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# The CREATES Act: PhRMA Opposes, GPHA Supports
- URL: https://www.fdaweb.com/the-creates-act-phrma-opposes-gpha-supports/
- Published: 2016-06-23T12:00:00.000Z
- Updated: 2026-09-14T21:11:34.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136032

The Pharmaceutical and Research Manufacturers of America (PhRMA) is opposing for safety reasons a Senate bill that is intended to target abusive delay tactics used by brand drug makers to block entry of generic drugs. The Creating and Restoring Equal Access to Equivalent Samples ([CREATES](https://www.leahy.senate.gov/press/statement-of-senator-patrick-leahy-on-introduction-of-the-creating-and-restoring-equal-access-to-equivalent-samples-creates?ref=fdaweb.com)) Act would resolve brand companies’ blocking efforts to argue that an FDA-mandated Risk Evaluation and Mitigation Strategy precludes them from providing potential generic competitors samples of a branded product so the generic company can perform the testing necessary to show that its product is equivalent, a prerequisite for FDA approval. It would allow a generic drug manufacturer facing a delay tactic to bring an action in federal court for injunctive relief (i.e., to obtain the sample it needs), The bill also authorizes a judge to award damages to deter future delaying conduct.

Despite the serious drug safety risks managed by a REMS with “elements to assure safe use (ETASU),” the CREATES Act “does not establish robust criteria that eligible product developers seeking to obtain such a drug must satisfy in order to protect patients and other individuals who come into contact with the drug during its distribution,” PhRMA said in [testimony](http://www.judiciary.senate.gov/download/06-21-16-safir-testimony?ref=fdaweb.com) 6/22 before the Senate Judiciary Committee. “The bill requires eligible product developers to obtain an ‘authorization’ from FDA before they can sue an innovator to force the transfer of drugs subject to an ETASU, and the agency shall issue such an authorization within 90 days,” PhRMA noted. But it contended that an “eligible product developer may elect, but is not required, to submit a clinical trial safety protocol that sets forth its plan for testing a drug in humans,” which is a safety concern. PhRMA’s testimony was provided by Covington & Burling partner **Peter Safir**.

“The bill provides that an eligible product developer need only show that such protocols and other documentation provide safety protections comparable to those provided by the innovator’s REMS — rather than equivalent to the existing REMS — or otherwise satisfy FDA that such protections will be provided,” Safir said. “This standard creates the distinct possibility that an eligible product developer will adopt less rigorous safety protections than the REMS with ETASU that was implemented by the innovator following careful discussions with and review by FDA.”

[Testifying](http://www.judiciary.senate.gov/download/06-21-16-safir-testimony?ref=fdaweb.com) on behalf of the Generic Pharmaceutical Association (GPhA), Amneal Pharmaceuticals assistant general counsel **Beth Zelnick Kaufman** said generics “do not support any policies that would jeopardize patient safety and any discussion or insinuation to the contrary you may hear today is simply an effort to distract us from the real issue we need to focus on: addressing the use of REMS or other non-FDA mandated restrictions on drug supply that are designed – often times explicitly – to block lower cost generics and biosimilars from coming to market.” Importantly, she said, the proposed legislation provides “crucial safety protections for both patients and researchers by ensuring that the FDA both reviews and approves the follow-on applicant’s testing protocols, informed consent documents, and informational materials before authorizing the follow-on applicant to obtain samples of brand-name products that are subject to an FDA-mandated REMS.”

Kaufman said GPhA also supports a provision in the CREATES Act that addresses a “common ploy by the brands to use the law’s shared-REMS requirement to prevent launch of a filed and otherwise ready to be approved generic competitor. This involves the statutory requirement that, unless waived, the brand and follow-on products must enter into a single, shared safety protocol. It has become another opportunity for brands to game the system.” The CREATES Act would allow a generic drug manufacturer facing this delay tactic to bring an action in federal court for injunctive relief (i.e. to enter court-supervised negotiations for a shared safety protocol).