Federal, state officials targeting anew EpiPen safety, soaring insulin costs

epipen-300x119Big Pharma’s rapacious profit-seeking can seem to hit no bounds, even if it afflicts millions: Just consider what federal and state regulators are mulling about the makers of a popular anti-allergy therapy and those who supply a critical diabetes medication.

The federal Food and Drug Administration has replied to Bloomberg News Service that, so far, in 2017, it has recorded 228 reports of EpiPen or EpiPen Jr. failures, and the failure of EpiPens to deploy correctly has been cited in seven deaths through mid-September.

The agency said it is monitoring closely these “adverse event complaints.” These are unconfirmed reports that do not necessarily tie a product to a harm. But they might constitute sufficient grounds to investigate further and to potentially order product recalls, though, so far, the FDA says it believes patients can keep using EpiPens on the market without worry.

Mylan, the maker of EpiPens, has been the focus of hot, running battles with regulators and lawmakers over the cost and safety of its product, which allows those with severe allergies to receive a swift, convenient dose of adrenaline to stave off a reaction powerful enough that it could lead to death.

Mylan and its highly compensated and well-connected executives infuriated company customers and members of Congress when it jacked up its prices from $50 per pen to $600 for a two-pack. The company also was accused of ripping off the federal government with Medicaid overcharges—a complaint that Mylan swiftly settled for $465 million, while taking in more than $1.3 billion in revenue for its disputed product.

The FDA earlier this year forced Mylan to recall EpiPens, with the agency noting that a part in the device was malfunctioning. Regulators said then that the number of pens involved was small but the potential for patient harms was significant, leading the FDA to publicize the recall widely.

The agency in September wrote to Mylan, warning that it might have problems in one of its plants and that some of its devices had developed leaks. FDA officials said the firm should investigate and remedy any issues before the agency had to crack down with another recall.

Mylan has steadfastly defended the safety, availability, effectiveness, and cost of its product.

Those also has been the arguments of Eli Lilly, Novo Nordisk, Sanofi and top pharmacy benefit manager CVS Health—firms all under growing fire for their roles in sending sky high the cost of diabetes-treating insulin.

Kaiser Health News, based on corporate filings and other documents, says that attorney generals in Washington, Minnesota, and New Mexico are pursuing investigative claims against the Big Pharma players through the civil justice system, working, too, with Florida and California.

Angry critics have accused drug makers and prescription benefit management (PBM) companies of possibly engaging in anti-competitive practices in the $20 billion market for insulin, a common product that millions of diabetics take to keep their blood sugar levels in check. Diabetes is the seventh leading cause of death in the United States, and just under 10 percent of all Americans suffer from the disease, which, in 2012, ran up an estimated $245 billion in total costs.

Patients and their advocates point out that insulin prices have soared from as little as $25 a vial a few years ago to more than $300 now for the same dose—and the makers’ charges somehow have moved in perfect lockstep.

States have demanded information from Big Pharma players on insulin-related issues such as pricing and business relationships, as well data on specific types of this product, Kaiser Health News has reported. States, if they move ahead and file lawsuits, would join a wave of patient, class actions against companies over insulin prices, the news service says. These civil actions all could take time to resolve.

Still, it is heartening to see that at least some elected officials are doing something about skyrocketing drug prices. In my practice, I see not only the huge harms that patients suffer while seeking medical services but also the carnage that can be inflicted on them by dangerous drugs. Their struggles to afford medical care, and especially outrageously priced dugs, is distressing.

Although Congress, at least, has shown some spine and willingness to publicly shame Big Pharma over its profit-seeking, the Trump Administration, so far, hasn’t backed up its regular barking with any real bite. Instead, regulators keep jawing about speeding up drug approvals and easing the patient-focused oversight that Big Pharma and medical device companies complain about so often and so bitterly.

A blue-chip panel, which was supposed to provide an action plan to combat the opioid drug abuse epidemic that has become the nation’s leading killer of Americans younger than 50, has served up its recommendations. Many are excellent. But they are undercut by a failure in realism: the panel, like the Administration, can’t seem to figure how to any money into an opioids’ fight so it could be most effective. This is unacceptable, and, as politicians in Washington somehow find trillions of dollars to potentially give tax cuts to huge corporations and the wealthiest Americans, and maybe to slash even more health insurance to millions, it is shameful.

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