The Creating and Restoring Equal Access to Equivalent Samples Act, or CREATES Act for short, was introduced earlier this year to try and end abusive delay tactics used by brand-name drug manufacturers to block the market entry of lower-cost generic competitors.
There are two delaying tactics that this bill targets. The first is the unreasonable refusal by brand-name drug makers to provide samples of their products to generic companies. Patented brand-name drug manufacturers are entitled to a period of market exclusivity following the approval of their products. This allows companies to gain a return on their investment and, thereby, incentivizes the development of much-needed, new treatments. However, many companies find ways to prevent the introduction of generic competition, even after the exclusivity period has ended, by withholding product samples. Without these samples, generic companies cannot prove to regulators that their new products are equivalent to already approved products, which is a requirement for generic drug approval.
Under the CREATES Act, this unreasonable withholding of sample products would end. The bill would allow generic companies to obtain a federal court order, or an ‘injunctive relief’, to force brand-name companies to provide access to the drug samples. The bill would also ensure that damages are awarded to deter any future delaying conduct.
The second delaying tactic that this bill targets is the refusal by brand-name drug companies to allow generic manufacturers to participate in safety-based regulatory protocols. For certain ‘high risk’ drugs, access to one of these protocols, known as a Risk Evaluation Mitigation Strategy with Elements to Assure Safe Use or ‘REMS with ETASU’, is necessary for marketing approval.
The CREATES Act would end this delaying tactic by allowing the FDA to approve alternative safety protocols for the generic manufacturers, rather than requiring access to a protocol developed with the brand-name drug company.
The CREATES Act is supported by a broad range of stakeholders in the industry, including physicians and consumers, providers and payers, companies and unions.
To find out more, click here to check out the full bill.