Hearings

House Committee on Energy and Commerce: “The Fiscal Year 2020 HHS Budget”
Tuesday, March 12, 2019: The Health Subcommittee held a hearing with Health and Human Services Secretary (HHS) Alex Azar on President Trump’s budget request related to the U.S. Department of Health and Human Services (HHS) and its agencies for fiscal year (FY) 2020. Find a link to witness testimonies, member statements and the hearing live feed here.

Why this is important: Secretary of HHS, Alex Azar, answered questions from members on health-related proposals from the president’s FY2020 budget for approximately five hours, with one recess. General themes included Democrats concerned about children separated from their families at the border, pre-existing condition protections (Texas ACA case ruling), drug pricing concerns, the opioid epidemic and the lack of transparency by HHS and the administration as a whole. Any mention of Medicare-for-All was noted as “socialist medicine” by members of the minority party, while the majority party reiterated it would not allow this budget to pass.

Secretary Azar began his remarks by announcing the new Acting FDA Commissioner, Ned Sharpless, following the resignation of the former commissioner, Scott Gottlieb, last week. For most of the witness questioning, the majority party expressed concerns of how budget cuts will eliminate Medicare and Medicaid coverage and raise premiums for Americans, and that proposals in the budget, such as block-granting Medicare and bypassing Congress in that implementation process, are deeply concerning. The minority party praised the president and Secretary Azar for the budget, firmly supporting the HHS budget and proposed programs throughout questioning. 

House Committee on Energy and Commerce: “Lowering the Cost of Prescription Drugs: Reducing Barriers to Market Competition”
Wednesday, March 13, 2019: The Health Subcommittee held a hearing on rising prescription drug costs and the obstacles faced by market competition. Find a link to witness testimonies, member statements and the hearing live feed here.

Why this is important: This legislative hearing discussed the introduction of the following seven bills meant to address rising prescription drug costs:

  • H.R. 938, the “Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019,” introduced by Reps. Schrader (D-OR) and Carter (R-GA), would discourage parking of 180-day exclusivity by a first generic applicant by allowing FDA to approve a subsequent generic application prior to the first applicant’s first date of commercial marketing when the following four conditions have all been met: (1) the subsequent application is ready for full approval; (2) a minimum of 30 months has passed since at least one first applicant submitted their application for the drug; (3) any related patent litigation has been fully resolved; and (4) no first applicant is approved.
  • H.R. 965, the “Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019,”introduced by Reps. Cicilline (D-RI), Sensenbrenner (R-WI), Nadler (D-NY), Collins (R-GA), Welch (D-VT) and McKinley (R-WV), would establish a process by which generic manufacturers could request that FDA authorize them to obtain sufficient quantities of samples for testing.
  • H.R. 985, the “Fair Access for Safe and Timely (FAST) Generics Act of 2019,” introduced by Reps. Welch, McKinley and Cicilline, establishes an authorization process by which generic manufacturers can gain access to samples of approved drug products that they are trying to genericize. 
  • H.R. 1499, the “Protecting Consumer Access to Generic Drugs Act of 2019,” introduced by Rep. Rush (D-IL), would make it illegal for brand-name and generic drug manufacturers to enter into agreements in which the brand-name drug manufacturer pays the generic manufacturer to keep a generic equivalent off the market.
  • H.R. 1503, the “Orange Book Transparency Act of 2019,” introduced by Rep. Kelly (D-IL), would help to ensure that the Orange Book is accurate and up-to-date, by requiring manufacturers to share complete and timely information with FDA, as well as ensuring that patents listed in the Orange Book are relevant to the approved drug product. Patents found to be invalid through a court decision or a decision by the Patent Trial and Appeal Board would be required to be removed promptly. 
  • H.R. 1506, the “Fair and Immediate Release (FAIR) of Generic Drugs Act,” introduced by Rep. Barragán (D-CA), would allow any generic filer who wins a patent challenge in court or is not sued for patent infringement by the brand manufacturer to share in the 180-day exclusivity period of first applicants that enter into patent settlements that delay entry.
  • H.R. 1520, the “Purple Book Continuity Act of 2019,” introduced by Subcommittee Chair Eshoo (D-CA), would amend the Public Health Service Act to codify publication of approved biological products in the Purple Book in a similar format and with similar requirements to the Orange Book, specify that the Purple Book should be published electronically on FDA’s website and updated routinely, and direct FDA to consider the types of patents that should be listed in the Purple Book.

House Committee on Appropriations: “Department of Health and Human Services Budget Request for FY 2020”
The Subcommittee on Labor, Health and Human Services, Education, and related agencies held a hearing with Health and Human Services Secretary (HHS) Alex Azar on President Trump’s budget request related to the U.S. Department of Health and Human Services (HHS) and its agencies for fiscal year (FY) 2020. Find a link to witness testimonies, member statements and the hearing live feed here.

Why this is important: Members of the subcommittee focused on the zero tolerance policy on family separations at the border, with Secretary Azar reiterating that he was mostly in the dark for the creation of this policy. Later on, Secretary Azar said that the next FDA commissioner must be someone dedicated to cutting back youth’s use of e-cigarettes, a comment he has made throughout a week’s worth of congressional questioning. Secretary Azar also defended the new Title X rules, arguing the rules were in line with congressional intent.

Senate Committee on Finance: “The President’s Fiscal Year 2020 Budget”
Thursday, March 14, 2019: The Senate Committee on Finance held a full committee hearing with Health and Human Services Secretary (HHS) Alex Azar on President Trump’s budget request related to the U.S. Department of Health and Human Services (HHS) and its agencies for fiscal year (FY) 2020. Find a link to witness testimonies, member statements and the hearing live feed here.

Why this is important: Members of the full committee questioned Secretary Azar on health-related proposals in the FY2020 budget in a two-part series held on one day. Azar acknowledged “absurdity” in the Medicare wage index after several senators complained about wide disparities in payments between states. Azar said HHS is seeking comments on a revision to the entire wage index system but cautioned that HHS can change the index only so much on its own. In regard to work requirements, Secretary Azar said that the more than 18,000 Arkansas residents who lost Medicaid coverage after work requirements took effect is a normal level associated with such a change. He also said complying with work requirements is not much to ask in return for health care paid for by taxpayers, a point he also made in an Energy and Commerce, Health Subcommittee hearing earlier in the week.

Read more on healthcare policy on the McGuireWoods Consulting website.