Consumers Union Documents
- Consumers Union Letter to FDA Commissioner on Avandia drug safety
In light of the credible estimates of possible continuing harm to patients caused by Avandia (diabetes medication) and the fact that there are readily available alternative treatments, Consumers Union recommends that the FDA make a decision by May on whether the drug’s sales and use should continue in the U.S.
- On the road with the Safe Patient Project
Our mission: ask a large gathering of orthopedic surgeons how long hip and knee implants should be warrantied.
- Consumer Reports: Warranties for Artificial Hips and Knees Needed
This week, Consumer Reports released a TV story that discussed the lack of warranties for artificial hips and knees, and Consumer Reports’ nationwide hospital ratings for hip and knee replacement surgery (available to subscribers of ConsumerReports.org).
- On our radar: Maine dialysis centers may be bought by dialysis corporate giant—what’s at stake for patients?
Three dialysis clinics run by the nonprofit hospital Eastern Maine Medical Center (EMMC) may soon be purchased by one of the country’s largest for-profit dialysis companies, Total Renal Care, Inc., a subsidiary of Colorado-based DaVita, Inc. The deal is expected to close early this summer after a state review process.
- Real People, Real Medical Device Stories
A simple hernia repair results in a lifetime of despair “The mesh that was put inside of me has caused so much damage that none of the nerves can ever be repaired. Now I face a lifetime of pain and struggle because of it.” – Jim Shull, Browns Mills, NJ When Jim Shull had Continue Reading
- GAO report: FDA Has Begun Efforts to Enhance Postmarket Safety, but Additional Actions Are Needed
This report examines the steps that FDA is taking to (1) enhance its processes for making decisions about the safety of marketed drugs, (2) improve access to data that help the agency identify drug safety issues, and (3) build its capacity to fulfill its postmarket drug safety workload. GAO reviewed FDA policies and planning documents, and interviewed FDA officials.
Research and Reports
- Drug Safety: FDA Has Conducted More Foreign Inspections and Begun to Improve Its Information on Foreign Establishments, but More Progress Is Needed
The GAO has written a report on the FDA’s progress on foreign drug inspections since 2008. In 2008, the GAO found that FDA had inspected relatively few foreign establishments and had inaccurate information in its databases from 2002 through 2007.
- Drug shortages: National survey reveals high level of frustration, low level of safety
ISMP survey: More than 1,000 near misses, errors, and adverse outcomes due to drug shortages in the US.