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Articles 1 - 11 of 11
Full-Text Articles in Law
Ensuring Effective Pain Treatment: A National And Global Perspective, Allyn L. Taylor, Lawrence O. Gostin, Katrina A. Pagonis
Ensuring Effective Pain Treatment: A National And Global Perspective, Allyn L. Taylor, Lawrence O. Gostin, Katrina A. Pagonis
O'Neill Institute Papers
Medical availability of effective pain medication is vitally important domestically and globally. Medical advances have substantially improved the technical capacity to control pain and diminish its consequences. Worldwide, millions of persons with chronic, acute, and terminal conditions have found relief from excruciating pain through medical intervention. However, richer countries have disproportionately benefited from improvements in access to and use of pain medication. The tragedy is that for most of the world's population, particularly persons in poorer countries, effective pain control is entirely unavailable.
Jesting Pilate, Carl E. Schneider
Jesting Pilate, Carl E. Schneider
Articles
I have two goals this month. First, to examine a case that's in the news. Second, to counsel skepticism in reading news accounts of cases. Recently, I was talking with an admirable scholar. He said that transplant surgeons sometimes kill potential donors to obtain their organs efficiently. He added, "This isn't just an urban legend - there's a real case in California." A little research turned up California v. Roozrokh. A little Googling found stories from several reputable news sources. Their headlines indeed intimated that a transplant surgeon had tried to kill a patient to get transplantable organs. CNN.com: …
Improving Access To Medicines Doesn't Have To Mean More Patents, Luigi Palombi
Improving Access To Medicines Doesn't Have To Mean More Patents, Luigi Palombi
Luigi Palombi
Access to medicines presupposes that there are medicines to access, but the development of medicines, especially those needed to treat diseases that inflict the poor and the disadvantaged, are especially difficult to access because of the pharmaceutical industry’s paradigm of medicines being inextricably linked to patents; meaning, without patents there is no incentive to undertake the necessary R&D to develop new medicines. This paper argues that this is a lie; told by pharmaceutical executives and spread by well meaning scientists. Uncontested by policymakers in the 1960’s it has become a truth that threatens scientific progress, the development of appropriate medicines …
Fda New Drug Review Times, Prescription Drug User Fee Acts, And R&D Spending, John Vernon
Fda New Drug Review Times, Prescription Drug User Fee Acts, And R&D Spending, John Vernon
John Vernon
FDA approval times have declined significantly since the enactment of the Prescription Drug User Fee Act (PDUFA) in 1992. As a result, present value expected returns to pharmaceutical R&D have likely increased. In the current paper we employ a unique survey dataset, one which includes data from 1990 to 1999 on firm-level pharmaceutical R&D expenditures for 7 large, U.S.-based drug companies. We estimate the effect FDA approval times have on firm R&D spending. Controlling for other factors such as pharmaceutical profitability and cash flows, we estimate that a 10 percent decrease (increase) in FDA approval times leads to an increase …
Will Everyone Get Their Best Medicine? Implications For Off-Label Use Of Pharmaceuticals In An American Universal Healthcare Regime, Kathryn Young
Will Everyone Get Their Best Medicine? Implications For Off-Label Use Of Pharmaceuticals In An American Universal Healthcare Regime, Kathryn Young
Saint Louis University Journal of Health Law & Policy
No abstract provided.
Improving Post-Approval Risk Surveillance For Drugs: Active Post-Market Risk Identification, Matthew Gordon
Improving Post-Approval Risk Surveillance For Drugs: Active Post-Market Risk Identification, Matthew Gordon
Michigan Telecommunications & Technology Law Review
Pre-approval clinical trials cannot possibly ensure that a drug will not have disastrous side effects once it arrives on the market. Post-approval drug safety data gathering was put in place to address this problem, but as implemented, it has not proven to be as effective as hoped. Congress recently overhauled the legislation regarding post-approval drug risk identification, and in doing so made a deliberate decision to put much of the burden of post-approval drug surveillance on the FDA through data mining. Further, the legislation gave the FDA the power to require post-approval clinical trials from drug makers only in limited …
Clear Notice For Conditions On Spending, Unclear Implications For States In Federal Healthcare Programs, Nicole Huberfeld
Clear Notice For Conditions On Spending, Unclear Implications For States In Federal Healthcare Programs, Nicole Huberfeld
Law Faculty Scholarly Articles
This Article explores Arlington Central School District Board of Education v. Murphy, a decision rendered by the first Roberts Court that may become a benchmark for Spending Clause jurisprudence. The majority in Arlington, led by Justice Alito, adopted the standard for constitutional conditions on spending that had been the dissenting view for years during the Rehnquist Court. More specifically, under the Pennhurst and Dole regime, the Court required Congress to provide "adequate" notice of conditions on spending, which seemed to be sufficient for the clear statement rule the Court (through Justice O'Connor) was seeking to institute. Arlington refashioned …
Regulatory Data Protection Under Trips Article 39(3) And Article 10bis Of The Paris Convention: Is There A Doctor In The House?, Christopher Wadlow
Regulatory Data Protection Under Trips Article 39(3) And Article 10bis Of The Paris Convention: Is There A Doctor In The House?, Christopher Wadlow
Christopher Wadlow
Article 39 of the WTO TRIPs Agreement has attracted much attention for the protection its final paragraph affords for regulatory data in the pharmaceutical and agrochemical industries, but the literature has tended to treat Article 39(3) in individual isolation. This is to ignore one of the most striking features of Article 39, which is that in contrast to every other substantive provision of TRIPs, it expressly defines its entire scope of application by reference to a pre-existing treaty, the Paris Convention for the Protection of Industrial Property, and specifically Article 10bis of the latter, dealing with unfair competition. This article …
"Obvious To Try": A Proper Patentability Standard In The Pharmaceutical Arts?, Andrew V. Trask
"Obvious To Try": A Proper Patentability Standard In The Pharmaceutical Arts?, Andrew V. Trask
Fordham Law Review
Pharmaceutical research often entails making small modifications to candidate drug molecules--modifications that might be deemed “obvious to try”--and then studying the largely unpredictable, yet critical, resulting biological effects. Recognizing this characteristic unpredictability, the U.S. Court of Appeals for the Federal Circuit has traditionally upheld the patentability of obvious-to-try pharmaceutical inventions. This approach has been challenged, however, by the U.S. Supreme Court's 2007 decision in KSR International Co. v. Teleflex Inc. This Note reviews the history of the obvious-to-try test and considers the Federal Circuit's post-KSR inconsistency regarding obviousness in the pharmaceutical arts. This Note argues that KSR does not permit …
Should Preemption Apply In A Pharmaceutical Context? An Analysis Of The Preemption Debate And What Regulatory Compliance Statutes Contribute To The Discussion, Jennifer A. Surprenant
Should Preemption Apply In A Pharmaceutical Context? An Analysis Of The Preemption Debate And What Regulatory Compliance Statutes Contribute To The Discussion, Jennifer A. Surprenant
Fordham Law Review
Should the Food and Drug Administration (FDA)’s determination that a product is safe negate a private litigant’s cause of action under state law in all circumstances, unless the FDA determines that the manufacturer withheld relevant information regarding the safety of the product? This Note concludes that such federal preemption is proper because the FDA is fully capable of making a determination regarding the adequacy of the information disclosed by a pharmaceutical manufacturer without state interference. Additionally, such interference on the state level hinders the FDA’s objectives and effective functioning. Thus, determinations about the adequacy of the information provided to the …
Pharma's Nonobvious Problem, Rebecca S. Eisenberg
Pharma's Nonobvious Problem, Rebecca S. Eisenberg
Articles
This Article considers the effect of the recent decision of the U.S. Supreme Court in KSR International Co. v. Teleflex, Inc. on the nonobviousness standard for patentability as applied to pharmaceutical patents. By calling for an expansive and flexible analysis and disapproving of the use of rigid formulas in evaluating an invention for obviousness, KSR may appear to make it easier for generic competitors to challenge the validity of drug patents. But an examination of the Federal Circuit's nonobviousness jurisprudence in the context of such challenges reveals that the Federal Circuit has been employing all along the sort of flexible …