Lawmakers Seek to Block Branded Rx Firms From Delaying Generics

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By Bronwyn Mixter

June 21 — Lawmakers are seeking to enact legislation that would stop branded drug companies from using FDA-mandated risk plans to block generic companies from obtaining drug samples for testing.

The Senate Judiciary Subcommittee on Antitrust, Competition Policy and Consumer Rights held a hearing June 21 on the proposed Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act (S. 3056). The bill would make it easier for generic drug companies to bring federal court cases and receive damages if they believe branded drugmakers are using a Food and Drug Administration-mandated risk evaluation and mitigation strategy (REMS) for certain drugs as a reason to thwart generic drugmakers' access to drug samples for testing. The FDA sometimes imposes a REMS on a drug or class of drugs to ensure the benefits outweigh the risks.

Sen. Charles Grassley (R-Iowa), a co-sponsor of the bill, said he is concerned that brand companies “are using an FDA regulatory process set up as a safety measure to block generic competition.” Grassley and other lawmakers said they are concerned about prescription drug prices and that competition from generic drugs lowers prices.

The panel didn't discuss when it would vote on the bill, which was introduced a week ago.

Delayed Negotiations

Beth Zelnick-Kaufman, assistant general counsel of Amneal Pharmaceuticals, said Amneal and the Generic Pharmaceutical Association (GPhA) “strongly support the CREATES Act.”

“We need to obtain brand samples for FDA-required testing” and “denying samples has nothing to do with safety,” Zelnick-Kaufman said. The CREATES Act also addresses when brand companies “drag their feet during shared REMS negotiations.” A shared REMS applies to both brand and generic products.

Zelnick-Kaufman said some brand companies delay negotiations on shared REMS with the generic companies, which keeps their products off the market. The legislation would require these negotiations to be completed in 120 days.

“The CREATES Act will help make the promise of affordable medicines a reality for more Americans,” Zelnick-Kaufman said.

Nitin Damle, president of the American College of Physicians, said that “if steps are not taken now, the very life-saving benefit of these drugs could be lost for many of our patients who won't be able to afford them.”

“Advances in medicine have been life saving, but they need to be affordable,” Damle said.

`Robust Criteria' Lacking

Peter O. Safir, senior counsel at Covington & Burling, who was asked to testify on behalf of the Pharmaceutical Research and Manufacturers of America (PhRMA), said the CREATES Act doesn't establish “robust criteria” for generic firms that are seeking to obtain drug samples “in order to protect patients and other individuals who come into contact with the drug during its distribution.”

For drugs with REMS that contain elements to assure safe use (ETASU), the CREATES Act first requires generic firms to obtain an authorization from the FDA before they can sue the branded company to force the transfer of drugs, Safir said. The FDA is required to issue this authorization in 90 days.

The ETASU are established to mitigate a specific and serious risk listed in the labeling of a drug, according to the FDA's website. For example, the ETASU can include certain training for health-care providers who prescribe the drug or monitoring requirements for patients taking the drug.

The bill doesn't give the FDA the authority to rescind an authorization if a developer doesn't comply with safety precautions for the drug, Safir said.

Also, the bill provides that a generic drug firm only needs to show that its safety protocols are comparable to the existing REMS, but not “equivalent” to the REMS, Safir said. Therefore, a generic firm may adopt less rigorous safety protections than the REMS, he said.

Safir also said 120 days “is an unreasonably short time” for negotiating a shared REMS.

To contact the reporter on this story: Bronwyn Mixter in Washington at

To contact the editor responsible for this story: Brian Broderick at

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