BOSTON— A Massachusetts pharmacy issued a voluntary recall Monday of some of its sterile compounding products after "foreign matter" was found in drug vials during an unannounced inspection by state and federal officials.
Pallimed Solutions Inc., of Woburn, was also ordered by the state board of pharmacy to stop all sterile compounding activities until further notice.
Most of the recalled items were used to prepare erectile dysfunction treatments for patients who have difficulty taking drugs orally. The company said fewer than 800 patients were involved.
The company described the recall as a precautionary measure and said it had received no reports of any illnesses or injuries. It also said it would continue with nonsterile compounding.
The Massachusetts Department of Public Health said it requested the recall after a joint inspection on Friday by the state pharmacy board and the U.S. Food and Drug Administration.
"The cease and desist was issued after foreign matter was observed in vials of injectable drugs," the Department of Public Health said in a statement.
Pallimed also was ordered to place all its compounded sterile products into quarantine while the investigation continued.
The company said there was no indication the products were tainted or unsafe. The state also said there were no reports of any patient harm.
A message was left with the FDA.
Massachusetts stepped up unannounced inspections of compounding pharmacies after a deadly fungal meningitis outbreak last year was linked to an injectable steroid produced at another Massachusetts company, New England Compounding Center.
That outbreak was responsible for 720 illnesses in 20 states, including 48 deaths, according to the most recent update from the Centers for Disease Control and Prevention.
Framingham-based NECC ceased operations in October and surrendered its license to the Massachusetts board.
Pallimed Solutions is a 7-year-old company that does business as Pallimed Pharmacy and has about 15 employees, according to its website. It said it regretted any impact on customers and that patient safety was its top priority.
"By undertaking this recall action, Pallimed will move forward to ensure that our products always meet the highest standards of safety and customer expectations," the company said in its statement.
On Nov. 27, the state ordered Pallimed to temporarily stop production of sildenafil citrate — the active ingredient in Viagra — for human use after inspectors found it had been prepared with improper components. The company said those issues were administrative in nature and had been resolved, and Monday's announcement was unrelated.
The state said the earlier order was still in place, pending the board's acceptance of a corrective plan.
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Source: WFAA (AP, 3/25)
Monday, March 25, 2013
Monday, March 18, 2013
Diabetes Drugs Evaluated by FDA on Pancreatic Cancer Risk
The Food and Drug Administration is reviewing unpublished findings by a group of academic researchers that suggest pre- cancerous cellular changes may be associated with Type 2 diabetes drugs called incretin mimetics, according to a statement today from the agency. The findings suggest the class of medicines may be linked to the risk of developing an inflammation of the pancreas tied to cancer and kidney failure that was previously reported in some of the medicines.
Doctors have been concerned that this category of diabetes treatments may damage the pancreas since the FDA said in 2007 it received a high number of reports of pancreatitis in patients taking Byetta. The agency issued a similar alert for Januvia in 2009. An analysis of insurance records published last month in the journal JAMA Internal Medicine showed such drugs may double a user’s risk of pancreatitis.
The drugs in the class include exenatide, liraglutide, sitagliptin, saxagliptin, alogliptin and linagliptin. They mimic incretin hormones that the body usually produces naturally to stimulate the release of insulin in response to a meal, the FDA said.
No Conclusions
The FDA said it hasn’t reached any new conclusions about the safety risks associated with the drugs and hasn’t determined whether they may cause or contribute to pancreatic cancer. The agency suggested patients continue taking the drugs and talk with their doctors.
Merck, the second-largest U.S. drugmaker, is confident in the safety of sitagliptin, which is found in Januvia as well as the company’s Janumet and Juvisync, Pamela Eisele, a spokeswoman, said in an e-mail. The Whitehouse Station, New Jersey-based company reviewed all the safety data available to them on sitagliptin and “find no compelling evidence establishing a causal relationship between the use of sitagliptin and pancreatitis or pancreatic cancer,” Eisele said.
Merck will continue to monitor the safety of the drug with regulatory agencies and scientific experts, she said.
Merck reported $4 billion in sales, or about 9 percent of total revenue, from Januvia last year. The daily pill blocks an enzyme that breaks down GLP-1. Janumet, which combines Januvia with the older diabetes drug metformin, generated $1.7 billion in sales last year.
Bristol-Myers, based in New York, acquired Byetta last year when it bought Amylin Pharmaceuticals. Byetta, which mimics GLP-1, had sales of $148 million for Bristol-Myers last year, and $159 million for Indianapolis-based Eli Lilly & Co. (LLY), which ended its marketing partnership with Amylin in 2011. Novo Nordisk’s Victoza generated about $1.6 billion in sales, according to data compiled by Bloomberg.
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Source: BloomBerg (Edney, 3/14)
Tuesday, March 12, 2013
Regional motorcyclists die in crashes at higher rate than other drivers
The friend, Martin Munguia, is working with MOTRAN President James Beauchamp to create an event that will encourage biker safety, inspired by the death of 36-year-old Joe Anthony Montemayor in a Feb. 5 crash on Big Spring Street in Midland.
The statistics were provided by the Texas Department of Transportation and cover the 12-county Odessa District for the years 2008 through 2012. They show that the number of crashes, deaths and injuries involving motorcycles remained mostly consistent (see breakout).
But the statistics also show a persistent and deadly problem when compared to total accidents.
The last two years, coinciding with the oil boom, saw great increases in crashes. In 2012, when there were 425,091 registered vehicles in the region, crashes increased 18 percent. Fatalities increased 47 percent to a total 147. And 10 of those people killed in 2012 were motorcyclists or their passengers.
“Unless you’ve got 42,549 registered motorcycles out there, it means your fatalities among motorcyclists are higher compared to the rest of the population,” Beauchamp said.
Munguia and Beauchamp are lobbying Midland and Odessa to issue official proclamations declaring a biker awareness day and they are still finding both a date and location for the event. Munguia has said he hopes to have the event next month, and Beauchamp has said he hopes to fold the event into the Drive Smart campaign, which includes outreach about issues like distracted driving.
“The bikers, they’re a close knit group and I think a couple of these recent fatalities have hit them pretty hard,” Beauchamp told the Odessa American last week. “It all comes back to awareness.”
Beyond the greater risk of injury should an accident occur, motorcyclists are less visible than cars and trucks, and drivers tend to have greater difficulty gauging their speed, Beauchamp said. Most accidents involving motorcycles happen during a turn.
Odessa spokesman Gene Powell said 2011 figures show 470 motorcycle fatalities statewide, accounting for 16 percent of traffic deaths. Motorcyclists are five times more likely to be injured in a traffic accident and 25 times more likely to die.
TxDOT’s Share the Road motorcycle safety campaign begins next month, which emphasizes many of the same safety measures promoted by Munguia and MOTRAN.
For greater safety, MOTRAN urges drivers to give motorcyclists more space, wait longer before turning when one is approaching and, generally, to pay more attention. Meanwhile, the agency urges motorcyclists to wear helmets, obey traffic laws and make themselves more visible through means such as blinkers, hand signals and running lights.
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Source: OA (Paul, 3/13)
Tuesday, March 5, 2013
Importance of a Drug's "Risk-Benefit" Profile Eludes Former FDA Commissioner
One would think that having a full understanding of a drug’s profile would be crucial to have before unleashing such a compound to patients around the world. Surprisingly, however, some are espousing the view that the U.S economy is being shackled by overregulation and that the Obama administration could stimulate economic growth by “lowering unnecessary barriers facing innovative U.S companies that are trying to bring new products to market.” For potential new drugs, the overregulation in question is the requirement to conduct late stage clinical trials to show the risk-benefit profile of the new medicine.
Critics of the pharmaceutical industry would deem such a proposal as another example of this industry’s attempt to exploit patients for profits. Ironically, it is not the pharmaceutical industry pushing this view. It is being brought forth by Dr. Andrew von Eschenbach, a former commissioner of the FDA and Dr. Tomas Philipson of the University of Chicago.
Von Eschenbach and Philipson have recently proposed a system in which a “drug could come to market after promising early-stage research in targeted patients, with appropriate post-marketing studies required”. In other words, if a drug works in 500 – 1000 patients, the FDA should allow this compound to be marketed to the patients who could benefit from it – which could be anywhere from 10,000 to millions of people. The company would then run surveillance studies to be certain that no unusual side effects arise during its use.
What are the benefits of this newly proposed system? This would eliminate the costly late stage studies (phase 3) that are now required by the FDA. These studies make up at least 25% of the overall R&D spending for innovative companies. Furthermore, drugs would be approved at least 3 – 4 years sooner, thus extending the amount of time a drug can be marketed on its existing patent. Presumably, these saving and added profits would be ploughed back into funding new R&D programs, thereby generating greater medical innovation.
This all sounds great, but what about unforeseen side effects? The authors handle this in the following way.
“Companies would still be liable for unforeseen side effects, but patients and doctors would be warned – through the drug’s labeling – that the product had been approved based on promising but provisional research.”
This is not the first time that von Eschenbach has made this proposal. He first discussed this in a Wall Street Journal op-ed last year . He based his arguments back then on the need for the U.S. to remain a leader in medical innovation and that the FDA’s clinical trial requirements were restricting this potential. Philipson and von Eschenbach frame their arguments this time on the belief that their proposal would help to stimulate the U.S. economy via the biopharmaceutical industry’s enhanced success.
This proposal was flawed last year and it is even more flawed today. I have no doubt that their system will result in reducing the money spent in getting new drugs to market. But phase 3 trials are crucially important for a number of reasons.
1) Phase 3 is a not a glorified efficacy trial. Rather, it exists to help to define the risk and benefits of a drug. You really can’t do such an evaluation solely on the results of a small subpopulation of patients.
2) Only with a full risk-benefit profile can the FDA judge whether a drug merits approval. A significant side effect for an obesity drug, which potentially would be taken by millions, would likely make its use untenable, whereas this same side effect for a new pancreatic cancer treatment may be perfectly acceptable given the life saving nature of the latter medicine.
3) Phase 3 studies are also needed to compare the efficacy of a new drug with existing therapies. How are doctors and patients to know whether a new drug should be used without knowing this?
The von Eschenbach/Philipson proposal, if adopted, would likely result in more drug recalls and more liability costs, resulting in a decrease of confidence in the work of pharmaceutical companies on the part of physicians and patients. Critics of the industry already challenge (wrongly, in my view) that new medicines offer little advantage to older products and may even be less safe. Eliminating phase 3 studies would erode the attempts that the industry is making to restore its image.
I, for one, feel that the FDA does a good job in evaluating the risks and benefits for new drugs under the current paradigm and I don’t believe that they are being restrictive. Hopefully, they will not pay heed to the advice of their former colleague. I also think that the pharmaceutical industry would benefit by disassociating itself from this proposal. Silence on this issue may cause people to assume pharma support.
______________________________________
Source: Forbes (LaMattina, 3/5)
Critics of the pharmaceutical industry would deem such a proposal as another example of this industry’s attempt to exploit patients for profits. Ironically, it is not the pharmaceutical industry pushing this view. It is being brought forth by Dr. Andrew von Eschenbach, a former commissioner of the FDA and Dr. Tomas Philipson of the University of Chicago.
Von Eschenbach and Philipson have recently proposed a system in which a “drug could come to market after promising early-stage research in targeted patients, with appropriate post-marketing studies required”. In other words, if a drug works in 500 – 1000 patients, the FDA should allow this compound to be marketed to the patients who could benefit from it – which could be anywhere from 10,000 to millions of people. The company would then run surveillance studies to be certain that no unusual side effects arise during its use.
What are the benefits of this newly proposed system? This would eliminate the costly late stage studies (phase 3) that are now required by the FDA. These studies make up at least 25% of the overall R&D spending for innovative companies. Furthermore, drugs would be approved at least 3 – 4 years sooner, thus extending the amount of time a drug can be marketed on its existing patent. Presumably, these saving and added profits would be ploughed back into funding new R&D programs, thereby generating greater medical innovation.
This all sounds great, but what about unforeseen side effects? The authors handle this in the following way.
“Companies would still be liable for unforeseen side effects, but patients and doctors would be warned – through the drug’s labeling – that the product had been approved based on promising but provisional research.”
This is not the first time that von Eschenbach has made this proposal. He first discussed this in a Wall Street Journal op-ed last year . He based his arguments back then on the need for the U.S. to remain a leader in medical innovation and that the FDA’s clinical trial requirements were restricting this potential. Philipson and von Eschenbach frame their arguments this time on the belief that their proposal would help to stimulate the U.S. economy via the biopharmaceutical industry’s enhanced success.
This proposal was flawed last year and it is even more flawed today. I have no doubt that their system will result in reducing the money spent in getting new drugs to market. But phase 3 trials are crucially important for a number of reasons.
1) Phase 3 is a not a glorified efficacy trial. Rather, it exists to help to define the risk and benefits of a drug. You really can’t do such an evaluation solely on the results of a small subpopulation of patients.
2) Only with a full risk-benefit profile can the FDA judge whether a drug merits approval. A significant side effect for an obesity drug, which potentially would be taken by millions, would likely make its use untenable, whereas this same side effect for a new pancreatic cancer treatment may be perfectly acceptable given the life saving nature of the latter medicine.
3) Phase 3 studies are also needed to compare the efficacy of a new drug with existing therapies. How are doctors and patients to know whether a new drug should be used without knowing this?
The von Eschenbach/Philipson proposal, if adopted, would likely result in more drug recalls and more liability costs, resulting in a decrease of confidence in the work of pharmaceutical companies on the part of physicians and patients. Critics of the industry already challenge (wrongly, in my view) that new medicines offer little advantage to older products and may even be less safe. Eliminating phase 3 studies would erode the attempts that the industry is making to restore its image.
I, for one, feel that the FDA does a good job in evaluating the risks and benefits for new drugs under the current paradigm and I don’t believe that they are being restrictive. Hopefully, they will not pay heed to the advice of their former colleague. I also think that the pharmaceutical industry would benefit by disassociating itself from this proposal. Silence on this issue may cause people to assume pharma support.
______________________________________
Source: Forbes (LaMattina, 3/5)
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