ABSTRACT

Prescription drug and medical device makers use capitalism to create a nearly $500 billion annual health care expense. This opportunity results from unique laws, policies, marketing, and advertising opportunities. The U.S. Food and Drug Administration, in an effort to oversee the development/approval of these products, has a host of policies and regulations. In spite of these efforts, pharmaceutical and device makers often have major control over clinical trial designs, trial data, and researchers’ publication decisions. Furthermore, the industry uses its economic clout to advertise to prescribers, pay consultants for provider education, and offer providers/institutions clinical trials contracts and consulting opportunities. In addition, billions of dollars are spent annually for drug and device makers’ direct-to-consumer advertising that encourages consumers to request products from providers that may or may not be the most clinically and/or financially appropriate options. At the same time, brand drugs in the U.S. are much more expensive than in peer countries. Clearly the U.S. culture’s belief in capitalism has been financially rewarding to the prescription drug and medical device industries, but costly for consumers/taxpayers.