Browsing by Subject "pharmaceutical market"

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    Addressing Looming Prescription Drug Shortages Through Legislative and Regulatory Approaches
    (2013-02-12) Friske, Eric
    An alarming increase in drug shortages in recent years presents a crisis affecting medical facilities across the nation, compromising patient care in a wide variety of serious illnesses. Many of the medications affected by these shortages are critical products, including oncology drugs, anesthetics, and antimicrobials. The frequency of drug shortages has steadily increased since 2005, nearly tripling over the span of five years. This Note proceeds in two parts. Part I provides back-ground on the recent drug shortage problems afflicting patients and medical facilities throughout the country and the current and proposed regimes available to address these problems. Part I.A provides background on the numerous underlying causes of drugs shortages, including the role of raw material supplies and manufacturing capabilities, and Part I.B examines the subsequent impact of shortages on patient care and the resources of medical facilities. Part I.C, Part I.D, and Part I.E explain the FDA’s existing drug shortage program, provide background on both the pending legislation in Congress meant to address current and future shortages, and the recent executive order issued in response to the shortage problem, respectively. Part II of this Note provides analysis of the proposed legislation for addressing the drug shortage problem and provides additional, alternative approaches for mitigating the occurrence and severity of shortages. This Note concludes that existing legislation makes important steps in assisting the FDA to adequately manage these shortages, but ultimately falls short of providing the multifaceted approach necessary to address the many underlying problems influencing these shortages.
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    Bringing Dormant GRAS(E) to Bloom: Reviving the GRASE Concept for Drugs
    (2013-02-12) Puchalski, Emily
    The cost of getting a new drug to market was estimated at $802 million in 2003, and more recent estimates have placed the cost at $1.3 billion and $1.7 billion. Making the commercial drug development process even more difficult, the time from initial development to use of a drug for patient treatment can be fifteen years. This expensive and time-intensive process produces many undesirable side effects including a low incentive to develop drugs for diseases primarily affecting the poor and competition from foreign countries with quicker approval processes. A partial solution may be found in § 321(p)(1) of Food, Drug, and Cosmetic Act, which could save certain drugs from the costs associated with the New Drug Application (NDA) required by the Food and Drug Administration (FDA) to get a new drug to market. The statutory provision applies to drugs that are “generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed.” Drugs falling within this provision have been referred to as “generally recognized as safe and effective,” or GRASE for short. The GRASE provision provides a mechanism to get these kinds of drugs to market more quickly. Despite the potential cost and time-saving benefits of GRASE, the standard for getting a drug designated as GRASE has been set so high that the provision has fallen out of use. The current GRASE system is broken and needs fixing. This Note presents previous proposals for lowering the cost and time requirements of FDA’s drug-approval process, concludes that the GRASE concept should be revived, and argues that a GRASE Notification System should be implemented because this system could lower the cost associated with drug development.