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FDA Dodges Death-Inspired Suit Over Study Volunteer Consent

Oct. 23, 2018, 8:03 PM

Two strikes, you’re out. A court rebuffed for the second time a public interest group’s suit seeking to force the Food and Drug Administration to amend its informed consent regulations to better protect clinical trial participants.

The suit was triggered by reports of at least 153 treatment-related deaths in clinical trials since 2013, including one during a cancer immunotherapy study sponsored by Juno Therapeutics Inc.

The Center for Responsible Science sued to force the FDA to add three disclosures to its informed consent regulations to give trial participants more information on the differences between animal and human testing. The group’s original complaint was tossed because the court said it didn’t have the authority to hear the suit. The group’s amended complaint failed on the same grounds, Judge James E. Boasberg of the U.S. District Court for the District of Columbia said in an Oct. 22 ruling.

The adequacy of informed consent is often a key element in suits involving medical research. And recruiting enough participants for clinical trials is an ongoing challenge for drug companies seeking FDA approval for their products. This is especially true in the race to develop innovative biologic cancer therapies such as CAR-T, which manipulates genes to train a patient’s immune system to attack cancer cells. One of the plaintiffs in the watchdog group’s suit is the father of a 24-year-old patient, Max Vokhgelt, who died two days after receiving treatment with CAR-T as part of a Juno clinical study.

Novartis AG, Kite Pharma Inc., and Gilead Sciences Inc. are among the companies pioneering CAR-T, which stands for chimeric antigen receptor T-cell therapies. Other companies including Juno, Bluebird Bio Inc., Celgene Corp., Cellectis SA, and Seattle Genetics are also racing to gain a foothold in a market worth billions of dollars.

Petition Denied

The center filed its suit after the FDA denied a 2014 petition asking the agency to revise its regulations to require that trial participants be informed when the drugs they are being given have been tested mostly in animals. Animal models can be unreliable predictors of human response, especially for the new biologic therapies like CAR-T coming to market, the center said.

In 2017, the agency turned down the request, finding it was overly broad because the informed-consent regulations apply to all clinical trials but the additional warnings the plaintiffs wanted only applied to clinical drug research.

After the FDA declined the petition, the plaintiffs filed suit claiming the agency’s denial was arbitrary and violated the Administrative Procedure Act.

Boasberg rejected the group’s original complaint because the center hadn’t sufficiently established it had the right to sue the FDA over those claims but he allowed the group to amend and refile their complaint to try to establish they did have that right.

The watchdog group fared no better on its second try. The center failed to sufficiently claim it had been injured by the FDA’s refusal to add more disclosures to the consent forms for clinical trial participants, the court said. Because the group couldn’t show it had standing — sufficient connection to and harm from the FDA’s denial of its petition — the court tossed the suit a second time.

The center is reviewing the opinion to determine the next steps, including a possible appeal, Alan Milstein with Sherman Silverstein Kohl Rose & Podolsky, told Bloomberg Law Oct. 23.

Bloomberg Law reached out to the government for comment but no one was available to respond.

Sherman Silverstein Kohl Rose & Podolsky represented the Center for Responsible Science, which describes itself as a nonprofit organization advocating for more modern and predictive test methods in drug development.

The Civil Division, Consumer Protection Branch, Justice Department, represented the FDA.

The case is Ctr. for Responsible Sci. v. Gottlieb, 2018 BL 388055, D.D.C., No. 17-2198 (JEB), 10/22/18.

To contact the reporter on this story: Dana A. Elfin in Washington at

To contact the editor responsible for this story: Randy Kubetin at