Express Scripts will cover those pricey new cholesterol drugs
October 6, 2015 | Hepatitis C, Pricing & Patient Access
By Ed Silverman

The drug makers that sell a new and expensive type of cholesterol-lowering treatment will provide discounts to the nation’s largest pharmacy benefits manager, a move that may defuse yet another simmering controversy over the cost of medicines.

In exchange for the givebacks, the benefits manager, Express Scripts, will give the drugs preferential placement on its formulary, a list of medicines that are eligible for insurance reimbursement. The size of the discounts, however, was not disclosed. Terms differ for each drug, but these also were not disclosed. Read More


Bloated claims: Bayer wins lawsuit over dietary supplement ads
October 6, 2015 | FDA, FTC, Marketing
By Ed Silverman

A federal judge has tossed a lawsuit that alleged Bayer made bloated advertising claims for a product for preventing … drum roll… constipation, diarrhea, gas, and bloating. And the ruling may have broader implications for companies selling dietary supplements.

Here’s the back story: For the past seven years, Bayer widely advertised a product called Phillip’s Colon Health for preventing those gastrointestinal problems. But the feds believed the company made claims that lacked scientific evidence, and pointed to a 2007 consent decree, requiring Bayer to back up promotional claims with evidence. The feds argued that Bayer failed to do so, yet implied the elixir could prevent, cure, or treat symptoms of gastrointestinal discomfort. Read More


Why the FDA should take more chances on riskier drugs
October 6, 2015 | Cancer, FDA
By Ed Silverman

Imagine you are diagnosed tomorrow with pancreatic cancer. Odds are you have a 6 percent chance of surviving more than five years. But if you had prostate cancer, a disease with many more treatment options, the likelihood of being alive in five years skyrockets to 99 percent.

But the FDA has not adjusted the drug approval process to raise the possibility of bringing life-changing drugs to patients. Instead, the agency will not approve a drug if there is more than a 2.5 percent chance that it doesn’t work — no matter which disease or how poor the prognosis. And in a new paper, an MIT professor takes the FDA to task for not being more flexible Read More


Pharmalot… Pharmalittle… Coffee and headlines are served…
October 6, 2015 | AIDS, Alzheimer's, Schizophrenia, Uncategorized
By Ed Silverman

Top of the morning to you. Another busy day is unfolding here on the Pharmalot campus, where the shortest of short people has left for the local schoolhouse and the official mascots are happily snoozing underfoot. As for us, yes, we are quaffing our ritual cups of stimulation and, of course, we invite you to join us. Meanwhile, we have assembled a few items of interest to help you along. Hope your day goes well and drop us a line if you hear something juicy...

The latest analysis of drug prices shows companies have often boosted prices beyond the inflation rate to drive their revenue, even when demand is flagging; If biotech industry leaders agree on anything, it’s that Turing Pharmaceuticals chief executive Martin Shkreli has made life difficult for all of them; The largest US health insurers want doctors to stick with standard diabetes treatments instead of a new drug called Jardiance from Eli Lilly; and The deadline for MannKind, which makes the Afrezza inhaled insulin, to settle debt totaling $32 million passed five days ago, but the company has said nothing publicly, which means debtholders were probably paid with cash, its least attractive option. Read More


Bristol-Myers pays $14M to settle charges of paying bribes in China
October 5, 2015 | Bribes, Uncategorized
By Ed Silverman

Bristol Myers-Squibb has agreed to pay nearly $14.2 million to resolve charges that it violated the Foreign Corrupt Practices Act by making illegal payments in China. In doing so, the company becomes the latest drug maker to get punished for paying bribes in order to boost sales in a foreign country.

The SEC has been eyeing the pharmaceutical industry for the past several years amid concerns that drug makers are paying bribes to unduly influence medical practice overseas. The issue gained particular notice two years ago when Chinese authorities fined GlaxoSmithKline nearly $500 million for paying bribes to physicians and others. Read More


How Martin Shkreli prevents generic versions of his pricey pill
October 5, 2015 | FDA, Patents, Pricing & Patient Access, Uncategorized
By Ed Silverman

Ever since Martin Shkreli accelerated the national debate over prescription drug pricing, there has been confusion over how he slammed the door on lower-cost generic versions of his pricey pill. After all, the drug, known as Daraprim, has been around for 62 years and no longer has patent protection. So wouldn’t his big boost in price - Shkreli’s Turing Pharmaceutical raised the cost from $13.50 to $750 a pill – entice generic drug makers to produce their own versions for a hefty profit?

Maybe it would. But Shkreli won't let that happen. Turing is using a so-called controlled distribution system that prevents generic drug makers from purchasing Daraprim. And without sufficient supplies, a generic drug maker is unlikely to have enough medicine to run clinical tests needed for FDA approval. Read More


Drug maker loses lawsuit filed to regain ‘lost’ marketing time
October 5, 2015 | FDA, Litigation, Marketing, Uncategorized
By Ed Silverman

The clock on marketing exclusivity can run even while a drug maker is awaiting clearance to sell a controlled substance, according to court ruling. The decision is a setback to Eisai, which claimed it unfairly lost valuable marketing time due to regulatory procedures. But a new bill winding its way through Congress could still override the decision.

Here’s the back story: In 2012, Eisai won FDA approval for two new drugs - the Belviq diet pill and the Fycompa epilepsy treatment - which triggered the beginning of a five-year marketing exclusivity period. This meant generic rivals could not sell lower-cost versions of either medication. But Eisai encountered launching delays because both drugs are controlled substances, which means they could not be marketed until the US DEA placed them on special lists for which distribution is restricted. Read More


Pharmalot.. Pharmalittle.. Good Morning, Everyone
October 5, 2015 | AIDS, Biosimilars, Cancer, FDA, Patents, Pricing & Patient Access, Uncategorized
By Ed Silverman

Hello, everyone, and welcome to another working week. The weekend respite flew by rather quickly, did it not? Well, that was to be expected. Now, the time has come to resume the usual routine of meetings and deadlines and what-not. So please join us as we fortify ourselves with a few cups of stimulation. A little edge can be a good thing, yes? Meanwhile, here are some tidbits to get you going. Have a smashing day and do stay in touch...

An agreement on the Trans Pacific Partnership trade pact is expected to be announced this morning and include a compromise on clinical trial data exclusivity on biologics; A single, 5,000 percent price hike on an anti-parasitic drug from Turing Pharmaceuticals garnered national media attention, but this was actually just one of hundreds of smaller price increases; A guerrilla advertising campaign in Australia is encouraging gay men to have unprotected sex in order to promote PrEP, a drug that combats HIV infection, but has not been approved for use there; and organizations involved in the anti-vaccine movement, such as SafeMinds, still hope to find some evidence that vaccines threaten children’s health, but a recent effort backfired. Read More


Many UK doctors have a negative view of the pharmaceutical industry
October 2, 2015 | Marketing
By Ed Silverman

You can add UK doctors to the list of people with a jaundiced view of the pharmaceutical industry. A new survey finds that 43 percent of general practitioners have a negative feeling about drug makers and believe the industry agenda is too focused on sales and marketing, according to Binley’s, a health care analysis firm that canvassed 551 physicians in England.

What’s more, 23 percent of the docs believe that drug makers do not understand how they go about their work or appreciate their needs and challenges. And 17 percent feel there is a lack of understanding among drug makers about the budgetary pressures that shape prescribing decisions. “Cynicism about the industry abounds,” says Binley's. Read More


Up and down the ladder: The latest comings and goings at…
October 2, 2015 | Executive Hiring, Uncategorized
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