Rx Drugs

Continuing drug shortage issues are a result of economic and policy failures that span many years, FDA Commissioner Scott Gottlieb told a crowd of researchers, health care providers, industry representatives and other experts during the agency’s Tuesday (Nov. 27) drug shortages public meeting, held in coordination with the Duke Margolis Center for Health Policy.

FDA Commissioner Scott Gottlieb called low prices and CMS reimbursement for generic prescription drugs a “root cause” of drug shortages in a blog post he co-authored with the agency’s drug center chief, Janet Woodcock, last week.

As pharmacy and other health care stakeholders convened last week to discuss myriad issues surrounding illegal online sales of prescription drugs, one FDA official called for companies that manage and sell internet domain names to ramp up enforcement of their terms of use agreements and stop allowing violative website operators to continue leasing domains under different website names. This, the official said, would help fix the whack-a-mole issue on FDA’s side of enforcement.

FDA Commissioner Scott Gottlieb on Monday (Nov. 19) introduced a new risk-based framework for how the agency will regulate software products that are designed to be used in conjunction with prescription drugs, also known as prescription drug-use-related software.

FDA is proposing to try out a minimally invasive dog drug study that the agency hopes will encourage industry to pursue similar studies, or ones that do not involve live dogs at all.

Kaleo CEO Spencer Williamson offered to lower the $4,100 price of the opioid overdose reversal drug Evzio as long as insurers give patients greater access to it, during his appearance on CBS’ “60 Minutes” on Sunday.

Incoming Senate Finance Committee chairman Charles Grassley (R-IA) and Senate Democratic Whip Dick Durbin (D-IL) on Friday asked the Trump administration to put in place by year’s end its proposal to require drug manufacturers disclose list prices in direct-to-consumer advertising, and they also called on HHS and CMS to adopt additional drug-price disclosure measures.

Lead sponsors Sens. Charles Grassley (R-IA) and Patrick Leahy (D-VT) are divided on whether they would still back a bill to support generic drug development if a pro-pharma provision were added to reverse changes Congress made to Medicare Part D payments in the coverage gap.

Potential incoming Energy & Commerce health subcommittee chair Rep. Anna Eshoo (D-CA) wants to hold hearings before developing her prescription drug policy priorities, she told Inside Health Policy on Tuesday (Nov. 13).