163 results match your criteria: "Boston University School of Law.[Affiliation]"
In Wyeth v. Levine, the Supreme Court held that an FDA-approved drug label did not preempt state tort law. Although the Supreme Court did not defer to the FDA's position, language in the opinion, and Breyer's concurring opinion, suggest that the FDA may be able to abrogate Wyeth v.
View Article and Find Full Text PDFHealth Aff (Millwood)
April 2011
Boston University School of Law, Massachusetts, USA.
Congress may reform drug pricing policies under Medicare Part D as part of a larger health reform effort. Currently, the "noninterference" provision prevents the government from negotiating drug prices on behalf of Medicare Part D prescription drug plans. Commonly considered reform proposals borrow ideas from Medicaid, either through returning dual eligibles to Medicaid drug pricing or by imposing mandatory rebates across the Part D population.
View Article and Find Full Text PDFJ Law Med Ethics
March 2010
Boston University School of Law, Boston, MA, USA.
Human papillomavirus (HPV) vaccines hold great promise for preventing cervical cancer, but 93 percent of mortality worldwide occurs in low- and middle-income countries, where high vaccine costs can restrict dissemination. Current models for promoting international access to health care innovations include differential pricing, advance market commitments, and voluntary and compulsory licensing. Some of these mechanisms have been effective, but much room for improvement remains.
View Article and Find Full Text PDFLancet Infect Dis
August 2007
Boston University School of Law, Boston, MA 02215, USA.
The problem of antimicrobial resistance has led some infectious disease experts and their professional societies to propose the use of transferable intellectual property rights (wildcard patents) and patent term extensions as methods to encourage antimicrobial research and development. We evaluate recent approvals of new antimicrobial classes and find that the number of new introductions is higher than previously suggested. More importantly, creating new patent rights is shown to be an inefficient and possibly counterproductive response to antimicrobial resistance.
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