Drug Lawsuit News Archive
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Drug Lawsuit News Archive
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Public Citizen Tells FDA to Create Safer Alternative -July 31, 2003
read article ....
Drug Tests Inadequate for Children - May 18, 2003 read article ....
Consumers Not Protected According to New Report -March 31, 2003 read article ....
Public Citizen filed suit against the U.S. Department of Health and Human Services -February 6, 2003 read article ....
Public Citizen Tells FDA to Create Safer Alternative
-July 31, 2003
According to the consumer advocacy group Public Citizen, patients are not receiving complete information and are sometimes being misled due to the governments allowance for private sectors to provide prescription drug content patient information. New information shows that the private-sector program is not living up to the FDAs initial goals or expectations of Congress.
The Public Citizen survey of the quality of information regarding 23 top selling drugs in 2002 that are required to carry the FDAs strongest warnings, called a black box warning, found that none of the patient drug information leaflets being distributed in a Washington, D.C. pharmacy complied with the 1996 laws guidelines. The 1996 Congress adopted law was that the private sector design and implement the program requiring the distribution of scientifically accurate and useful written information with all new and refill prescriptions, such as adverse drug effects and how the drug should be used.
The FDA created a timetable that by 2000 75% of patients would be receiving patient information leaflets and by 2006 95% of patients would be receiving patient information leaflets. The consumer group has filed suit against the U.S. Department of Health and Human Services in February 2003 because the FDA refused to hold a hearing regarding consumer drug information availability. For more information on drug recalls contact us to confer with a drug recall attorney.
Drug Tests Inadequate for Children
- May 18, 2003
Health specialists believe about 75% of all drugs prescribed to American children have not yet undergone adequate pediatric trials. Pediatricians believe a lack of testing has probably been the blame for many dangerous drug side effects and deaths among children. Now, a group of doctors, childrens health advocates, and government officials are pushing for more drug testing in pediatrics by requesting the FDA require pharmaceutical companies to test all new drugs that will be used among children.
In the past, specialists have assumed that by decreasing drug doses based on weight would cover how to prescribe to children. More and more, experts are finding this assumption to be deadly and dangerous. As more pediatric trials are being performed, the importance of the trials is being realized, however immediate changes are being sought after before a tragic outcome first occurs. For more information on drug recalls contact us to confer with a drug recall attorney.
Consumers Not Protected According to New Report
-March 31, 2003
The Public Citizen consumer group issued a press release on March 31, 2003 in response to the new report, saying that in light of the U.S. Department of Health and Human Services Inspector Generals confirmation that the current drug review process in the U.S. does not protect consumers from potentially deadly prescription medications, changes should be implemented. Of the FDA approved drugs since 1996, seven drugs have been removed from the market after determining the drugs were not safe. The more recent drug recalls included Rezulin and Redux.
An FDA survey conducted by the Inspector General that included 40% of the agencys long-term reviewers had replied that the FDA review process has worsened since their individual employment start. The drug recall report recommended that the drug review process be lengthened from the current 6-12 months to a month of two longer. Public Citizens Health Research Groups deputy director Peter Lurie had strong feelings about the FDA approval process and the recent drug recalls that have caused injury and death to some patients saying, Unless the agency gets out of the snug bed it is currently sharing with industry, unsafe drugs will continue to slip through the safety net.
Included in the Inspector Generals survey of 401 new drug reviewers within the FDAs Center for Drug Evaluation and Research, 58% said that six months for new drug review was inadequate and 25% felt that the target 10-month new drug review was also inadequate. Physicians and scientists said they felt pressured to recommend drugs be approved even when they may not be completely confident of the drugs safety, efficacy, or quality, with an 18% responding similarly.
The Public Citizen had prior research on drug recalls and the safety of FDA approved drugs in the past and feels that the new report is consistent with past findings. Back in December 1998, Public Citizen performed a study with finding showing 19 FDA medical officers had identified 27 new drugs that had been reviewed in the past three years despite the officers opposition. The FDA continued forward and approved the drugs regardless. For more information on drug recalls contact us to confer with a drug recall attorney.
Public Citizen filed suit against the U.S. Department of Health and Human Services
-February 6, 2003
The FDA proposed a rule in 1995 to require the distribution of scientifically accurate and useful written information with new and refill prescriptions. This drug information would include adverse effects and direction on how to best use that prescription, and the FDA set a goal that by 2000 75% of patients would receive patient information leaflets, eventually leading up to 95% by 2006. In 1996, Congress passed a law that would integrate this FDA proposed timetable and required the private sector to design and implement the new program.
Congress stated that the private sectors program failure to meet quality and quantity criteria by 2001 would allow the FDA to take public comment on alternative methods to provide patients would more accurate and useful drug prescription leaflets. In June 2002, the FDA did recognize the private sectors program failed to meet the intended goals, however the agency failed to discuss other methods to improve the prescription drug leaflets. The agencys failure to uphold the law was a violation according to the Public Citizen consumer group.
Public Citizen filed suit against the U.S. Department of Health and Human Services on February 6, 2003 for failing to allow the public to comment on new rules regarding patient information leaflets distributed with prescription drugs, which was stated back in 2001. The FDAs assessment of the private sectors program found that 89% of patients were receiving informational leaflets but they contained just half the information considered essential for patients to safely take the drugs. Not one of the drug leaflets met any of the seven outlined quality criteria as proposed.
According to Public Citizen, the FDA is failing to properly educate patients of potential drug dangers that are essential in reducing the number of unnecessary drug deaths and injuries. Its inexcusable for the FDA to stand in the way of that, according to Public Citizen Health Research Groups Director Sidney Wolfe. Read entire press release . . .
