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Drug Prices, Dying Patients, and the Pharmaceutical Marketplace: A New Conditional Approval Pathway for Critical Unmet Medical Needs
Get PDFPrescription drugs have been a major topic in the news for much of the past year. There are two issues which appear often: first, the very high prices of new drugs, particularly the specialty drugs developed for serious diseases; and second, the time required for FDA approval in relation to the perceived need for earlier access to new therapies for critically ill patients. Much less in the news, but lurking behind both issues, is the need for better information for physicians and patients to use in making decisions about prescribing and taking drugs, and for insurance companies and the government to use to structure their pharmaceutical benefits plans. This Article proposes an approach to accelerated access and drug prices that would generate this much needed information for doctors, patients, the government, and private insurers. The new form of conditional approval proposed here would be similar to the parallel track program developed by the FDA in the 1990s, during the HIV crisis. I argue that, like parallel track, the FDA could implement the conditional approval proposed here under its existing authority, that this approach would allow critically ill patients wide access to desperately needed drugs, and would also control prices for drugs that have not demonstrated clinical benefit until sufficient information is available about their real safety and efficacy
Legal Considerations in Pediatric and Adolescent Obstetrics and Gynecology
Get PDFProviding gynecologic and obstetric care for minors raises important legal issues and it is critical that health-care providers understand those legal issues. State laws are often somewhat complicated and unsettled in the areas minors’ of consent to treatment, privacy and information, and abuse reporting requirements. State statutes commonly give minors the authority to consent to treatment for STIs, pregnancy, and contraception. There are, however, many variations among states in these areas. Most states limit the ability of minors to consent to abortion without some parental (or court) involvement. In some circumstances, a physician may provide information to parents if it is in the best interest of the minor, but in other cases (especially regarding abortion) parental notification may be required. All states have laws requiring the reporting of physical, mental, or sexual abuse or human trafficking of minors. These laws also vary considerably from state to state. Involving minors in human studies carries special, and often complex, obligations for legal and ethical review. The laws governing gynecologic and obstetric care for minors are complex and state regulations change frequently. It is, therefore, important that those providing such care have an ongoing relationship with legal counsel who can ensure that their practices meet the requirements of the law. Counsel should also be available for consultation as needed
The Faulty Foundation of the Draft Restatement of Consumer Contracts
Get PDFProfessor Gregory Klass\u27s replication study of the Draft Restatement of the Law of Consumer Contract\u27s empirical analysis of privacy policies found troubling and pervasive problems with the Reporters\u27 coding of cases. We extended Professor Klass\u27s study with a replication of the coding of the two largest datasets supporting the Draft Restatement, those on the enforceability of unilateral contract modifications and those on the enforceability of clickwrap assent. For the replication, we reviewed 186 cases blind to the Reporters\u27 coding.
We found that nearly two-thirds of the cases in the unilateral modification dataset were irrelevant to the hypothesis tested by the Reporters. The irrelevant cases included business-to-business cases, vacated and reversed decisions, a duplicate decision, and cases determined on statutory grounds specific to credit card agreements. The remaining relevant cases were atypical, almost entirely involving enforcement of arbitration clauses, express contractual clauses permitting unilateral modifications, or credit card agreements.
Likewise, we found that nearly half of the cases in the clickwrap assent dataset were irrelevant to the Reporters\u27 tested hypothesis. The irrelevant cases included business-to-business cases, another duplicate decision, and cases with neither contracts nor clickwrap agreements. The overwhelming majority of the relevant cases involved the sui generis contexts of enforcement of arbitration clauses or forum selection clauses. Among such cases, we also found a materially higher rate of non-enforcement of clickwrap agreements than the Reporters found.
Based on our attempt to replicate the Reporters\u27 coding, we lack confidence that the Draft Restatement correctly and accurately restates the law of consumer contracts
Robbing the Cradle: The Implications of Depleting Financial Incentives for Orphan Drug Manufacturers and Imposing Stricter Research Guidelines for Rare Pediatric Diseases
Get PDFSame Pill, Different Price: The Case for Policy Reform in the United States Based on Pharmaceuticals’ Access Strategies in International Markets
Get PDFComputational Experimentation
Get PDFExperimentation conjures images of laboratories and equipment in biotechnology, chemistry, materials science, and pharmaceuticals. Yet modern day experimentation is not limited to only chemical synthesis, but is increasingly computational. Researchers in the unpredictable arts can experiment upon the functions, properties, reactions, and structures of chemical compounds with highly accurate computational techniques. These computational capabilities challenge the enablement and utility patentability requirements. The patent statute requires that the inventor explain how to make and use the invention without undue experimentation and that the invention have at least substantial and specific utility. These patentability requirements do not align with computational research capabilities, which allow inventors to file earlier patent applications, develop prophetic examples, and provide supporting disclosure in the patent specification without necessarily conducting traditional, laboratory-based experiments. This Article explores the contours and applications of computational capabilities on patentability, proposes reforms to the utility doctrine and to patent examination, responds to potential critiques of the proposed reforms, and analyzes innovation policy in the unpredictable arts. In light of increasing computational experimentation, this Article recommends strengthening the utility requirement in order to prevent a state of patent law in which enablement is subsumed into utility
The Value of Deviance: Understanding Contextual Privacy
Get PDFRecent decisions by the Supreme Court in Carpenter v. United States and the Illinois Supreme Court in Rosenbach v. Six Flags Entertainment Corporation signal a shift in the traditional understanding of what exactly is protected by a privacy interest. Carpenter distinguished between a police officer’s observation of a suspect’s location and a perpetual catalogue of a person’s movements obtained through cell site location information (CSLI). The pervasive and vast quantity of information from CSLI exposed a protected privacy interest. In Rosenbach, the Illinois Supreme Court found the unique and personal quality of biometric information meant that consent and disclosure requirements under the state’s Biometric Information Privacy Act (BIPA) were not “merely technical in nature” and did not require additional allegations of harm. These decisions move away from a binary conception of privacy - which ignores distinctions between types of information disclosures and the harm emanating from them - toward a contextual conception of privacy - which takes into account the quality and quantity of information as well as the original purpose of the disclosure.An examination of sociological definitions of deviance help to understand contextual privacy. Section I notes that sociological deviance is highly contextual and relational, depending not only on the specific behavior or characteristic, but also on the group that defines or enforces the characteristic as deviant. Because deviance depends on the potential imposition of sanctions by others, the manner of disclosure and the extent of distribution of information matters. Section II examines the “Nothing to Hide” arguments developed by Professor Daniel Solove and noted in the dialogue between the majority and the dissenters in Carpenter. Section III argues that there is inherent value to deviance. A better understanding of the concept of deviance not only adds value to specific policy debates about privacy and security, but also highlights the importance of diversity in our communities
The Temptations of Scapegoating
Get PDFWe say “it is better that ten guilty persons escape, than one innocent suffer.” Evidence of the law’s 10:1 preference for false acquittals, however, is weak. In actuality, the “twofold aim … that guilt shall not escape or innocence suffer” weights the avoidance of false convictions and false acquittals equally. Likewise, the Supreme Court’s claim that “the central purpose of a criminal trial is to decide the factual question of the defendant’s guilt or innocence” is, it turns out, porous. The truth sought at trial need be only true enough—verdicts are legally true if fairly arrived at. While the risk of false convictions is considered acceptable, the materialization of that risk is by all accounts a non-trivial event.
Scapegoating is such an event. Scapegoats overpay for their part (if part there be) in harm-causing events, without which there can be false accusations, but no scapegoats. Here I identify four types of scapegoating, which I designate as 1) frame-ups, 2) axe-grindings, 3) patsies, and 4) reckonings. None track the original Levitical sense of the term, whereby Aaron transferred the collective guilt of the people to a goat that he banishes with their sins. That Levitical sense still has point: for example, Dr. Larry Nassar recently took a sentence of 40 to 175 years so that, we might say, the structures that enabled his sexual abuse of some 200 girls can go unabated.
Yet few of the nearly 20,000 Westlaw mentions of scapegoating rely on this strict sense of the term. Instead, most point to more extended senses. Here I attempt the first taxonomy of scapegoating in senses of the term that have been stretched over time, but stretched neither unnaturally nor all out of shape. My intention is to help us reach discovery or agreement as to when and why scapegoating can pose a nontrivial temptation to those sitting in judgment, thereby threatening to undermine principles of equality in punishment: principles of treating humans as ends in themselves