Specialists Losing Trust in FDA Following Alleged Unbiasedness in New Drug Approval Process
According to a survey conducted by independent market research firm Spherix Global Insights, over 40% of surveyed physicians reported plummeting confidence in the FDA. The dissatisfaction appears to be most related to the agency’s perceived inability to remain apolitical and the level of transparency with medical professionals regarding new patient drugs.
The agency’s decision to approve Aduhelm (Aducanumab), accused of lacking substantive clinical trial data, is an example of decisions being made with total disregard for the Advisory Committee’s overwhelming recommendations against doing so, resulting in would-be prescribing physicians refusing to administer the drugs to patients.
Over 70% of the surveyed specialists felt the FDA standards for Advisory Committee input required updating and re-establishing. 40% felt that in addition to such, the FDA should be bound by any recommendations made by the Committee, for the safety of patients.
While some specialists were disappointed by hasty releases onto the market, others pointed to extensive wait times as the root of their frustrations with the FDA. The seemingly never-ending inspection of drugs is especially troubling for the medical community considering the hundreds of clinical trials required to pass before being submitted to the FDA for final analysis.
For many, these unnecessary delays and denials solidify sentiments that the administration does not prioritize patient health and well-being, choosing instead to fulfill underlying agendas.
Concerns regarding unbiasedness are not novel or unique to the medical community. The American public’s trust in health leaders and organizations has decreased significantly in recent years with many voicing fears that drugs and vaccines are cleared for release for political and fiscal gain. A Kaiser Family Foundation poll reports only 42% of doctors still trust the FDA to act with the best interest of patients in mind, echoing the nation’s fears.
In July of this year Janet Woodcock, FDA Acting Commissioner, requested an independent investigation into the relationship between the FDA and Aduhelm manufacturer Biogen. Woodcock’s request is unsurprising considering past studies have shown that the new approval process that allowed Aduhelm and other medications like it to hit the market are more likely to require annual safety-label changes or more serious black-box warnings.