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Thursday, February 28, 2013
Dr. Omidi's Blog: WEDNESDAY, FEBRUARY 27, 2013 Controversy in Culpability Surrounding Meningitis Outbreak
Because the fungal meningitis outbreak was so catastrophic in terms of lives lost and pain needlessly suffered, it was only a matter of time before survivors began to seek remuneration from the parties responsible. Not only are the owners of the compounding pharmacy being sued, many of the physicians who administered the tainted shots are also facing litigation.
While it cannot be denied that the blame for the fungal meningitis disaster lays at the feet of a compounding pharmacy that flouted not only governmental regulations, but also basic pharmaceutical practices of health, safety and due diligence, many patients are nonetheless beginning to wonder if the clinics that administered the tainted shots shouldn’t bear some responsibility as well.
The entire matter is extremely delicate. While it is true that the New England Compounding Center was woefully inept at maintaining an environment suitable for the production of an extremely delicate and difficult to manufacture drug, the Massachusetts regulatory boards did little, if anything to oversee or police their practices. The NECC was inspected several times by the FDA as well as state board officials, who issued warnings and concerns that were completely ignored, and yet the regulatory bodies did nothing to follow up on those warnings, leaving thousands of patients in jeopardy.
One of the main reasons compounding pharmacies distribute so many vials of epidural steroid is because many physicians believe in the studies that report of the dangers of using injectable drugs that contain preservatives. While there are many conflicting studies regarding the potential hazards of preservatives in injectable applications, the crux of the objection to the commonly used pharmaceutical preservatives is that they may trigger outbreaks of arachnoiditis, an incurable inflammation of the arachnoid membrane which surrounds the spinal column. This condition is painful, chronic, has debilitating side effects, and requires more or less constant pain management therapy and treatment. Injectable steroids that do not contain preservatives can only be obtained through compounding pharmacies, not FDA regulated drug companies
Hospira issues 3 recalls as it faces crucial FDA inspection
February 27, 2013 | By Eric Palmer
Sterile injectables maker Hospira ($HSP) is having to recall lots of 5 different products even as FDA inspectors are in one of its plants conducting what the company hopes will be a final inspection that will return the drugmaker to the agency's good graces.
Over the last several days, Hospira recalled three lots of propofol injectable emulsion after reports came to light that some vials had visible particles embedded in the glass. These were found in some retained samples. It is recalling one lot of preservative-free morphine sulfate injection after a customer found either a loose crimp or no crimp on the flip-top vial, which raises the possibility of contamination. It also recalled three lots of diazepam injection, furosemide injection and Quelicin (succinylcholine chloride) injection for the same problem with loose crimping in flip tops.
The company said all of the recalls are voluntary and there have been no reports of patients being affected by any of the recalled products, although in each case there is a chance for serious effects.
Read more: Hospira issues 3 recalls as it faces crucial FDA inspection - FiercePharma http://www.fiercepharma.com/story/hospira-issues-3-recalls-it-faces-crucial-fda-inspection/2013-02-27#ixzz2MAnwvSbt
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Sterile injectables maker Hospira ($HSP) is having to recall lots of 5 different products even as FDA inspectors are in one of its plants conducting what the company hopes will be a final inspection that will return the drugmaker to the agency's good graces.
Over the last several days, Hospira recalled three lots of propofol injectable emulsion after reports came to light that some vials had visible particles embedded in the glass. These were found in some retained samples. It is recalling one lot of preservative-free morphine sulfate injection after a customer found either a loose crimp or no crimp on the flip-top vial, which raises the possibility of contamination. It also recalled three lots of diazepam injection, furosemide injection and Quelicin (succinylcholine chloride) injection for the same problem with loose crimping in flip tops.
The company said all of the recalls are voluntary and there have been no reports of patients being affected by any of the recalled products, although in each case there is a chance for serious effects.
Read more: Hospira issues 3 recalls as it faces crucial FDA inspection - FiercePharma http://www.fiercepharma.com/story/hospira-issues-3-recalls-it-faces-crucial-fda-inspection/2013-02-27#ixzz2MAnwvSbt
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FDA HAS RAMPED UP INSPECTIONS OF APIs--From FiercePharma Manufacturing: FDA warning to Abbey questions quality of API for sterile drugs Warning Letter lists repeat violation on water quality February 27, 2013 | By Eric Palmer Read more: FDA warning to Abbey questions quality of API for sterile drugs
The FDA says an active pharmaceutical ingredient maker in Philadelphia had yet to qualify that its purified water was in fact pure enough to make APIs two years after the agency noted a deficiency.
Abbey Color was told in a new warning letter posted to the FDA website this week that the agency is dissatisfied with the steps the company has taken to demonstrate that its water is suitable for use in manufacturing fluorescein USP, an API used in sterile drug products.
The inspection was conducted nearly a year ago, but the agency notes the company had promised in 2010 that it would make sure it had a reliable source of quality water. The most recent inspection found Abbey still passes spec endotoxin and total organic carbon test results. But inspectors found the operational parameters and effectiveness of an endotoxin removal unit had not been qualified and that Abbey was not monitoring the microbial and chemical attributes of the feed water.
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The FDA has been ramping up inspections of APIs, and drugmakers using additional user fees that kicked in this year from generic manufacturers. But that work is being put to risk by looming across-the-board budget cuts from the current sequestration fight in Congress. A recent Congressional Budget Office (OMB) ruling said that user fees have to be cut as well. Regulatory Focus recently figured the cuts would mean a loss of about $200 million from the FDA's base budget and an estimated $112 million (annualized) in lost user fees.
- here's the warning letter
Read more: FDA warning to Abbey questions quality of API for sterile drugs - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/fda-warning-abbey-questions-quality-api-sterile-drugs/2013-02-27#ixzz2MAm4Tpmh
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FDA's Drug Center Creating New Office Of Pharmaceutical Quality, Hamburg Says Wednesday, February 27, 2013 from Pharmaceutical Law & Industry Report ®
By Bronwyn Mixter
The Food and Drug Administration's Center for Drug Evaluation and Research is working on creating a new office of pharmaceutical quality, FDA Commissioner Margaret A. Hamburg said Feb. 22.
Speaking at the Generic Pharmaceutical Association's (GPhA) annual conference, Hamburg said the new office would not impose any new quality requirements but rather enforce existing quality standards.
“We must be strategic and have systems in place for continual quality surveillance,” Hamburg said. “Quality is one of our highest priorities” in 2013, she added.
In 2012, CDER Director Janet Woodcock said CDER was exploring the idea of creating a new Office of Pharmaceutical Quality (OPQ) to oversee quality throughout the lifecycle of a drug (10 PLIR 1196, 9/14/12).
The generic drug user fees give FDA the funding it needs to reduce the backlog of generic drug applications, Hamburg said.
Hamburg said FDA has collected $125 million in GDUFA fees for 2013 so far. However, she noted, the budget situation and sequestration have “significant implications” for using generic user fees and budget dollars. Budget cuts under the Budget Control Act of 2011--known as sequestration--are scheduled to be implemented at the beginning of March, while legislation funding the federal government expires at the end of March. In September 2012, a report from the White House Office of Management and Budget classified all budgetary resources available to FDA, including user fees, as subject to sequestration (10 PLIR 1332, 10/12/12).
In 2012, FDA issued three draft guidances for industry on biosimilars, and the agency “is moving forward to finalize” these guidances, Hamburg said (10 PLIR 173, 2/10/12).
“So far FDA has yet to receive an application for a biosimilar product,” Hamburg said. “We are ready” and “eager to engage in that next stage of the process.”
Hamburg said FDA has met with several manufacturers about developing biosimilar products.
Additionally, Hamburg said FDA is seeking public comments on its strategic plan to prevent drug shortages. FDA published a notice requesting comments in the Feb. 12 Federal Register (78 Fed. Reg. 9,928) (11 PLIR 206, 2/15/13). The Food and Drug Administration Safety and Innovation Act (FDASIA) requires the development and implementation of a strategic plan for enhancing FDA's response to preventing and mitigating drug shortages, according to the notice.
The Federal Register notice requesting comments on FDA's drug shortage plan is at http://www.gpo.gov/fdsys/pkg/FR-2013-02-12/pdf/2013-03198.pdf.
Source found here
The Food and Drug Administration's Center for Drug Evaluation and Research is working on creating a new office of pharmaceutical quality, FDA Commissioner Margaret A. Hamburg said Feb. 22.
Speaking at the Generic Pharmaceutical Association's (GPhA) annual conference, Hamburg said the new office would not impose any new quality requirements but rather enforce existing quality standards.
“We must be strategic and have systems in place for continual quality surveillance,” Hamburg said. “Quality is one of our highest priorities” in 2013, she added.
In 2012, CDER Director Janet Woodcock said CDER was exploring the idea of creating a new Office of Pharmaceutical Quality (OPQ) to oversee quality throughout the lifecycle of a drug (10 PLIR 1196, 9/14/12).
Generic User Fees
Hamburg also said the Generic Drug User Fee Amendments of 2012 (GDUFA) is moving forward, and “it is going to make an enormous difference.”The generic drug user fees give FDA the funding it needs to reduce the backlog of generic drug applications, Hamburg said.
Hamburg said FDA has collected $125 million in GDUFA fees for 2013 so far. However, she noted, the budget situation and sequestration have “significant implications” for using generic user fees and budget dollars. Budget cuts under the Budget Control Act of 2011--known as sequestration--are scheduled to be implemented at the beginning of March, while legislation funding the federal government expires at the end of March. In September 2012, a report from the White House Office of Management and Budget classified all budgetary resources available to FDA, including user fees, as subject to sequestration (10 PLIR 1332, 10/12/12).
Biosimilars
FDA is moving forward with creating a biosimilars pathway, Hamburg said. A pathway to approve biosimilars was created in a 2010 law, but FDA is still implementing it.In 2012, FDA issued three draft guidances for industry on biosimilars, and the agency “is moving forward to finalize” these guidances, Hamburg said (10 PLIR 173, 2/10/12).
“So far FDA has yet to receive an application for a biosimilar product,” Hamburg said. “We are ready” and “eager to engage in that next stage of the process.”
Hamburg said FDA has met with several manufacturers about developing biosimilar products.
Additionally, Hamburg said FDA is seeking public comments on its strategic plan to prevent drug shortages. FDA published a notice requesting comments in the Feb. 12 Federal Register (78 Fed. Reg. 9,928) (11 PLIR 206, 2/15/13). The Food and Drug Administration Safety and Innovation Act (FDASIA) requires the development and implementation of a strategic plan for enhancing FDA's response to preventing and mitigating drug shortages, according to the notice.
The Federal Register notice requesting comments on FDA's drug shortage plan is at http://www.gpo.gov/fdsys/pkg/FR-2013-02-12/pdf/2013-03198.pdf.
Source found here
Ed Silverman's Pharmalot blog-What’s Not To Like? Facebook And The FDA
• Pharma Blog » 2013 » February » 27
Last month, the FDA tagged a dietary supplement maker for a laundry list of infractions, but one item tucked away in a December 11 warning letter stands out. The agency complained to Amarc Enterprises that one of its products was ‘liked’ last year on its Facebook page. This was cited as one example of numerous testimonials that could be construed as claims that cause the Poly MVA supplement to be considered a drug. - See more at: http://www.pharmalot.com/2013/02/whats-not-to-like-facebook-and-the-fda/#sthash.ewA1JpWz.dpufFDA does not anticipate furloughs if automatic budget cuts hit POSTED: Wednesday, February 27, 2013, 6:52 AM David Sell
If automatic federal budget cuts kick in Friday, patients, pharmaceutical companies — and the authorities paid to protect the first group and watch over the second — could be effected soon and over time.
Evaluations of drugs and medical devices might take longer as the Food and Drug Administration curtails operations. Patients might not get some medicine. Philadelphia Airport handles shipments of products and executives in the globalized drug business, so customs inspections, screening of passengers and air traffic control might delay delivery of both. Philadelphia has also been a hub of investigation and prosecution of health-care fraud, and the Justice Department expects temporary furloughs for employees.
The White House said Sunday night that the legally mandated cuts (yes, “sequestration”) would mean cuts of 13 percent for defense programs and 9 percent for non-defense programs through the end of the fiscal year on Sept. 30. Last fall, the Office of Management and Budget estimated that an 8.2 percent cut for FDA would amount to $318 million.
“A sequestration of the magnitude contemplated, and this late in the budget year, will have public health consequences for an agency that is already making every dollar count,” FDA spokeswoman Erica Jefferson said Tuesday.
As of Tuesday, Jefferson said, the FDA did not anticipate furloughing employees, but will meet its tighter budget through cost cuts in travel and training, contracts and collaborations. The FDA has a regional office in Philadelphia, and 13 foreign offices in Asia, Europe, Latin America, Africa and the Middle East, but overseas inspections could be impacted.
User fees paid by branded and generic drug companies were meant to help fund the FDA’s evaluation process, but budget cuts won’t help that effort.
There were goals for such approval decisions previously, but no new timetable has been established.
Continue reading here
Advocate says FDA mission 'at risk' from lack of funds By Elise Viebeck - 02/27/13 03:00 PM ET fda budget
The head of a stakeholder group told the Food and Drug Administration (FDA) Wednesday that funding has not kept pace with the agency's ever-expanding portfolio.
Diane Dorman, president of the Alliance for a Stronger FDA, told the agency's Science Board that the current $2.5 billion budget is "dramatically less" than the FDA requires.
"This amount might have met the FDA's funding needs in late 2007 ... but not now," Dorman said.
Read more: http://thehill.com/blogs/healthwatch/medical-devices-and-prescription-drug-policy-/285309-advocate-says-fda-mission-at-risk-from-lack-of-funds#ixzz2MAf3aifI
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Diane Dorman, president of the Alliance for a Stronger FDA, told the agency's Science Board that the current $2.5 billion budget is "dramatically less" than the FDA requires.
"This amount might have met the FDA's funding needs in late 2007 ... but not now," Dorman said.
Read more: http://thehill.com/blogs/healthwatch/medical-devices-and-prescription-drug-policy-/285309-advocate-says-fda-mission-at-risk-from-lack-of-funds#ixzz2MAf3aifI
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