Rx Drugs

All 50 states and several pharmacy retail chains have suspended use of Johnson & Johnson’s COVID-19 vaccine after FDA and the Centers for Disease Control and Prevention on Tuesday (April 13) recommended a pause after revealing that six women who received the shot experienced a rare blood clotting event known as cerebral venous sinus thrombosis (CVST).

Brand drug makers are now open to ending some patent-gaming industry practices, including “product hopping” and possibly “patent thicketing,” and lowering Medicare reimbursement to doctors for administering drugs, according to a legislative agenda released by the Pharmaceutical Research and Manufacturers of America Tuesday (April 13).

Acting FDA chief Janet Woodcock announced Monday (April 12) that Patrizia Cavazzoni will succeed her as permanent director of the agency’s drug center, leading some to speculate that Woodcock either expects to be nominated for the permanent FDA chief position or is contemplating retirement and wants to secure long-term leadership of the drug center.

Researchers from academia and the federal government found a biochemical pathway they say might explain why COVID-19 is so difficult to treat, and they suggest that pairing antiviral drugs, such as remdesivir, with a Janus kinase inhibitor, such as ruxolitinib, might be more effective in treating the disease than monotherapy alone.

The Senate Finance Committee will hold confirmation hearings for CMS Administrator-nominee Chiquita Brooks-LaSure and Deputy HHS Secretary-nominee Andrea Palm on April 15, months after the Biden White House announced the appointments and as Democrats gear up for a potentially major health care overhaul.

The American Hospital Association and the American Society of Health-System Pharmacists want to meet with FDA to make their case that insurer “white bagging” policies, which prevent hospitals from buying outpatient drugs from the specialty pharmacies of their choice, threaten supply chain security and pose safety risks to patients.

The Medicare Payment Advisory Commission unanimously voted in favor of draft recommendations to cover all preventive vaccines under Part B for free to beneficiaries.

The White House is expected to roll out the health care priorities for its two-part infrastructure package sometime this Spring, and the health piece potentially could move separately now that the Senate parliamentarian has agreed Democrats have another shot passing their priorities through a simple majority.

The U.S. Office of Special Counsel, an independent federal investigative agency, told President Joe Biden and key congressional committees that a credible whistleblower complaint shows FDA watered down troubling inspection findings in at least four instances at biologics plants in recent years, including at a Merck plant that now produces Johnson & Johnson vaccines.