All articles tagged with #drug regulation
A STAT opinion piece assesses Vinay Prasad's tumultuous FDA tenure, noting his push for clearer, stronger data in rare-disease approvals but arguing his impulsive, confrontational approach caused chaos and eroded the agency's credibility; his upcoming departure leaves a controversial legacy about balancing rigorous evidence with regulatory pragmatism.
Former FDA regulator Richard Pazdur, who recently left the agency, says political interference and a new voucher program for accelerated drug reviews have breached the firewall between politics and reviewers, with opaque meetings and limited staff access raising concerns about transparency and independence in drug approvals.
Richard Pazdur, the top FDA drug regulator, plans to retire just weeks after starting the job, amid concerns over the agency's legal and procedural approaches to drug approvals, contributing to recent instability at the FDA.
Richard Pazdur, the top drug regulator at the FDA, resigned just three weeks after taking the role amid disagreements over agency overhaul plans and concerns about transparency and legality, highlighting ongoing turmoil within the agency.
The FDA's top drug regulator, Dr. Pazdur, has submitted his resignation after 26 years, raising concerns about leadership stability and the future of drug regulation, amid ongoing debates over the agency's programs and political influence.
Richard Pazdur, the top drug regulator at the FDA, has announced his retirement at the end of the month, adding to concerns about leadership instability at the agency amid recent turnover.
The FDA has appointed oncology expert Richard Pazdur as the new head of the Center for Drug Evaluation and Research, succeeding George Tidmarsh amid a period of leadership turmoil.
The FDA is facing challenges in appointing a new head of its drug center following the abrupt departure of George Tidmarsh, with potential candidates like Richard Pazdur and Mary Thanh Hai declining the role, prompting the agency to open the position to internal staff.
The FDA has appointed biotech veteran George Tidmarsh as the head of its drug regulation division amid ongoing regulatory upheaval under HHS Secretary Robert F. Kennedy Jr., with concerns over vaccine skepticism and drug approval processes.
The FDA has appointed biotech veteran George Tidmarsh as the director of its Center for Drug Evaluation and Research, bringing extensive experience in drug development, oncology, and pediatrics to the role.
The FDA is set to appoint former biotech executive George Tidmarsh as the new director of the Center for Drug Evaluation and Research, where he will oversee drug approvals and regulation amidst ongoing debates over accelerated approvals and advertising practices, bringing his industry experience to address controversial issues like opioid marketing and drug safety.
The FDA has issued a warning about tianeptine, a substance sold as a dietary supplement but known as 'gas station heroin' due to its opioid-like effects and potential for overdose and dependence, despite not being approved in the US. It is often sold online and in shops, with reports of addiction, withdrawal, and overdose cases, raising concerns about its unregulated use and detection challenges.
The FDA has proposed removing oral phenylephrine from cold, cough, and allergy medications, as it is ineffective as a decongestant. This decision follows a unanimous advisory committee conclusion and years of scientific evidence showing phenylephrine's ineffectiveness compared to a placebo. The proposal, open for public comment, could significantly impact the $1.76 billion market of over-the-counter decongestants, affecting popular brands like Sudafed and Tylenol. The ruling does not apply to nasal sprays or eye drops, where phenylephrine is more effective.
The FDA plans to remove oral phenylephrine, a common ingredient in over-the-counter cold medicines, from the market due to its ineffectiveness as a nasal decongestant. This decision follows a review of data showing minimal absorption of the drug when ingested, rendering it no more effective than a placebo. The public can comment on the proposal until May 7, 2025, after which manufacturers may need to reformulate or withdraw affected products. The Consumer Healthcare Products Association opposes the move, arguing for consumer choice.
The Supreme Court is hearing a case brought by anti-abortion doctors challenging the FDA's regulatory actions on abortion pills, with potential implications for the entire drug approval process. The case questions the FDA's scientific expertise and the loosening of restrictions on mifepristone, the drug at the center of the case. Siding with the FDA are major medical associations and pharmaceutical companies, while the challengers argue that the FDA's changes are unjustified and unsafe. The case also involves a procedural hurdle regarding legal standing, and a decision is expected by summer.