Welcome to the Committee on Energy and Commerce.

Discussion Draft Considers Input from Broad Spectrum of Experts and Stakeholders Washington, D.C. — House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) today unveiled a discussion draft with policy proposals to address the drug shortages facing America.  “America is the leader in developing innovative treatments and cures. Yet the economics of our convoluted health care system create shortages—particularly of low-cost and generic drugs—that harm patients in need. The responses to our RFI on addressing drug shortages overwhelmingly made clear that we need to address the root causes of shortages with a multifaceted approach. This discussion draft is part of our committee’s thoughtful, deliberative process to offer long-term solutions to these issues so that patients can access the drugs they need. I hope this draft will lead to bipartisan legislation, and I welcome feedback and collaboration from my colleagues across the aisle and chamber, stakeholders, and subject matter experts,” said Chair Rodgers .  Key Details:  Provide Market Flexibility : Drug manufacturers that produce low-cost drugs and generics are often already operating on thin margins. Imposing restrictions in Medicaid and the 340B Program that hold the cost of these drugs at artificially low levels undermines the economic stability of these supply chains, driving many of these drugs into shortages. The discussion draft will give manufacturers of generic, sterile injectable drugs for serious diseases, such as cancer treatments, more flexibility to respond to market pressures, so they can invest in manufacturing and ramp up production when potential shortage situations arise.  Increase Transparency from Drug Middlemen: Increases disclosure requirements on group purchasing organizations that control bulk contracts between drug manufacturers and health care providers. Bringing these agreements to light may help cut down on arrangements where companies are incentivized not to produce drugs.  Hold the Food and Drug Administration Accountable and Support our Supply Chains: Requires the Food and Drug Administration (FDA) to exercise the reporting requirement authorities it already possesses, includes reporting on certain active pharmaceutical ingredient (API) metrics for generics, and establishes a pilot program for FDA to conduct preapproval inspections for new domestic sterile manufacturing facilities. Require More Information to Stop Shortages : Requires a government watchdog to examine how policies, like the 340B Program’s penny pricing policies and Medicaid’s generic drug inflationary rebate, interact with drugs that have experienced shortages within the past decade. Additional requirements include data analysis and recommendations from the Department of Health and Human Services related to how Medicare reimburses for certain drugs and how to protect against drug shortages, including the use of market-based pricing.  Those who wish to submit comments or feedback can do so at drugshortages@mail.house.gov by August 25, 2023.  CLICK HERE to read the discussion draft.  CLICK HERE to read a section by section.  BACKGROUND ON THE COMMITTEE’S DRUG SHORTAGE EFFORTS :  July 18, 2023 : E&C Republicans Press FDA Over Inadequate Inspection of Drug Manufacturing in India and China  June 12, 2023 : Chair Rodgers and Ranking Member Crapo sent an RFI to stakeholders and experts.   May 11, 2023 : Chair Rodgers and OI Subcommittee Chair Morgan Griffith (R-VA) convene subcommittee hearing titled “Examining the Root Causes of Drug Shortages: Challenges in Pharmaceutical Drug Supply Chains.”   March 27, 2023 : Chair Rodgers and Subcommittee Chair Griffith, and Subcommittee on Health Chair Brett Guthrie (R-KY) wrote to the FDA requesting information into how the agency is managing drug shortages. You can read the FDA’s response here, which notes that only 44 percent of companies are complying with existing requirements to report information on the volume of drugs made at each facility to the FDA. 

Washington, D.C. —  House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) delivered the following opening remarks at today’s  Full Committee markup  of six bills. Excerpts and highlights below: REAUTHORIZING THE NTIA “For decades, America has led the world in technologies that have transformed people’s lives and raised their standard of living from state-of-the-art communications networks, to cutting edge automotive technologies. “To win the future, we must continue to lead. “Right now, China is our number one national security, economic, and technological threat. “They’re challenging the global influence of the U.S. in these key industries. “We must confront these challenges by promoting American innovation and entrepreneurship. “Our bill to reauthorize NTIA will help us beat China by providing NTIA the tools needed to use resources like spectrum more efficiently, streamline regulations, and advance connectivity across the United States. “This will enhance internet and public safety services across the country and create more economic opportunities for millions of Americans. “The bill promotes broadband deployment by strengthening agency coordination and secures our networks from foreign threats.” STOPPING CHINA’S SCHEME TO CONTROL AMERICA’S AUTOMOTIVE FUTURE “We also have several solutions before us that will ensure Americans continue to have the ability to choose the vehicles and fuels that best serve their needs. “This is a critical moment in history. “We need to be honest with the American people about how forcing them to switch to electric vehicles plays right into China’s scheme to control our automotive future. China already controls access to critical minerals necessary for EVs. “It controls 76 percent of global battery cell production capacity for electric vehicles, around 75 percent of all lithium-ion batteries, and the majority of processing and refining capacity for over half of the world’s lithium, cobalt, and graphite. “And last quarter, it became the largest exporter of new motor vehicles in the world, surpassing Japan. “Instead of forcing Americans to switch to EVs, let’s get back to the true goals, which are reducing carbon emissions, improving fuel efficiency, and preserving Americans’ access to affordable transportation choices. “The legislative solutions today will ensure we don’t hand our automotive or communications future to the Chinese Communist Party. “America, not China, must lead the way in cutting edge technologies. “We need to stay focused on securing America’s leadership in these sectors through innovation, entrepreneurship, and promoting a free, competitive market to lower costs for people. “That’s how we’ve led for decades and how we win the future.”

Washington, D.C. — House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) and Ranking Member Frank Pallone, Jr., (D-NJ), along with Senate Health, Education, Labor, and Pensions Committee Chair Bernie Sanders (I-VT) and Ranking Member Bill Cassidy, M.D. (R-LA), today announced a bicameral Request for Information (RFI) to subject matter experts and stakeholders regarding Food and Drug Administration (FDA) regulation of cannabidiol (CBD).  KEY EXCERPTS :  “Since hemp was descheduled five years ago, consumers, manufacturers, and policymakers have sought clarity regarding the legal status of CBD. Farmers, food and beverage groups, and state regulators have shared their policy priorities with Congress. Questions remain about the best way to provide a legal pathway to market for CBD products.”  […]  "In January 2023, FDA announced that it would like to work with Congress to craft a legislative approach to the regulation of CBD products. We are assessing the potential for a regulatory pathway for hemp-derived CBD products that prioritizes consumer safety and provides certainty to the U.S. market.”  The Members request responses to the RFI be submitted to CBD@mail.house.gov and CBD@help.senate.gov by August 18, 2023.  The RFI’s requests and questions include:  Please comment on the concerns FDA has raised with regard to regulating most CBD products through existing pathways (i.e., conventional foods, dietary supplements, and cosmetics), and FDA’s view that there is a need for a new regulatory pathway for CBD products. If existing regulatory pathways are sufficient for regulating CBD products, please explain how these existing pathways can be used to address the concerns raised by FDA, as appropriate.  How has the absence of federal regulation over CBD created a market for intoxicating, synthetically-produced compounds, such as Delta-8 THC, THC-O, THC-B, HHC-P, and others?  How should a new framework for CBD products balance consumer safety with consumer access?  What precedent exists in foods, dietary supplements, tobacco, and cosmetics for requirements of labeling to present risks to special populations in labeling (e.g., children, pregnant and lactating women, consumers taking certain drugs, etc.)? What amount and type of evidence has been required to support such requirements?  CLICK HERE to read the full RFI. 

Washington, D.C. — House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) and Ranking Member Frank Pallone, Jr., (D-NJ), along with Senate Health, Education, Labor, and Pensions Committee Chair Bernie Sanders (I-VT) and Ranking Member Bill Cassidy, M.D. (R-LA), today announced a bicameral Request for Information (RFI) to subject matter experts and stakeholders regarding Food and Drug Administration (FDA) regulation of cannabidiol (CBD).  KEY EXCERPTS :  “Since hemp was descheduled five years ago, consumers, manufacturers, and policymakers have sought clarity regarding the legal status of CBD. Farmers, food and beverage groups, and state regulators have shared their policy priorities with Congress. Questions remain about the best way to provide a legal pathway to market for CBD products.”  […]  "In January 2023, FDA announced that it would like to work with Congress to craft a legislative approach to the regulation of CBD products. We are assessing the potential for a regulatory pathway for hemp-derived CBD products that prioritizes consumer safety and provides certainty to the U.S. market.”  The Members request responses to the RFI be submitted to CBD@mail.house.gov and CBD@help.senate.gov by August 18, 2023.  The RFI’s requests and questions include:  Please comment on the concerns FDA has raised with regard to regulating most CBD products through existing pathways (i.e., conventional foods, dietary supplements, and cosmetics), and FDA’s view that there is a need for a new regulatory pathway for CBD products. If existing regulatory pathways are sufficient for regulating CBD products, please explain how these existing pathways can be used to address the concerns raised by FDA, as appropriate.  How has the absence of federal regulation over CBD created a market for intoxicating, synthetically-produced compounds, such as Delta-8 THC, THC-O, THC-B, HHC-P, and others?  How should a new framework for CBD products balance consumer safety with consumer access?  What precedent exists in foods, dietary supplements, tobacco, and cosmetics for requirements of labeling to present risks to special populations in labeling (e.g., children, pregnant and lactating women, consumers taking certain drugs, etc.)? What amount and type of evidence has been required to support such requirements?  CLICK HERE to read the full RFI. 

Administration refuses to produce documents related to supercharged pathogen experiments Washington, D.C. — House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA), Subcommittee on Health Chair Brett Guthrie (R-KY), and Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-VA), on behalf of the Health and Oversight Subcommittees’ Republicans, today wrote to Department of Health and Human Services (HHS) Secretary Xavier Becerra.   As part of an ongoing investigation, their letter requests a voluntary videotaped, transcribed interview with Dr. Bernard Moss, a leading pox virus researcher at the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH), regarding reported experiments he has conducted or proposed to supercharge strains of the mpox virus.  BACKGROUND :  In November 2022, Energy & Commerce Republicans, then in the minority, launched an investigation into a proposed NIAID mpox virus enhancement experiment, which has reportedly made the disease 1000 percent more lethal in mice. Dr. Moss discussed the experiment in an interview with Science magazine . According to an article in the October 19, 2022, Science magazine, scientists were alarmed about these mpox experiments, and that an outbreak strain lab escape could spark a substantially more deadly mpox epidemic.   The Chairs, now in the majority, reopened the investigation in March 2023, also providing a notice to preserve all documents and communications related to the topic.  Following an inadequate response from HHS that simply stated that the study “has not been formally proposed, and NIAID has no plans to move forward with this research,” the Chairs requested a videotaped, transcribed interview with Dr. Moss in May 2023. The Chairs noted “Dr. Moss has been with the NIH since 1966, is one of the leading authorities on pox viruses, and one of the NIH’s most accomplished researchers. He has received numerous awards and prizes. […] The admission that he did not formally propose this research, and the NIAID has no plans to pursue it seems extraordinary. It seems unlikely that Dr. Moss changed his mind. On the other hand, it is hard to believe the NIAID has apparently overruled one of its most highly respected scientists.”   HHS sent a response on June 30, 2023, attaching a letter purportedly written by Dr. Moss. However, the explanation in the letter raised more questions and inconsistencies. HHS and NIH have so far not produced any requested documents.  KEY LETTER EXCERPT :  “It is vital for the committee to get a full understanding about how such risky research proposals are developed and overseen to support our legislative efforts in pandemic preparedness and protection of public health.”  […] “In the event one of the above dates is not selected, the Committee will be forced to consider compulsory process to secure Dr. Moss’s attendance.”  CLICK HERE to read the letter.

Washington, D.C. — House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA), Subcommittee on Health Chair Brett Guthrie (R-KY), and Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-VA), on behalf of the Health and Oversight Subcommittee Republicans, sent a letter to Food and Drug Administration (FDA) Commissioner Robert Califf. The letter raises questions regarding the FDA’s insufficient foreign drug inspections conducted in India and China.  KEY EXCERPT:   “The FDA’s recent decision to address shortages of critical drugs by allowing the temporary import of otherwise unapproved drugs from India and China makes having effective foreign inspection programs in those countries critical. […] Given that approximately 32 percent of generic drugs and 45 percent of active pharmaceutical ingredients are from these two countries, we are worried that the United States is overly reliant on sourcing from foreign manufacturers with a demonstrated pattern of repeatedly violating FDA safety regulations .”  KEY BACKGROUND FACTS:   FDA Foreign Inspections:   Chinese and Indian manufacturers receive the most FDA Warning Letters. These violations have included:  carcinogens in medicines,   destroying or falsifying of data,   and non-sterile manufacturing processes.  The COVID-19 pandemic stopped most in-person inspections of foreign drug manufacturers from March 2020 until April 2022.   In lieu of in-person inspections, the FDA resorted to alternatives and workarounds, such as remote interactive inspections of drug manufacturing facilities on a voluntary basis.  Once FDA inspections resumed, they did so at a much lower level than before the pandemic.   One analysis found that out of approximately 2,800 foreign manufacturing facilities, the FDA inspected only 6 percent of them, with just 3 percent of Indian manufacturers being inspected.  Between fiscal years (FY) 2020 and 2022, the FDA conducted only 40 inspections in China as compared to 131 inspections in FY 2019 alone.   On January 8, 2023, the Government of China ended its requirement that international arrivals quarantine for two weeks upon entry to the country.   However, the FDA only began in-person inspections in China in April 2023.  Additional Governmental Concern with FDA Inspection Inadequacy:   The Department of Defense recently announced that it will begin independently testing the quality and safety of imported generic drugs.  The non-partisan Government Accountability Office (GAO) also criticized the FDA’s foreign inspection program in a report published last year, noting that the FDA faced “unique challenges” and that it is inadequate at holding foreign manufacturers accountable for repeatedly violating regulations.  In particular, the GAO was concerned that the FDA’s practice of conducting preannounced foreign inspections is ineffective and raises “questions about the equivalence of foreign to domestic inspections.”  Unannounced Inspection Pilot Program and Discontinuation:   From 2014 to 2015, the FDA conducted a pilot program in India that eliminated extended advance notice for inspections.   During that time, the FDA conducted short notice or unannounced visits and selected sites for the program that the agency believed had significant issues.   The pilot program appears to have been successful at exposing widespread misconduct and significant violations of FDA regulations, including falsified quality records.   Despite the pilot program’s success, the FDA elected to discontinue it.  Challenges Posed by China’s National Security Law:   The ruling Communist Party of China announced a reinterpretation of its already sweeping National Security Law to expand the scope of the law beyond state secrets to cover “data, materials, or items related to … national interests.”   The law’s new interpretation is so broad that it would allow officials to arrest FDA inspectors or block access to manufacturers’ records if officials deem it in the national interest.   Authorities have already raided the offices of companies that specialize in collecting market information in China and detained employees.  The Chairs requested answers related to questions, including the following, by August 1, 2023:  Section 3112(e) of the CARES Act gave the FDA additional authority to require manufacturers to report certain supply chain information to it. The FDA’s May 9, 2023, letter to the Committee stated that only 44 percent of facilities are reporting the required data to the FDA. Based on the FDA’s letter, a disproportionate percentage of noncompliant API and finished dose formula facilities are located outside of the United States. How many regulatory actions has the FDA enforced against noncompliant foreign facilities regarding the CARES Act reporting requirements? Provide a list of all foreign facilities that have been penalized for noncompliance. Include in your response a detailed description of the action taken by the FDA.  The FDA ensures the quality of drugs and other pharmaceutical products through manufacturers’ compliance with facility registration and Current Good Manufacturing Practice (CGMP) regulations. The Food and Drug Administration Safety and Innovation Act (FDASIA, P.L. 112-144) contained several provisions providing the FDA greater insight into the original sources of excipients, API, and finished dosage products. Specifically, Section 703 requires that drug manufacturers identify the name and place of business of all establishments involved in the production of drug excipients, while Section 711 revises CGMP regulations to require oversight over the production of any raw materials for the manufacture of a drug. The FDA has indicated in its recent requests for additional authorities over supply chain information that it does not currently have access to original sources for API and other drug excipients, notwithstanding these and other provisions providing such authorities.   Given its authorities under FDASIA, why does the FDA take the position that it does not have visibility into where API and drug excipients are sourced?   Explain in detail, how the FDA processes information received under Sections 703 and 711. As part of your response, explain how has the data received under Sections 703 and 711 informs FDA’s foreign inspections programs and drug shortage response efforts?  Was the FDA consulted by the Department of Defense regarding its decision to independently test the quality and safety of generic drugs it purchases? If yes, provide communications and documents related to the consultation.  How many FDA inspectors are currently conducting foreign inspections? Include in your response how many of these inspectors are operating in each country.  CLICK HERE to read the letter.  BACKGROUND ON THE COMMITTEE’S DRUG SHORTAGE EFFORTS :   July 12, 2023 : Chair Rodgers announces plans to release drug shortage discussion draft following robust response to RFI.  June 12, 2023 : Chair Rodgers and Ranking Member Crapo (R-ID) sent an RFI to stakeholders and experts.   May 11, 2023 : Chair Rodgers and OI Subcommittee Chair Morgan Griffith (R-VA) convened a hearing titled “Examining the Root Causes of Drug Shortages: Challenges in Pharmaceutical Drug Supply Chains.”   March 27, 2023 : Chair Rodgers, Subcommittee Chair Griffith, and Subcommittee on Health Chair Brett Guthrie (R-KY) wrote to the FDA requesting information into how the agency is managing drug shortages. You can read the FDA’s response here, which notes that only 44 percent of companies are complying with existing requirements to report information on the volume of drugs made at each facility to FDA.