According to a story from wepclinical.com, the Creating and Restoring Equal Access to Equivalent Samples Act, also known as the CREATES Act, was introduced in 2017 in order to accelerate the introduction of generic drugs and put an end to underhanded delaying strategies conceived by brand name manufacturers to inhibit the introduction of low cost alternatives.
The bill is specifically meant to address two common strategies employed by these manufacturers.
The first tactic is the flat out refusal on the part of brand name manufacturers to send samples of their drug products to generic manufacturers. This is done despite the fact that brand name manufacturers are granted an episode of total market exclusivity in order to facilitate a reasonable degree of profitability for the company. This also serves to motivate companies to develop new treatments. The refusal to send samples prevents the introduction of the generic competitor, as the generic companies are unable to prove that their product is identical in effect to the original. This is a necessity for the generic drugs to gain approval.
Brand name companies also undercut generics by keeping them from participating in regulatory procedure that is considered a safety necessity under current law. This is especially pertinent to drugs that are regarded as high risk.
The CREATES Act is aimed at ending both of these unethical practices. The bill would permit generic companies to pick up a federal court directive that would require brand name manufacturers to give samples to generics. Additionally, the bill would award appropriate damages as a deterrent to continued delaying behavior. Generic companies would also be able to be held to alternative safety measures by the FDA, which undercuts the second tactic that prevents generics from engaging in safety regulations.