FDA

Posted on December 22, 2008 by Blake Bailey

 

House Energy and Commerce Committee ranking Republican Rep. Joe L. Barton of Texas asked for clarification from the Food and Drug Administration (FDA) this week concerning deaths related to the blood thinner heparin. His letter called into question the adequacy of the agency's review of the deaths. He highlighted previous correspondence from the FDA he received in October that tied two cases of heparin-related deaths to drugs produced by American Pharmaceutical Partners (APP). The APP heparin was not tested for contaminants, according to a FDA  letter.  FDA spokeswoman Karen Riley gave no substantive response but said "the agency looks forward to clarifying the issue with Barton."

 

How can the United States Supreme Court or President Bush seriously think that it is a good idea to preempt private law suits against pharmaceutical companies based upon FDA approval. Surely this approach to rights reserved to states and individuals can't be removed in such a cavalier fashion.

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FDA warns bayer about aspirin

Posted on November 11, 2008 by Blake Bailey

The FDA has warned Bayer about its aspirin claims. According to the AP, the FDA "scolded [Bayer] in two warning letters for never submitting proof that its pills -- Bayer Women's Low Dose Aspirin + Calcium and Bayer Aspirin with Health Advantage -- are effective in battling heart disease and osteoporosis."

Janet Woodcock of the FDA's Center for Drug Evaluation and Research said that if these aspirin-containing products are overused or not used properly, consumers can be at risk for internal bleeding and other issues. 

Treatments for these two diseases are required to be reviewed by a board of government scientists and cannot be sold over-the-counter.  

For such "combo pills," dietary supplements and drugs, to be legally marketed, they are subject to approval and generous regulation. 

What comments do you have about the weakness of the FDA and ways we might be able to improve it? Do you agree with me that potential of personal injury lawsuits provide a second line of protection for the consumers?

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Fentanyl deaths

Posted on June 6, 2008 by Blake Bailey

Fentanyl is a opiate 100 times more powerful than morphine. Originally this drug was put out as Duragesic®  made by Johnson & Johnson. Although originally it was used in operations, it later was applied in patches for patients with chronic serious pain. Numerous generic versions of the fentanyl patch, including Sandoz (manufactured by Alza), Mylan, Watson and Actavis hit the market. Although intended for only serious pain symtoms, some doctors prescribed it to those not needing such a potent medication. "Fold-over defects" and "stringer leakers" have caused leakage from the patches to over-medicate and kill patients.

A second Public Health Advisory regarding fentanyl pain patches has been issued, which stated that "reports indicate that doctors have inappropriately prescribed the fentanyl patch to patients for acute pain following surgery, for headaches, occasional or mild pain, and other indications for which a fentanyl patch should not be prescribed."

Johnson & Johnson recalled approximately 32 million patches because of possible leak defects. The recall includes Duragesic® and Sandoz brands. Actavis Inc., the United States manufacturing and marketing division of the international generic pharmaceutical company Actavis Group HF announced that 14 lots of fentanyl transdermal system CII patches sold in the United States are being voluntarily recalled.

Once again, patients have relied vainly on the FDA, pharmaceutical companies and their treating physicians for a good faith review of the medications prescribed.  

http://www.bailey-law.com/lawyer-attorney-1215852.html

 
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