Astellas: Hospital Discounts Before Pediatric Approval

In the Astellas Mycamine pediatric settlement, Astellas Pharma US agreed to pay $7.3 million to resolve allegations that it promoted Mycamine, an injectable antifungal containing micafungin sodium, for children before pediatric approval. A former sales representative’s complaint described children’s-hospital contracts, a study turned into dosing instructions and paid physicians carrying the promotional message. The alleged campaign reached both the hospital’s purchasing decision and the doctor’s prescribing decision.

What the Mycamine Settlement Covered

The Department of Justice announced the settlement on April 16, 2014, covering alleged pediatric promotion from 2005 through 2010. Astellas, based in Northbrook, Illinois, manufactured and sold Mycamine. The pharmaceutical fraud case began with a former Astellas sales representative’s lawsuit under the False Claims Act.

The announcement described adult approvals for serious Candida fungal infections, including infections in the esophagus, blood and abdomen, and prevention of Candida infections in adults undergoing stem-cell transplants. It said Mycamine had no approval for any pediatric use from 2005 through June 2013.

The settlement allocated $4.2 million to the federal government and $3.1 million to state Medicaid programs. The Justice Department also announced that the former sales representative would receive a whistleblower reward from the recovery.

How the Pediatric Promotion Allegedly Worked

The whistleblower’s complaint described a campaign that joined hospital pricing, sales materials and physician promotion.

The Discount Came With a Prescribing Target

The complaint alleged that children’s hospitals had to commit to Mycamine use to qualify for substantial discounts:

The alleged bargain rewarded hospitals for pediatric use while taxpayers faced claims for prescriptions the programs did not cover. The complaint alleged that sales representatives received monthly compliance reports and were directed to call on hospital pharmacists when prescriptions fell below the target. Children’s hospitals were among those accounts. The alleged price bargain came with a system for checking whether the hospital delivered the business.

The complaint also described a budget impact calculator used to sell hospital savings, with default settings for unapproved indications and dosages. Purchasing staff were being offered an economic argument for expanding use in a population the drug’s approval did not yet cover.

A Study Became the Dosing Standard

The whistleblower alleged a specific instruction for answering pediatric dosing questions:

That allegation gives a sales instruction a physical form: turn over the article and use the next page to answer the doctor’s question.

Medical Information Carried the Sales Message

According to the complaint, sales staff were told to distribute pediatric studies in response to requests about candidiasis treatment, comparative Mycamine data, AmBisome treatment or the article itself. The whistleblower alleged that the company presented these exchanges as responses to “appropriate unsolicited requests” while expecting them to generate off-label prescriptions.

The complaint also described an Astellas notice to its sales force suspending the use of certain reprints in such responses.

Paid Physicians and the Missing Warning

The complaint alleged that Astellas and its agent Roche paid outside physicians per appearance to discuss Mycamine’s merits with doctors and pharmacists treating children. These physicians were called “thought leaders” inside the company. The whistleblower alleged that promotional meetings included discussion of pediatric dosing and that sales representatives arranged private meetings with paid physicians.

The allegation connects paid speaker programs to the same pediatric sales effort. It also raises a question about the message reaching prescribers: the complaint alleged that Astellas and Roche promoted Mycamine to children’s hospitals without warning about liver-tumor risk.

What Is Considered Off-Label Promotion?

Off-label promotion means promoting a drug beyond its approved uses, including to a patient population the approval does not cover. Mycamine’s alleged pediatric campaign shows how the same disease can become a different promotion question when the patients are children.

The complaint alleged that representatives carried adult indications into children’s hospitals and used pediatric study material to support the pitch. It also alleged that sales staff faced pressure to present Mycamine as safe for children and superior to Merck’s competing drug Cancidas, which had a pediatric indication.

The connection to government reimbursement was central to the case. The Justice Department said the promoted pediatric use was not a medically accepted indication during the alleged period and therefore was not covered by federal health care programs. The complaint alleged that the campaign would cause Medicare and Medicaid providers to submit claims for those prescriptions. The alleged sales strategy reached the public bill through the hospital, doctor and pharmacy.

What a Sales Employee Could See

A sales employee could know how the hospital contract, account report and promotional material fit together. In this case, the complaint described representatives receiving prescribing reports, making follow-up calls to pharmacists, answering dosing questions and arranging meetings with paid physicians. That knowledge gives the transactions a context that an invoice alone cannot supply.

Public Citizen’s 2018 report, Twenty-Seven Years of Pharmaceutical Industry Criminal and Civil Penalties: 1991 Through 2017, found that whistleblower revelations contributed to 92 of 170 federal pharmaceutical settlements in the period it studied. The Mycamine complaint illustrates the kind of detail an employee can bring: what the sales force was told to do with a particular hospital and a particular piece of paper.

A whistleblower case under the False Claims Act can pay 15% to 30% of what the government recovers. Our work with a pharmaceutical insider connects their knowledge of the campaign to the prescriptions, payment claims and decisions behind it.

The Promotion Pattern Beyond Mycamine

Other healthcare fraud cases connect sales instructions and physician influence to allegedly noncovered prescriptions. Former Eli Lilly sales representatives brought civil cases over Zyprexa promotion for noncovered uses. AstraZeneca’s Seroquel civil settlement addressed allegations involving promotion and payments to physicians recruited as authors of company-prepared articles. The commercial channels differ, but the government-payment question follows the prescription in each.

Astellas’s later Xtandi matter concerned copay assistance funds. The Mycamine case concerned the earlier pediatric sales campaign.

You Know What the Sales Team Was Told

If you know how hospital discounts, dosing materials or paid speakers drove pediatric prescriptions, talk with our whistleblower experts about the campaign you saw. We work beside you to build the case and bring in pharmaceutical fraud whistleblower lawyers who understand off-label promotion and government reimbursement. We stay with you from the first account of the sales campaign through the pursuit of the government’s recovery.