The law widely known as CREATES, which was enacted in December 2019 as part of the Further Consolidated Appropriations Act of 2020, makes available an important new pathway for developers of potential drug and biological products to obtain samples of brand products1 that they need to support their applications. The full text of the new law is available here. CREATES establishes a private right of action that allows developers to sue brand companies that refuse to sell them product samples needed to support their applications. If the product developer prevails, the court will order the sale of samples, award attorneys’ fees and litigation costs to the product developer, and may impose a monetary penalty on the brand company.
The product developer must take a number of specific steps (outlined in the law) before the brand company must sell them product samples under CREATES. One of these steps – if the brand product for which samples are sought is subject to a Risk Evaluation and Mitigation Strategy (REMS) with elements to assure safe use (ETASU) – is that the product developer must first obtain a Covered Product Authorization (CPA) from FDA. CREATES does not require this step for products that are not subject to REMS with ETASU.2
Q: How do I obtain a CPA from FDA?
A: FDA intends to issue guidance on obtaining a CPA. In the meantime, interested developers seeking CPAs should submit their requests as follows:
- for generic products, submit the request as a controlled correspondence to the CDER NextGen Collaboration Portal3 (general questions may be submitted to GenericDrugs@fda.hhs.gov);
- for 505(b) products and biological products, submit the request to your pIND file or IND (with a copy to the related marketing application, if there is one). If you do not have a pIND or IND number, request a file number as described here and submit the request to that numbered file. Please also email a copy of your CPA request to ONDCommunications@fda.hhs.gov.
Please prominently identify the request as a “REQUEST FOR COVERED PRODUCT AUTHORIZATION.” Requests should specify that the product developer is seeking a CPA and the product for which a CPA is being sought. If the samples will be used for purposes of development and testing that involve human clinical trials, requests should be accompanied by study protocols, informed consent documents, and informational materials for testing demonstrating that safety protections comparable to those in the REMS for the brand product will be provided for in the study/studies for which samples are sought. If the samples will be used for purposes of development and testing that do not involve any testing in humans, the request should state that the samples will not be used for testing in humans.
Q: Why did FDA take down the list of products about which it has received inquiries about access to samples?
A: The public posting of the list of products about which FDA had received RLD access inquiries from generic developers was intended to increase transparency and raise awareness about the scope of the RLD access problem to help facilitate the development of meaningful solutions. The enactment of CREATES in December 2019 established a process for obtaining RLD samples. In addition, CREATES includes specific requirements about who RLD access inquiries should be directed to (i.e., a named corporate officer of the brand company) and where in the court system product developers should seek a remedy if brand companies do not provide them with samples as required. Because the original posting of the list has served its purpose and the law identifies parties other than FDA as those to whom RLD access inquiries and complaints should be directed, FDA is removing the list.
1 As used on this page, the term “brand products” refers to products approved under sections 505(b) or (j) of the Federal Food, Drug and Cosmetic Act or sections 351(a) or (k) of the Public Health Service Act.
2 FDA’s online listing of approved REMS is available at https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm. Product developers should check this listing to confirm that the product for which they seek a CPA is covered by a REMS with ETASU before submitting a CPA request.
3 For more information, see guidance for industry, Controlled Correspondence Related to Generic Drug Development.