Up and Down the Ladder: Job Changes… The latest comings and goings…
October 30, 2015 | Executive Hiring
By Ed Silverman

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us and we’ll share it with others. That’s right. Send us your changes and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going, especially with all the ongoing layoffs. Despite the downsizing, there is movement. Here are some of the latest comings and goings. Recognize anyone? Read More


Pharmalot.. Pharmalittle.. As the weekend nears.. we’re catching up on Valeant and…
October 30, 2015 | Cancer, Drug Development, FDA, Generics, Legislation, Mergers and Acquisitions, Pharmacy Benefit Managers, Pricing & Patient Access, Research & Development, Uncategorized
By Ed Silverman

And so, another working week will soon draw to a close. You were waiting for this moment, yes? This is, of course, our treasured signal to daydream about weekend plans. As usual, our agenda is rather modest. We plan to putter around the castle and catch up on some reading. And what about you? This is, of course, a nice time of year to watch the leaves fall, preferably in a location that does not require you to do any raking. Or better yet, you could search for the Great Pumpkin. Intriguing, yes? Whatever you do, have a jolly old time. But please, be safe. See you soon…

Valeant Pharmaceuticals has cut ties with Philidor Rx Services, which is now shutting down. And yesterday, CVS Health, Express Scripts and Optum Rx, the three largest pharmacy benefits managers in the US, decided not to work with the mail-order pharmacy; As drug makers race to launch CAR T cells, which may be the most effective treatments ever seen for leukemia and other blood cancers, they are grappling with how to make them widely available in a reliable and cost-efficient way; Pfizer faces political risks in Washington if it proceeds with a bid for Allergan, but with little chance of legislation to curb such tax inversion deals, the Obama administration may be able to throw up only limited obstacles; and In nearly 100 news articles describing 36 cancer drugs, words like "breakthrough" and "miracle" were used, even though 50 percent of the time those drugs were not approved by the FDA. Read More


FTC raises anticompetitive concerns about FDA naming proposal for biosimilars
October 29, 2015 | Antitrust, Biosimilars, FDA, FTC, Patient Safety, Pricing & Patient Access
By Ed Silverman

What’s in a name? A contentious debate over identifying biosimilars is sparking concern from antitrust regulators. These drugs are designed to emulate expensive biologics and are forecast to save billions of dollars in US health care costs. But finding the best approach for naming biosimilars has confounded regulators and divided the pharmaceutical industry amid clashes over patient safety and the potential for big profits.

At issue is whether biosimilars should be given the same name as biologics. Two months ago, the Food and Drug Administration issued draft guidelines that suggested both biologics and biosimilars can use the same name. But the agency also proposed that biosimilar names add a four-letter suffix that differs from the four-letter suffix that should follow a biologic brand name medicine. Essentially, the FDA appeared to be trying to appease as many people as possible, but that hasn't worked. Read More


Former Warner-Chilcott president arrested for alleged kickback scheme
October 29, 2015 | Bribes, Litigation, Off-Label Promotion, Uncategorized, Whistleblower
By Ed Silverman

A former president of Warner-Chilcott, which is now owned by Allergan, was arrested today for conspiring to pay kickbacks to physicians. At the same time, the company agreed to plead guilty to health care fraud and pay $125 million to resolve criminal and civil charges in connection with illegally promoting several drugs.

An indictment alleges that between 2009 and 2012, W. Carl Reichel created a strategy to give doctors money, free meals and phony speaking fees in exchange for writing prescriptions of Warner-Chilcott drugs. The authorities also charged him with providing sales reps with unlimited expense accounts in order to wine and dine doctors, and said he suggested targeting doctors who were already frequently prescribers. The arrest marks one of the rare instances in which federal authorities are attempting to hold the executive of a drug maker accountable for allegedly breaking the law. Read More


Doctor indicted for taking kickbacks and giving drug maker patient data
October 29, 2015 | Bribes, Litigation, Patient Privacy, Uncategorized
By Ed Silverman

In an unusual move, federal authorities indicted a physician for releasing patient data and accepting $23,500 in exchange for writing prescriptions for a pair of drugs sold by Warner-Chilcott, which is now owned by Allergan.

The indictment, which was filed last week, states that Warner-Chilcott sales reps approached Dr. Margaret Luthra, a gynecologist in Springfield, Mass., to serve as a so-called speaker, according to court documents. The drug maker approached her in 2010 because she was a “high volume prescriber” of Actonel and Atelvia, which are treatments for osteoporosis, the court records say. The move is an outgrowth of a whistleblower lawsuit filed by two former Warner-Chilcott sales reps, although it's unusual for physicians to be caught up in this way in such litigation. Read More


Does it make sense for Pfizer to buy Allergan? What the wags say…
October 29, 2015 | Mergers and Acquisitions
By Ed Silverman

The likelihood that Pfizer would eye another huge deal - and that Allergan was a potential target - has been simmering for weeks. After all, Pfizer execs have hardly made it a secret that, after failing to win control of AstraZeneca last year, they remain interested in another big drug maker that would not only jumpstart growth, but provide a tax benefit.

But with every potential combination, however, there are questions. Will a tax inversion - which prompted the White House to tighten rules last year - invite another round of regulations in order to further discourage such deals? Would a deal accelerate Pfizer plans to split into separate entities selling brand name and generic drugs? And who would run a merged company - does Saunders stay or go? Read More


Pharmalot.. Pharmalittle.. Good Morning.. We’re catching up on Valeant, Walgreen and..
October 29, 2015 | Antitrust, Cholesterol, Diabetes, FDA, FTC, Layoffs, Mergers and Acquisitions, Product Recall, Quality Control, Uncategorized, Vaccines
By Ed Silverman

Good morning, folks. A happy, shiny sun is hovering over the Pharmalot campus where, after a brief road trip, we have resumed our usual ritual of brewing needed cups of stimulation and foraging for interesting items. However, we are also kvelling since our shortest of short people celebrates a birthday. We will tend to that later, though, since a long to-do list awaits. As always, we hope you have a smashing day and, of course, do keep in touch...

The New England Journal of Medicine has endorsed Robert Califf as the next FDA commissioner amid chatter that he has a pro-industry tilt; The widely used class of cholesterol-lowering drugs known as statins may undermine the effectiveness of flu shots; Valeant Pharmaceutical relies on some pushy, "back door" tactics to get prescriptions filled; and two US senators urged the US Federal Trade Commission to scrutinize the Walgreens Boots Alliance $9.4 billion bid for Rite Aid. Read More


Most Americans want Washington to lower prescription drug prices
October 28, 2015 | AIDS, Cancer, Direct-to-Consumer Advertising, FDA, Hepatitis C, Pricing & Patient Access
By Ed Silverman

For those who believe that opinion polls are proxies for temperature readings, the pharmaceutical industry could use an aspirin.

Amid ongoing turmoil over prescription drug prices, a new poll finds that 77 percent of Americans want the White House and Congress to ensure that expensive drugs for treating chronic conditions - such as cancer, HIV, hepatitis, and mental illness - are affordable. And 63 percent want government action to lower drug prices, in general. In fact, these were the two health care items that mattered most to the more than 1,200 adults who were queried by the Kaiser Family Foundation. Read More


Pharmalot.. Pharmalittle.. Good Morning.. We’re catching up on Theranos, Amgen and..
October 28, 2015 | Alzheimer's, Cancer, FDA, Layoffs, Legislation, Litigation, Marketing, Patents, Pricing & Patient Access, Quality Control, Uncategorized
By Ed Silverman

Top of the morning to you. And a fine one, it is. Although a bit cloudy here in New England, our spirits remain sunny. As you know, our philosophy, courtesy of the Morning Mayor, is quite simple: Every brand new day should be unwrapped like a precious gift. So while you tug on the ribbon, we will search for a cup of stimulation. And of course, here is your menu of morning tidbits. Have a smashing day and do keep us in mind for interesting developments...

The FDA issued inspection notices to Theranos for using its blood-collection device without securing needed approval; The FDA approved a virus called Imlygic for treating advanced-stage melanoma, a development that could herald a new age of viral therapies; The debate over drug prices, and complaints from consumer advocates about safety concerns, have fueled Senate Democratic resistance to pharma-friendly provisions in the 21st Century Cures Act; Walgreen Boots Alliance agreed to buy Rite Aid for about $9.4 billion, in a move that would create a drug store giant as companies across the US health care industry look for ways to bulk up; and Breast Cancer Now, a UK health charity, is urging Roche to drop the price of its Kadlyca key breast cancer drug before the National Health Service stops funding it next week. Read More


Budget requires generic makers to pay Medicaid rebates tied to inflation
October 27, 2015 | Generics, Legislation, Pricing & Patient Access, Uncategorized
By Ed Silverman

For those concerned about the rising cost of pharmaceuticals, Congress is proposing some relief. The two-year budget deal proposed by lawmakers this week unexpectedly includes a provision that would require generic drug makers to pay additional rebates to state Medicaid programs for any medicine that increases in price faster than the inflation rate.

The move comes at a time of rising concern over drug prices. The cost of new medicines for hard-to-treat diseases, such as cancer and hepatitis C, worry public and private payers, who call them budget busters. And there is growing outrage at companies such as Valeant Pharmaceuticals and Martin Shkreli’s Turing Pharmaceuticals for buying drugs and then boosting the prices to sky-high levels. Read More