Product Liability and Innovation Managing Risk in an Uncertain Environment (1994) / Chapter Skim
Currently Skimming:
Regulation, Litigation, and Innovation in the Pharmaceutical Industry: An Equation for Safety
Regulation, Litigation, and Innovation in the Pharmaceutical Industry: An Equation for Safety
Pages 120-128
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 120... ...
But pharmaceuticals present an especially complex challenge. Like Fermat's equation, the question itself is unanswerable unless reference is made to the impact of the federal regulatory process that governs every aspect of the prescription drug cycle and makes reduction of liability risk intrinsic to new drug development.
|
From page 121... ...
In fact, the term "pharmaceutical" derives from the ancient Greek pharmakon, which literally means both "medicine" and "poison." Pharmaceuticals are categorized by the legal community as belonging to the class of "unavoidably unsafe products" including vaccines, blood, and medical devices, which offer desired benefits but are not without risk.) The law recognizes that the medical value of pharmaceutical products differentiates them from other products such as lawnmowers or household cleaning products.
|
From page 122... ...
In fact, manufacturers have the continuous legal obligation to "utilize methods of warning which will be reasonably effectively and are "required to keep abreast of the current state of knowledge of its products as gained through research, adverse reaction reports, scientific literature, and other available knowledge" (Fern and Sichel,1985~. This obligation to warn leads some industry experts to believe that product labeling is the key factor in reduction of pharmaceutical liability risk.
|
From page 123... ...
Regulated development phases encompass laboratory testing; clinical studies of the pharmacologic profile of a new drug, its efficacy and tolerability by patients; and extensive clinical trials to study the effects of the drug in humans over specified periods of time. Pharmaceutical developers spend an average $359 million to bring a new drug to market, often for one limited application (U.S.
|
From page 124... ...
Institutional Review Boards are established at investigational sites to implement programs that monitor patient safety and ensure patient rights. Patients who volunteer for clinical trials are protected by stiff federal regulations and ethical standards.
|
From page 125... ...
Not even explored in this paper are the indirect costs to society of the regulatory process, including global competitiveness, the impact of the regulatory process on drug pricing, the limited access of critically ill patients to therapies in development, and reimbursement issues that arise when physicians prescribe drugs for off-label applications. Also not addressed is the disincentive to innovation caused by the fact that the regulatory process erodes patent protection.
|
From page 126... ...
While no sound scientific study ever proved a causal relationship between Bendectin and birth defects, and the FDA continued to affirm its safety, nearly 1,700 lawsuits were brought against the manufacturer (Pharmaceutical Manufacturers Association, 1993~. The manufacturer won almost every case that went to court, but the price was too high.
|
From page 127... ...
The Pharmaceutical Manufacturers Association calls for the creation of a uniform federal tort liability system, as opposed to the current patchwork of state laws and the barring of punitive damages against manufacturers if they have already met the stringent requirements of the FDA. Other nations have diminished the lure of the industry's deep pockets and the impact of high jury awards by instituting social insurance schemes to redress injury.
|
From page 128... ...
when more women are included in studies? Presented at the Women in Clinical Trials Workshop of the FDA-Regulated Products Workshop, Food and Drug Law Institute, Washington, D.C.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.