Rx Drugs

Senate Finance Committee Chair Chuck Grassley said Senate Majority Leader Mitch McConnell (R-KY) told fellow Republicans to withhold support for the Finance drug pricing bill, but the Iowa Republican hopes to build support by negotiating with the House and urging the president to add his personal touch to the White House’s backing of S. 2543.

The Trump administration on Wednesday moved forward on its plan to let states and drug makers import lower-cost prescription drugs from other countries.

Stephen Hahn, shortly after being sworn in as FDA commissioner on Tuesday (Dec. 17), emailed FDA staff that he’s optimistic about continuing to advance FDA’s talent, expertise and infrastructure, and said he will adhere to sound data and uphold the law.

FDA unveiled a draft proposal for a new qualification process for drug development tools, including biomarkers, clinical outcome assessments, and other methods or materials used to aid in drug development and regulatory review.

Congress included the pro-generic CREATES Act to help pay for five months of so-called Medicare and Medicaid “extenders” in the one-year government funding bill, plus a few minor biologics policies.

An FDA analysis shows the average manufacturer price (AMP) for generic drugs can be up to 54% lower than the brand drug price before competition when there are at least two generic competitors on the market.

The House rejected a GOP drug pricing proposal that, among its slew of bipartisan provisions, calls for reforming FDA’s over-the-counter drug monograph regulatory framework and establishing a user fee program for OTC drugs.

Federal lawmakers from California grilled the American Kidney Fund over its decision to stop providing premium assistance to about 3,700 patients with end-stage renal disease, but AKF says it made it clear the charity could not operate under a recently enacted California bill and believes the state is looking for someone to blame now that about 3,700 patients will lose premium assistance.

The House Rules Committee on Tuesday (Dec. 10) cleared House Speaker Nancy Pelosi’s drug pricing bill (H.R. 3) for a floor vote after Pelosi reached a deal with progressives to increase the minimum number of drugs subject to negotiation each year to 50 and to restore Rep. Pramila Jayapal’s (D-WA) amendment to extend price-spike protections to private plans.