Biogen: First the Payments, Then the Consulting Topics

In the Biogen whistleblower settlement, the company agreed to pay $900 million in 2022 to resolve allegations of speaker-program and consulting kickbacks for multiple sclerosis prescriptions. The complaint described a consulting business run backward: management decided how many meetings to hold and how much money to pay doctors, then expected staff to find subjects for those doctors to discuss.

A former Biogen director of regional marketing brought the case and continued it after the government declined to join. The Justice Department’s September 26, 2022 announcement covered alleged payments to induce prescriptions for Avonex, Tysabri and Tecfidera from January 1, 2009 through March 18, 2014.

Two Biogen Settlements, Two Payment Routes

The speaker case concerned alleged payments to healthcare providers who could prescribe Biogen’s drugs. A separate settlement announced in 2020 concerned alleged payments through foundations that covered patients’ Medicare copays for Avonex and Tysabri. The products overlapped. The money reached different people for different purposes.

These pharmaceutical fraud settlements involved alleged kickbacks, but the records tell distinct stories. In the speaker case, the question was why particular doctors received consulting and speaking opportunities. In the copay case, it was how patients receiving free drugs became patients whose purchases generated Medicare revenue for Biogen.

Consulting Topics Came After the Decision to Pay

Two former employees alleged in the third amended complaint that Biogen selected consultants for their prescription volume and influence over other doctors. What they could tell the company about its products came second. The alleged order of decisions was explicit:

The complaint alleged that Regional Marketing ran the consultant meetings without the Market Research department requesting or overseeing them. Employees recorded the consultants’ opinions, produced executive summaries and circulated them, but the marketing plans had already been written. The feedback did not change those plans. The paperwork showed that consultation had occurred. The alleged business purpose was to get money to prescribers.

A Small Group Controlled Most Prescriptions

The complaint described an expensive, continuing-treatment market in which a relatively small group of neurologists could direct millions of dollars in drug revenue. It alleged that the doctors and nurses Biogen paid in 2009 and 2010 collectively wrote approximately 60% of prescriptions in the multiple sclerosis market.

That concentration explains the alleged commercial strategy. The complaint described Avonex losing ground to competing treatments that were easier to administer. It alleged that Biogen wanted to protect Avonex’s eroding market share, expand Tysabri’s share and establish demand for its new oral drug, Tecfidera. Paying the doctors who controlled the prescriptions put the marketing money close to the purchasing decision.

The complaint also described spreadsheets tracking payment opportunities for important prescribers whose business Biogen feared losing. According to the complaint, management wanted to make sure those doctors had opportunities to receive payments and would keep prescribing Avonex and Tysabri. For someone inside a marketing department, the connection between a prescriber list and a meeting budget is the heart of that allegation.

The Forms Were Part of the Allegation

A former senior product manager for Tecfidera contributed the complaint’s account of that drug’s consultant meetings. The complaint alleged that Biogen’s head of compliance urged caution about written communications concerning those meetings. It also alleged that a compliance manager supplied terminology for Needs Assessment Forms so the forms could withstand government inspection.

These allegations concern the reason recorded for spending the money. A form describing a need for medical advice looks different beside an instruction to create more payment opportunities for selected doctors. The complaint placed those two accounts of the same meetings side by side.

Speaker Training With Very Little Speaking

Biogen allegedly paid doctors to train as speakers and paid them again to give presentations, even when nobody attended. The complaint said the company trained hundreds of additional Avonex and Tysabri speakers despite having more trained speakers than it could use and little demand for more promotional meetings.

The details make the alleged mismatch concrete. A doctor could receive an expenses-paid training weekend and then give only one or two presentations. Audiences were frequently just one other physician, sometimes a colleague from the speaker’s own office. The company was allegedly paying for a restaurant presentation of information the doctors could have discussed at work.

Separate Avonex and Tysabri training programs offered another payment opportunity. According to the complaint, much of the content overlapped, but doctors attending both received two expenses-paid weekends and double the training fee. The complaint alleged that Compliance questioned the duplication and that management ignored the warning.

The complaint described a choice for returning speakers: another paid training conference or an unpaid 15-minute update video. It alleged that most doctors who renewed chose the paid training. The alleged incentive sat inside the renewal process itself.

Dinner Meetings and Patient Programs

The complaint put speaker fees for dinner meetings at $2.3 million in 2010, before the cost of the meals.

According to the complaint, Patient Education Programs extended the payment system to doctors Biogen considered insufficiently experienced to teach other physicians. They spoke instead to patients at hotels or community centers. The complaint alleged that the events raised those doctors’ local profiles and could attract patients to their practices, with Biogen expecting prescribing loyalty in return.

Across the consulting and speaking arrangements, the complaint tied its allegations to an itemized payment record:

The Same Audience Problem Appeared at Novartis

Novartis admitted in its July 2020 speaker-program settlement that it repeatedly paid for dinners attended by the same groups of doctors, often colleagues or friends. Doctors sometimes rotated as the speaker and collected the speaking fee. Novartis also admitted paying honoraria for events that never happened.

That parallel makes attendance records useful beyond showing who ate dinner. They can show whether a program was reaching new listeners or repeatedly creating paid opportunities for the same prescribers. Biogen’s complaint raised that question through tiny audiences, overlapping training and payments for unattended events.

Ignored Compliance Warnings and Government Claims

The whistleblowers alleged that Biogen violated the Anti-Kickback Statute by paying doctors to induce prescriptions that generated Medicare and Medicaid claims. The alleged payoff to Biogen came at taxpayers’ expense.

The court’s April 2018 account of the complaint described repeated concerns about the speaking and consulting programs that employees communicated and management allegedly ignored. An insider’s account of why a program existed and what managers did with warnings mattered alongside the payment records.

The Government Declined the Speaker Lawsuit

The government declined to join the Biogen speaker lawsuit, and the former employee continued the qui tam case on the government’s behalf. The settlement ultimately allocated $843,805,187 to the United States and $56,194,813 to 15 states.

The Justice Department reported that the whistleblower would receive approximately 30% of the federal proceeds.

A whistleblower case under the False Claims Act can pay 15% to 30% of what the government recovers. In this case, the employee’s knowledge of the programs became a detailed account of the payments, the prescribing incentives and the company’s internal decisions.

The Separate Copay Case Moved Patients Off Free Drugs

Biogen agreed to pay $22 million in the separate copay settlement announced on December 17, 2020. The government alleged that Biogen used Chronic Disease Fund and The Assistance Fund to pay Medicare copays for patients taking Avonex and Tysabri. Advanced Care Scripts, the specialty pharmacy that helped arrange the transfers, agreed to a separate $1.4 million settlement.

The alleged business change was straightforward: patients already receiving a drug free from Biogen moved to foundation assistance, and their purchases then generated Medicare revenue for the company. The foundations covered the patients’ share of the bill.

For Avonex, the government alleged that Biogen identified Medicare-eligible patients in its free-drug program in 2011 and arranged for Advanced Care Scripts to move them to Chronic Disease Fund. Biogen paid the foundation. The pharmacy promptly sent batches of copay-assistance applications for those patients, and the foundation approved most of them.

For Tysabri, the government described a similar arrangement with The Assistance Fund in 2012. Biogen made payments in the second and third quarters, and the pharmacy followed each with batches of applications for patients previously receiving free drugs. The government alleged another Tysabri transfer to Chronic Disease Fund in 2013.

Those sequences explain why donation dates and application files matter together. The allegation was that Biogen’s money and the pharmacy’s patient transfers worked in coordination to generate reimbursed purchases. A charitable payment on one ledger and a batch of applications on another were parts of the same alleged arrangement.

The announcement also stated an approximately $3.96 million whistleblower reward in connection with that settlement.

What Proof Do You Need as a Whistleblower?

For these Biogen allegations, the useful evidence connected who received the money, why the company paid it and how prescriptions generated government claims. Our whistleblower experts work with you on those connections.

In the pharmaceutical business, the movement of a drug and the movement of money follow different paths. These Biogen allegations show why that distinction matters: a consulting fee reached a prescriber, while foundation assistance covered a patient’s share of a reimbursed purchase.

A 2021 literature review, Risks of Corruption in the Healthcare and Pharmaceutical Sector and the Impact of a Pandemic, in Proceedings: Security Challenges During COVID-19, maps the different participants in marketing, distribution and delivery of health care. It identifies trust in doctors, public funding and participants with different interests as conditions that create opportunities for abuse. In the Biogen allegations, the company directed money toward the people making prescribing or purchasing decisions while government programs paid the resulting claims.

For the speaker case, the revealing records included prescriber targeting, consultant budgets, training choices, attendance and ignored compliance concerns. For the copay case, they included free-drug enrollment, foundation funding and batches of assistance applications. Someone who knows how one of those systems works may understand a connection that the payment description alone conceals.

You Know Why the Money Was Spent

If you worked with speaker budgets, consultant approvals or transfers from a free-drug program, tell our whistleblower experts what drove those decisions. We work beside you to build your strongest pharmaceutical kickback whistleblower case around what you know, bring in pharmaceutical fraud whistleblower lawyers who understand prescriber payments and copay arrangements, and stay with you through the case.