The U.S. Court of Appeals for the Ninth Circuit Tuesday revived a class-action Racketeer Influenced and Corrupt Organizations (RICO) suit against Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, and Eli Lilly and Co., of Indianapolis. In so doing, the appeals court held that patients and third-party payers suing pharmaceutical companies for concealing an allegedly unknown safety risk about a drug can satisfy the proximate cause requirement for a RICO suit. The lawsuit, brought by patients who had taken the companies’ diabetes drug Actos (pioglitazone) and a third-party health care payer fund, alleged Takeda and Lilly conspired to commit mail and wire fraud by intentionally misleading doctors, patients and payers about the drug’s bladder cancer risk. The plaintiffs sought to recover damages under RICO for their purchase of Actos, which they allege they wouldn’t have used had they known of the risk. A lower court had dismissed the case, saying the plaintiffs lacked RICO standing because they failed to allege the claimed RICO violation was the proximate cause of their losses. The Ninth Circuit panel disagreed, concluding that, although doctors served as intermediaries between “defendants’ fraudulent omission of Actos’s risk of causing bladder cancer and plaintiffs’ payments for Actos, prescribing physicians did not constitute an intervening cause to cut off the chain of proximate causation.” In addition, the appellate court ruled in remanding the case to the lower court that the plaintiffs adequately alleged reliance on the drug companies’ alleged misrepresentations and omissions. The ruling deepens a circuit split on the issue, which means the Supreme Court may weigh in if the Ninth Circuit decision is appealed.

The FDA is seeking comments on whether it should create a pilot program for the toxicological and quality evaluation of novel excipients for human drugs and biologics. Historically, the agency has reviewed the safety of novel excipients only within the context of an investigational new drug, a new drug application or a biologics license application, but stakeholders have encouraged the FDA to set up a novel excipient review program outside that context. Proponents of such a program have said the FDA's recognition of a novel excipient would reassure sponsors that the ingredient could be used in a drug development program while minimizing the risk that the agency would raise safety concerns when reviewing a drug application, according to a notice slated for publication in Thursday’s Federal Register. Because of a perceived risk aversion on the part of drug developers, novel excipients may be avoided in drug development programs under the current system, even when the excipients have potential public health benefits, stakeholders have told the FDA. The comment deadline is Feb. 3.

The FDA is issuing a draft guidance on establishing the effectiveness of drugs intended to treat interstitial cystitis/bladder pain syndrome, a complex, poorly understood syndrome of unknown cause. Incorporating recommendations the FDA received at a December 2017 advisory committee meeting on trial design features, the draft discusses key considerations such as enrollment criteria and efficacy endpoint selection. It also provides general recommendations on trial design features, statistical considerations and the use of patient-reported outcome instruments to demonstrate a clinically meaningful change with treatment. Comments should be submitted by Feb. 3.

Rising Pharmaceuticals Inc. agreed to pay more than $3 million in deferred prosecution and civil agreements to resolve a federal felony price-fixing charge and civil False Claims Act (FCA) violations involving a generic blood pressure drug. As part of the agreements, the Saddle Brook, N.J.-based generic drug company admitted that it conspired with a competitor to fix prices and allocate customers for benazepril hctz in 2014 and 2015, according to the U.S. Department of Justice (DoJ). The agreements call for the company to cooperate fully with DoJ’s ongoing criminal investigation into the generics industry and to pay $1.1 million in civil damages for the FCA violations, $438,066 in restitution and a fine of $1.5 million. Since Rising Pharmaceuticals has filed for bankruptcy, both agreements must be approved by the bankruptcy court. DoJ noted that the felony charge against the company was the fourth the department has filed in its investigation. Previously, two executives pleaded guilty to criminal antitrust violations, and Heritage Pharmaceuticals Inc., now doing business as Avet Pharmaceuticals Inc., of New Brunswick, N.J., entered into a deferred prosecution agreement with the DoJ’s Antitrust Division.

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