The CREATES Act: Ending Regulatory Abuse, Protecting Consumers, and Ensuring Drug Price Competition of 2016

The current version of the CREATES Act would, if enacted by Congress, enhance competition and consumer welfare. Specifically, the Act would promote welfare-enhancing competition in the market for brand name pharmaceuticals and biological products (biologics), and their lower-priced generic and biosimilar substitutes, without inappropriately undermining the intellectual property rights of individuals who bring forth new innovative medical treatments that greatly improve the quality of American health care. The Act also would not impose undue burdens on the manufacturers of brand name drugs and biologics. The Act would further its objectives in two ways. First, it would help prevent prospective generic and biosimilar entrants from unreasonably being denied access to the drug samples that are needed for regulatory testing to enter the market, without challenging the validity of the established firms’ intellectual property protections. Second, it would afford prospective generic and biosimilar competitors access to safety-based regulatory protocols required to compete in the market. This Act, as well as other measures designed to promote generic entry and competition in drug markets, merit serious congressional consideration.

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