Is the FDA losing credibility?

The FDA calls drug approval a “balancing act” between acceptable risks and benefits on its website. The FDA’s approval process may favor drug companies over consumers, and FDA approval does not guarantee safety. Big Pharma pays for the majority of drug safety reviews, provides the FDA with safety data for the review and has the option to have drugs approved faster with fewer clinical trials.

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 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.

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.

Congress and the executive branch exercise broad influence over the FDA, while the courts serve as a check on agency authority. Congress sets the agency’s budget and establishes the legal parameters for agency decisions. At the same time, the president has the power to appoint (with confirmation by the Senate) and remove the FDA commissioner. In addition, the secretary of the Department of Health and Human Services (HHS), also a presidential appointee, has the legal authority to override the FDA’s rulemaking4 and approval decisions. In contrast, the White House can block agency regulations and guidance.

Although these authorities have rarely been used, some critics worry that they leave the FDA too susceptible to political officials interfering with the agency’s scientific decision-making for partisan ends.

Are doctors the final approval wall between new drugs and patients? Research shows that patients overwhelmingly trust their doctors to do what’s right. Take the newly approved Alzheimer’s drugs. Will physicians prescribe it based on the “hope of caregivers,” or will they ask the drug companies for hard data? Will physicians broadly prescribe the new weight loss drugs or wait to understand the implications of long-term use?

Drug companies are facing a huge patent cliff in the coming years. It’s in their best interests to show postive outcomes for new drugs in development. Can we trust them for follow-up data and studies?