Cancer Scientist Richard Pazdur Picked As FDA’s Top Drug Regulator
Pazdur will head the FDA's Center for Drug Evaluation and Research, replacing George Tidmarsh. Other pharma news is on telehealth prescriptions for certain controlled substances, health information privacy related to wearable devices and mobile health apps, and more.
The Washington Post:
FDA Taps Oncology Expert Pazdur As Nation’s Top Drug Regulator
The Trump administration has named Richard Pazdur, a longtime oncology expert at the Food and Drug Administration, as the nation’s top drug regulator. Pazdur will lead the agency’s Center for Drug Evaluation and Research, which regulates over-the-counter medicines and most prescription drugs. He replaces George Tidmarsh, who federal officials say resigned over a week ago after being placed on leave over allegations that he misused his authority, in a tumultuous period for the FDA. (Diamond and Roubein, 11/11)
In other pharma and tech developments —
AP:
Trump Pardons Pharmacist Who Pleaded Guilty To Health Care Fraud
President Donald Trump has pardoned Tennessee Republican Rep. Diana Harshbarger’s husband, who pleaded guilty more than a decade ago to health care fraud and other crimes and served time in federal prison. Robert Harshbarger Jr. was a licensed pharmacist in 2013 when he admitted substituting a cheaper drug imported from China that was not approved by the U.S. Food and Drug Administration for the iron sucrose that the FDA had approved for kidney dialysis patients to use. He was sentenced to and served four years in prison. Trump signed the pardon document on Friday. (Superville, 11/11)
Stat:
Telehealth Prescribing Of Ritalin, Addiction Medications OK'd Again
The Trump administration appears poised to extend a temporary, Covid-era rule allowing health providers to prescribe certain controlled substances, like ADHD medications and treatments for opioid addiction, via telemedicine. (Facher, 11/11)
Politico:
Wearables Could See HIPAA-Style Regulation
Despite voicing some uncertainty about Robert F. Kennedy Jr., Sen. Bill Cassidy (R-La.) wants to regulate one of the Health secretary’s favored components of his Make America Healthy Again agenda to combat chronic disease: wearable health devices. What’s new: Cassidy, chair of the Senate Health, Education, Labor and Pensions Committee, wants to safeguard health data collected by wearables and health apps, which he says are “helpful tools, but present new privacy concerns that didn’t exist when it was just a patient and a doctor in an exam room.” (Brensel and Schumaker, 11/11)
The Wall Street Journal:
Obesity Drugs Are About To Go Mass-Market
Companies don’t generally cut prices out of generosity. For most of Big Pharma, drug discounts have largely been about damage control. After months of tariff threats and talk of tougher pricing rules that weighed on their shares, several chief executives have made their way to the White House to announce drug-pricing deals in exchange for regulatory relief. (Wainer, 11/11)
The Washington Post:
Inside The CIA’s Secret Mission To Sabotage Afghanistan’s Opium
In a decade-long covert operation, the U.S. spy agency dropped modified poppy seeds in an attempt to degrade the potency of Afghanistan’s billion-dollar opium crop. (Strobel, 11/12)
