HealthCare Roundtable e-News – March 11, 2020

Funding Bill to Fight COVID-19 Outbreak Signed into Law, Does Not Give Govt. Power Over Drug Prices

Lawmakers reached a deal last Wednesday (Mar. 4) to provide $8.3 billion in funding to fight the coronavirus outbreak in the United States. The deal includes $3.1 billion for developing vaccines and drugs, plus $300 million to cover the cost of those drugs for those who can’t afford them, and was signed into law by the President on Friday.

The funding bill does not, however, give the government more power to control prices of COVID-19 drugs and vaccines. House Democrats initially intended to include a provision that would have given the government more authority to keep prices low on drugs developed in part with government money, but the language in the bill only reiterates the authority the government already has.

“The language in the bill that addresses reasonable pricing is an accurate statement of the current law and reflects the best practices that have been consistently used by ASPR and BARDA in every procurement they have conducted during the current Administration,” said John Clerici, managing principal of Tiber Creek Partner LLC and counsel at Blank Rome LLP.

Rep. Rosa DeLauro (D-Conn.), stated that the bill gives “authority for the Secretary of Health and Human Services to make the vaccines, therapeutics, and diagnostics developed from funding in this bill to be affordable in the commercial market.” In her statement, the Congresswoman urged Secretary Azar to make use of that provision.

Grassley Drums Up Support for Updated Drug Pricing Bill and Potential $80 Billion in Savings

Last week, Senate Finance Committee Chair Chuck Grassley (R-Iowa) addressed increasing prescription drug prices on the senate floor to draw support for his proposed drug pricing plan, which he and Sen. Ron Wyden (D-Ore.) say will save more than $80 billion. Grassley claimed that in addition to the $80 billion in savings, the updated plan would also reduce patient out-of-pocket spending in Part D by $50 billion and reduce premiums by $1 billion over ten years.

While the previous drug pricing plan was estimated to save closer to $105 billion, a Grassley spokesperson said the Congressional Budget Office lowered the score to account for the cost of a new provision to lower beneficiary co-insurance by 5%. (InsideHealthPolicy)

On the Senate floor, Grassley claimed that the bill, “would protect taxpayers from being put on the hook for unlimited price hikes that have no basis in a functioning free market.” Grassley and Wyden are planning to unveil the updated plan shortly, and are hopeful that the new plan will draw more support from members of the GOP. Most Republicans have opposed policies on making drug companies pay back the government when they raise prices faster than inflation, but several have said that they would support the bill if Grassley were to remove inflationary rebates. Senate Democrats, however, said they would withdraw support for the bill without the measure on rebates. (InsideHealthPolicy)

FDA Issues Final Guidance on Path for Authorized Biologics

The FDA published a final guidance last Thursday (Mar. 5) opening up a path for authorized biologics, one of several published by the FDA in recent weeks to facilitate the March 23 transition, by which certain products previously approved as drugs will be licensed as biologics. The final guidance named the ‘Deemed To Be a License’ provision of the Biologics Price Competition and Innovation Act, requires that a marketing application for a “biological product” must be submitted as a biologics license application (BLA) under section 351 of the Public Health Service Act (PHS Act).

Any person (including an application holder for a biological product that is the subject of a ‘deemed’ 351(a) BLA) may seek to establish the biosimilarity or interchangeability under section 351(k) of the PHS Act of a proposed biosimilar or interchangeable product to another biological product licensed or deemed licensed under section 351(a) of the PHS Act,” the final guidance says.

Commenting on the final guidance, one biologic product expert explained that nothing about the wording change would prevent an authorized biologic from coming to market similar to how an authorized generic would; however, the authorized biologic still wouldn’t be able to be substituted at the pharmacy because interchangeability designation only applies to biosimilars. More information on interpreting the “Deemed to be a License” provision can be found here. (InsideHealthPolicy)

GOP Seeks Democratic Support for ACA Fix Protecting Pre-existing Conditions Ahead ofTexas Lawsuit

House Republicans called out Democrats last week for refusing to move a legislative fix that would preserve a provision of the Affordable Care Act protecting pre-existing conditions. Conversations on pre-existing conditions have developed in recent weeks since the Supreme Court agreed to take up Texas vs. United States, a case to review whether the ACA’s individual mandate is unconstitutional.

Rep. David Joyce (R-Ohio), who first introduced the bill in 2018 and reintroduced it last year, stated, “deliberate, bipartisan steps must be taken to protect coverage for this vulnerable population as the Affordable Care Act’s litigation inches closer to a conclusion,” Joyce wrote in the letter. “I stand ready to work with you and my colleagues across the aisle to advance my legislation, which would do just that.” (InsideHealthPolicy)

Members of the GOP have been reluctant to answer questions in recent months over their support for the lawsuit. President Trump has expressed his support for the lawsuit, despite the popularity of Obamacare in recent polls reaching record highs.