Conflicts of interest frequently arise when industry experts advise federal agencies. Critics claim agencies’ decisions to waive conflicts of interest often lack consistency and clarity, but they have yet to propose a comprehensive system to improve the conflict of interest waiver process.
83_649
The American health care system is on a glide path toward ruin. Medical spending is rising at an unsustainable rate: it is on track to reach 30 percent of gross domestic product (“GDP”) a quarter century from now and half of GDP within seventy-five years. The number of Americans without health insurance is approaching fifty million, and surging unemployment could push this figure much higher. Most of the care that patients receive is of unproven value, and up to one hundred thousand Americans die prematurely each year from medical mistakes. So it is for good reason that health reform has returned to the top of the nation’s political agenda. A decade and a half after the collapse of President Clinton’s health reform plan, Americans are again pressing for relief from soaring costs and telling pollsters and politicians that they want medical care for all. The main difference, this time, is that the problems have grown much worse.
82_389
Should the law recognize an individual’s right not to be a genetic parent when genetic parenthood does not carry with it legal or gestational parenthood? If so, should we allow individuals to waive that right in advance, either by contract or a less formal means? How should the law’s treatment of gestational and legal parenthood inform these questions? Developments in reproductive technology have brought these questions to the fore, most prominently in the preembryo disposition cases a number of courts have confronted—disputes over the use of stored frozen preembryos that couples have fertilized in the course of In Vitro Fertilization (IVF)— but other examples abound.
81_1115
This bibliography serves as the 2002-2005 update to Gerontology and the Law: A Selected Annotated Bibliography. First published in 1980 by Law Library Journal, the bibliography has since been updated seven times between 1982 and 2001 in the Southern California Law Review. The original bibliography and the first five updates provide citations to a variety of books, articles, and other law related materials on various aspects of the law and gerontology. Starting with the sixth update, the style and content of the bibliography was changed in two ways: first, the bibliographers took a more selective approach in choosing resources to include and second, the bibliographers added descriptive annotations briefly describing the source after each citation.
80_1077
On August 24, 2006, after years of scientific research and politically charged debate, the U.S. Food and Drug Administration (“FDA”) approved an application for over-the-counter (“OTC”) status for Plan B, a type of emergency contraception (“EC”) previously available only by prescription. This FDA decision came more than two years after the agency’s much criticized denial of Plan B’s OTC application in 2004. The primary criticism of the 2004 denial was that it appeared reproductive politics were interfering in the FDA’s usual scientific process. Finally science won out, however, and in August 2006, the FDA announced that Plan B’s application for OTC status would be approved for “consumers 18 years and older.” The drug will remain prescription-only for girls under eighteen years of age.
While the FDA’s approval of Plan B’s OTC application will ease access to the drug for women eighteen and older, a significant and pervasive obstacle remains for women of all ages. Although a prescription will no longer be required for those women to obtain Plan B, the medication will be available only from behind a pharmacy counter, leaving the decision of whether to dispense the drug in the hands of the pharmacist on duty. This obstacle may seem innocuous, but the reality is far different.
80_865
No matter how much fascination it may provide to the lives of the lonely, the curious, the adventurous, or the ordinary, it is undeniable that pornography poses problems. This statement is not startling or revolutionary; no other industry has unfailingly produced equal parts astounding revenue, excitement, shame, and fear among every echelon of society. For decades, the adult film industry has operated a thriving worldwide empire centered in Southern California, generating billions of dollars in revenue and producing thousands of films per year. Notwithstanding its status as one of the largest industries in a heavily regulated state, the adult film industry has flourished for decades without a discernible trace of government oversight. In recent years, however, a particularly insidious problem within the industry has perched itself precariously at the threshold of the public consciousness and has threatened to end the government’s historical indifference toward the industry’s practices.
In the spring of 2004, a spate of HIV infections among performers in the Southern California adult film industry induced a panic when it was discovered that over sixty performers had been exposed to the disease. In response to the potential outbreak, several major pornography companies voluntarily halted production for several weeks, and over fifty performers who had been identified as having sexual intercourse with the infected performers agreed to place themselves on a “quarantine list,” ceasing all adult film work while awaiting their HIV test results. Although the industry’s proactive response managed to contain the infection’s spread, the crisis sharply called into question the adequacy of current screening and testing procedures in the adult film industry, and underscored the need for increased preventative measures.
79_667
The landmark Health Insurance Portability and Accountability Act (“HIPAA”), which President Bill Clinton signed into law on August 21, 1996, was enacted in response to advances in information technology and their dramatic impact on the health care industry. Until recently, most medical records were paper-based, but technological developments have made it increasingly efficient to collect, retain, transmit, and exchange health care data. Title II of HIPAA includes the Administrative Simplification provisions, which mandate the promulgation and adoption of national standards for electronic transactions, thereby encouraging the use of electronic data systems.
Electronic data transmission has sped the delivery of care and the processing of claims, improved systems for identifying and treating those at risk for disease, facilitated medical research, and helped to detect fraud and abuse. But at the same time, by reducing the logistical obstacles to dissemination that had previously helped to preserve the confidentiality of hard-copy records, shifting from paper-based to electronic information systems has increased the risk that sensitive information may become vulnerable to inappropriate uses and disclosures.
Consequently, with the shift to electronic data management, there has been a concomitant increase in concerns about the confidentiality and privacy of medical information. These concerns have been compounded by changes in the health care delivery system, including the rise in integrated and managed-care networks, which have resulted in more entities maintaining and exchanging information. Increasing numbers of individuals and organizations, including some not even affiliated with physicians or health plans, now have access to medical records
79_497
Twenty-five years ago, federal courts opened the door to the biotechnology revolution by granting patents on genetic inventions. Since that time, decisions across five disparate doctrines reflect confusion over the question of whether the definition of a biotechnology invention should include things beyond the state of the art at the time of the invention. Reaching beyond the state of the art may make sense for mechanical inventions, but it is wreaking havoc in doctrines related to biotechnology.
This Article argues that in uncertain arts such as biotechnology, the definition of an invention should be limited to the state of the art at the time of the invention. Granting rights beyond knowledge at the time of the invention projects an enormous shadow across the future and creates untenable results. The temptation to restrain that reach has led to strange doctrinal twists and an unworkable body of law. After twenty-five years of experience, it is time to rethink our view of the proper shape of rights in this realm.
79_1