FDA appoints industry veteran as Chief Drug Regulatory Officer, approval speed, advertising oversight may face a turning point.

According to an insider, the director of the Food and Drug Administration (FDA), Matt Machari, has chosen former biotechnology executive George Tidmarsh to serve as the agency's chief drug regulator. The insider stated that Tidmarsh, who also works as a pediatrician at Stanford University, may be appointed as the director of the Center for Drug Evaluation and Research (CDER) as soon as Monday Eastern Time. At CDER, the 65-year-old Tidmarsh will oversee one of the largest and most important departments at the FDA. The department has around 5700 employees and is responsible for reviewing the majority of new drug applications. The current acting director of CDER, Jacqueline Corrigan-Curry, recently announced her resignation. As a veteran in the field of biotechnology, Tidmarsh has been involved in the development of multiple approved drugs. His appointment may provide some reassurance to the pharmaceutical industry, which is facing pressure to reduce prices and bring manufacturing back under the Trump administration. One of the controversial issues Tidmarsh will face is the expedited approval system, which has become more common in recent years but has been criticized for allowing unproven drugs to remain on the market for extended periods. However, supporters argue that this process allows critically ill patients to access drugs more quickly. Additionally, Tidmarsh will play a key role in reassessing the FDA's regulatory approach to prescription drug advertising. Health Minister Robert F. Kennedy Jr. has long been critical of direct-to-consumer drug advertising, and Machari has already indicated that the FDA is reevaluating its regulatory methods. Last year, at a forum at Stanford University on the review system and scientific discourse, Tidmarsh questioned the inconsistency of the FDA in drug regulation. He pointed out the FDA's long-standing restrictions on drug companies' promotion of "off-label" uses, yet allowed vaccine manufacturers to advertise to consumers during the pandemic without following standard disclosure requirements, illustrating a stark contrast. He said, "This difference suggests that the FDA's regulation of free speech may be arbitrary and inconsistent." While the FDA's vaccine division has been in the spotlight recently due to the COVID-19 vaccines, decisions made by the drug division have sparked greater controversy. CDER has approved marketing strategies for opioid drugs like OxyContin for chronic pain, despite lacking sufficient evidence to support the long-term efficacy of such drugs. This decision has to some extent paved the way for the abuse of opioid drugs. In a recent podcast, Tidmarsh mentioned that he met Machari at a meeting at Stanford University last fall. The meeting brought together many individuals critical of restrictive measures and mandates during the pandemic, many of whom now hold key positions in government health departments. Tidmarsh appears to share Machari's criticism of the scientific community's "groupthink." In a podcast about a year ago, he mentioned the culture in academia that suppresses dissenting opinions and how research funding is increasingly concentrated in the hands of a few. Last year, Tidmarsh wrote on LinkedIn, "Academic science is rife with fraud, it's time to root out this corruption." He supported the "Resident Detective" project, which supports investigative reporters from the website "Retraction Watch" tracking retractions in academic journals due to scientific fraud. Tidmarsh earned medical and doctoral degrees in cancer biology from Stanford University, where he also held a clinical position. He has also worked for several biotechnology companies, including CEO of La Jolla Pharmaceutical Co., which developed a drug to treat sepsis and is now acquired by Innoviva. As a trained pediatric oncologist, Tidmarsh has been working for years to address the issue of shortages of traditional life-saving cancer drugs. In an interview with a medical journal last year, he likened the American generic drug market to the "Wild West," stating that predatory contracting practices could potentially squeeze out manufacturers.