As many people, including myself have previously?reported, the Food and Drug Administration’s drug approval policies?need to be changed.? The institute of Medicine, which is a panel of?15 experts from academic and professional organizations, published a scathing report .? The analysis by the 15 member panel was unanimous in it’s criticisms and recomendations .
Many of these recommendations have long been resisted by the?pharmaceutical industry, Congress, and believe it or not, the FDA.? Many of the recommendations by the panel cannot be instituted by the FDA itself, but would require congressional approval.?
- The FDA commissioner would be appointed to a six year term.
- Drug manufacturers should be mandated to publish all clinical trials in a government run database.? Patients and physicians should be ale to see all outcomes positive and negative.
- Upon a drugs approval for human use there should be a moratorium on advertising until the drug has been on the market long enough to illuminate unrecognized side effects.? Packaging for new drugs should also contain a symbol alerting patients that the drugs safety is not fully known.
- The FDA should reevaluate the safety and effectiveness data of new drugs within 5 years of their initial release.
These recommendations seem pretty logical to me.? Will they be implemented? Who knows? Just remember who has resisted these changes in the past.
Sen. Charles E. Grassley (R-Iowa), who has led a number of investigations into the workings of the FDA in recent years, said the agency’s reaction to a report it had commissioned speaks volumes.
“The FDA appears to be focused on damage control rather than addressing its core problems,” Grassley said in a statement. “As a science-based agency, the FDA is remarkable for its lack of introspection, second-guessing, and failure to assess its own performance and capabilities in a systematic way.”
