Rx Drugs

The White House on Tuesday welcomed House Speaker Nancy Pelosi’s ideas on drug pricing, hiking President Donald Trump’s pressure on Senate Republicans and the drug industry to back a less aggressive, but strongly pharma-opposed, drug-pricing bill passed by the Senate Finance Committee.

A draft of House Speaker Nancy Pelosi’s Medicare price negotiation bill circulating among lobbyists calls for using international prices as an upper limit for what Americans pay for drugs and imposing harsh penalties to keep drug makers at the negotiating table, instead of relying on a third-party arbitrator as a backstop to negotiation.

After health organizations and former FDA heads, including former FDA chief Scott Gottlieb, urged the White House to tap Acting FDA Commissioner Ned Sharpless as the permanent FDA chief, another contender for the role appeared: Stephen Hahn, chief medical executive of MD Anderson’s Cancer Center.

Acting FDA Commissioner Ned Sharpless defended the agency’s expedited approval policies, saying the agency can speed up approvals while also preserving the standards of safety and efficacy.

FDA denies allegations in an ongoing lawsuit with drug pricing undertones that two drugs approved to treat Lambert-Eaton myasthenic syndrome (LEMS), Firdapse and Ruzurgi, are the same even though they are indicated for different populations.

The senior director of health programs at The Pew Charitable Trusts doesn’t expect a dramatic upheaval at FDA’s Office of Antimicrobial Products after its longtime director, Ed Cox, departed on Sunday (Aug. 25) to become vice president of regulatory affairs at drug maker Regeneron.

Surgeon General Jerome Adams issued an advisory on Thursday (Aug. 29) warning about the dangers of marijuana use to adolescents and pregnant women, and urging more research and awareness on the long-term effects of marijuana use across different user populations.

Patients who were exposed to contaminated blood pressure drugs are at a much lower risk of cancer over their lifetime than FDA originally estimated, agency drug center director Janet Woodcock said Wednesday (Aug. 28).

The government is putting up new barriers to drug copay coupons, and pharmacy benefit managers say the new rules will help control drug spending.