Methods for deformulating drugs

October 25, 2018

The FDA has a number of regulatory routes through which a company can seek approval for a generic drug. The most notable is the Abbreviated New Drug Application (ANDA) route whereby a generic company develops an exact copy of the innovator product and can use the safety and efficacy data from the innovator in their submission. This route was facilitated in the 1980s through the Drug Price Competition and Patent Term Restoration Act, informally known as the Hatch-Waxman Act after Senator Orrin Hatch and Representative Henry Waxman who sponsored it. The US government at the time were concerned about the low number of generic drug approvals. Before the Hatch-Waxman act, innovator companies could easily create legal obstacles for companies looking to develop generic medicines; this made generic drug development an unattractive industry. The Hatch-Waxman Act removed many of these obstacles, successfully incentivising generics companies to produce affordable generic medicines, whilst simultaneously protecting innovator companies by allowing them a sufficient exclusivity period after the initial release of their drug and keep innovation profitable.

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