A Handbook of Contemporary Research
Edited by Rochelle C. Dreyfuss and Katherine J. Strandburg
Chapter 18: Data Secrecy in the Age of Regulatory Exclusivity
Rebecca S. Eisenberg* INTRODUCTION Drug regulation works in tandem with the patent system to defer generic entry in the market for pharmaceutical products, thereby preserving lucrative market exclusivity more effectively than the patent system could do without the regulatory assist.1 Firms need regulatory approval to sell their products,2 and to get that approval they need data showing that their products meet regulatory standards.3 Prior to passage of the Drug Price Competition and Patent Term Restoration Act of 1984 (commonly known as the Hatch-Waxman Act)4 drug developers relied upon confidential treatment of the data they submitted to the Food and Drug Administration (FDA) in support of a New Drug Application (NDA) to keep their data out of the hands of generic competitors who might otherwise use it to get competing versions of the same products approved. Although competitors could conduct their own trials and submit their own data, the costs of such trials were generally prohibitive for generic products that would be sold at competitive prices rather than at the premium prices charged for drugs available from only one source. As a result, the regulatory entry barrier often continued to exclude competition even after relevant patents expired.5 The Hatch-Waxman Act changed the rules, striking a new balance between the interests of innovators and generic competitors. To facilitate generic entry, the Hatch-Waxman Act lowered the regulatory entry barrier for generic versions of previously approved products, allowing approval of an ‘Abbreviated New Drug Application’ (ANDA) upon a showing * Robert and Barbara...
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