Amgen Settlement and Corporate Integrity Agreement
Adding to the long list of pharmaceutical settlements involving off-label promotion, Amgen Inc., the world’s largest biotechnology company, recently entered into a settlement agreement with the U.S. Department of Justice to resolve criminal liability and false claim act allegations involving its improper promotion of certain drugs. Amgen, a biotechnology company, agreed to pay $762 million—the single largest criminal and civil False Claims Act settlement involving a biotechnology company in U.S. history, according to the announcement.
Amgen entered a guilty plea before U.S. District Judge Sterling Johnson of the...
Source: Policy and Medicine - February 19, 2013 Category: Health Medicine and Bioethics Commentators Authors: Thomas Sullivan Source Type: blogs
Tuesday Health Notes
■ First up, some great Food Pyramid news:
"Researchers ... in Spain have found that beer can help the body rehydrate better after a workout than water or Gatorade."
Apparently, the carbonation is a key factor, and the carbs help out, too.
■ Next, some good news for stroke survivors:
"A single injection, then a five-minute wait ... Now they're walking more steadily, reading more easily, concentrating better, speaking more clearly and regaining use of once-rigid limbs"
The secret? A 25mg shot of etanercept (an anti-inflammatory med). And the results?
"Of the total studied, more than 80 percent saw improvements in t...
Source: InsureBlog - February 12, 2013 Category: Medical Lawyers and Insurers Source Type: blogs
One Down, 13 To Go: A Biosimilar Bill Falls Flat
As more than a dozen state legislatures mull over bills that would make it more difficult to allow substitution of biosimilars, at least one effort appears to have gone nowhere. Despite identical bills that were introduced in the state Senate and House in Mississippi, the twin pieces of legislation failed to proceed to committee votes and, as a result, cannot be reintroduced in the current legislative session.
This apparently marks the first such defeat for a closely watched effort by such big biotechs as Genentech and Amgen to thwart rivals from having easy entre to their lucrative markets. Over the past few weeks, you ma...
Source: Pharmalot - February 8, 2013 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Amgen Avastin Biologics Biosimilars Eli Lilly FDA Genentech Herceptin Roche Source Type: blogs
In a Pre-emptive Strike, Amgen & Genentech (Roche) Lobby States to Block Biosimilars
No doubt you've heard of how Amgen essentially paid off U.S. Senators to sneak a provision in the "fiscal cliff" bill that delays price restraints on a class of drugs used by kidney dialysis patients, including Sensipar, a drug made by Amgen (see "Big Pharma buys off the Senate"). That "richly embroidered loophole" will cost taxpayers a half a billion dollars.Although a bill was proposed to close the Amgen loophole in federal law, Amgen and Genentech, which is owned by Roche, are lobbying (i.e., paying) state lawmakers to block generic versions of their products according to the New York Times (see here). Specifically, the...
Source: Pharma Marketing Blog - January 29, 2013 Category: Pharma Commentators Tags: Amgen Genentech Roche Lobbying generics biosimilar Source Type: blogs
Lipitor & Plavix: The Last of the Small Molecule Best Sellers?
Forbes just published a list of "Best Selling Drugs of All Time" (see here). I created the following chart from the data cited (click on it for a larger view):"Tellingly," notes the Forbes author, Simon King, "each of the products in the list above best positioned to record an increase in peak annual sales over the next five years is a biologic; Humira, Enbrel, Rituxan, Herceptin and Lantus being the chief candidates. This is driven by a number of factors – the later launch of certain brands, for example – but also illustrates the robustness of leading biologic franchises that do not face direct substitutable generic c...
Source: Pharma Marketing Blog - January 28, 2013 Category: Pharma Commentators Tags: Drug prices Plavix Humira Lipitor Pfizer drug pipeline orphan drugs Blockbuster Source Type: blogs
Amgen Whistleblower Fights To Unseal Documents
Despite a $762 million settlement between Amgen and the US Department of Justice for off-label marketing of various medicines (back story), the clash between the biotech and one of the whistleblowers is not over yet. A bitter dispute, in fact, continues to rage over an arbitration award – and the related proceedings – involving a former Amgen employee.
The long-running battle has pitted the biotech against Elena Ferrante, who once worked as a sales rep promoting the Enbrel rheumatoid arthritis treatment, but claimed Amgen sales managers encouraged reps to promote off-label and encouraged physicians to prescribe...
Source: Pharmalot - January 15, 2013 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Amgen Enbrel JAMS Off Label Marketing Whistleblower Source Type: blogs
Some "Off-Label" Speech is No Longer Politically Correct
The Supreme Court has ruled that corporations are people protected by the U.S. Constitution and Bill of Rights just like us ordinary folk. That means, for one thing, the government cannot limit the freed of speech of corporations. This issue has been much discussed since last month's U.S. Court of Appeals 2-to-1 split decision to throw out the conviction of a sales representative for promoting off-label use of a prescription drug (see here).This decision is already having an impact on speech, but not the speech of drug companies. It could be making the word "off-label" politically incorrect for use by the U.S. Department o...
Source: Pharma Marketing Blog - January 5, 2013 Category: Pharma Commentators Tags: off-label promotion DOJ Source Type: blogs
How Much? Payers And The New Pfizer RA Pill
Two months ago, the FDA approved a pill from Pfizer called Xeljanz that is being used to treat adults with moderately to severely rheumatoid arthritis who did not respond to, or cannot tolerate, methotrexate, a standard of care. Some Wall Streeters expect the drug, which competes with such biologics as Humira, to become a blockbuster.
The drug is the first in a class of medications known as JAK inhibitors for RA and data has indicated the pill would offer similar efficacy to such widely used injectables that, collectively, generate some $13 billion in annual sales for treating rheumatoid arthritis. As noted previously, Xel...
Source: Pharmalot - January 3, 2013 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Abbvie Amgen Enbrel Humira Pfizer Rheumatoid Arthritis Xeljanz Source Type: blogs
