Is Glaxo Keeping Its Commitment To Releasing Paxil Trial Data?
For the past year, GlaxoSmithKline has vowed to usher in a new era of transparency by creating a system to disclose detailed clinical trial data, a widely publicized move that has been hailed by many critics of the pharmaceutical industry who have accused drugmakers of deliberately concealing vital information that should be accessible to others in order to confirm safety and effectiveness.
Now, though, a group of researchers is putting the drugmaker to the test by requesting detailed data for an infamous study of its Paxil antidepressant, but are squabbling with the drugmaker over information being sought. In the process,...
Source: Pharmalot - October 28, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Another Controversy Over The FDA And Prescription Painkillers
What a difference a day makes. Last Thursday, the FDA recommended reclassifying commonly used prescription painkillers that contain hydrocodone, such as Vicodin, to a more restrictive ranking on the national law enforcement schedule. The move, which was a significant policy change, was widely hailed as a positive, if long overdue, step in attempting to curb the misuse and abuse of these medicines.
The next day, however, the agency ignored the advice of its own advisory panel and approved the first opioid to contain only hydrocodone, a step that was quickly criticized by patient advocates. Why? Zohydro ER is designed to be ...
Source: Pharmalot - October 28, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Pharmalot... Pharmalittle... Good Morning
Welcome to another working week, everyone. We hope the weekend was a refreshing respite, because that familiar routine of meetings and deadlines has returned. This morning, though, we would like to stop to remember a time when AIDS drugs were not readily available or capable of maneuvering the disease into a chronic state, a time that was chronicled by the late Lou Reed in a poignant song about the many people who passed away and were no longer seen cavorting in the annual Halloween Parade in New York's Greenwich Village. Reed is no longer with us, but his song is worth hearing again to remember the lost lives (please list...
Source: Pharmalot - October 28, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Eisai Loses Lawsuit Against DEA Over Scheduling Epilepsy Pill
In a setback to Eisai that also raises questions for the pharmaceutical industry, a federal appeals court has dismissed a lawsuit the drugmaker filed against the US Drug Enforcement Agency for failing to schedule its Fycompa epilepsy pill as a controlled substance. Eisai charged the DEA with “unreasonably” and “egregiously” delaying what “historically, has been a straightforward, relatively simple task.”
As we noted at the time the lawsuit was filed last August, the pill was approved by the FDA a year ago and a scheduling recommendation was sent in January. The delay meant not only lost sales, but Eisai also ma...
Source: Pharmalot - October 25, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Oops! FDA Panel Chair Cancels Speech To industry Insiders
After an embarrassing disclosure yesterday, the chair of the FDA Dermatologic and Ophthalmic Advisory Committee has backed out as a featured speaker at an upcoming conference that is designed to provide pharmaceutical industry insiders with tips on how to deal with the FDA and its advisory panels.
Lynn Drake, a Harvard Medical School lecturer, was to have spoken about “The Pitfalls To Avoid As You Prepare For, And Present To, An Advisory Committee,” this coming February at a conference called FDA Advisory Committee Prep that will be held at the Westin Georgetown Hotel in Washington, DC.
As we noted, the conference broc...
Source: Pharmalot - October 25, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
FDA Recommends Tighter Restrictions On Certain Painkillers
REPEATING FROM YESTERDAY EVENING: In a major change of policy, the FDA has recommended reclassifying commonly used prescription painkillers that contain hydrocodone, such as Vicodin, to a more restrictive ranking on the national law enforcement schedule. The drugs are currently classified as Schedule III controlled substances.
The moves comes amid a growing effort to find a midpoint that balances patient need for pain relief with ongoing concerns over abuse and addiction associated with these medications. Last March, a bill was introduced in Congress to reschedule the drugs (see this and this). And the agency decision foll...
Source: Pharmalot - October 25, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Up And Down The Ladder... Job Changes
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 with it others. That’s right. Send us your announcements 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 layoffs. Despite the downsizing, there is movement. Here are some of the latest changes. Recognize anyone?
And here is our regular feature. Send us a photo and we will spotlight a different person each week. This time around, we note that Eli Lilly promoted Alfonso "Chito" Zulueta to senior vp and president of...
Source: Pharmalot - October 25, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Pharmalot... Pharmalittle... The Weekend Nears
And so, yet another working week is drawing to a close. As you know, this is our treasured signal to daydream about weekend plans, although we are getting a headstart because, once again, we are rolling up the sidewalks early in order to enjoy another use-it-or-lose-it vacation day. In any event, our agenda is interesting, starting off with a birthday celebration for our shortest of short people, a book signing by a friend and a fresh installment in our 'Let's-see-them-before-they-die' concert series. But what about you? Anything special planned? How about catching up with old friends? Or shopping for a cozy autumn sweater...
Source: Pharmalot - October 25, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Former Teva Chair Says Teva Execs Should Get A Pay Cut, Too
The effort by Teva Pharmaceuticals to accelerate a $2 billion cost-cutting program by eliminating 5,000 jobs has met with stiff resistance in Israel, where the drugmaker is based and employs about 8,000 people, although about 800 of those jobs will go as part of the plan (back story). Workers at one plant are on strike and the head of the opposition Labor Party said executives should have taken a pay cut, too.
Guess who agrees? Meir Heth, who was Teva chairman from 1994 until 2002 and served as a Teva board member from 1977 until 2009. He is also plain spoken. He was interviewed by Globes, the Israeli business news site, a...
Source: Pharmalot - October 24, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
An Independent Board To Oversee Clinical Trial Data Disclosure?
Over the past year, the heated controversy over disclosing clinical trial data has grown more heated. For instance, pharmaceutical industry trade groups have attacked a proposal by the European Medicines Agency and two drugmakers took court action to prevent the EMA from releasing data. The BMJ will no longer publish studies unless anonymized patient-level data is made available (see this). And a UK parliamentary committee criticized the government for failing to push industry harder for data (back story).
Meanwhile, an aggressive online campaign called AllTrials is trying to pressure drugmakers to agree to greater disclos...
Source: Pharmalot - October 24, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
An FDA Panel Chair Talks To Industry Insiders About FDA Panels
Would you pay $1,899 to attend a conference where the chair of an FDA advisory committee is slated to talk to pharmaceutical industry insiders about how to prepare for an advisory committee? And here is another question: is this sort of talk that the FDA would like its committee chairs to give to some of the same people whose companies will appear before that committee?
These questions are being raised because Lynn Drake, a Harvard Medical School lecturer who chairs the FDA Dermatologic and Ophthalmic Advisory Committee, will be speaking about “The Pitfalls To Avoid As You Prepare For, And Present To, An Advisory Committ...
Source: Pharmalot - October 24, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Canadian Agency Restores Funding To Drug Safety Group
After more than a year of intrigue that involved accusations of privacy breaches, staff firings, an apparent suicide and lawsuits, the British Columbia health ministry in Canada has restored funding to a controversial program called Therapeutics Initiative, which evaluates a government database for drug safety and effectiveness.
In a brief statement on its web site, the ministry says that a contract with Therapeutics Initiative has been restored with $550,000 in funding, along with another $150,000 for several contracted reviews. Some 280 ministry employees have also received privacy and data security training, somethin...
Source: Pharmalot - October 24, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Former Bristol-Myers Exec Gets One Year For Insider Trading
A former Bristol-Myers Squibb executive who pleaded guilty to insider trading was sentenced on Wednesday to one year in prison and a $10,000 fine. Robert Ramnarine, 46, a former executive director of pension and savings, bought stock options in three drugmakers that were targeted for acquisition, which yielded more than $311,000 in profits (see this). He faced up to three years in prison and a $5 million fine.
Ramnarine traded even as he was responsible for conducting due diligence into pension and savings plans of three drugmakers being reviewed - ZymoGenetics, Pharmasset and Amylin Pharmaceuticals. Bristol-Myers (BMY) bo...
Source: Pharmalot - October 24, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Pharmalot... Pharmalittle... Good Morning
Rise and shine, everyone, another busy day is on the way. As usual, the Pharmalot corporate campus is humming this morning as the short people bounce out the door to their schoolhouses and the official mascots chase wildlife around the grounds. As for us, we are preparing for another round of meetings and phone calls and research. We trust you relate, so please join us for the mandatory cup of stimulation. Although we are trying something a wee bit different today - a spot of Earl Grey tea, with milk. Whatever you fancy, hope you have a wonderful day and conquer the world...
Glaxo Shifts Some Retirees To Health Exchanges (...
Source: Pharmalot - October 24, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Drug Swapping: Omnicare Pays $120M To Settle Kickback Charges
Once again, Omnicare is settling kickback and false claims charges. The nation’s largest nursing home pharmacy will pay $120 million to the US government to resolve allegations of engaging in ‘swapping,’ which refers to offering below-market discounts on Medicare Part A medications in exchange for the opportunity to also sell Medicaid and Medicare Part D drugs, which provide a much higher return.
Starting in 1998, Medicare began paying nursing homes a flat fee to care for patients, which included the cost of medicines, putting the facilities at risk if prices rose. And so, Omnicare allegedly provided “commercially ...
Source: Pharmalot - October 23, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
