The FDA’s recently criticized review and approval process is under investigation by the Government Accountability Office. The GAO is investigating reports that the review process allowed 2 blockbuster drugs through without sufficient proof of their effectiveness or lack of harmful side effects.
Sen. Charles Grassley, an Iowa Republican, requested the investigation after studies have shown that the drugs allowed through did not reduce the chance of heart attack and artery-clogging plaque or help to control blood sugar any better than other drugs.
The issue now being considered concerning the review process is whether the FDA’s approval process should take into account increased survival or just biological measures as it currently does.
The two drugs let through were Avandia and Vytorin.
If you have taken Avandia and were diagnosed with primary pulmonary hypertension, contact the PPH lawsuit attorneys of Williams Kherkher at 1-866-950-9000 to discuss your case and to determine any legal options.
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