Rx Drugs

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).

FDA Commissioner Scott Gottlieb tried to assure a National Academies of Sciences, Engineering and Medicine (NASEM) committee that while the agency plans to develop and publish prescribing guidelines for acute pain, the agency does not intend to regulate the practice of medicine.

CMS Administrator Seema Verma said Wednesday (Nov. 14) the administration is committed to giving drug plans more leverage to negotiate lower prices for drugs in protected classes.

The American Medical Association recommends capturing outpatient charity care provided by hospitals and stand-alone physicians in determining 340B eligibility, and the doctors group agreed to discuss with specialists what 340B eligibility criteria to give policymakers, according to a preliminary readout of the group’s House of Delegates interim meeting this week.

A health care lawyer said a bill recently introduced in the Senate that would give FDA authority to require generic drug manufacturers update their labels would be greatly improved if it included liability protection for generics.