Representing the healthcare organization in a post-Sarbanes-Oxley world: new rules, new paradigms, new perils

The Sarbanes-Oxley Act (Act) significantly changed the expected corporate behavior of public companies. The Act governs the relationship between corporate organizations and their in-house or outside counsel. Under Section 307 of the Act, the Securities and Exchange Commission initially proposed expansive rules regarding counsel's duties. After comments and criticism from much of the bar, a final, narrower, version of rules under Section 307 (Final Rule) was adopted. The Final Rule contains alternative reporting procedures, attorney responsibilities, and sanctions for violations. In addition to the Act, the American Bar Association's (ABA) Task Force on Corporate Responsibility(Task Force), which was itself a reaction to Enron, reported on the importance of counsel's role in a corporate setting (Cheek Report). The ABA adopted amendments to its Model Rules of Professional Conduct (Model Rules) 1.6 and 1.13 as proposed in the Cheek Report. The Final Rule and amended Model Rules together suggest that attorneys may owe duties beyond those owed to their clients.     

A new beginning

Liverpool Law Review -     

Investigational new drug applications and new drug applications--FDA. Final rule

The Food and Drug Administration (FDA) is amending its regulations pertaining to new drug applications (NDA's) to clearly define in the NDA format and content regulations the requirement to present effectiveness and safety data for important demographic subgroups, specifically gender, age, and racial subgroups. FDA also is amending its regulations pertaining to investigational new drug applications (IND's) to require sponsors to tabulate in their annual reports the numbers of subjects enrolled to date in clinical studies for drug and biological products according to age group, gender, and race. This action is intended to alert sponsors as early as possible to potential demographic deficiencies in enrollment that could lead to avoidable deficiencies later in the NDA submission. This rule does not address the requirements for the conduct of clinical studies and does not require sponsors to conduct additional studies or collect additional data. It also does not require the inclusion of a particular number of individuals from specific subgroups in any study or overall. The rule refers only to the presentation of data already collected.     

Doctors and allocation decisions: a new role in the new Medicare

The role of the physician in the allocation of health care resources has come under renewed scrutiny in recent years. Doctors have always had to face the reality of scarce resources and to do their work in the context of social injustices. With the advent of Medicare and Medicaid came the rhetoric of universal access and the "right to health care." At the same time the field of bioethics was emerging and contributing ideas about other kinds of rights, such as the right to die with dignity. Physicians during this time did not see their role as that of gatekeeper, but rather as advocate for the best care for each individual patient. The 1980s has brought a new awareness of limited resources and the necessity for a rationale for allocation of resources. These social and professional shifts have confronted physicians with the need for yet another shift in their ethical stance. If they are to take part in allocation decisions, for the continued well-being of their patients and of the public health, they will need a new perspective on biomedical ethics. This role can be an ethical one for physicians providing certain criteria are met: there must be universal access to a basic minimum level of care, physicians' levels of income must not be directly related to treatment choices, there must be a closed financial system within which meaningful trade-offs can be made, and there must be an ethically acceptable framework for decision-making.     

The new ancillary offenses

This paper was originally presented at the first conference of the Society for the Reform of Criminal Law, Inns of Court, London, England, July 26–29, 1987. It constitutes part of a chapter in a larger work in progress.     

走进新时代

“一元复始 ,万象更新”。时间老人又一次撞响了新年的钟声 ,历史也随之翻开了新的一页。我们憧憬着、期待着、设计着的 2 0 0 0年 ,终于带着世纪老人的祝福叩响了每一个人的心弦 !在新千年的第一个春天来临的美好时刻 ,《山东法学》更名为《法学论坛》 ,内文由 56页增至 1 1 2页。本刊的这一改刊大动作 ,决不单纯是一个期刊名称的变化和容量的增加 ,它标志着《山东法学》适应依法治国、建设社会主义法治国家的需要 ,在内容上向理论的深层次迈出了重要的一步 ,实现了跨世纪的历史性飞跃 !从此以后 ,本刊将开始一个历史新纪元 !回想昨天 ,山…