The U.S. House Energy and Commerce Committee needed two days of hearings to get through a spending measure that provided the FDA with $500 million for its part in the government response. The CDC would receive $7.5 billion for vaccine distribution and tracking, all developments that ran parallel to an announcement that another 200 million doses of vaccine will be delivered by the end of July at a cost of $3.7 billion.
On the first day of the Energy and Commerce hearing, the Department of Health and Human Services announced that the federal government has taken contracts with two vaccine manufacturers, Pfizer Inc., of New York, and Moderna Inc., of Cambridge, Mass. The new purchases bring the total U.S. purchase amount to 600 million doses, enough to vaccinate 300 million, assuming a need for two injections per patient.
Committee chairman Frank Pallone (D-N.J.) said on the first day of the hearing that the overall bill includes four sections, including the public health emergency, monies for the Medicaid program, funds for the Children’s Health Insurance Program, and “a grab bag” of miscellaneous items. The bill is proceeding in the House under the budget reconciliation process, which means a simple majority will be needed for passage in both the House and the Senate. The Senate passed consolidated resolution 5 by a vote of 51-50 Feb. 5, and the first three sections of the version reviewed in the House had been passed for transmission to the House Budget Committee by press time Feb. 12.
Also on the first day of the hearing, Rep. Cathy McMorris Rodgers (R-Wash.), said, “the majority is moving forward with a hyper-partisan process,” adding that the bill was released to committee members only late in the night before the first day of the hearing. Rodgers said the bill lacked key information that is routinely required under budget reconciliation rules, adding that the lack of accountability did not bode well for the credibility of the legislation. Indeed, few, if any, of the amendments proposed by committee Republicans passed, including amendments dealing with maternal health despite bipartisan support.
Under section 3001, the bill provides $7.5 billion to the CDC for vaccine distribution and tracking. This amount will also enable CDC to provide supplies that are ancillary to vaccine administration along with assistance to ensure vaccine availability in underserved areas. The CDC would receive an additional $1 billion for a public information campaign to promote vaccination, characterized as “vaccine confidence activities” as described in section 3002.
FDA monies would be used for inspections
Under section 3003, the Department of Health and Human Services (HHS) would receive $5.2 billion for research and development into medical products for the pandemic along with efforts to bolster manufacturing of vaccines. These funds would remain available until expended, the same status as accorded the $500 million package for the FDA, part of the overall HHS allocation. The FDA funds would be directed toward evaluation of products with regard to the newer variants of the SARS-CoV-2 virus, including vaccines, therapies and diagnostics. However, the funds would also be used to enable the FDA to conduct inspections of facilities that manufacture these products, and give the agency the resources needed to conduct oversight of the supply chains for each class of products.
Section 3011 provides $46 billion for a national program of testing and contact tracing, while section 3012 adds $1.75 billion for genetic sequencing for new and emerging variants of the SARS-CoV-2 virus, and associated surveillance activities. The CDC would receive $500 million for a data infrastructure modernization program, while section 3035 provides funding for testing, contact tracing and mitigation activities at congregate settings, such as nursing homes.
The votes on amendments on the first day ran on party lines, such as an amendment by Rep. Fred Upton (R-Mich.), which would have directly provided the National Institutes of Health with $1 billion for research, including research that was delayed due to the pandemic. The amendment fell, with 25 aye votes and 31 nays. The opposition to the Upton amendment was largely premised on an aversion by the majority to exceed the amounts the committee was authorized to consider.
The amendment by Rep. Steve Scalise (R-La.) for an investigation into nursing home deaths fell to a party-line vote, and an amendment by Rep. Michael Burgess (R-Texas), which was directed toward maternal health, likewise fell, this time because committee chairman Pallone said the amendment “would complicate” passage of the larger bill.
Another amendment, by Rep. Daniel Crenshaw, R-Texas, would require a report from the Department of Health and Human Services summarizing how COVID-19 vaccines are distributed to states. This amendment drew some support from Democrats on the committee, but was voted down due to the lack of budgetary implications as required for bills reviewed under budget reconciliation rules.
Alliance: FDA will need more non-COVID funding
The Alliance for a Stronger FDA said the FDA stakeholder community “appreciates and supports the House Energy and Commerce Committee’s decision to include $500 million in no-year money to support COVID-19 activities at FDA.” The monies will ensure the agency has the resources needed to respond to the pandemic, and the Alliance said that neither the pandemic nor the related FDA responsibilities “can be neatly segmented by fiscal year, so the flexibility provided by these funds is enormously valuable.”
The Alliance said that the FDA’s responsibilities have grown substantially in the past year, even discounting the work imposed on the agency by the pandemic. Consequently, “additional base funding will be needed in FY 22,” the Alliance said, adding “we look forward to working with the administration and the appropriations committees to fully support the agency’s funding needs in areas such as food safety, cell and gene therapy, digital health and advanced manufacturing.”