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In their response, the AGs noted Pennsylvania Rules of Professional Conduct include a “safe harbor” provision allowing lawyers to make extrajudicial statements on various matters, including claims and defenses in litigation. Read More
The guidance also clarifies when applications will be dropped from the system due to nonpayment and includes a section on troubleshooting and staying up to date with guidance updates. Read More
In one of his first actions since assuming office on Monday, California Gov. Gavin Newsom signed an executive order requiring state officials to negotiate drug prices for the state’s Medicaid program. Read More
As the partial government shutdown neared the end of a third week, FDA Commissioner Scott Gottlieb announced via Twitter that the agency will re-allocate user fee money from drug reviews to cover post-market drug safety surveillance. Read More
The FDA unveiled a five-year strategy on Wednesday for its Sentinel post-market safety surveillance system, detailing major goals through the year 2023. Read More
One proposal would require HHS to impose a price ceiling on branded drugs of no more than their median price in Canada, France, Germany, Japan and the United Kingdom. Read More
“Despite the increased public pressure from politicians, we continue to see hundreds of prescription medication prices increase more than four times the inflation rate,” said Rx Savings Solutions CEO Michael Rea. Read More
For the pricing model to be viable, MedPAC says, the private vendors the program would pay for Part B drugs would need to negotiate substantial price discounts from drugmakers. Read More
FDA Commissioner Scott Gottlieb released a letter that tried to raise his staff’s morale, noting that “it’s in times of challenge and uncertainty that the public needs us most.” Read More
Eli Lilly said it supported giving consumers more information but claimed the CMS plan might “create more confusion than clarity for patients.” Read More
A group of opioid manufacturers and distributors filed for a gag order against Ohio Attorney General Mike DeWine and two other prominent attorneys in connection with multidistrict opioid litigation. Read More
CDER released its latest annual report on drug safety priorities on Tuesday, detailing how it approached drug safety in 2018 — including how it handled the valsartan impurity crisis. Read More