was sharply criticized for granting long-awaited wage increases in exchange for promises of unspecified though sizable savings on health care expenses. Now, some of the specifics are coming into focus: City officials and union leaders say they hope to push municipal workers to use walk-in clinics more and emergency rooms less, order generic drugs more often than brand-name ones, and buy them through the mail rather than at retail pharmacies to achieve bulk discounts. The city hopes the unions will agree to steer workers to use centralized, cheaper centers for blood tests, X-rays or M.R.I.s, rather than having those tests performed in doctors’ offices or at costly physician-owned facilities. Patients who resist could face higher copayments, while savings would be passed on to the city in lower premiums. The cost-cutting comes with high stakes: If the city and unions are unable to save a total of $3.4 billion on health care by 2018, a mediator will be empowered to order increases in workers’ premiums to cover the shortfall, officials said. As an added inducement, if the unions help the city exceed that goal, the first $365 million in additional savings would be distributed as lump-sum bonuses to workers, officials said. Any savings beyond that would be split evenly between the city and its employees. In interviews, Harry Nespoli, chairman of the Municipal Labor...

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Warning Unheeded, Heart Drugs Are Recalled

More problems with generic drugs. Today's post was shared by The New York Times and comes from www.nytimes.com

For years, Dr. Harry Lever, a cardiologist at the Cleveland Clinic, has been warning nearly anyone who would listen of his growing suspicions about generic versions of a widely used heart drug, Toprol XL.

Patient after patient, he said, would visit his office complaining of chest pains or other symptoms after switching from the brand-name version, made by AstraZeneca, to a generic product, often one made in India. When he switched them back to the brand — or to another generic — the symptoms disappeared, he said. Dr. Lever wrote a letter outlining his concerns to the Food and Drug Administration in 2012, and this year, he traveled to Washington to try to get the attention of Congress.

Dr. Lever could not prove that the generic drugs were to blame. “You see enough people and you get a feel, but it’s anecdotes,” he said in an interview Monday. “It’s not science.”

Now, Dr. Lever is feeling a sort of sad vindication. Two large Indian manufacturers, Wockhardt and Dr. Reddy’s Laboratories, have announced recalls over the last two months totaling more than 100,000 bottles because their products were not dissolving properly — therefore probably not working as they should. The drug is a beta blocker that treats high blood pressure and heart ailments.

The recalls are the latest in a string of recent problems involving generic drugs, especially those made in India. Wockhardt, for example, is now banned from exporting drugs to...
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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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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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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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FDA Proposes Letting Generic-Drug Makers Change Labels

Today's post was shared by FairWarning and comes from online.wsj.com

The Food and Drug Administration proposed allowing generic drug companies to change drug labels after getting reports of bad reactions in patients, a step that could open the generic industry up to greater potential legal liability. In 2011 and again this year, the Supreme Court issued rulings that shielded generic drug makers from consumer personal-injury lawsuits, even though the justices have allowed similar product-liability claims against makers of branded drugs. The step Friday by the FDA means that generic companies—which sell about 84% of the prescription drugs by volume in the U.S.—would have the same ability to change their labels as brand companies. The FDA would review any proposed changes, as it already does with changes to branded-drug labels. "Our effort is to keep all the labels the same, and to level the playing field," said Janet Woodcock, director of the FDA's center for drug evaluation and research. The proposal, she said, "would change current procedures, where only the brand companies can unilaterally put certain safety information in the label." The Generic Pharmaceutical Association reacted cautiously, saying it is concerned that multiple labels on the same drug "could drive up costs…and should be approached very carefully." Some of the leading makers of generic drugs include Hospira Inc., HSP +0.55%Hospira Inc.U.S.: NYSE$38.74 +0.21+0.55% Nov. 12, 2013 4:00 pm Volume (Delayed 15m) : 2.36MAFTER HOURS$38.58 -0.16-0.43% Nov. 12, 2013...

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Prescription-Drug Coupons — No Such Thing as a Free Lunch

The cost of pharmaceuticals prescribed in workers' compensation claims remains a seriously advancing cost to the system.  Employers blame injured workers for the cause and the demand. Is the actual demand being driven by the pharmaceutical industry? The following is shared from The New England Journal of Medicine www.nejm.org.

Visit nearly any official website for a brand-name drug available in the United States and, mixed in with links to prescribing and safety information, you'll find links to drug “coupons,” including copayment-assistance programs and monthly savings cards. Most offers are variations on “Why pay more? With the [drug] savings card, you can get [drug] for only $18 per prescription if eligible” or “Get a free 30-capsule trial of [drug] with your doctor's prescription and ask your doctor if [drug] is right for you.” Why do manufacturers offer drug coupons? Are they good for patients in the long run? Are they even legal? Commercial drug-insurance plans typically have tiered pharmaceutical formularies to guide prescription-drug use, requiring relatively small patient copayments (approximately $5 to $15) for inexpensive generic drugs and higher copayments (perhaps $25 to $100) for brand-name drugs. Manufacturers use coupons to reimburse patients for this difference in copayments when they buy brand-name medications, so that, for people with commercial insurance coverage, the out-of-pocket costs are the same as those for generic drugs. Drug coupons are implemented through subsidies paid by drug manufacturers. Patients nearly always print coupons off...

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Joseph S. Ross, M.D., and Aaron S. Kesselheim, M.D., J.D., M.P.H.
N Engl J Med 2013; 369:1188-1189 September 26, 2013 DOI: 10.1056/NEJMp1301993

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