Does the FDA have the authority to regulate drugs intended for lethal injection, or other devices used for execution (such as electric chairs, gallows, firing squads, and firearms), as "drugs" or "devices" under the FDCA? How would the FDA Tobacco case apply to this question?

Regulatory llll Review A Publication of the Penn Program on Regulation News | Education | Feb 6, 2019 The New Face of Title IX Due Process Daniel Kees Education Department's proposed rule could transform procedural protections under Title IX. Sexual harassment and other forms of gender-based violence occupy a larger segment of the national conversation than ever before. Repeated revelations of harassment by famous men have dominated the news cycle over the past year, but a major part of the larger national conversation has also focused on sexual misconduct on college campuses. https://www.theregreview.org/2019/02/06/kees-new-face-title-ix-due-process/ Page 1 of 5The New Face of Title IX Due Process | The Regulatory Review 'I'UQI22. 1":35 PM Recently, the Trump Administration took a major step to revise federal policy related to campus sexual assault. In November 2018, the US. Department of Education proposed a rule that would change how schools respond to sexual harassment and assault under Title IX, the federal law prohibiting sex-based discrimination in any federally funded school. The period for public comment on the proposed rule ended last week. The proposed rule would take the novel step of articulating a denition for Title IX sexual harassment, which the Education Department considers consistent with Supreme Court case law: unwelcome conduct so \"severe, pervasive, and objectively offensive\" that it denies a person equal access to an education. Schools would need to dismiss formal complaints alleging harms that fail to meet the Education Department's denition of harassment. Last year, the Education Department rescinded Obama-era guidance documents advising schools on a different way to handle sexual misconduct and other Title IX violations. Under the Obama Administration standard, schoolsnot law enforcement had the responsibility to investigate sexual assault allegations. Although this responsibility would continue under the proposed rule, Education Secretary Betsy DeVos stated that the Obama guidance did not offer sufcient due process protections for persons accused of sexual assault. Unlike Obama-era guidance, the Trump Administration's proposed rule would require formal due process protections for the students involved. Although schools must still provide a meaningful response to all reports of sexual harassment, only formal complaints would trigger the requirement that they investigate. This distinction would give schools greater discretion in handling informal complaints of sexual harassment. Schools would have to provide formal written notice to the accused that species the alleged misconduct, and the schools' grievance procedures would include a presumption of innocence until the school makes a determination of responsibility. ht![.Js:Mwww.1heregrevieworgCl'l9"02illilf'kees-nevArAi'atm-litle-int-due-ptocess;r Page 2 01'5 The New Face of Title IX Due Process i The Regulatory Review 11,!9J22. 7:35 PM Students would be given the opportunity to review all evidencewhich cannot be copied or downloadedused in the investigative report, and students would have at least 10 days to submit optional written responses prior to the report's ling. The Education Department's proposal specifies that schools would not be able to restrict either party's ability to discuss matters of the case, which means that schools could not issue a \"gag order\" to keep proceedings condential. This action could pose problems for students wanting to keep the case private. If an investigation is initiated, the schoolnot the students involvedcarries the burden of proof and the burden of evidence gathering to determine responsibility. The on-campus Title IX Coordinator or a school-appointed investigator would interview the students and witnesses, collect documentary or other types of evidence, compile a report, and perform all other investigation-related duties. This person, however, could not also serve as the decision-maker or as part of a decision-making panel. In the proposed rule, the Education Department rejected a \"single investigator\" or \"investigator-only\" model for the Title IX grievance process, reasoning that the separation of investigative and decision-making duties would create a fairer process. Under the proposed rule, schools could apply the clear and convincing evidence standard or the Obama-backed preponderance of the evidence standard. The lower preponderance standard, however, would only be available if the school already uses it for non-sexual harassment conduct violations that carry the same maximum disciplinary penalties. Schools must use the same standard for complaints involving students and employees, including faculty, a move the Department says will lead to fairer outcomes, as students have traditionally had fewer formal protections than faculty in misconduct investigations. The proposed rule would also require colleges and universities to conduct a live hearing that could include cross-examination. Subject to school approval, the students' chosen advisors, who may be attorneys, would perform the cross- examination. The proposed rule would require that an advisor conduct the htlszlwwaheregreview.orgi20'i9)'024'06.ikees-newfacetitleixdueprocessl Page 3 01'5 The New Face of Title IX Due Process | The RegulatoryI Review 1119,92. 7'35 PM questioning because it bars personal confrontation between the students, who can request that crossexamination take place with students in separate rooms, allowing the accused to watch live via technological means. The proposed rule would also require that \"rape shield\" protectionswhich generally prohibit questions about an accuser's sexual historybe in place during the hearing proceedings. After reaching a decision, schools would issue a written decision outlining the investigation's ndings and evidentiary support, the decisionmaking rationale, the appropriate sanctions, and information about the school's appeals process. In the proposed rule, the Education Department emphasized that all students must be treated equitably throughout the process and that all remedies must be designed to \"restore or preserve access\" to the school's educational program or activity. If schools comply with these grievance procedures, the proposed rule would create a safe harbor against a nding of \"deliberate indifference\" in court, reducing the viability of a lawsuit against a school for its handling of a Title IX investigation. Proponents of the proposal applaud what they consider its transparency and focus on accountability. Secretary DeVos said in a press release that the proposal's goal is to make Title IX grievance proceedings \"more transparent, consistent, and reliable.\" She also noted that protecting the accuser and the accused \"are not mutually exclusive ideas.\" Opponents of the proposed rule argue that the focus on protecting accused students would create barriers that deny equal protection to those who report sexual harassment. For example, they point to a provision that allows students to submit to an informal resolution, such as a mediation, at any point before a responsibility determinationwhich Obama guidance ruled out due to its potential chilling effect on reporting assaults. The Education Department, however, says this options gives schools more exibility in handling sexual harassment matters. Critics also contend that the proposed rule creates \"procedural and technological challenges\" for schoolswhich vary in their capacities to investigate Title IX i'ltt[:1s:l'fwww.tl'leregreview.orgu'z()'IQICIrZJ'OSJkees'I'newvfacevtl'tlevintrt'iuevprocess;r Page 4 of 5 The New Face of Title IX Due Process | The Regulatory Review 111'9122, 7135 PM complaintsto comply with the grievance procedures. Many critics argue that the lack of a gag order might hurt accusers' reputations on campus and that hearings might re-traumatize assault Victims. Some opponents also lament that the rule would completely absolve schools of misconduct occurring off campus at places like fraternity partiesa likely setting for campus sexual assault. The Education Department denies that the rule would make such a geographic distinction, and it afrms that school liability will be based on the particular facts of the casesuch as whether an offcampus event was paid for by the school or occurred on property the school owns. The proposed rule has also drawn criticism by individuals and groups that view the change as harmful to student safety. The Society of Women Engineers (SWE), for example, said that Title IX is critical to the \"persistence and ultimate success\" of women in the academic setting, who now make up a majority of college graduates. SWE warned that inadequate protections would lead to a continued shortage of engineering talent in the United States. Former Vice President Joe Biden tweeted that the proposal would \"discourage sexual assault reporting and investigations,\" and he urged people to voice their concerns through the public notice-andcomment period that accompanies proposed rules. Now that the comment period has closed, the Education Department will begin the process of reviewing public input as it works to nalize the rule. Tagged: Barack Obama, Department of Education, Donald Trump, Due Process, Proposed Rule, Title IX h1tps:lit-.niuvii_1herearetrievworgum0'1Biroziflm'lkees-net-.r-face-title-i)