Supporters of the CREATES Act have legitimate concerns but take the wrong approach to resolving them. Some drugs require particular scrutiny to ensure that they are safe for use; in these instances, the FDA can require manufacturers to develop “risk evaluation and mitigation strategies” (REMS) with “elements to assure safe use” (ETASU). Makers of generic drugs have accused some brand-name drug makers of hiding behind these protocols to avoid sharing samples of their products for testing.
The generic manufacturers may not be concerned about it, but the CREATES Act’s solution damages intellectual property without solving the problem. Under this legislation, generic drug makers could sue if brand-name manufacturers didn’t provide samples within a month. Brand-name drug manufacturers drive the research and development that make breakthroughs possible; the CREATES Act jeopardizes the reward they reap after all the risks have been taken. Innovators would be left with the unpalatable choice of divulging their intellectual property or facing litigation. They shouldn’t be forced into this position.
More details on the problems with the CREATES Act:
Center for the Protection of Intellectual Property Blog
American Conservative Union Op-Ed in The Hill