Faculty Bibliography

In its decades-long effort to assure the safety, efficacy, and security of medicines and other products, the Food and Drug Administration has struggled with issues of funding, proper associations with industry, and the balance between consumer choice and consumer protection. Today, these challenges are compounded by the pressures of globalization, the introduction of novel technologies, and fast-evolving threats to public health. With essays by leading scholars and government and private industry experts, FDA in the Twenty-First Century addresses perennial and new problems and the improvements the agency can make to better serve the public good.The collection features essays on effective regulation in an era of globalization, consumer empowerment, and comparative effectiveness, as well as questions of data transparency, conflicts of interest, industry responsibility, and innovation policy, all with an emphasis on pharmaceuticals. The book also intervenes in the debate over off-label drug marketing and the proper role of the FDA before and after a drug goes on the market. Dealing honestly and thoroughly with the FDA's successes and failures, contributors rethink the structure, function, and future of the agency and the effect policy innovations may have on regulatory institutions in other countries.

Can your employer require you to travel to India for a hip replacement as a condition of insurance coverage? If injury results, can you sue the doctor, hospital or insurer for medical malpractice in the country where you live? Can a country prohibit its citizens from helping a relative travel to Switzerland for assisted suicide? What about travel for abortion? In Patients with Passports, I. Glenn Cohen tackles these important questions, and provides the first comprehensive legal and ethical analysis of medical tourism. Medical tourism is a growing multi-billion dollar industry involving millions of patients who travel abroad each year to get health care. Some seek legitimate services like hip replacements and travel to avoid queues, save money, or because their insurer has given them an incentive to do so. Others seek to circumvent prohibitions on accessing services at home and go abroad to receive abortions, assisted suicide, commercial surrogacy, or experimental stem cell treatments. In this book, author I. Glenn Cohen focuses on patients traveling for cardiac bypass and other legal services to places like India, Thailand, and Mexico, and analyzes issues of quality of care, disease transmission, liability, private and public health insurance, and the effects of this trade on foreign health care systems. He goes on to examine medical tourism for services illegal in the patient's home country, such as organ purchase, abortion, assisted suicide, fertility services, and experimental stem cell treatments. Here, Cohen examines issues such as extraterritorial criminalization, exploitation, immigration, and the protection of children. Through compelling narratives, expert data, and industry explanations Patients with Passports enables the reader to connect with the most prevalent legal and ethical issues facing medical tourism today.

The ANPRM requested public comment on how the current regulations for protecting human research subjects might be modernized and revised to improve efficiency and enhance protections. The ANPRM represents the first potential revision ...