Promoting generic drug availability: Reforming the Hatch-Waxman Act to prevent unnecessary delays to consumers

St. John's Law Review, Spring 2001 by Giles, Laura

8 See Findlay, supra note 6.

9 See Carter, supra note 7, at 231. ("This IND application provides notice that clinical (human) trials will be conducted, contains information about the pre-clinical results, outlines the proposed clinical studies, identifies experienced clinical investigators who will conduct the trials and provides other information about the manufacturing and testing processes.")

10 See id. at 230-31. Clinical trials essentially mean that a manufacture is allowed to test the drug on human subjects. Prior research was conducted on animals.

11 See Findlay, supra note 6. The four stages are: (I) safety, where clinical testing is conducted on a limited number of people to establish the safety of various doses; (II) efficacy, where the drug is tested for effectiveness on a small group of patients; (III) side-effects and long term use effects, where the drug is assessed for safety and effectiveness in wider clinical use; and (IV) post approval, where the drug company continues to test the newly-approved drug for adverse reactions and. is obligated to report the nature and frequency of any reactions. Id.; see also Jeffrey & N. Gibbs & Bruce F. Mackler, Food and Drug Administration Regulation and Products Liability: Strong Sword, Weak Shield, 22 TORT & INS. L.J. 194, 204 (1987).

12 See Findlay, supra note 6 (stating that phase I may take from 10 to 18 months; phase II may take from 21 to 35 months; phase III may take from 28 to 55 months).

13 See generally 21 U.S.C. 355(b) (1994); 21 C.F.R. 56, 314 (2000). 14 Carter, supra note 7, at 232.

16 See 21 U.S.C. 355(d) (1994); 21 C.F.R. 314.50 (2000); see also Gibbs & Mackler, supra note 11, at 205.

16 Id. (stating that companies often have to provide additional information to the FDA).

17 Id. Another method is known as a "rolling" NDA, which speeds up the approval process. With a "rolling" NDA, the company does not file an application, but discusses the submission and resubmission with the FDA. When the company does file an NDA, it essentially has a perfect file, which the FDA can quickly approve. See Findlay, supra note 6, at 228. The average approval time for NDAs submitted in 1997 was 15 months. See Carter, supra note 7, at 234 (citing The FDA Modernization Act of 1997, Pub L. No. 105-115, available at http://www.fda.gov/ opacom/backgrounders/modact/htm (last visited July 10, 2001)).

18 See Carter, supra note 7, at 233. The drug may still be classified as a new drug for many years. Phase IV research takes place at this time. Id.

19 See Michael P. VanHuysen, Reform of the New Drug Approval Process, 49 ADMIN. L. REV. 477, 478-79 (1997). In the United States, it takes between $300 and $500 million for a single drug to complete the FDA approval process. See id.; see also Stolberg & Gerth, supra note 1 (describing the tactics employed by designer drug companies to acquire patents).

20 See HOw INCREASED COMPETITION FROM GENERIC DRUGS HAS AFFECTED PRICES AND RETURNS IN THE PHARMACEUTICAL INDUSTRY, Fig. 3 and accompanying text, available at http://www.cbo.gov/showdoc.cfm?index=655&sequence=4&from=5 (last visited July 11, 2001).