Valparaiso University Law Review Volume 27 Number 1 Fall 1992 pp.95-137 Fall 1992 Getting There First With the Best: The Need to Shorten the Prescription Drug Approval Process Mark A. Kassel Follow this and additional works at: https://scholar.valpo.edu/vulr Part of the Law Commons Recommended Citation Mark A. Kassel, Getting There First With the Best: The Need to Shorten the Prescription Drug Approval Process, 27 Val. U. L. Rev. 95 (1992). Available at: https://scholar.valpo.edu/vulr/vol27/iss1/3 This Notes is brought to you for free and open access by the Valparaiso University Law School at ValpoScholar. It has been accepted for inclusion in Valparaiso University Law Review by an authorized administrator of ValpoScholar. For more information, please contact a ValpoScholar staff member at
[email protected]. Kassel: Getting There First With the Best: The Need to Shorten the Presc Notes GETTING THERE FIRST WITH THE BEST: THE NEED TO SHORTEN THE PRESCRIPTION DRUG APPROVAL PROCESS I. INTRODUCTION Due to unnecessary time delays, high costs and safety concerns, drug regulation in the United States is in need of reform.' The United States consistently lags behind the rest of the developed world in the approval of new, innovative, and efficient medications.2 Therefore, the Food and Drug Administration (FDA) needs to implement creative and effective changes in the prescription drug approval process3 in order to protect the health of the American public. Most Americans think that the FDA's stringent process for approving new prescription drugs guarantees that prescription drugs are successfully monitored.4 The American public assumes that safe and innovative drugs are made available to the public as quickly' and cost effectively6 as possible, while unsafe7 products are kept off the market.' However, this confidence placed in the FDA is unwarranted.