Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

As a presidential candidate, President Barack Obama said he supported individuals’ rights to import cheaper drugs from other countries provided the FDA beefed up its inspections to ensure the imports are safe. His new budget plan backs up that claim, according to Reuters. The plan, released earlier this week, says it “supports the Food and Drug Administration’s (FDA’s) efforts to allow Americans to buy safe and effective drugs from other countries.”

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The FDA received reports of about debris in syringes filled with heparin and saline distributed by AM2PAT as early as 2005, yet the agency didn’t follow up on those complaints until 2007, after five deaths and hundreds of illnesses were linked to the contaminated syringes, according to the Associated Press.

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Scientists are proposing new standards for testing the quality and safety of heparin with new equipment that can analyze a broader range of impurities than the screening tools currently in use, according to the Daily Herald. The proposal stems from last year’s tainted heparin scandal that resulted in the deaths of more than 80 Americans and illness in hundreds more. Batches of heparin were later found to have been contaminated with oversulfated chondroitin sulfate (OSCS) during manufacturing at Baxter International’s China plant. OSCS is a heparin-mimicking contaminant that can cause serious allergic reactions in humans.

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Lawmakers’ concern over the U.S. becoming too reliant on foreign countries to produce drugs are calling for a rule to require certain drugs to be made or stockpiled in the U.S., according to the New York Times. The Times quotes Sen. Sherrod Brown of Ohio as saying that relying on other countries to produce our country’s medicines opens the door to “supply disruptions, counterfeit medicines, even bio-terrorism.”

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In an ongoing effort to ensure the safety of foods and drugs imported to the United States, the FDA is opening offices in foreign countries to oversee quality control of those products. The agency announced this week that it has opened two offices in India, according to Med Page Today.

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FDA chief scientist and principal deputy commissioner Dr. Frank Torti will serve as the agency’s acting commissioner when Dr. Anderew Von Eschenbach leaves office this week, a position he will hold until the Obama administration appoints a new leader and the Senate approves the choice, according to Scrip World Pharmaceutical News.

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The FDA announced today that it will launch a voluntary two-year pilot program to help promote the safety of drugs and active drug ingredients made outside the U.S. As part of the Secure Supply Chain program, the FDA will select 100 volunteers to maintain control over drug products beginning with when they are produced until it enters the U.S.

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Actor Dennis Quaid and his wife Kimberly now have closure in their year-long heparin overdose lawsuit against Cedars-Siani Medical Center, according to OK! and Entertainment Tonight. The entertainment media reported that a Los Angeles judge has signed off on the $750,000 settlement the couple reached with Cedars-Siani last month. According to the settlement, the hospital did not admit wrongdoing in the potentially fatal overdose of heparin that was accidentally administered to the couple’s newborn children Zoe Grace and Thomas Boone Quaid. The settle also allows for the couple to pursue claims for their children in the future. The California Department of Public Heath fined Cedars-Siani $25,000 for the error.

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A class action lawsuit has been filed against Baxter Healthcare Corp., claiming the company began substituting ingredients in its anti-coagulant heparin with a dangerous counterfeit to “reap greater profits as a result of utilizing cheap component parts,” according to The Madison St. Clair (Illinois) The Record.

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Just weeks after the FDA requested revised labeling for the low molecular weight heparin, Innohep, the FDA announced that its maker Celgene Corporation has issued a “Dear Healthcare Professional” letter describing a controlled clinical study that suggests an increased risk of death in elderly patients who received Innohep. Innohep contains tinzaparin sodium that is given to patients in conjunction with warfarin sodium intravenously to treat blood clots that have occurred deep in the veins of hospitalized patients who may or may not have also experienced the occurrence of blood clots in their lungs (pulmonary embolism).

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