Congress

The Trump administration is expected to keep drug pricing on center stage in 2019 following a flurry of action last year. In 2018, the administration released a 44-page blueprint with ideas and questions on potential ways to lower drug prices and reduce out-of-pocket costs, and HHS, FDA and CMS proposed a torrent of regulations and notices.

As the government shutdown continues into its second week and Congress works to reach a spending deal, it is still unclear what will happen to a legislative package that would reform FDA’s over-the-counter (OTC) drug oversight and reauthorize a number of hazard preparedness programs at HHS.

The judge overseeing a challenge to CMS’ approval of Medicaid work requirements in Arkansas agreed to give the federal government more time to respond to the challengers’ legal arguments due to the partial government shutdown.

CMS is automating the system that determines whether drugs are properly classified in the Medicaid Drug Rebate Program as Congress gets closer to giving CMS the power to force drug reclassifications to recoup Medicaid rebates, according to a letter CMS sent earlier this year to Sen. Chuck Grassley (R-IA), who wrote the Medicaid-rebate bill.

Civica Rx, the non-for-profit generic drug maker founded by hospitals, supports Sen. Elizabeth Warren’s bill to let the government make generic drugs, and Civica Rx President and CEO Martin Van Trieste said a government generic drug maker would complement the work Civica is doing to stop drug shortages and price spikes.

A bill that would have expanded the government’s definition of “natural cheese” to include additives and artificial ingredients, as well as exclude certain pasteurized process cheeses and plant-based cheeses from the definition, failed in the House on Thursday (Dec. 20) a few hours after Rep. Frank Pallone (D-NJ) called on fellow members to oppose the bill, which he said crossed into FDA's jurisdiction.

With one day left in the 115th session of Congress, the House on Thursday (Dec. 20) passed a legislative package that combines the pandemic preparedness bill with legislation that would reform the way FDA regulates over-the-counter drugs.

Legislation to recoup unpaid Medicaid drug rebates has run into trouble in the Senate, even though observers had been optimistic just days ago that the upper chamber would pass the measure.

Odds are decent that the Senate will vote this year on a House package of Medicare and Medicaid bills that includes a measure aimed at stopping drug companies from gaming the Medicaid rebate system, but sources say first the upper chamber must deal with concerns from a couple of fiscal conservative GOP senators over a separate provision that would increase federal Medicaid funding to help states establish health homes for kids with complex needs.