Galveston Bay Personal Injury Lawyer - Heparin

FDA Posts List of Drugs They Are Watching

Scott Kappes — Wed, 10 Sep 2008 17:37:15 GMT

The FDA has the responsibility of protecting citizens of the United States from potentially harmful and dangerous drugs. Late last week the agency released a list of drugs that are currently on the FDA’s watch list of potentially harmful medications. The list names 20 different medications, citing particular issues associated with each of them. There is no indication of how many reports the FDA has received concerning the injuries associated with each medication nor is there any indication for patients to stop taking medications included in the list.

Food and Drug Administration officials said they are trying to walk a fine line in being more open to the public while avoiding needless scares. Congress, in a drug safety bill passed last year, ordered the agency to post quarterly listings of medications under investigation.

The list includes drugs several drugs that have already had highly publicized problems, like Heparin; as well as several other medications that have not been in the public eye. A number of drugs on the list were cited as having confusing instructions or similar names that has lead to overdoses or improper use.

This list is the first of its kind, but in coming months and years the FDA will continue to post a list of drugs under investigation each quarter.

Consumer advocates are pleased with the recent actions and are calling it “a step in the right direction;” however, many industry groups are concerned that the list will created unwarranted panic among patients taking these medications.

The full list of can be viewed here.

Originally posted at InjuryBoard by Scott Kappes

Bush Requests Increased FDA Funding

Scott Kappes — Tue, 10 Jun 2008 18:22:17 GMT

The White House has increased its budget request for the U.S. Food and Drug Administration by a whopping $275 million. The request comes on the heals of a rough year for the FDA that was capped off by the recall of the popular blood thinner Heparin, after it was discovered that the product had been contaminated somewhere in the Chinese supply line. The agency’s commissioner Andrew von Eschenbauch told Congress in a meeting earlier this year that more funding was need to ensure the safety of medications in an increasingly international supply chain.

The money would augment $2.4 billion previously sought by President George W. Bush for the fiscal year starting Oct. 1, said U.S. Health and Human Services Secretary Michael Leavitt in a conference call with reporters yesterday. More resources are needed to police food, drugs and medical devices, Leavitt said.

The additional funding would allow the FDA to conduct a minimum of 1,000 additional foreign plant inspections and over 1,000 additional domestic inspections as well. Over the next several years the market for pharmaceutical compounds will become even more dependent on foreign markets and additional funding for the FDA is a necessary step to ensure the safety of the medication being administered to millions of Americans each year.

Originally posted at InjuryBoard by Scott Kappes

Congressman Says FDA Cannot be Trusted

Scott Kappes — Wed, 30 Apr 2008 18:35:30 GMT

Yesterday after hearing the stories of families that lost loved ones that were treated with contaminated Heparin, Rep. John Dingell said, “Our citizens can no longer trust that their food, drugs, and medical devices are safe when the FDA says they are.” Heparin was recalled in February when it was discovered that batches of the drug had become contaminated. The contamination was traced back to China and now the FDA suspects that it may have been intentional. While this has not been proven, FDA commissioner Andrew von Eschenbauch has said that the contaminant could not have been derived by any of the normal means of manufacturing. The contaminated Heparin has been linked to 81 deaths.

Most of the Chinese plants that produce Heparin have never been inspected by the FDA and this is a real problem. How can the FDA ensure the safety of ingredients coming from plants that have never been under the FDA’s microscope?

The agency currently spends about $10 million a year inspecting foreign plants, but it would take about $250 million to do regular inspections at the ever-growing number of foreign facilities that make ingredients for the U.S. market. Dingell and Rep. Bart Stupak (D-Mich.), both of whom sit on the House Energy and Commerce Committee, are backing a bill that would give the agency lots more money for foreign inspections.

To place American lives at risk because the FDA does not have the funding it needs to ensure that medications are safe is unacceptable. If the FDA is going to continue to allow ingredients to be manufactured in other countries some sort of monitoring system must be put in place.

Originally posted at InjuryBoard by Scott Kappes

Economic Fraud Cited in Heparin Recall

Scott Kappes — Thu, 17 Apr 2008 15:06:06 GMT

The FDA has announced that they now believe that the ingredient found in tainted lots of Baxter’s Heparin was most likely not a mistake. The compound, a heparin-like substance identified last month as a modified form of chondroitin sulfate, is cheaper to produce than heparin and was probably used for economic reasons. The FDA has no specific evidence of fraud at this time, but FDA commissioner, Andrew von Eschenbach, told reporters that the chemical would not have been derived in any of the normal procedures used to extract heparin from pig intestines.

The tainted stocks of heparin, mostly recalled in February, have been linked to as many as 62 deaths. Baxter and their ingredient supplier Scientific Protein Laboratories claim that the contamination occurred before the product reached either company. If profit was the motive and fraud can be proven, all of those involved could be in for a very rocky road ahead. The FDA has said that they will not investigate the motive for the use of the contaminating compound, but will leave the investigation up to Chinese authorities.

Originally posted at InjuryBoard by Scott Kappes