ABSTRACT

A great deal of Legislation and resulting Regulation has been enacted to affect business. Some Legislation and Regulation are specifically aimed at control of marketing activities. Since the People elect the legislators, they do, indirectly, enact the laws as well. The defensive Price increases may have offset the Price reductions achieved through the competition introduced by the Waxman–Hatch law and certainly led to the charge of "Greedy". Waxman used his position to gain a thorough knowledge of the Drug industry. His legislative initiatives in the Drug area included the Patent Restoration/Abbreviated New Drug Application Bill that bears his name, the Orphan Drug Act, and the Drug export law. In 1988, Congress enacted the Medicare Catastrophic Coverage Act to provide protection for catastrophic medical costs and to add a limited long-term care benefit. The beneficiaries, including the low-income beneficiaries who would receive the Drug benefit without added premiums, rebelled, and Congress repealed the benefit in 1989.