Groups with ties to pharma want to block CDC opioid prescribing guidelines
November 10, 2015 | Painkillers, Uncategorized
By Ed Silverman

The US Centers for Disease Control and Prevention, which has prepared preliminary prescribing guidelines for primary care physicians. The recommendations, outlined in a webinar in September and subsequently leaked online, call on doctors to prescribe opioids only after other therapies have failed.

This is a crucial effort. Family doctors write the vast majority of prescriptions for painkillers. Yet there is considerable opposition to the guidelines — and much of the reproach comes from organizations that represent patients suffering from cancer and pain. And some of the groups receive backing from drug makers that sell these pills. Read More


Pharmalot.. Pharmalot.. Good Morning.. Catching up on J&J, Mallinckrodt and..
November 10, 2015 | Compound Pharmacies, Counterfeit Medicines, Diabetes, FDA, Litigation, Mergers and Acquisitions, Patient Safety, Quality Control, Uncategorized
By Ed Silverman

Rise and shine, another busy day is on the way. And here on the Pharmalot campus, where clouds are hovering and leaves are falling, we are coping with our mandatory cup of stimulation. Our to-do list is so crammed, in fact, that posting may be sporadic over the next day or two as we complete some more involved efforts than usual. Meanwhile, here is the usual, although lengthy, items of interest. Hope you have a successful day and do keep in touch...

US prosecutors plan to ask the Canadian and British governments to extradite officials with an online pharmacy on charges of smuggling $78 million worth of mislabeled, unapproved and counterfeit cancer drugs into the country; Federal prosecutors in at least four states are mounting investigations into what they describe as widespread fraud by compounding pharmacies in claims to the Tricare health-insurance program; Mallinckrodt stock plummeted by more than 25 percent yesterday after Andrew Left of Citron Research, the short seller, tweeted the drug maker has "more downside" than Valeant Pharmaceuticals; A jury ordered Johnson & Johnson to pay $1.8 million to a Maryland man who developed female breasts while taking the company's Risperdal antipsychotic drug; an Indian government official says that complaints about quality issues at Indian drug makers are part of a “turf war” with Western companies. Read More


Supreme Court asked to review Namenda product switching case
November 9, 2015 | Antitrust, FTC, Generics, Litigation, Marketing, Patents
By Ed Silverman

The US Supreme Court is weighing a request from Allergan to rule on whether drug companies can pull a medication from the market as generic competition looms in order to force patients to switch to new versions of the drug. The move, which may hinge on antitrust laws, will be closely watched by the pharmaceutical industry.

Allergan’s request follows a heated battle between the drug maker and New York Attorney General Eric Schneiderman over a tactic known variously as product-hopping or forced switching, which involves pushing consumers from one product to another. A federal appeals court earlier this year ruled that a switch Allergan had planned would harm consumers. Read More


Pharmalot.. Pharmalittle.. Good Morning.. Catching up on Amgen, Pfizer and..
November 9, 2015 | Cholesterol, Diabetes, FDA, Generics, Legislation, Litigation, Medicaid, Mergers and Acquisitions, Patents, Pricing & Patient Access, Uncategorized
By Ed Silverman

Good morning, everyone, and welcome to another working week. Once again, a weekend respite has come and gone. We hope it was invigorating and relaxing, because the usual routine of meetings, deadlines and what-not has returned. As always, we are attacking our own to-do list with help from a cup of stimulation. Please join us, or grab a bottle of water, if you prefer. Meanwhile, here are some tidbits. Have a great day and do keep in touch...

Harvard Pilgrim Health Care has agreed to cover Amgen’s pricey new cholesterol drug in exchange for a discount and potential rebates if the treatment fails to meet performance targets; Pfizer told investors it had a 25.5% global tax rate in 2014, but could have cut its rate to 7.5% by reporting foreign earnings the way most U.S. companies do; and a Delaware federal judge granted a request from AstraZeneca for a temporary restraining order that bars Dr. Reddy’s Laboratories from selling a generic version of the Nexium heartburn drug, because the copy allegedly infringes on the 'Purple Pill' trademark. Read More


CMS warns state Medicaid programs on hepatitis c drug restrictions
November 6, 2015 | Hepatitis C, Medicaid, Pricing & Patient Access, Uncategorized
By Ed Silverman

Demonstrating concern over prescription drug costs, the Obama administration wrote state Medicaid programs that they may be violating federal law by restricting access to hepatitis C medicines. At the same time, the Centers for Medicare and Medicaid Services wrote four drug makers asking for information about pricing arrangements with insurers and pharmacy benefits managers.

“The rhetoric around health care costs can become heated, particularly around the cost of prescription drugs,” Andy Slavitt, the CMS acting administrator, wrote in a blog post disclosing the notice. “At times, it can appear as if some of those who produce the pharmaceuticals and those whose lives often depend on them have unaligned interests. But we will not make progress by polarizing this debate.” Read More


Pharmalot.. Pharmalittle.. As the weekend nears, catching up on Valeant, PhRMA and..
November 6, 2015 | AIDS, Diabetes, FDA, Generics, Mergers and Acquisitions, Patents, Pricing & Patient Access, Quality Control, Uncategorized
By Ed Silverman

And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, as you may recall, our treasured moment to daydream about weekend plans. Our agenda is quite modest. We hope to clear some leaves from the campus, visit with the Pharmalot ancestors and do some writing. And what about you? Once again, we remind you this is a lovely time of year to enjoy the great outdoors. You could also make plans for a winter get-away or simply take stock. The possibilities are endless. Well, whatever you do, have a grand time, but be safe. See you soon...

There is rising uncertainty about J. Michael Pearson’s tenure as chief executive of Valeant Pharmaceuticals after hedge fund investor Bill Ackman expressed doubts publicly; Faced with nationwide rebukes and attacks from presidential candidates over drug prices, the PhRMA trade group is confronting a public storm unlike any in years; A Food and Drug Administration advisory panel overwhelmingly called for heightened label warnings on widely prescribed antibiotics called fluoroquinolones; and Sanofi chief executive officer Olivier Brandicourt plans to put some assets such as the animal health and European generics units under review, and cut costs by $1.63 billion. Read More


Chicago claims to release new details about deceptive opioid marketing
November 5, 2015 | Litigation, Marketing, Painkillers, Patient Safety
By Ed Silverman

Chicago officials have filed a revised lawsuit alleging several drug makers deceptively marketed their opioid painkillers. And the city contends the updated document contains new evidence that the companies made false claims about their medicines.

Among the alleged false claims - the medicines were not likely to be abused but improved the ability of patients to function. Another claim was that the drugs were safer than over-the-counter painkillers known as NSAIDs, or nonsteroidal anti-inflammatory drugs. The companies being sued are Purdue Pharma, Endo International, Teva Pharmaceuticals, Actavis, and Johnson & Johnson’s Janssen unit. Read More


HPV vaccine not linked to chronic pain or fainting: European regulators
November 5, 2015 | Cancer, Patient Safety, Side Effects, Uncategorized, Vaccines
By Ed Silverman

The controversial HPV vaccine does not cause chronic pain or dizziness, despite reports from patients’ families complaining of those side effects, European regulators said Thursday after an extensive review.

The European Medicine Agency began its review in July after families complained that girls who were vaccinated suffered complex regional pain syndrome, or CRPS, a chronic pain that affects limbs. Other families said the vaccines caused postural orthostatic tachycardia syndrome, or POTS, which causes dizziness and fainting. Read More


Pharmalot.. Pharmalittle.. Good Morning.. Catching up on Pfizer, Valeant, Shkreli and..
November 5, 2015 | Bribes, Cancer, Diabetes, FDA, Generics, Hepatitis C, Marketing, Mergers and Acquisitions, Painkillers, Pharmacy Benefit Managers, Pricing & Patient Access, Quality Control, Uncategorized
By Ed Silverman

Hello, everyone, and how are you today? We are just fine, thank you. Our outlook is brightened by the delightful combination of a shiny sun enveloping the leafy Pharmalot campus and a few cups of stimulation, which are as needed as ever. Feel free to join us. Remember, no prescription is required. And now, time to get cracking. We trust that you can relate. So here are a few items of interest to help you along. Have a great day and keep in touch...

Pfizer is increasing its financial assistance to patients, doubling the allowable income level for people to receive dozens of its medicines for free; What does Martin Shkreli think of the US Senators investigating pricing practices at his company? "The senators have their facts wrong," he says; Gilead Sciences’ blockbuster hepatitis C medicine Sovaldi may trigger an abnormally slow heartbeat and put patients at risk of passing out; and Roche's Kadcyla, an expensive breast cancer drug, will remain on the list of medicines available on the UK's National Health Service after the drug maker agreed to lower the price. Read More


Senators probe Valeant and Shkreli over drug prices, while House Dems form a task force
November 4, 2015 | FDA, FTC, Pricing & Patient Access, Uncategorized
By Ed Silverman

Consumers are angry over prescription drug costs and now all three branches of the federal government are trying to take action. A pair of US Senators has opened an investigation into prescription drug pricing in response to growing reports of companies buying medicines and then raising prices to previously unforeseen heights.

Separately, the secretary of the US Department of Health and Human Services plans to hold a day-long conference on Nov. 20 to look at ways of speeding the discovery of innovative drugs, but also discuss how medicines can be made more affordable. Meanwhile, some House Democrats formed a new task force on drug pricing and are pressing to have subpoenas issued to Martin Shkreli's Turing Pharmaceuticals and Valeant Pharmaceuticals. Read More