Amgen, FDA Squabbling Like Kids Over Pediatric Exclusivity


Amgen Inc. and the FDA can’t even agree on what should be included in the agency’s administrative record supporting its May decision to deny Amgen an extra six months of pediatric exclusivity for its kidney drug Sensipar.

Judge Randolph Moss of the U.S. District Court for the District of Columbia will hold a hearing Sept. 20 to hear from both sides about what the administrative record should include. In papers filed with the court, Amgen accuses the FDA of cherry-picking documents supporting its decision and excluding documents that could cast doubt on its decision to deny pediatric exclusivity for Sensipar.

Amgen is fighting so hard even on the administrative record because the ultimate outcome in the case will have large financial implications for the biotech giant. Sensipar (cinacalcet hydrochloride tablets), a drug used to treat chronic kidney disease in adults undergoing dialysis, pulled nearly $1.6 billion into Amgen’s coffers in 2016. Therefore, an extra six months on the market without generic competition would be quite lucrative for the Thousand Oaks, Calif.-based company.

The FDA can award pediatric exclusivity—an extra six months of market exclusivity—to a drug sponsor in return for testing the drug in children. Once Sensipar’s patent protection and any associated exclusivity grants run out, the FDA is free to approve generic competitors.

Amgen wants the FDA to supplement the record with additional documents for drugs other than Sensipar that the agency referred to in its decision and with all of its prior pediatric exclusivity decisions, including ones inconsistent with the Sensipar decision.

Meanwhile, the FDA, in its filing opposing the request to supplement the existing record, said the court should reject Amgen’s attempt to expand what’s included in it. Its request is unreasonable and would pull in information only peripherally relevant to the Sensipar decision, the agency said.

Stay tuned ... this fight is far from over.

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