On The Hill

The Coronavirus continues to dominate the headlines nationally and on Capitol Hill as HHS Secretary Alex Azar faced many questions about the administration’s plan of action, including its $2.5 billion supplemental budget request. Azar’s appearance before four congressional committees this week on HHS’ FY 2021 budget also brought up issues such as drug pricing, insulin costs, kidney care, and attempts at repealing the Affordable Care Act.

 

Sen. Josh Hawley (R-MO) announced he was drafting legislation to secure the United States medical product supply chain after reports of potential American drug shortages due to the Coronavirus outbreak in China.

 

Also, Sen. Martha McSally (R-AZ) announced she was introducing her own drug pricing legislation, adding to the number of bills seeking approval from both chambers and President Trump.

 

 

 

The administration sent a supplemental budget request to Congress earlier this week for $2.5 billion to combat the coronavirus.

 

The package proposes reprogramming existing unspent funds within HHS, including hundreds of millions of dollars in fiscal 2020 cash to fight Ebola. In total, the administration is seeking just $1.25 billion in new funding, relying on extra flexibility to unlock the rest.

 

More than $1 billion would go toward vaccine development, and the other funds would go toward stockpiling protective equipment like masks, according to the Office of Management and Budget. While the money is meant to be spent in 2020, the request contains language that would allow the spending to continue through 2021 if needed. ^[1]

 

Senate Minority Leader Chuck Schumer (D-NY) was openly furious about the lack of funding that the administration requested, claiming they have no plan to deal with the virus. Schumer unveiled his own funding request, asking for $8.5 billion. ^[2]

 

A link to the administration’s full supplemental request can be found here.

 

 

 

The House Ways & Means Committee’s hearing with HHS Secretary Alex Azar on the 2021 HHS budget covered a wide variety of subject areas ranging from the US response to the coronavirus outbreak, prescription drug prices and the costs of insulin, to the administration’s efforts on kidney care.

 

Committee Democrats led by Chairman Richard Neal (D-MA) expressed their concern with the administration’s response to the virus and to what they believe is an ill-prepared and underfunded response to something that could become a major breakout. Numerous Democrats grilled Azar on drug price negotiations and questioned why the administration wouldn’t support H.R. 3, when it includes a provision allowing the HHS Secretary to negotiate prices. Azar stated the administration’s concerns with the bill, namely that it would stall innovation. Committee Republicans, including Reps. David Schweikert (R-AZ) and Devin Nunes (R-CA) pointed to H.R. 19, the H.R. 3 alternative, in which Azar noted that the administration agrees with many aspects of the bill, including Part D reforms.

 

Reps. Tom Reed (R-NY) and Mike Kelly (R-PA) both addressed the issue of insulin pricing, and whether or not there would be any generic substitutes in the near future. Azar pointed to the administration’s biosimilar pathway that he said would do exactly what they were both looking for in a speedier way for addressing the high costs.

 

An executive summary of this hearing can be found here.

 

 

 

Prescription drug prices and the preparation for the coronavirus also headlined the House Energy & Commerce Health Subcommittee’s hearing with HHS Secretary Alex Azar on HHS’s FY 2021 budget. Nearly every committee member from both sides of the aisle addressed the concerns surrounding the coronavirus and whether or not HHS is adequately funded to combat the epidemic.

 

Chairwoman Anna Eshoo (D-CA) and Rep. Eliot Engel (D-NY) mentioned that the President has said on numerous occasions that he wants to negotiate prescription drug prices and questioned why the administration doesn’t support H.R. 3 in that case. Azar made it clear that the administration does not support the bill because they believe the negotiation framework in there is not practical or implementable. Azar pointed to the bipartisan Grassley-Wyden bill as more likely to pass through both chambers and getting signed into law.

 

Ranking Member Greg Walden (R-OR) and Rep. John Shimkus (R-IL) pointed to H.R. 19, the alternative to H.R. 3, as Azar mentioned that the administration would likely support many aspects of that bill. Azar also noted the administration’s support of out of pocket caps and reducing costs for seniors.

 

An executive summary of this hearing can be found here.

 

 

 

Members of the House Appropriations Committee largely turned their focus on the administration’s $2.5 billion emergency funding request to help address the coronavirus. Members from both sides of the aisle criticized the request and stated that it is not nearly enough funding to address this potentially monumental outbreak. Chairwoman Rosa DeLauro (D-CT) was particularly blunt in her opposition to the proposal, while Ranking Member Tom Cole (R-OK) mentioned that they need to not be “penny-wise” and that they need to come up with something else for a plan of action. HHS Secretary Alex Azar made it clear that he would come back to Congress with a request for more funds, if the $2.5 billion ends up not being sufficient.

 

Outside of talk surrounding the coronavirus, Reps. Kay Granger (R-TX), Jamie Herrera Beutler (R-WA), and Mark Pocan (D-WI) all asked questions surrounding the large percentage of pharmaceutical drugs and critical ingredients that are being manufactured in China. Azar noted that they have been actively and aggressively addressing these concerns, and that to date, they are not aware of any shortages.

 

An executive summary of this hearing can be found here.

 

 

 

Both Republican and Democratic Senators on the Senate Appropriations Committee hammered HHS Secretary Alex Azar over the administration’s response to the coronavirus outbreak.

 

Senate Appropriations Chairman Richard Shelby (R-AL) accused the administration of lowballing the funding, which he said could cause significant issues down the road. Ranking Member Patty Murray (D-WA) and Sen. Brian Schatz (D-HI) grilled Azar on the lack of transparency surrounding where the amounts of funding were going and why the administration was making cuts to the programs needed to help address the epidemic. Azar emphasized that the funding request, particularly the more than $1 billion that would be drawn from other health programs, was an “option,” suggesting that the administration isn’t drawing a hard line. Azar also claimed that President Trump has taken the most aggressive containment measures in history.

 

Most Senators focused their questioning around the coronavirus, with the exception of Sen. Tammy Baldwin (D-WI) and Sen. Marco Rubio (R-FL) quickly addressing prescription drug prices and the amount of pharmaceutical ingredients coming in from China. Sen. Lamar Alexander (R-TN) also touched briefly on his surprise billing legislation and asked that the Secretary continue to keep the issue atop his priorities.

 

An executive summary of this hearing can be found here.

 

 

 

Hawley Releases Supply Chain Legislation

 

Senator Josh Hawley (R-MO) is introducing legislation to help secure the United States medical product supply chain. The Medical Supply Chain Security Act comes after reports of potential American drug shortages due to the Coronavirus outbreak in China.

 

The Medical Supply Chain Security Act will:

 

●    Require that manufacturers report imminent or forecasted shortages of life-saving or life-sustaining medical devices to the FDA just as they currently do for pharmaceutical drugs. This new information on devices would be added to the FDA’s annual report to Congress on drug shortages.

 

●    Allow the FDA to expedite the review of essential medical devices that require pre-market approval in the event of an expected shortage reported by a manufacturer.

 

●    Give new authority to the FDA to request information from manufacturers of essential drugs or devices regarding all aspects of their manufacturing capacity, including sourcing of component parts, sourcing of active pharmaceutical ingredients, use of any scarce raw materials, and any other details the FDA deems relevant to assess the security of the U.S. medical product supply chain.

 

A detailed summary of the bill can be found here.

 

 

 

Senator Martha McSally (R-AZ) announced that she will introduce legislation to lower the cost of prescription drugs for Arizonans. Her bill aims to significantly lower patients’ out-of-pocket expenses by promoting a more competitive and transparent marketplace for prescription drugs.

 

Sen. McSally’s bill contains four key provisions:

 

●    Allow Medicare to directly negotiate prices of drugs that are past their original patent expiration but still maintain a monopoly for that drug.

 

●    Permit the safe re-importation of prescription drugs from Canada that meet FDA safety standards.

 

●    Curb the ability of drug companies to abuse the patent system to delay competition and prevent cheaper alternatives from entering the market.

 

●    Cap the out-of-pocket costs for prescription drugs for seniors on Medicare at $3,100 each year. ^[3]

 

 

 

A bill to ban all tobacco flavors and tax e-cigarettes passed the House on Friday (Feb. 28) on a 213-to-195 vote after Democratic leaders scrambled to secure support within their caucus.

 

The legislation, H.R. 2339, squeaked by with 17 Democrats voting against it.

 

 

 

^[1] Cook, Nancy. “Trump sending coronavirus budget request to Congress.” Politico. 24 Feb. 2020. https://www.politico.com/news/2020/02/24/trump-coronavirus-budget-request-117275

 

^[2] Carney, Jordain. “Schumer requesting $8.5 billion in emergency funding on coronavirus.” The Hill. 26 Feb. 2020. https://thehill.com/homenews/senate/484679-schumer-requesting-85-billion-in-emergency-funding-on-coronavirus

 

^[3] “McSally Unveils Legislation to Lower the Cost of Prescription Drugs.” McSally.senate.gov. 21 Feb 2020. https://www.mcsally.senate.gov/mcsally-unveils-legislation-lower-cost-prescription-drugs