Health

Washington, D.C. — In a new letter to Attorney General Merrick Garland and Department of Health and Human Services (HHS) Secretary Xavier Becerra, House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) and Subcommittee on Health Chair Brett Guthrie (R-KY) requested information related to rescheduling of marijuana.  KEY LETTER EXCERPTS :  “We write to express our concerns with the recent notice of proposed rulemaking titled ‘Schedules of Controlled Substances: Rescheduling of Marijuana,’ to transfer marijuana from Schedule I to Schedule III of the Controlled Substances Act (CSA). The circumstances surrounding this proposed rule are unusual, and we are concerned by the process that led to this determination.”  [...]  “We support research into innovative therapies to improve patient outcomes, but we are concerned with how the normal process was circumvented to achieve a result for political purposes and we have a number of unanswered questions.”  BACKGROUND :  History:   Marijuana is a psychoactive substance that has been listed in Schedule I since the CSA was enacted in 1970.  All substances in Schedule I are classified as having no accepted medical use and a high potential for abuse.  This means that the manufacturing, possession, and distribution of marijuana is illegal at the federal level, except for certain research approved by the Drug Enforcement Administration (DEA).  During the Obama administration in 2016, the DEA and HHS, acting through the Food and Drug Administration (FDA), conducted a multi-year review of whether to transfer marijuana from Schedule I to a lesser schedule. Both the DEA and HHS agreed that marijuana continued to meet the criteria to be considered a Schedule I substance.  HHS concluded that “[…] marijuana has a high potential for abuse, has no accepted medical use in the United States, and lacks an acceptable level of safety for use even under medical supervision.”  President Biden made a public statement on October 6, 2022, issuing pardons for all simple possession federal offenses of marijuana, requesting all Governors do the same with state level offenses, and requiring HHS and DOJ to begin the administrative process to quickly review how marijuana is scheduled under federal law.  While the administration has the authority to alter a substance’s scheduling status, it is bound by the CSA to consider factors, including whether a substance has a medical use and to determine its potential for abuse and dependence, prior to changing its scheduling status.  Process:   The DEA typically determines whether a substance has a medical use if it has been approved for marketing under the Food Drug and Cosmetic Act (FDCA) and by conducting a five-part test, which considers the following:  (1) there were adequate safety studies,  (2) the drug’s chemistry is known and reproducible,  (3) there are adequate and controlled studies,  (4) the drug is accepted by qualified experts, and  (5) there is widely available scientific evidence.  However, this proposed rule indicates that HHS notified the DEA that HHS disagreed with the existing process and decided to develop its own test to determine whether a substance has medical use under the CSA.  This test is comprised of two considerations:  (1) if there is widespread medical use of such a substance under the supervision of a licensed health care practitioner operating within a State-authorized program and,  (2) if so, there is credible scientific evidence to support medical use of such substance.  HHS analyzed marijuana by utilizing its own two-part test, determined it has a medical use, and therefore recommended to transfer marijuana from Schedule I to Schedule III of the CSA.  DOJ received HHS’s recommendation and declared that this new two-part test is sufficient to establish medical use, which is an unusual deviation from the typical process.  It is notable that the proposed rule states, “DEA has not yet made a determination as to its views of the appropriate schedule for marijuana,” seeming to indicate that the DEA is not yet convinced of the merits of this review.  Additionally, most of the professional organizations listed in the HHS “Basis for the Recommendation to Reschedule Marijuana into Schedule III of the Controlled Substances Act” have released position statements that either request more evidence or oppose using marijuana as medicine for their specialties.  Further Considerations:   To date, the FDA has not approved a New Drug Application (NDA) necessary to have satisfied the criteria required under the previous five-factor analysis, such as adequate and well-controlled studies proving safety and efficacy, for a drug product containing botanical marijuana to treat any medical condition(s); thus, it has remained a Schedule I drug without a currently accepted medical use.  This is misaligned from typical practice, as the presence of a marketing application approved to treat a certain condition or disease has been central to the FDA's determinations.  The Delta-9-tetrahydrocannabinol (THC) potency in marijuana is also continuing to increase.  According to the proposed rule, THC potency has spiked from about three percent in 1991 to 17 percent in 2017 and it notes, “[…] DEA anticipates that additional data on public safety risks, risks from acute and chronic marijuana use via oral and inhaled administration routes, and the impact of THC potency may be appropriate for consideration.”  The proposed rule also states, “the vast majority of professional organizations did not recommend the use of marijuana in their respective specialties; however, none specifically recommended against it, with the exception of the American Psychiatric Association, which states that marijuana is known to worsen certain psychiatric conditions.”  Further, HHS’s own report to Congress titled “Health Effects of Cannabis and Cannabinoids and Barriers to Research” states that “[m]ore research is needed to evaluate the therapeutic potential of cannabis and cannabinoids as a means of safely and effectively treating various indications […] it is also worth noting that the U.S. jurisdictions that have legalized the use of cannabis products for medicinal purposes have often done so with inadequate scientific research to support all allowable uses.”  CLICK HERE to read the letter.

Washington, D.C. — In a new letter to Department of Health and Human Services (HHS) Secretary Xavier Becerra and National Institutes of Health (NIH) Director Monica Bertagnolli, 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) requested documents and transcribed interviews related to an approved MPVX experiment.  The letter comes after the Committee released an interim staff report on the experiment as well as an NIH reform framework . It notes that a failure to produce the requested documents by August 8, 2024, may lead to issuance of a subpoena to compel compliance. HHS and the NIH continue to withhold critical documents requested by the Committee last year.  KEY EXCERPT :  “For nearly a year and a half, the Department of Health and Human Services (HHS), the NIH, and NIAID misled the Committee. Both HHS and the NIH told us a risky MPXV research proposal at the NIAID had not been “'formally proposed' or 'planned' when in fact this project was submitted and received approval before the NIH’s Institutional Biosafety Committee (IBC) on June 30, 2015, as documented in written meeting minutes. The misleading statements were included in the following communications to the Committee:  Letter from the HHS Assistant Secretary for Legislation dated April 26, 2023.  Letter from Dr. Bernard Moss to Chair Rodgers, dated June 30, 2023.  Written statements presented at the September 21, 2023, meeting between Committee staff and NIH/NIAID officials from Dr. Bernard Moss, Dr. Steven Holland, NIAID Director of the Division of Intramural Research, and Jeffery Potts, Chief of the Biorisk Management Branch within the NIH Division of Occupational Health and Safety.  “This deception is unacceptable and has led the Committee to conclude that NIAID cannot be trusted to oversee its own research of pathogens or determine whether an experiment poses enhanced risks of a potential pandemic or other serious public health outbreak.”  [...] “NIAID’s lack of candor to this point suggests that it cannot be trusted to oversee the research projects that it funds. Therefore, this Committee will explore policy options to address this inherent conflict of interest and lack of transparency.”  ADDITIONAL BACKGROUND :  A new strain of MPXV has recently emerged that increases the risk of this disease causing a major public health outbreak or a potential pandemic. Since January, the Democratic Republic of the Congo has reported more than 4,500 suspected mpox cases and nearly 300 deaths, numbers that have roughly tripled from the same period last year, according to the World Health Organization.  Congo recently declared the outbreak across the country a health emergency. An analysis of hospitalized patients suggests recent genetic mutations are the result of continued transmissions in humans.  CLICK HERE to read the letter.

Washington D.C. — House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) delivered the following opening remarks at today’s Health Subcommittee hearing titled “Are CDC's Priorities Restoring Public Trust and Improving the Health of the American People?”  “For decades, America enjoyed its status of having one of the pre-eminent public health infrastructures in the world. “Federal agencies conducted cutting edge research and facilitated private sector efforts to advance science and keep our citizens safe. “Then the COVID-19 pandemic struck.” MISSION CREEP & MISPLACED PRIORITIES “The CDC was established to assist states and localities in controlling infectious disease outbreaks. “COVID-19 should have been the agency’s moment to shine. “Unfortunately, on almost every level—the CDC fell flat. “From egregious flaws in testing, confusing—and, at times, blatantly misleading—communication mishaps, and one-size-fits-all guidance and mandates, the CDC failed at its primary job of helping states and localities detect, respond to, and control a disease outbreak. “These failures beg the question, why did the CDC fail to execute its principal mission at the time of most need? “Was it because the agency’s focus has strayed too far from its core mission? “Is the agency spread too thin across competing and misguided priorities, and how do we refocus the agency to most effectively meet the needs of the American people? “It is notable that between fiscal years 2013 and 2014, non-communicable disease funding increased by 150 percent. “Over the same time period, there have been consistent increases in the rates of chronic diseases, such as diabetes, obesity, and hypertension. “There is clearly a disconnect here—Congress has a responsibility to understand what the return on that investment has been. “As the Committee responsible for overseeing the CDC, we must question the effectiveness of these programs, understand who at CDC is responsible for evaluating these programs, and whether these investments would be better directed elsewhere.” BROKEN PUBLIC TRUST “The unfortunate truth is that Americans have lost faith in our public health agencies—particularly in the CDC. “The agency’s many failures rightfully led people to question whether the guidance being released was actually grounded in science, reason, or even common sense. “As our Committee helped to uncovered, the six-foot social distancing rule 'just kind of appeared,' as Dr. Fauci put it. “More recently, Dr. Fauci attributed the decision to mandate the six-foot social distancing rule entirely to CDC. “And yet the CDC has failed to explain how it was coming to its conclusions during that time, who was making these decisions, why it was issuing such guidance, and how that guidance would keep people safe. “The CDC failed to explain how our understanding of the science evolved and changed over time. “And the CDC failed to offer any kind of nuance as to who was vulnerable and who wasn’t. “These failures led to massive learning loss for our children that set them decades behind, a mental health crisis, and economic hardship.” RESTORING PUBLIC TRUST “We need the CDC to be successful and credible for the health and future of our nation—but there is a lot of work that needs to be done to restore people’s trust. “Late last year, we held a hearing with the Director of the CDC, Dr. Cohen. At that hearing we heard updates on the CDC-wide 'Moving Forward' initiative. “We likely have differing opinions on how productive and effective that initiative has been and the outcomes it has generated. “However, I think that initiative does show that we can all agree that work must be done to rebuild public trust in the CDC and our public health institutions. “That work will only be successful if the CDC’s leadership and your Centers and Offices are truly committed to reform and are willing to show you can make the hard decisions that need to be made. “This means admitting where inefficiencies exist and taking accountability for mistakes. “It means being honest about what you know and do not know, and when you know it.  “It means making honest attempts to streamline and—perhaps in some cases—eliminate programs that are no longer working for the American people. “And it means showing the American people you value their judgment, their individual perspectives, and that you are committed to regaining their trust. “My hope is that we can work together to achieve this, starting with today’s conversation.” 

Washington, D.C. — In a new letter to Department of Health and Human Services (HHS) Secretary Xavier Becerra and National Institutes of Health (NIH) Director Monica Bertagnolli, 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) requested documents and transcribed interviews related to an approved MPVX experiment.  The letter comes after the Committee released an interim staff report on the experiment as well as an NIH reform framework . It notes that a failure to produce the requested documents by August 8, 2024, may lead to issuance of a subpoena to compel compliance. HHS and the NIH continue to withhold critical documents requested by the Committee last year.  KEY EXCERPT :  “For nearly a year and a half, the Department of Health and Human Services (HHS), the NIH, and NIAID misled the Committee. Both HHS and the NIH told us a risky MPXV research proposal at the NIAID had not been “'formally proposed' or 'planned' when in fact this project was submitted and received approval before the NIH’s Institutional Biosafety Committee (IBC) on June 30, 2015, as documented in written meeting minutes. The misleading statements were included in the following communications to the Committee:  Letter from the HHS Assistant Secretary for Legislation dated April 26, 2023.  Letter from Dr. Bernard Moss to Chair Rodgers, dated June 30, 2023.  Written statements presented at the September 21, 2023, meeting between Committee staff and NIH/NIAID officials from Dr. Bernard Moss, Dr. Steven Holland, NIAID Director of the Division of Intramural Research, and Jeffery Potts, Chief of the Biorisk Management Branch within the NIH Division of Occupational Health and Safety.  “This deception is unacceptable and has led the Committee to conclude that NIAID cannot be trusted to oversee its own research of pathogens or determine whether an experiment poses enhanced risks of a potential pandemic or other serious public health outbreak.”  [...] “NIAID’s lack of candor to this point suggests that it cannot be trusted to oversee the research projects that it funds. Therefore, this Committee will explore policy options to address this inherent conflict of interest and lack of transparency.”  ADDITIONAL BACKGROUND :  A new strain of MPXV has recently emerged that increases the risk of this disease causing a major public health outbreak or a potential pandemic. Since January, the Democratic Republic of the Congo has reported more than 4,500 suspected mpox cases and nearly 300 deaths, numbers that have roughly tripled from the same period last year, according to the World Health Organization.  Congo recently declared the outbreak across the country a health emergency. An analysis of hospitalized patients suggests recent genetic mutations are the result of continued transmissions in humans.  CLICK HERE to read the letter.

Washington, D.C. — In a new letter to Attorney General Merrick Garland and Department of Health and Human Services (HHS) Secretary Xavier Becerra, House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) and Subcommittee on Health Chair Brett Guthrie (R-KY) requested information related to rescheduling of marijuana.  KEY LETTER EXCERPTS :  “We write to express our concerns with the recent notice of proposed rulemaking titled ‘Schedules of Controlled Substances: Rescheduling of Marijuana,’ to transfer marijuana from Schedule I to Schedule III of the Controlled Substances Act (CSA). The circumstances surrounding this proposed rule are unusual, and we are concerned by the process that led to this determination.”  [...]  “We support research into innovative therapies to improve patient outcomes, but we are concerned with how the normal process was circumvented to achieve a result for political purposes and we have a number of unanswered questions.”  BACKGROUND :  History:   Marijuana is a psychoactive substance that has been listed in Schedule I since the CSA was enacted in 1970.  All substances in Schedule I are classified as having no accepted medical use and a high potential for abuse.  This means that the manufacturing, possession, and distribution of marijuana is illegal at the federal level, except for certain research approved by the Drug Enforcement Administration (DEA).  During the Obama administration in 2016, the DEA and HHS, acting through the Food and Drug Administration (FDA), conducted a multi-year review of whether to transfer marijuana from Schedule I to a lesser schedule. Both the DEA and HHS agreed that marijuana continued to meet the criteria to be considered a Schedule I substance.  HHS concluded that “[…] marijuana has a high potential for abuse, has no accepted medical use in the United States, and lacks an acceptable level of safety for use even under medical supervision.”  President Biden made a public statement on October 6, 2022, issuing pardons for all simple possession federal offenses of marijuana, requesting all Governors do the same with state level offenses, and requiring HHS and DOJ to begin the administrative process to quickly review how marijuana is scheduled under federal law.  While the administration has the authority to alter a substance’s scheduling status, it is bound by the CSA to consider factors, including whether a substance has a medical use and to determine its potential for abuse and dependence, prior to changing its scheduling status.  Process:   The DEA typically determines whether a substance has a medical use if it has been approved for marketing under the Food Drug and Cosmetic Act (FDCA) and by conducting a five-part test, which considers the following:  (1) there were adequate safety studies,  (2) the drug’s chemistry is known and reproducible,  (3) there are adequate and controlled studies,  (4) the drug is accepted by qualified experts, and  (5) there is widely available scientific evidence.  However, this proposed rule indicates that HHS notified the DEA that HHS disagreed with the existing process and decided to develop its own test to determine whether a substance has medical use under the CSA.  This test is comprised of two considerations:  (1) if there is widespread medical use of such a substance under the supervision of a licensed health care practitioner operating within a State-authorized program and,  (2) if so, there is credible scientific evidence to support medical use of such substance.  HHS analyzed marijuana by utilizing its own two-part test, determined it has a medical use, and therefore recommended to transfer marijuana from Schedule I to Schedule III of the CSA.  DOJ received HHS’s recommendation and declared that this new two-part test is sufficient to establish medical use, which is an unusual deviation from the typical process.  It is notable that the proposed rule states, “DEA has not yet made a determination as to its views of the appropriate schedule for marijuana,” seeming to indicate that the DEA is not yet convinced of the merits of this review.  Additionally, most of the professional organizations listed in the HHS “Basis for the Recommendation to Reschedule Marijuana into Schedule III of the Controlled Substances Act” have released position statements that either request more evidence or oppose using marijuana as medicine for their specialties.  Further Considerations:   To date, the FDA has not approved a New Drug Application (NDA) necessary to have satisfied the criteria required under the previous five-factor analysis, such as adequate and well-controlled studies proving safety and efficacy, for a drug product containing botanical marijuana to treat any medical condition(s); thus, it has remained a Schedule I drug without a currently accepted medical use.  This is misaligned from typical practice, as the presence of a marketing application approved to treat a certain condition or disease has been central to the FDA's determinations.  The Delta-9-tetrahydrocannabinol (THC) potency in marijuana is also continuing to increase.  According to the proposed rule, THC potency has spiked from about three percent in 1991 to 17 percent in 2017 and it notes, “[…] DEA anticipates that additional data on public safety risks, risks from acute and chronic marijuana use via oral and inhaled administration routes, and the impact of THC potency may be appropriate for consideration.”  The proposed rule also states, “the vast majority of professional organizations did not recommend the use of marijuana in their respective specialties; however, none specifically recommended against it, with the exception of the American Psychiatric Association, which states that marijuana is known to worsen certain psychiatric conditions.”  Further, HHS’s own report to Congress titled “Health Effects of Cannabis and Cannabinoids and Barriers to Research” states that “[m]ore research is needed to evaluate the therapeutic potential of cannabis and cannabinoids as a means of safely and effectively treating various indications […] it is also worth noting that the U.S. jurisdictions that have legalized the use of cannabis products for medicinal purposes have often done so with inadequate scientific research to support all allowable uses.”  CLICK HERE to read the letter.

Washington, D.C. — In new letters to the Department of Health and Human Services (HHS) Inspector General and Government Accountability Office (GAO) Comptroller General, House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA), House Ways and Means Committee Chair Jason Smith (R-MO), and House Judiciary Committee Chair Jim Jordan (R-OH) ask for systemic reviews of Obamacare enrollment to determine the breadth of improper enrollment and its underlying causes.  The letters come following the release of a paper from Paragon Health Institute, which estimates that four to five million people are improperly enrolled in fully-subsidized Obamacare plans at a cost of $15 to $26 billion per year to taxpayers.  KEY EXCERPT FROM THE LETTERS:   The Democrat-passed tax-and-spend laws resulted in tens of billions of additional taxpayer dollars being spent to prop up Obamacare plans by increasing subsidies given to insurance companies far above those originally authorized by Congress. Recently, the Congressional Budget Office (CBO) estimated that making those subsidy levels permanent would add nearly $400 billion to the deficit on top of the hundreds of billions in existing Obamacare spending.  A key feature of this expansion increases subsidies for insurance companies such that the full cost of premiums for individuals with incomes between 100 and 150 percent of the Federal Poverty Level (FPL) is paid for by American taxpayers, often referred to as “zero-premium” plans. This policy, coupled with the Biden administration's regulatory actions to eliminate program integrity controls in the federal exchanges, such as prohibiting key eligibility verification procedures, appears to have created both the incentive and opportunity for individuals and brokers to misstate enrollees’ income to place them in benchmark plans receiving the maximum subsidy.  Individuals enrolled in this income cohort nationwide exceed the total number of potentially eligible individuals. This problem appears to be particularly acute in certain states, with some reporting hundreds of thousands, and, in one case, millions more individuals enrolled in these plans than are reasonably likely to be eligible. More than half of all enrollees in the federal exchange now report incomes between 100 and 150 percent of FPL—notably higher than the historical average of roughly 40 percent—further demonstrating the breadth of the enrollment incongruity.  While individuals may reasonably misestimate their income at any given point, the scale of the problem suggests malicious intent from certain actors involved. There have been documented issues with broker behavior surrounding these “zero-premium” plans, with reports and litigation detailing practices of consumers having their plan switched by such brokers without their consent.  Estimates show the cost of improperly enrolled individuals in “zero-premium” plans are $15 billion to $20 billion per year and potentially as high as $26 billion per year. If these estimates are accurate, it implies that these improper payments represent more than half the cost of making the expanded subsidies permanent.  Runaway deficits and debt are threatening to breach historic levels in the next decade, and, by 2054, the cost of simply servicing our national debt will more than double relative to Gross Domestic Product (GDP), crowding out other important national priorities. Given this grave situation, it is critical that the federal government safeguard increasingly scarce resources to ensure that every dollar spent goes as far as possible to improve Americans’ wellbeing.  CLICK HERE to read the letter to HHS Inspector General Christi Grimm. CLICK HERE to read the letter to GAO Comptroller General Gene Dodaro.