|
|
|
|
|
|
|
successful. The survivors in the future cost containment environment will be those with clearly defined corporate missions and R & D strategies. |
|
|
|
|
|
|
|
|
The future depends on innovation, not imitation. New drug development can be encouraged in a number of ways (Table 4), and the rewards are great [100]. Who knows what dramatic drug discoveries remain to be found in a new synthetic compound, a fresh soil sample, or a plant obtained from some pristine forest? In any event, let us all hope that the cost containment and product liability approach that is governing drug development will be replaced by a more rational approach. |
|
|
|
 |
|
|
|
|
1. M. M. Rumore and S. Strauss. Legal aspects of pharmacoepidemiology. J. Pharmacoepidemiology 1: 3, 1990. |
|
|
|
|
|
|
|
|
2. 1994 Law Department Spending Survey. Price Waterhouse L.L.P., December 1994. |
|
|
|
|
|
|
|
|
3. W. W. George. Medical technology and competitiveness in the world market. Reinventing the environment for innovation. Presented to the Food and Drug Law Institute 38th Annual Education Conference, Washington, D.C., December 1994. |
|
|
|
|
|
|
|
|
4. Medical Malpractice and Product Liability Lawsuits1992. U.S. Dept. of Justice, Washington, D.C., April 13, 1995. |
|
|
|
|
|
|
|
|
5. D. Hoffmeister and J. Nygaard. What a product manager should know about products' liability in the 1990s. Drug Info. J. 28: 879, 1994. |
|
|
|
|
|
|
|
|
6. National Research Council, Washington, D.C., February 1990. |
|
|
|
|
|
|
|
|
7. PhRMA Advertisement. Washington Post. April 28, 1995. |
|
|
|
|
|
|
|
|
8. 2 U.S.C. Sec. 247 (b)(j) (1983). |
|
|
|
|
|
|
|
|
9. Restatement (Second) of Torts. Section 402A, comment g, (1965). |
|
|
|
|
|
|
|
|
10. F. C. Woodside. Concepts and Relationships Underlying Injuries Involving Drug and Medical Devices. Drug Product Liability Reporter vol. 1, F. C. Woodside and M. Dixon, Eds., Matthew Bender, New York, 1989, p. 19. |
|
|
|
|
|
|
|
|
11. Restatement (Second) of Torts. Section 402A, comment k, (1965). |
|
|
|
|
|
|
|
|
12. L. D. Bauer and L. D. Stith. The Duty to Warn. Products Liability. Pharmaceutical Drug Cases, D. E. Vinson and A. H. Slaughter, Eds., Shephard's/McGraw Hill, New York, 1988, p. 129130. |
|
|
|
|
|
|
|
|
13. Brochu v Ortho Pharmaceutical Corp., 642 F2d 652 (1st Cir 1981). |
|
|
|
|
|
|
|
|
14. Wadleigh v Rhone-Poulenc Rorer Inc, MDL-986. |
|
|
|
|
|
|
|
|
15. Barson v E. R. Squibb & Sons, 682 P2d 832 (Utah 1984). |
|
|
|
|
|
|
|
|
16. Tinnerholm v Parke-Davis & Co., 285 F Supp 432, 448 n 12 (SDNY 1968), modified, 411 F2d 48 (2d Cir 1969). |
|
|
|
|
|
|
|
|
17. J. Braithwaite. Corporate Crime in the Pharmaceutical Industry. Routledge & Kegan Paul, London, 1984, p. 51. |
|
|
|
|
|
|
|
|
18. 59 Fed. Reg. 54034 (Oct. 27, 1994). |
|
|
|
|
|
|
|
|
19. 59 Fed. Reg. 54046 (Oct. 27, 1994). |
|
|
|
|
|