7,030 research outputs found

    Is the Food and Drug Administration Safe and Effective?

    Get PDF
    In the United States, drug safety and efficacy are primarily regulated by the Food and Drug Administration (FDA) and the legal system, which gives manufacturers large incentives to produce safe drugs and provide proper warnings for side effects, since patients can sue manufacturers that provide unsafe drugs and/or insufficient warnings. In this paper, we begin by examining the efficiency implications of this joint regulation of drug safety. We find that joint regulation of drug safety can be inefficient when the regulatory authority mandates a binding and well enforced level of safety investment. In this case, product liability has no effect on a firm's safety investment, but affects welfare by raising a firm's costs and therefore prices. Using these results, we calibrate a model of the pharmaceutical market and find that, depending on the share of liability costs in marginal costs, a product liability exemption for activities that are well regulated by the FDA could increase consumer welfare by 47.847.8-754.7 billion annually (4-66 percent of sales) and producer welfare by 11.911.9-173.9 billion annually (1-15 percent of sales). In addition, we summarize the welfare effects of recent legislation, the Prescription Drug User Fee Acts (PDUFA), which mandated faster FDA review times in exchange for user fees levied on the pharmaceutical industry. Overall, we find that the faster review times mandated by PDUFA raised social surplus by 1831billion,andthatatmost,theconcomitantcostofreduceddrugsafetywas18-31 billion, and that at most, the concomitant cost of reduced drug safety was 5.6-$16.6 billion.

    Affine Macdonald conjectures and special values of Felder-Varchenko functions

    Get PDF
    We refine the statement of the denominator and evaluation conjectures for affine Macdonald polynomials proposed by Etingof-Kirillov Jr. and prove the first non-trivial cases of these conjectures. Our results provide a q-deformation of the computation of genus 1 conformal blocks via elliptic Selberg integrals by Felder-Stevens-Varchenko. They allow us to give precise formulations for the affine Macdonald conjectures in the general case which are consistent with computer computations. Our method applies recent work of the second named author to relate these conjectures in the case of Uq(sl^2)U_q(\widehat{\mathfrak{sl}}_2) to evaluations of certain theta hypergeometric integrals defined by Felder-Varchenko. We then evaluate the resulting integrals, which may be of independent interest, by well-chosen applications of the elliptic beta integral introduced by Spiridonov.Comment: 26 pages. v3: minor edits for published versio

    On the Beurling dimension of exponential frames

    Get PDF
    We study Fourier frames of exponentials on fractal measures associated with a class of affine iterated function systems. We prove that, under a mild technical condition, the Beurling dimension of a Fourier frame coincides with the Hausdorff dimension of the fractal
    corecore