Krista Hessler Carver" /> 
Krista Hessler Carver" />
On December 20, 2019, the President signed the Further Consolidated Appropriations Act, 2020. Effective on that day, Section 610 of Division N of this Act contains provisions previously introduced in various bills as "the Creating and Restoring Equal Access to Equivalent Samples Act" or "CREATES Act." Section 610 establishes a private right of action in which a company that seeks to develop a generic or biosimilar product (referred to as the "eligible product developer") may sue the innovator for an injunction and monetary award for not selling samples of the approved product for developmental testing on a timely and "commercially reasonable" basis. The provision also amends the single, shared REMS provisions of the Federal Food, Drug, and Cosmetic Act ("FDCA").
Section 610 marks a substantial change from prior law, and the provision includes tight timelines for sale of samples to avoid potential exposure to civil liability. Innovators should consider developing standard operating procedures and training programs to ensure their organizations are prepared to address samples requests. Establishing clear processes upfront will be essential to avoiding unnecessary delays and, by extension, minimizing the risk of litigation under this new law. Companies should also be aware that section 610 explicitly carves out any impact of the legislation on existing antitrust law. As a result, in addition to litigation initiated under the new private right of action, antitrust litigation related to a refusal to provide samples also remains a possibility.
Civil Action Section 610 establishes a private right of action for an "eligible product developer" to sue a "license holder" in federal court if the license holder does not provide "sufficient quantities" of the requested "covered product" on "commercially reasonable, market-based terms." The eligible product developer may seek injunctive relief, attorney's fees, and a monetary award.
"License holder" and "covered product" are broadly defined. The former includes the holders of new drug applications, abbreviated new drug applications, and both full and biosimilar biologics license applications. "Covered product" similarly includes a product approved or licensed in any of these applications, as well as a drug-biologic combination and "when reasonably necessary to support approval," any product, including any device, that is marketed or intended for use with the drug or biologic. This term generally excludes drugs in shortage, however.
New Cause of Action
A cause of action under Section 610 has four elements. The eligible product developer (referred to here as the "developer") must prove by a preponderance of the evidence:
FDA Authorization Process
An eligible product developer seeking samples of a covered product subject to REMS with ETASU may request a "covered product authorization" from FDA. FDA must act on the request within 120 days under section 610. To obtain authorization for purposes of human clinical trials, a developer must (a) submit specific materials to FDA (protocols, informed consent documents, and informational materials for testing) that include patient safety protections comparable to those provided by the REMS for the covered product or otherwise satisfy the agency that such protections will be provided; and (b) meet any other requirements established by the agency. If the proposed testing does not involve human clinical trials, then the developer must agree to comply with any conditions that FDA deems necessary in order to receive an authorization.
A covered product authorization issued by FDA must state that the license holder will not violate the REMS for the covered product if it provides samples under the terms of the authorization. Section 610 also amends section 505-1 of the FDCA to state that providing samples of a covered product to a developer will not violate any REMS applicable to the covered product.
The authorization process established under section 610 largely codifies FDA draft guidance. 1 One FDA draft guidance, which is applicable to generic drugs for which the reference listed drug ("RLD") has a REMS with ETASU, outlines a process in which the agency reviews protocols, informed consent documents, and informational materials for the proposed bioequivalence study to determine if they provide safety protections comparable to the REMS with ETASU. FDA then may issue a "safety determination letter" indicating that the agency will not consider the RLD sponsor's provision of samples to the developer to violate the REMS. FDA has a performance goal to issue 90% of safety determination letters within 60 days. 2 FDA has stated in draft guidance that the agency would follow a similar process of issuing safety determination letters for samples used in biosimilarity testing. 3
Section 610(g) states that nothing in section 610, the amendments it makes, or section 505-1 of the FDCA shall be construed to prohibit a license holder from providing a developer samples in the absence of an FDA authorization or to negate the applicability of the REMS with ETASU for the covered product.
Section 610 sets forth three affirmative defenses for a license holder:
If the developer prevails, the court must order the license holder to provide sufficient quantities of covered product on commercially reasonable, market-based terms "without delay" and award "reasonable" attorneys' fees and costs to the developer. The court also must award a monetary amount if it finds that the license holder delayed providing samples to the developer "without a legitimate business justification" or failed to comply with a court order to provide samples. The monetary amount awarded to the developer must be "sufficient to deter the license holder from failing to provide eligible product developers with sufficient quantities of a covered product on commercially reasonable, market-based terms," not to exceed the revenue earned for the covered product during the period beginning at the end of the 31-day period described above and ending on the date when the developer receives sufficient quantities of the covered product. The court may issue an order to provide samples before conducting further proceedings to determine whether the developer is entitled to fees, costs, and a monetary amount or the amount of such rewards.
Limitation of Liability
Section 610 shields a license holder from liability for a developer's failure to follow adequate safeguards to assure safe use of the covered product during development or testing activities described in section 610 (including the developer's transportation, handling, use, or disposal of the covered product).
Amendments to Law on Single, Shared REMS
Section 610 also amends the prior presumptive requirement under the FDCA that an RLD and any generic drug be subject to a single, shared system of REMS with ETASU absent an FDA waiver. FDA previously published two draft guidance documents on shared REMS and waivers. 4
Now, under the FDCA as amended by section 610, an applicant submitting an abbreviated new drug application ("ANDA") generally may use either a single, shared REMS with the RLD holder or a "different, comparable aspect" of the ETASU. FDA may require a single, shared REMS if it determines that "no different, comparable aspect of the [ETASU] could satisfy the [ETASU] requirements," however. The statute defines "different, comparable aspect" to mean that the REMS "uses different methods or operational means.. but achieves the same level of safety." Under amended section 505-1, FDA may require modification of an innovator's REMS to accommodate "different, comparable aspects" of the ETASU for the generic drug.
Next Steps
License holders should consider adopting procedures and taking other steps to ensure responses to requests for samples within the short timelines established by section 610. Potential next steps include the following:
