Who Will Replace FDA's Janet Woodcock? Can Anyone?
Who might replace Janet Woodcock when she retires as head of the FDA’s all-important Center for Drug Evaluation and Research? Some may wonder, in fact, if anyone can replace Woodcock, a forceful and high-energy bureaucrat with a 20-year institutional memory and controversial profile that sometimes riles consumer advocates while placating pharmaceutical executives.
Although Woodcock, a formidable personality known for maintaining a frantic pace and offering blunt statements, is not scheduled to retire for a year or more, speculation is already mounting about a successor. But as Reuters notes, no one has been groomed for...
Source: Pharmalot - October 10, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
India Plans To Boost Oversight By Hiring Hundreds Of Inspectors
Faced with fast growth of its domestic pharmaceutical industry and increasing quality-control problems at some of its biggest drugmakers, Indian authorities plan to add 110 inspectors – a 65 percent boost above current levels – over the next six months as part of a plan to invest $500 million, and perhaps as much as $3 billion*, in order to boost oversight, according to InPharma Technologist. Hundreds more inspectors are expected to be hired later (here is the plan).
The planned initiative comes amid sweeping changes planned for licensing manufacturing facilities and a growing number of scandals. In recent weeks, the U...
Source: Pharmalot - October 10, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Teva To Cut 5,000 Jobs As Key Drug Patent Expiration Looms
Faced with a looming patent expiration for its biggest-selling drug, Teva Pharmaceuticals is accelerating a $2 billion cost-cutting plan that was begun less than a year ago by cutting 5,000 employees, which amounts to roughly 10 percent of its global workforce.
The drugmaker also intends to take other, unspecified steps that involve “selective trimming of assets that no longer fit its core business or are not critical to its future,” and “scale down oversized parts of the company,” according to a statement.
The move comes less than three months after a US court invalidated the 2015 patent on its Copaxone multiple s...
Source: Pharmalot - October 10, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Pharmalot... Pharmalittle... Good Morning
Rise and shine, everyone, yet another busy day is on the way. And unfortunately, this appears to be a rather rainy one. Nonetheless, our spirits remain sunny. As you may recall, in times like these, we repeat a favorite saying courtesy of the Morning Mayor: 'Every brand new day should be unwrapped like a precious gift.' So while you tug on the ribbon, please join us for a welcome cup of stimulation and a few tidbits to get things going. Hope you accomplish much today and do stay in touch if you hear anything fascinating...
FDA Places Partial Hold On Ariad Cancer Drug Trial Over Side Effects (Reuters)
NIH Enrolls A Dozen Cr...
Source: Pharmalot - October 10, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Maine Residents Are Importing Drugs From Foreign Pharmacies
The pharmaceutical industry may be fuming, but as of today, Maine residents can start purchasing prescription drugs over the Internet, thanks to a contentious law that has some predicting the initiative could be duplicated in still more states. Residents are allowed to purchase medicines from Internet pharmacies in Canada, the UK, New Zealand and Australia (back story here).
The law underscores the extent to which prescription drug pricing remains an issue, despite the passage of the Medicare D program several years ago. Many state employees, as well as workers in the city of Portland and one large company, claimed they sa...
Source: Pharmalot - October 9, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Will Orphan Drug Reimbursement Policies Remain Stable?
As another conference on rare diseases takes place this week in Maryland, a survey finds that orphan drugs may account for a small portion of prescription drug spending, but three quarters of all pharmacy directors are moderately to extremely concerned about the impact these medications have on their overall spending. And slightly more than half are looking at way to mitigate costs.
At the same time, many pharmacy directors were unable to estimate the number of patients using orphan drugs, 40 percent do not use metrics to gauge the impact usage has on spending, and only 30 percent anticipate any policy changes by 2015 towa...
Source: Pharmalot - October 9, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Most Publicly Available Clinical Trial Outcomes Are Incomplete: Study
As the debate over disclosing clinical trial data intensifies, a new study finds that publicly available sources do not contain the same detailed information about patient outcomes that can be found in the case study reports most drugmakers do not want to disclose.
The study, which was published in PLoS Medicine, compared information available in CSRs with information in journals and registry reports. The researchers found that unpublished CSRs included complete information for 86 percent of relevant patient outcomes, but the combined publicly available sources provided complete information for only 39 percent of the out...
Source: Pharmalot - October 9, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Former Lilly Employees Charged With Stealing R&D Secrets
Did three former Eli Lilly employees secretly swipe confidential information and convey this to a Chinese drugmaker? This is the allegation that was debated in a federal court yesterday, where federal prosecutors accused Guoqing Cao, Shuyu Li and an unnamed individual of being traitors, according to the Indianapolis Business Journal.
An indictment charged that Cao and Li, both of whom are biologists with doctoral degrees, with seven counts of theft and conspiracy to commitment theft. They allegedly e-mailed sensitive information about nine experimental Lilly drugs to the unnamed person who is employed by Jiangsu Hengrui Me...
Source: Pharmalot - October 9, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Pharmalot... Pharmalittle... Good Morning
Good morning, everyone, and how are you today? We are happy to report that a shiny sun is hovering over the Pharmalot corporate campus where, once again, assorted short people are hustling off to their local schoolhouses. As for us, we are staring at the to-do list and attempting to sort out priorities. Never an easy task. We suspect that you can relate. So why not use this as a signal to get cracking. Here are some tidbits to help you along. Hope your day is smashing and do stay in touch...
Former Sanofi And Celgene Execs Plead Guilty To Insider Trading (Associated Press)
Celltrion CEO Faces Stock Manipulation Probe In So...
Source: Pharmalot - October 9, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Knock, Knock! Who's There? In India, It's A Surprise Visit From FDA
The next time a drugmaker in India hears an unexpected knock at the door, there may be an FDA inspector standing on the other side. Why? The agency is planning to follow the same system of facility inspections in India that is followed in the US and other developed countries, including aggressive surveillance and surprise visits, according to LiveMint.
“India has become a priority location for the FDA as it houses the largest number of FDA-approved drug manufacturing plants outside the US and it is also emerging as the largest exporter of generic drugs to that country,” an unnamed source, who is familiar with agency pl...
Source: Pharmalot - October 8, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
HHS And Consumer Group Spar Over Pfizer And Purdue Documents
Four years ago, a consumer advocacy group asked the US Department of Health & Human Services to provide detailed information about the extent to which two drugmakers – Pfizer and Purdue Pharma –were complying with Corporate Integrity Agreements. These are reached as part of a settlement with the federal government for illegal activities and require regular reports to demonstrate compliance.
Public Citizen Health Research Group sought this information in order to determine whether the drugmakers complied with their agreements. Pfizer, for instance, had signed multiple CIAs between 2002 and 2009 involving different e...
Source: Pharmalot - October 8, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
The Op-Ed: Drugmakers Unfairly Restrict Pet Med Pharmacies
For the past couple of years, a Wisconsin pharmacy that specializes in pet medicines has railed against a few big drugmakers – including Merck, Pfizer and the Merial unit run by Sanofi – for restricting its ability to sell prescription drugs to pet owners. In most instances, however, the same drugs can be purchased from a veterinarian. Reports have suggested this arrangement benefits the veterinarians by increasing their business, while the drugmakers stand to gain from having specialists promote specific products. Race Foster, a veterinarian who heads Drs Foster and Smith, an online pet pharmacy, contends many pharmac...
Source: Pharmalot - October 8, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Supreme Court Asks Solicitor General About Whistleblower Cases
The US Supreme Court has asked the US Solicitor General to comment on a case that calls into question whether whistleblowers may be restricted from filing lawsuits alleging drugmakers duped federal healthcare programs into paying for medicines (see page 6). And what may be at stake is the ability of the federal government to recover billions of dollars from healthcare fraud.
The case involves a Takeda Pharmaceutical sales manager named Noah Nathan, who claims the drugmaker defrauded Medicare by falsely marketing higher doses of its Kapidex treatment for gastroesophageal reflux disease, or GERD, than what was approved by th...
Source: Pharmalot - October 8, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Supreme Court Rejects Novartis Bid To Hear Punitive Damages Case
In a setback to Novartis, the US Supreme Court has decided not to review a case in which the drugmaker argued that punitive damages should not be awarded by juries in product liability lawsuits. Why? Novartis hoped to convince the court that such penalties purportedly encroach on the ability of the FDA to enforce its authority.
As we wrote last week, Novartis cited a 2009 ruling by the Supreme Court that a Vermont woman named Diana Levine had the right to sue Wyeth, which is now owned by Pfizer (PFE), in state court after alleging damage caused by one if its drugs. The drugmaker unsuccessfully cited preemption, which is th...
Source: Pharmalot - October 8, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Pharmalot... Pharmalittle... Good Morning
Hello, everyone, and how are you this morning? A strong sun and cool breeze are enveloping the leafy Pharmalot corporate campus, where we await the arrival of the grounds crew to tidy up. This may be a long wait, however. In the interim, yes, we are brewing a needed cup of stimulation - our flavor is the seasonal favorite, Pumpkin Spice - and we invite you to join us, as always. An extra kick at the start of the day is always welcome, yes? Now, though, the time has come to get cracking. So here are a few items of interest. Have a grand day...
Glaxo Seeks To Market First Malaria Vaccine (The Guardian)
The Shutdown Update On...
Source: Pharmalot - October 8, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
