The below story from the AP about Obama’s pick for the FDA is good news for all Heparin advocates because it signals a shift from a corporate friendly FDA to one based on science and consumer safety. Nominated for head of the FDA, Dr. Margaret Hamburg has received little opposition in committee and her confirmation is expected soon. More significant is the Obama administration intent to substantially increase the FDA’s budget and to stop political appointees from silencing the scientists at the FDA.
More money and independence is absolutely needed at the agency. Swine flu is only a small part of the agenda. Food and drug contamination are bigger threats. The FDA can simply not allow a thirty-year backlog on inspections of overseas drug plants. The FDA cannot do its job with a regulatory structure that allows the new plants to produce until the FDA finds something out of compliance. The law must require inspection and compliance, before drugs are shipped to the U.S. The conditions found by the FDA at Chanzghou SPL where Heparin was contaminated, cannot be allowed to exist in facilities making pharmaceuticals.
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WASHINGTON (AP) — President Barack Obama’s pick to oversee food and drug safety pledged on Thursday to revamp protection of the nation’s food supply to help prevent future disease outbreaks.
Dr. Margaret Hamburg, a bioterrorism expert who once served as New York City health commissioner, breezed through her confirmation hearing before the Senate Health, Education, Labor and Pensions committee, with no senators expressing opposition.
Hamburg, 53, said she wants to restore public confidence in the Food and Drug Administration by putting science first and running an open and accountable operation.
The full Senate is expected to vote on her nomination before Memorial Day. If confirmed, Hamburg’s most immediate task will be to oversee development of a vaccine for the new swine flu. But she said food safety will be her major ongoing project.
“The agency is facing a range of new and daunting challenges,” Hamburg told senators. “These include the globalization of food and drug production, the emergence of new and complex medical technologies, and the risk of adulteration or deliberate terror attacks on our food and drug supplies.”
The FDA oversees products ranging from peanut butter to cancer drugs to medical imaging machines — a portfolio that represents about a quarter of consumer products. A few years ago, it was shaken by the withdrawal from the market of Vioxx, a painkiller that turned out to have serious heart risks. More recently, outbreaks of foodborne illness have exposed haphazard oversight of the nation’s far-flung food supply chain. Within the agency, scientists in the medical devices center are in revolt over what they say is management interference. And a federal judge recently ruled that the FDA improperly politicized a decision on emergency birth control during the Bush administration.
On top of all that, the FDA must play a critical role in developing a vaccine for the new swine flu virus and ensuring that enough vaccine can be made to protect the public.
Hamburg, as an assistant health secretary under President Bill Clinton, helped lay the groundwork for the government’s bioterrorism and flu pandemic preparations.
The swine flu vaccine will be her first task. “I look forward to being actively involved in discussion on such critical issues as how much vaccine to make, whether to alter seasonal vaccine manufacturing, and, ultimately, whether to recommend vaccination for the American people,” Hamburg said.
Vaccinating the entire population for swine flu would be a huge undertaking, and might require more than one shot. It would also have to be coordinated with preparations for the regular flu season. But such a large scale effort may not be needed if the virus turns out to be mild.
Turning to food safety, Hamburg said it will require sustained effort, more money, and stronger laws to improve the situation. She wants to shift from chasing outbreaks after they have broken out to preventing them first. That would require all food companies to follow written safety plans, overseen by federal and state inspectors. Traceability and import safety — weak links in the system — would have to be strengthened.
Obama’s budget, released Thursday, calls for a $260-million increase for the FDA’s food safety program. Past budget cuts have hit the food inspection program hard, and part of the new funding would go to rebuild the ranks of inspectors.
Hamburg said she supports FDA regulation of tobacco and allowing Americans to import low-cost brand name prescription drugs from abroad, positions consistent with Obama’s.
Hamburg’s professional career has centered on public health. She is the daughter of two doctors, and her family background includes African-American and Jewish heritage. Her mother was the first black woman to earn a medical degree from Yale University. She credits her father’s side of the family for imbuing in her a passion for social concerns.
___
Associated Press writer Erica Werner contributed to this report.
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Rep. Barton Demands Answers about Heparin Contamination
Finally someone in Washington has remembered that there are still consequences to what they called a “catastrophe” last year.
According to the Dow Jones Newswire, Rep. Joe Barton, R.-Texas, “is pressuring the U.S. Food and Drug Administration for more information about contaminated heparin from China amid concerns that the agency doesn’t know what caused U.S. patients to get sick or die while taking the blood thinner last year.”
Barton is a member of the House Energy and Commerce Committee which held hearings last year. He has written a letter to the FDA demanding the agency turnover databases on the Heparin contamination. According to Dow Jones:
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According to the Dow Jones Newswire, Rep. Joe Barton, R.-Texas, “is pressuring the U.S. Food and Drug Administration for more information about contaminated heparin from China amid concerns that the agency doesn’t know what caused U.S. patients to get sick or die while taking the blood thinner last year.”
Barton is a member of the House Energy and Commerce Committee which held hearings last year. He has written a letter to the FDA demanding the agency turnover databases on the Heparin contamination. According to Dow Jones:
Barton is trying to determine whether anyone in China has been held responsible for contaminating heparin that ultimately sickened and killed U.S. citizens.It is time that the FDA went public with all it knows about the Heparin Catastrophe. Freedom of Information Requests have been pending before the agency for more than a year now. What does the FDA know? Why are they not telling the American public about the full breadth of this poisoning?
“We don’t seem to be any further along a year later from understanding” this issue, said an Republican staffer for the committee, who asked not to be named. “What are they doing about it? Is this an acceptable practice in China?”
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FDA Warns Qingdao Heparin Company, conclusion
The FDA warning letter to Qingdao Jiulong Biopharmaceuticals Co. Ltd. concluded as follows:
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Please also address in your response to this letter the following issues:Maybe you should write the FDA and tell them what you think about importing dangerous drugs from China?
During the inspection, the investigators were informed that your firm does not distribute heparin sodium directly to the U.S. and that the product manufactured was shipped to Shanghai. During an inspection conducted at a U.S. facility, we found purchase orders and information indicating that since 2005, heparin sodium manufactured at your facility was being shipped into the U.S. Please clarify whether you shipped drugs directly to the U.S. and provide a list of all lots of heparin sodium (intended for experimental or commercial use) shipped to the U.S. since your firm started to manufacture heparin sodium. Please also identify whether you shipped drugs that you understood were ordered by or ultimately destined for the U.S., even if you did not ship them directly to the U.S. yourself. Also include a list of any other customers to whom you have supplied heparin sodium or other substances intended for the U.S. market. Include the amounts shipped and dates of all shipments.
Please also explain the relationship between your firm and (b)(4). Please provide information regarding any lots of heparin sodium that were shipped by (b)(4) on your firm’s behalf, including lot numbers, dates of shipments and amounts.
In light of the above and the fact that your predecessor (Qingdao Kangyuan) was never inspected by FDA and apparently no longer manufactures heparin sodium, we expect you to address the reliability of any information generated regarding the manufacture, processing, testing, packaging, and labeling of heparin sodium shipped to the U.S. and used to support your DMF 22222.
One way you can do this is by employing a third party auditor to conduct a validity assessment of the information you have provided or intend to provide to support your DMF regarding the production of heparin sodium. Conducting such an audit could expedite the process of re-qualifying your facility.
The listed deficiencies are not to be considered an all inclusive list of deficiencies at your facility. FDA inspections are audits, which are not intended to address all deviations from CGMP or all violations which may exist at a firm. If you wish to ship your products to the U.S., you are responsible for ensuring compliance with all U.S. standards for CGMP and all other applicable U.S. laws and regulations.
Until FDA has confirmed corrections of the deficiencies and compliance with CGMP, this office may recommend withholding approval of any new applications listing your firm as the drug manufacturer. In addition, shipments of articles manufactured at Qingdao Jiulong Biopharmaceutical Co., Ltd located at Jiulong Indusrial Garden Jiaozhou, Qingdao, Shangdon Providence 266319, People’s Republic of China facility and shipped into the U.S. are subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C; Act [21 U.S.C. 381(a)(3)], in that, the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of Section 501(a)(2)(B) of the FD&C; Act [21 U.S.C. 351(a)(2)(B)].
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice. Please respond to this letter within 30 days of receipt. Please identify your response with FEI 3006745882. If you have any questions concerning this letter, you may contact Carmelo Rosa, Compliance Officer at the address and telephone numbers shown below.
U.S. Food & Drug Administration Center for Drug Evaluation and Research Division of Manufacturing and Product Quality International Compliance Team White Oak Building 5110903 New Hampshire Avenue Silver Spring, Maryland 20993 Tel: (301) 796-3667 Fax: (301) 301-847-8741
Sincerely,
/s/
Richard L. Friedman Director Division of Manufacturing and Product Quality Office of Compliance Center for Drug Evaluation and Research Office of Compliance
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FDA Warns Qingdao Heparin Company, continued
In the third part of the FDA warning letter to Qingdao Jiulong Biopharmaceuticals Co. Ltd. the focus was on the presence of the OSCS contamination:
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3. Your firm failed to investigate specific discrepancies related to the lots of impure drugs supplied to your customers. We learned that heparin sodium lots manufactured at your facility were determined to be contaminated with OSCS. At the time of the inspection, no investigation had been conducted into this repeated and unacceptable contamination.Only one inference is possible from these detailed complaints by the FDA: The Chinese don’t seem to care about the safety of a drug intended for IV use with the sickest of Americans. Such complete failure could not have slipped by even the most cursory of investigation.
From our investigation, it appears that your customer requested that your firm investigate the OSCS contamination. Although the contamination of these lots was discussed during the inspection, you apparently had not initiated an investigation to determine the root cause of the contamination, identified whether other lots were implicated, or taken appropriate corrective actions to prevent recurrence of this contamination.
Your firm’s failure to investigate these significant customer complaints is a serious deviation from CGMP. It is your firm’s responsibility to ensure that drugs manufactured at your facility are produced in compliance with CGMP. This includes establishing adequate systems to detect such quality issues before an adulterated product is distributed, and promptly implementing corrective measures to prevent recurrence.
No information was provided to assure that any of your firm’s internal practices or upstream sources (e.g., suppliers) that may have been involved in the contamination of the 19 lots produced has been identified and removed from your supply chain. Please include in your written response to this letter a copy of all investigations regarding OSCS that may have been conducted after the inspection, the root cause of the contamination, and the corrective actions implemented to prevent recurrence. Also include the list of the crude and other upstream suppliers for all of the contaminated lots.
The investigators were informed during the inspection that all lots of heparin sodium produced at your facility would be tested using the CE and NMR methods beginning in September 2008. Please state in your response whether your firm has begun to test the heparin sodium using these methods or if these analyses are being outsourced, and when this testing commenced. If your firm has decided to outsource these tests, include in your response the identity of the contract laboratory, their physical address and the qualification report.
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
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