Biomedical Engineering Reference
In-Depth Information
Innovative biomedical developments pose intricate difficulties for
regulators. A long history of significant adverse events in biomedicine
has generated a complex system of rules for the entrance of new
products into the marketplace. In the US, the Food and Drug
Administration (FDA) is the main consumer protection agency
responsible for regulating new medical products. The FDA was
established in 1906 by the US Pure Food and Drugs Act and has
evolved over time to now have a range of regulatory functions
focused around food, prescription drugs, cosmetics, over-the-counter
health supplements and medical devices (Borchers et al., 2007). The
FDA was originally created by public pressure for a consumer-focused
agency to protect the public from adulterated foods and inferiorly
produced medicines (Borchers et al., 2007). Subsequent shifts in the
Agency's remit are largely attributable to community pressure
surrounding adverse events (Borchers et al., 2007).
Early pre-cursors of the modern-day clinical trial can also be
found in the history of the FDA. Prior to the Pure Food and Drugs
Act, the 'poison squad' was formed in the Department of Agriculture
to conduct scientific testing of food additives and their impact
(Borchers et al., 2007). Healthy male volunteers were recruited and,
after a control period of meals without additives, were fed meals
with increasing amounts of the compound under study until a
dosage safety limit could be determined (Borchers et al., 2007: 5).
The commentators describing this early clinical experiment describe
it as '… an important first step in introducing science into
policy-making' (Borchers et al., 2007: 5).
By 1938, several consumer issues and attempts to strengthen the
original Pure Food and Drugs Act led to the replacement of this act
by the Food, Drugs and Cosmetics Act that established the Food and
Drug Administration in its current form (Borchers et al., 2007). One
of the key drivers that helped get the new act through was a
particularly serious chain of adverse reactions related to one
pharmaceutical product in which over 100 individuals died (Borchers
et al., 2007). The Food, Drugs and Cosmetics Act 1938 is argued to
be '… the first law worldwide that required scientific safety testing
before a drug could be approved for marketing, with the burden of
proof being on the manufacturer' (Borchers et al., 2007: 7). Later, in the
