Buy this domain.
FDA Not Inspecting Foreign Drug Makers Says GAO Report | cialis online

FDA Not Inspecting Foreign Drug Makers Says GAO Report

AddThis Social Bookmark Button

The Food & Drug Administration (FDA) inspects only a fraction of the foreign drug manufacturers who supply ingredients for medications sold in the US, and it doesn’t even know exactly how many foreign firms might be doing so. As a result, the FDA can in no way guarantee the safety of the US drug supply. That frightening conclusion was reached following a Government Accountability Office (GAO) audit of the FDA’s foreign drug inspection practices.

Unfortunately, the FDA is often the only defense Americans have against defective drugs from foreign suppliers. For instance, Chinese chemical companies are rarely inspected by Chinese regulators. Often, Chinese manufacturers produce other chemicals in addition to drug ingredients, including fertilizers and industrial solvents. This makes it much more likely that Chinese-made drug ingredients will end up contaminated with a toxic chemical. That is what happened in 2006, when at least 138 Panamanians died or were disabled after the poisonous ingredient, diethylene glycol, was mixed into Chinese-made cold medicine. In January, one Chinese company was accused of shipping counterfeit pharmaceutical ingredients to the US. Yet, in 2007, the FDA was only able to inspect 13 of China’s 714 drug manufacturing facilities.

Yesterday, at a hearing of the House Energy and Commerce subcommittee that has been looking into import safety, a GAO representative said that the FDA only has inspection records for one third of the foreign manufactures that could be making drugs for export to the US. According to the GAO, the FDA was unable to identify a previous inspection for a whopping 2, 133 facilities out of 3,249 suppliers from a list it uses to set inspection priorities. The GAO said that at its current pace, it would take the FDA more than 13 years to inspect each foreign drug supplier once. Yet foreign companies are allowed to manufacture about 80% of the ingredients that go into medications sold in the US.

Even when foreign companies are inspected, the GAO says that the FDA is doing a terrible job. For one thing, the FDA has no translators on staff, so inspectors must rely on translators provided by the foreign manufacturers. And foreign drug manufacturers are not held to anything approaching the level of scrutiny that US drug makers endure. While domestic drug manufacturers are subject to inspection at least every two years, there is no such requirement for foreign drug suppliers. Also, foreign drug makers are given advance notice of FDA inspections, while US companies must undergo surprise examinations.

Representatives from the pharmaceutical industry told the congressional committee that they do not rely on foreign regulators, or even the FDA, to insure that imported drug ingredients meet US safety standards. US drug companies perform periodic inspections of their foreign suppliers and test some shipments before they enter the country. But even they complained about the disparities between the way the FDA regulates US and foreign drug manufacturers.

The problems with FDA oversight of foreign drug makers are nothing new. Shockingly, the GAO presented a report with similar conclusions to Congress nearly a decade ago. Since then, the FDA has done nothing to improve its oversight of foreign drugs. At yesterday’s hearing, FDA Commissioner Andrew von Esenbach promised that the agency has taken steps to improve its inspection system for foreign drug makers. Despite the evidence presented at yesterday’s hearing, von Esenbach insisted that the US drug supply is safe.

« »

Leave a Reply

You must be logged in to post a comment.




Defective Johnson & Johnson Depuy ASR Hip Implants

The Johnson & Johnson Depuy ASR Hip Implant is suppose to last 15 years, but can fail in only a few years after surgery. Victims with faulty hip implants endure excruciating pain, pain in the groin, death of tissue in the hip joint and loss of surrounding bone. GET ALL THE FACTS NOW! CLICK HERE!

CAT Scans Radiation Exposure

If you had a CT or CAT scan and now have a band of missing hair, skin reddening or any other problems possibly related to a radiation overdose, you may have been exposed to much radiation due to incorrect settings on these machines. CONTACT US TODAY!

Water Contamination From Fracking

Hydraulic Fracturing of Fracking a way to extract natural gas from shale is contaminating water supplies across the country. Get the facts to keep your drinking water safe for your family.

Overexposure to PCBs

Many people unknowingly have been exposed to high levels of PCBs. Recently 3 schools in NY City were found to have dangerous levels of PCBs throughout. Many workers for Monsanto, General Electric, and Westinghouse were exposed to high levels of PCBs. PCBs are a dangerous toxic substance that doesn't break down easily and can cause chloracne, bleeding and neurological disorders, liver damage, spontaneous abortions, malformed babies, cancer, and death. GET THE FACTS!
Overexposure to

Great Photography

Tallis Photo, the number one photographer for great corporate, wedding, and special occasion photos. CONTACT US TODAY!

Poligrip Lawsuit

Super Poligrip or Fixodent May Cause Nerve Damage. 800-LAW-INFO

Personal Injury Lawyer Nassau County

If you or someone you love was injured CONTACT US TODAY!

Nursing Home Blog

When a loved one is abused at a nursing home, it is time to take action. STOP nursing home abuse!

Car Accident Lawyer Nassau County

If you or someone you love was injured in an auto accident CONTACT US TODAY!

Suffolk County Auto Accident Lawyer

If you or someone you love was injured in an auto accident in Suffolk County, NY CONTACT US TODAY!

Don't Be Denied Veterans Benefits

If you or someone you love was denied veterans benefits CONTACT US TODAY!

Oil Rig Spills Lawyer

Oil Rig Spills harm the environment and cause heavy losses to coastal game and fishing industries, as well as a loss of waterway usage, resulting in a loss of income to individuals and businesses, and a loss of beach front usage. Don't let a spill cause you harm, CONTACT US TODAY!

Whistle Blower

Stand up and say what you think is right. See something, say something.