How the CREATES Act got generic makers access to brand samples

In fiscal 2025, FDA issued 51 letters authorizing generic drug developers to obtain samples of brand-name drugs sold under restricted safety programs, according to the agency's GDUFA performance report to Congress¹. A year earlier it issued 43, the fiscal 2024 report² says.

Those letters, called Covered Product Authorizations, exist because of a 2019 law known as the CREATES Act. Before it passed, generic developers told FDA again and again that they could not buy enough of a brand drug to run the tests every generic needs. Drugs sold under a federal safety program called a REMS were part of that problem, and the law gave them an extra step of their own, according to FDA³.

Sample access is one of the less visible ways generic entry can be slowed. FDA and GAO reports since 2019 track what the law has and has not changed.

What a REMS is

Section 901 of a 2007 law, the Food and Drug Administration Amendments Act¹¹, gave FDA authority to require a Risk Evaluation and Mitigation Strategy for a drug with a serious safety risk. Most medicines manage risk through labeling alone. A REMS adds required steps, and the strictest ones include what the statute calls elements to assure safe use, or ETASU.

Under 21 U.S.C. 355-1(f)⁷, those elements can require that prescribers be specially trained or certified, that pharmacies or other dispensers be specially certified, that the drug be dispensed only in certain settings such as hospitals, that patients show documentation of safe-use conditions such as lab results, that patients be monitored, or that each patient be enrolled in a registry. FDA's REMS overview⁶ gives one example, a long-acting injectable antipsychotic that may be given only in certified facilities able to observe patients for at least three hours.

Why samples became a fight

A generic developer has to prove its product is bioequivalent to the brand, its reference listed drug, which requires testing against the brand itself. A brand under a REMS that limits who may dispense it cannot simply be ordered from a wholesaler, and some brands without a REMS are also sold only through limited distribution channels. In those cases the developer depends on the brand company, or distributors it chooses, agreeing to sell.

Congress anticipated part of the problem in 2007. The REMS statute says no brand holder "shall use any element to assure safe use" required by FDA "to block or delay approval" of a generic application. The provision did not, however, give generic developers a way to force a sale.

FDA tried several workarounds. A 2019 GAO report⁸ describes a 2014 FDA draft guidance under which FDA would write letters telling brand companies that selling samples to a particular developer would not violate the REMS. FDA also posted a public list of the products about which generic developers had sent it sample-access inquiries, meant, the agency later explained³, to "raise awareness about the scope of the RLD access problem." It has since taken the list down, saying the posting "has served its purpose" now that the law directs inquiries elsewhere.

Antitrust enforcers were watching too. In Senate testimony on Nov. 27, 2018⁹, an FTC commissioner said a brand company may improperly invoke REMS requirements to justify refusing samples, and that, based on data reported to FDA, generic firms had been "unable to obtain samples of 52 branded pharmaceutical drugs." As of GAO's October 2019 report⁸, the FTC had not brought its own case charging a company with an antitrust violation for refusing to provide samples.

GAO also noted a gap in FDA's tools. FDA's letters applied only to REMS drugs, and the agency told GAO its options were more limited for drugs without a REMS, even though those drugs had been subject to the same practices.

What CREATES requires

Congress enacted the Creating and Restoring Equal Access to Equivalent Samples Act on Dec. 20, 2019, as section 610 of Division N of the Further Consolidated Appropriations Act, 2020 (Public Law 116-94), according to FDA's fiscal 2025 GDUFA report¹. FDA posts the full text of the law⁴. Its sample provisions are codified at 21 U.S.C. 355-2, and they cover developers of both generics and biosimilars.

Under the statute, FDA's role is narrow. It does not referee sales or sue anyone. Its main job is issuing the authorization for REMS products, and its guidance on how to obtain a Covered Product Authorization⁵, published in September 2022, remains a draft. The FDA page on CREATES³ says the agency took down its list of access inquiries once the law gave developers a direct route, because the law "identifies parties other than FDA" to whom those inquiries and complaints should go.

What has happened since

Before passage, the Congressional Budget Office scored the standalone CREATES Act of 2019 bill, which was later folded into the appropriations law. In an April 25, 2019, estimate¹⁰, CBO projected that earlier entry of lower-priced generics and biosimilars would cut federal direct spending by $3.3 billion and raise revenues by $0.6 billion over 2019 to 2029.

FDA's figures show the authorization step in steady use, with 43 letters in fiscal 2024 and 51 in fiscal 2025. FDA does not publish which drugs they cover, and the reports do not say how many developers later had to sue to get samples.

Samples are one of several points where a brand's rights and a generic's timeline meet. Patent challenges are covered in our Hatch-Waxman explainer, petitions to FDA in citizen petitions and generic approval, and the review itself in Inside FDA's Office of Generic Drugs. When a restricted drug finally gets its first copy, it shows up on FDA's first generics list and on GxRadar's approvals page.

FDA's next count of Covered Product Authorizations, for fiscal 2026, will appear in the agency's GDUFA performance report for that year. Until then, any developer seeking samples of a product under a REMS with elements to assure safe use still has to get FDA's authorization first.