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The Latest

From the Committee

Jul 25, 2024
Press Release
E&C Republicans Press HHS and NIH over Withheld Documents About Risky MPVX Experiment at NIAID, Threaten Subpoena

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.


More News & Announcements


Jul 25, 2024
Press Release

Bipartisan E&C Leaders Press WADA President for Additional Information About its Failure to Penalize Chinese Swimmers Who Failed Drug Doping Tests

Letter comes on the eve of athletes competing in the Paris Olympics and after WADA’s President refused to attend an Energy and Commerce Committee oversight hearing Washington, D.C. — In a new letter to World Anti-Doping Agency (WADA) President Witold Banka, bipartisan House Energy and Commerce Committee leaders pressed for answers regarding WADA’s handling of positive doping cases within China’s national swimming team ahead of the Tokyo Olympics. The letter contains questions that bipartisan Committee Members would have asked during a recent Subcommittee on Oversight and Investigations hearing , which Mr. Banka was invited to attend but refused to appear. Witnesses that did testify at the hearing included: Michael Phelps, American swimmer and Olympic gold medalist   Allison Schmitt, American swimmer and Olympic gold medalist   Travis Tygart , Chief Executive Officer, United States Anti-Doping Agency (USADA) KEY EXCERPTS:   “We write today to express our sincere disappointment at your refusal to accept our invitation to attend and provide testimony at our recent Subcommittee hearing. Members of Congress have important questions for the World Anti-Doping Agency (WADA) and are especially concerned about recent reports of your handling of dozens of cases of doping within the Chinese swimming team.  “WADA purports to maintain the integrity of sports by creating a fair and competitive sporting environment free from doping. As a U.S. taxpayer supported entity, WADA has a responsibility to the American people to ensure this integrity by enforcing international testing requirements. We believe WADA has fallen short of this important mission. ”  [...]   “ We are particularly concerned with the excessive deference being extended toward CHINADA—a state-funded operation with leadership deeply intertwined with the Chinese Communist Party (CCP), as current [Chinese Anti-Doping Agency] CHINADA director Li Zhiquan also serves as a Committee Secretary for the CCP. At a meeting in 2023, Zhiquan called on CHINADA employees to be 'loyal to the party' and to 'hold high the great banner of Xi Jinping Thought on Socialism with Chinese Characteristics for a New Era.' Furthermore, WADA’s reported sponsorship arrangement with ANTA Sports—the Chinese athletic company sponsoring the Chinese Olympic Committee and China’s national swimming federation—could be perceived as a conflict of interest. Since WADA is expected to uphold and maintain international anti-doping standards, WADA’s apparent lack of skepticism and failure to enforce the rules against CHINADA is troubling. While we are aware that WADA has opened an investigation, we are concerned that international scrutiny was necessary to force due diligence that should be routine .”  [...]  “This incident unfortunately reinforces our concern that WADA appears to be reverting to its previous poor management practices.”  [...]  “With the Paris Summer Olympic Games Opening Ceremony just a day away , the Committee seeks to better understand the circumstances surrounding WADA’s decision not to appeal the decision to clear the twenty-three swimmers who tested positive for trimetazidine.”   BACKGROUND :  In January 2021, 23 Chinese swimmers (“23 swimmers”) tested positive for trimetazidine, or TMZ, a banned substance improperly used to increase stamina and hasten recovery times.  Three months after the positive tests, CHINADA initiated an investigation into the source of the TMZ and by June 2021 claimed the athletes ingested the banned substance through food tainted in a hotel kitchen.  According to reporting, Chinese investigators “offered no explanation […] for how a prescription drug available only in pill form had contaminated an entire kitchen.”  In reliance on “external legal advice” and its science department, WADA determined that CHINADA’s claims were “plausible” and chose not to appeal the decision or further investigate the matter.  Three of these Chinese swimmers went on to win gold medals at the Tokyo Olympic Games in July of 2021.  China has selected 11 swimmers that tested positive for TMZ before the Tokyo Games to compete in the upcoming Paris Games.  In a strikingly similar case, Kamila Valieva, a Russian figure skater, also tested positive for the banned substance TMZ during the 2022 Beijing Olympics.  The Russian Anti-Doping Agency (RUSADA) issued a provisional suspension but was quickly cleared by RUSADA’s discipline board, since Valieva claimed she ingested the substance by mistake through a contaminated source.  Rather than simply accept RUSADA’s contamination explanation, WADA appealed the decision and ultimately, Valieva received a four-year ban from competition and was retroactively stripped of her gold medal. The letter was signed by Committee Chair Cathy McMorris Rodgers (R-WA) and Committee Ranking Member Frank Pallone, Jr., (D-NJ), Subcommittee on Innovation, Data, and Commerce Chair Gus Bilirakis (R-FL) and Ranking Member Jan Schakowsky (D-IL), and Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-VA) and Ranking Member Kathy Castor (D-FL). CLICK HERE to read the full letter.



Jul 25, 2024
Press Release

E&C Republicans Open Inquiry into NTIA’s Online Domain Name Registry Contracts Ahead of Renewal

Washington, D.C. — In a new letter to the National Telecommunications and Information Administration, House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA), Subcommittee on Communications and Technology Chair Bob Latta (R-OH), and Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-VA) requested information about the agency’s internet domain name registry agreement with Verisign, Inc. (Verisign). BACKGROUND :  The NTIA represents the United States government on the Governmental Advisory Committee of the Internet Corporation for Assigned Names and Numbers (ICANN), the multi-stakeholder, not-for-profit entity that was founded in 1998 to coordinate the Internet domain name system, among other Internet management-related activities. Since 2001, Verisign has operated the .com and .net domain name registries.   Verisign manages the .com registry under two agreements—a .com Registry Agreement between ICANN and Verisign and a Cooperative Agreement between the NTIA and Verisign.  Both of these agreements are in place through November 30, 2024.  As the expiration dates of these agreements approach, some have suggested that the NTIA should reassess certain aspects of both agreements.   Under the Cooperative Agreement’s terms, it will automatically renew on November 30, 2024, unless Verisign provides written notice of non-renewal within 120 days of its expiration.   The Department of Justice has previously recommended ICANN hold a competitive bidding process for renewals of registry agreements.   The current agreement, as amended, has allowed Verisign, with ICANN’s agreement, in each of the last four years of every six-year contract period, to increase the maximum price Verisign charges for yearly registration or renewal of a .com name by up to seven percent over the maximum price it charged in the previous year.   Verisign has since instituted a price increase of the maximum amount in every year it was allowed to do so.   KEY LETTER EXCERPT :  “With both a role in advising ICANN and as a party to the Cooperative Agreement, the NTIA bears responsibility for supporting a domain name system that enables the growth of online commerce. Both individual consumers and businesses depend on responsible management of the .com system. Monopolistic elements and excessive domain name price increases stifle the ability of potential .com registrants to conduct business online.  “As such, we seek more information about the NTIA’s process in considering the renewal of both the Registry Agreement and the Cooperative Agreement.”  CLICK HERE to read the letter. 



Jul 25, 2024
Press Release

E&C Leaders Ask DOJ, HHS for Information Regarding Unusual Process for Marijuana Rescheduling

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.


Trending Subcommittees

Innovation, Data, and Commerce


11 Updates

Interstate and foreign commerce, including all trade matters within the jurisdiction of the full committee; consumer protection, including privacy matters generally; data security; motor vehicle safety; regulation of commercial practices (the Federal Trade Commission), including sports-related matters; consumer product safety (the Consumer Product Safety Commission); product liability; and regulation of travel, tourism, and time. The Subcommittee’s jurisdiction can be directly traced to Congress’ constitutional authority “to regulate Commerce with foreign nations, and among the several States, and with the Indian Tribes.”


Communications & Technology


10 Updates

Electronic communications, both Interstate and foreign, including voice, video, audio and data, whether transmitted by wire or wirelessly, and whether transmitted by telecommunications, commercial or private mobile service, broadcast, cable, satellite, microwave, or other mode; technology generally; emergency and public safety communications; cybersecurity, privacy, and data security; the Federal Communications Commission, the National Telecommunications and Information Administration, the Office of Emergency Communications in the Department of Homeland Security; and all aspects of the above-referenced jurisdiction related to the Department of Homeland Security.


Energy, Climate, & Grid Security


13 Updates

National Energy Policy, energy infrastructure and security, energy related Agencies and Commissions, all laws, programs, and government activities affecting energy matters. National Energy Policy focuses on fossil energy; renewable energy; nuclear energy; energy conservation, utility issues, including but not limited to interstate energy compacts; energy generation, marketing, reliability, transmission, siting, exploration, production, efficiency, cybersecurity, and ratemaking for all generated power. Energy infrastructure and security focuses on pipelines, the strategic petroleum reserve, nuclear facilities, and cybersecurity for our nation’s grid. Our jurisdiction also includes all aspects of the above-referenced jurisdiction related to the Department of Homeland Security. Agencies and Commissions in our jurisdiction include: The US Department of Energy, the Nuclear Regulatory Commission; and the Federal Energy Regulatory Commission.


Recent Letters


Jul 25, 2024
Press Release

Bipartisan E&C Leaders Press WADA President for Additional Information About its Failure to Penalize Chinese Swimmers Who Failed Drug Doping Tests

Letter comes on the eve of athletes competing in the Paris Olympics and after WADA’s President refused to attend an Energy and Commerce Committee oversight hearing Washington, D.C. — In a new letter to World Anti-Doping Agency (WADA) President Witold Banka, bipartisan House Energy and Commerce Committee leaders pressed for answers regarding WADA’s handling of positive doping cases within China’s national swimming team ahead of the Tokyo Olympics. The letter contains questions that bipartisan Committee Members would have asked during a recent Subcommittee on Oversight and Investigations hearing , which Mr. Banka was invited to attend but refused to appear. Witnesses that did testify at the hearing included: Michael Phelps, American swimmer and Olympic gold medalist   Allison Schmitt, American swimmer and Olympic gold medalist   Travis Tygart , Chief Executive Officer, United States Anti-Doping Agency (USADA) KEY EXCERPTS:   “We write today to express our sincere disappointment at your refusal to accept our invitation to attend and provide testimony at our recent Subcommittee hearing. Members of Congress have important questions for the World Anti-Doping Agency (WADA) and are especially concerned about recent reports of your handling of dozens of cases of doping within the Chinese swimming team.  “WADA purports to maintain the integrity of sports by creating a fair and competitive sporting environment free from doping. As a U.S. taxpayer supported entity, WADA has a responsibility to the American people to ensure this integrity by enforcing international testing requirements. We believe WADA has fallen short of this important mission. ”  [...]   “ We are particularly concerned with the excessive deference being extended toward CHINADA—a state-funded operation with leadership deeply intertwined with the Chinese Communist Party (CCP), as current [Chinese Anti-Doping Agency] CHINADA director Li Zhiquan also serves as a Committee Secretary for the CCP. At a meeting in 2023, Zhiquan called on CHINADA employees to be 'loyal to the party' and to 'hold high the great banner of Xi Jinping Thought on Socialism with Chinese Characteristics for a New Era.' Furthermore, WADA’s reported sponsorship arrangement with ANTA Sports—the Chinese athletic company sponsoring the Chinese Olympic Committee and China’s national swimming federation—could be perceived as a conflict of interest. Since WADA is expected to uphold and maintain international anti-doping standards, WADA’s apparent lack of skepticism and failure to enforce the rules against CHINADA is troubling. While we are aware that WADA has opened an investigation, we are concerned that international scrutiny was necessary to force due diligence that should be routine .”  [...]  “This incident unfortunately reinforces our concern that WADA appears to be reverting to its previous poor management practices.”  [...]  “With the Paris Summer Olympic Games Opening Ceremony just a day away , the Committee seeks to better understand the circumstances surrounding WADA’s decision not to appeal the decision to clear the twenty-three swimmers who tested positive for trimetazidine.”   BACKGROUND :  In January 2021, 23 Chinese swimmers (“23 swimmers”) tested positive for trimetazidine, or TMZ, a banned substance improperly used to increase stamina and hasten recovery times.  Three months after the positive tests, CHINADA initiated an investigation into the source of the TMZ and by June 2021 claimed the athletes ingested the banned substance through food tainted in a hotel kitchen.  According to reporting, Chinese investigators “offered no explanation […] for how a prescription drug available only in pill form had contaminated an entire kitchen.”  In reliance on “external legal advice” and its science department, WADA determined that CHINADA’s claims were “plausible” and chose not to appeal the decision or further investigate the matter.  Three of these Chinese swimmers went on to win gold medals at the Tokyo Olympic Games in July of 2021.  China has selected 11 swimmers that tested positive for TMZ before the Tokyo Games to compete in the upcoming Paris Games.  In a strikingly similar case, Kamila Valieva, a Russian figure skater, also tested positive for the banned substance TMZ during the 2022 Beijing Olympics.  The Russian Anti-Doping Agency (RUSADA) issued a provisional suspension but was quickly cleared by RUSADA’s discipline board, since Valieva claimed she ingested the substance by mistake through a contaminated source.  Rather than simply accept RUSADA’s contamination explanation, WADA appealed the decision and ultimately, Valieva received a four-year ban from competition and was retroactively stripped of her gold medal. The letter was signed by Committee Chair Cathy McMorris Rodgers (R-WA) and Committee Ranking Member Frank Pallone, Jr., (D-NJ), Subcommittee on Innovation, Data, and Commerce Chair Gus Bilirakis (R-FL) and Ranking Member Jan Schakowsky (D-IL), and Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-VA) and Ranking Member Kathy Castor (D-FL). CLICK HERE to read the full letter.



Jul 25, 2024
Press Release

E&C Leaders Ask DOJ, HHS for Information Regarding Unusual Process for Marijuana Rescheduling

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.



Jul 25, 2024
Press Release

E&C Republicans Open Inquiry into NTIA’s Online Domain Name Registry Contracts Ahead of Renewal

Washington, D.C. — In a new letter to the National Telecommunications and Information Administration, House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA), Subcommittee on Communications and Technology Chair Bob Latta (R-OH), and Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-VA) requested information about the agency’s internet domain name registry agreement with Verisign, Inc. (Verisign). BACKGROUND :  The NTIA represents the United States government on the Governmental Advisory Committee of the Internet Corporation for Assigned Names and Numbers (ICANN), the multi-stakeholder, not-for-profit entity that was founded in 1998 to coordinate the Internet domain name system, among other Internet management-related activities. Since 2001, Verisign has operated the .com and .net domain name registries.   Verisign manages the .com registry under two agreements—a .com Registry Agreement between ICANN and Verisign and a Cooperative Agreement between the NTIA and Verisign.  Both of these agreements are in place through November 30, 2024.  As the expiration dates of these agreements approach, some have suggested that the NTIA should reassess certain aspects of both agreements.   Under the Cooperative Agreement’s terms, it will automatically renew on November 30, 2024, unless Verisign provides written notice of non-renewal within 120 days of its expiration.   The Department of Justice has previously recommended ICANN hold a competitive bidding process for renewals of registry agreements.   The current agreement, as amended, has allowed Verisign, with ICANN’s agreement, in each of the last four years of every six-year contract period, to increase the maximum price Verisign charges for yearly registration or renewal of a .com name by up to seven percent over the maximum price it charged in the previous year.   Verisign has since instituted a price increase of the maximum amount in every year it was allowed to do so.   KEY LETTER EXCERPT :  “With both a role in advising ICANN and as a party to the Cooperative Agreement, the NTIA bears responsibility for supporting a domain name system that enables the growth of online commerce. Both individual consumers and businesses depend on responsible management of the .com system. Monopolistic elements and excessive domain name price increases stifle the ability of potential .com registrants to conduct business online.  “As such, we seek more information about the NTIA’s process in considering the renewal of both the Registry Agreement and the Cooperative Agreement.”  CLICK HERE to read the letter.