FDA controversy countdown - Dr Nicola Davies examines the FDA's most controversial drugs

Controversy and the US Food and Drug Administration (FDA) – the two are certainly not strangers. When it comes to the FDA, controversy, criticism, and speculation are never far behind, says Dr Davies in her monthly FDA blog for The Pharma Letter.

This is hardly surprising considering the FDA is the world’s biggest healthcare watchdog. In 2017, the FDA achieved a record high of 1,027 new drug approvals, a milestone the agency expects to exceed in 2018.1 With so many drug approvals, it is perhaps inevitable that some may become the subject of controversy. Further compounding the scope for controversy is the approval process the Administration must follow, which compels the agency to make “all-or-nothing decisions based on limited evidence.”2

Research suggests that less than half of all randomized controlled trials (RCTs) that supported the FDA’s approval of anticancer drugs go on to achieve the threshold of clinical benefit. 3 In other words, only 50% of approved anticancer drugs have medical benefits. A study by Charles Seife from New York University found that out of 57 FDA clinical trials: 22 had false information; 42 had protocol violations; 35 were affected by inaccurate recordkeeping; 30 failed to protect patient safety; and, 20 had unspecified violations.4 Approximately one-third of all drugs declared safe by the FDA go on to exhibit major safety problems later.4