Pallone and Eshoo on House Passage of Ten Health Care Bills
Energy and Commerce Committee Chairman Frank Pallone, Jr. (D-NJ) and Health Subcommittee Chairwoman Anna G. Eshoo (D-CA) released the following joint statement after the House of Representatives passed ten health care bills today:
“The House passed a broad range of health legislation today with strong bipartisan support,” Pallone and Eshoo said. “The 10 bills include legislation to support new research into health disparities, improvements to food and drug labeling, and a new $10 million grant program for trauma centers that intervene in cyclical violence. The House also continued its bipartisan work to combat the opioid epidemic by providing $1.5 billion annually in grants to states and tribal organizations to support substance use disorder treatment and prevention, as well as new tools and authorities to prevent the illegal distribution of controlled substances. We commend members for their continued commitment to working together to pass legislation that improves the health and well-being of the American people and look forward to seeing these bills signed into law.”
The House of Representatives passed the following bills:
H.R. 4499, the “NIMHD Research Endowment Revitalization Act of 2020,” was introduced by Reps. Nanette Diaz Barragan (D-CA), Earl “Buddy” Carter (R-GA), and the late John Lewis (D-GA). The bill authorizes the National Institute on Minority Health and Health Disparities to facilitate research on minority health disparities through research endowments at current or former centers of excellence. The bill passed on the House Floor by voice vote.
H.R. 5668, the “Making Objective Drug Evidence Revisions for New Labeling Act of 2020” or the “MODERN Labeling Act of 2020,” was introduced by Reps. Doris Matsui (D-CA) and Brett Guthrie (R-KY). The bill allows the Food and Drug Administration (FDA) to require modifications of outdated labeling for certain generic drugs to ensure labels have complete and accurate information. The bill would require FDA to report any actions taken under this new authority to update labeling for covered drugs, including the number of drugs, description of the changes and the rationale, as well as any FDA recommendations to modify the program. The bill passed on the House Floor by voice vote.
H.R. 4712, the “Fairness in Orphan Drug Exclusivity Act,” introduced by Reps. Madeleine Dean (D-PA), Marc Veasey (D-TX), Carter (R-GA), and David McKinley (R-WV). The bill closes a loophole in the Orphan Drug Act by requiring drug manufacturers seeking orphan drug designations under the rarely used cost recovery pathway to demonstrate the absence of any reasonable expectation that the costs they incur in developing and making those drugs available in the United States for such disease or condition. The legislation requires FDA and the manufacturer to take into account the sales of all of the manufacturer’s drugs developed under the same orphan drug designation. This legislation will ensure that the incentives provided under the Orphan Drug Act are only provided to manufacturers that meet the criteria of the program as intended. The bill passed on the House Floor by voice vote.
H.R. 2466, the “State Opioid Response Grant Authorization Act of 2020,” was introduced by Reps. David Trone (D-MD), Kelly Armstrong (R-ND), Mikie Sherrill (D-NJ), and Denver Riggleman (R-VA). The bill authorizes the Substance Abuse and Mental Health Services Administration (SAMHSA) State Opioid Response Grants program to align with the grant authority provided through the 21st Century Cures Act. The bill also authorizes support for State actions to address stimulant use. The bill passed on the House Floor by voice vote.
H.R. 2281, the “Easy Medication Access and Treatment for Opioid Addiction Act” or the “Easy MAT for Opioid Addiction Act,” was introduced by Rep. Raul Ruiz (D-CA). The bill would require the Drug Enforcement Administration (DEA) to allow a practitioner to dispense up to a three-day supply of medication-assisted treatment. This practice is intended to relieve potential acute withdrawal symptoms while the individual awaits longer-term treatment. Currently, practitioners are only authorized to provide a one-day supply of such drugs. The bill passed on the House Floor by voice vote.
H.R. 2117, the “Food Allergy Safety, Treatment, Education, and Research Act of 2020” or the “FASTER Act of 2020,” was introduced by Rep. Matsui. The bill would require the Centers for Disease Control and Prevention (CDC) to expand the collection of information related to the prevalence of food allergies for specific allergens and to include that information in reports to Congress. The bill would also amend the Federal Food, Drug, and Cosmetic Act (FFDCA) to include sesame as a major allergen and allow FDA, through regulation, to add other food ingredients as major allergens based on the prevalence and severity of allergic reactions to the food ingredient. Additionally, the bill would require FDA to include patient experience data on treatments for patients with food allergies in its reports on patient experience data. The bill passed on the House Floor by voice vote.
H.R. 5855, the “Bipartisan Solution to Cyclical Violence Act of 2020,” was introduced by Reps. C.A. Dutch Ruppersberger (D-MD) and Adam Kinzinger (R-IL). The legislation would create a grant program at the Department of Health and Human Services (HHS) to support trauma centers with violence intervention and violence prevention programs. Program support would be provided to conduct research to reduce the incidence of re-injury and re-incarceration caused by intentional violent trauma. The bill passed on the House Floor by voice vote.
H.R. 3878, the “Block, Report, And Suspend Shipments Act of 2020,” was introduced by Reps. McKinley and Debbie Dingell (D-MI). The bill would create additional requirements for drug manufacturers and distributors who discover a suspicious order for controlled substances. In addition to reporting a suspicious order of controlled substances to DEA, a manufacturer or distributor must also exercise due diligence, decline to fill the order or series of orders, notify DEA of each suspicious order or series or orders and the indicators that led to the belief that filling such orders would be a violation. These requirements would become effective one year following enactment. The bill passed on the House Floor by voice vote.
H.R. 4806, the “Debarment Enforcement of Bad Actor Registrants Act of 2020” or the “DEBAR Act of 2020,” was introduced by Rep. Robert Latta (R-OH). The bill would amend the Controlled Substances Act to allow the Attorney General to prohibit any registrant from manufacturing, distributing, or dispensing a controlled substance or a list I chemical if that registrant meets or has met any of the conditions for suspension or revocation of registration, or has a history of prior suspension or revocations. The bill passed on the House Floor by voice vote.
H.R. 4812, the “Ensuring Compliance Against Drug Diversion Act of 2019,” was introduced by Rep. Morgan Griffith (R-VA). The bill terminates the controlled substance registration of any registrant if the registrant dies, ceases legal existence, discontinues business or professional practice, or surrenders registration. A registrant who ceases legal existence or discontinues business is required to notify DEA. Registrants must receive written consent from DEA in order to assign or transfer a registration. Registrants are also required to return certain documentation if a registrant’s work is discontinued. The bill passed on the House Floor by voice vote.