Clinical and Regulatory Affairs Whistleblowers: The Gap Between Data, Promotion and Certification

A pharmaceutical regulatory affairs whistleblower can connect the data inside a drug company to false statements used to obtain government payment. You may know what a trial found, what a quality investigation uncovered or what the company promised the Food and Drug Administration. Then you see the version sent to doctors or used to obtain coverage. The difference may be a missing risk, a claim the study never supported or a diagnosis changed to get a prescription paid.

For pharmaceutical whistleblowers, that knowledge can explain how a manufacturer caused a false claim even when a pharmacy or physician submitted the bill. We work with you to connect the scientific or regulatory fact, the company’s statement and the government payment.

Which Pharmaceutical Insiders See the Gap?

Clinical development and statistics staff may understand the result behind a claim of benefit. Medical writing and medical affairs staff may see how that result becomes language for prescribers. Regulatory and safety staff may know what information the company submitted and what it left out. Quality and compliance staff may see the investigation or control that contradicts the outward account.

A new drug application based on the company’s own safety and effectiveness investigations requires full reports of those investigations. The Food and Drug Administration determines whether the drug may be sold and what its approved labeling says. Government health care programs apply their own payment and coverage rules. An insider may understand the science behind a statement while another part of the business uses it to get prescriptions paid.

Clinical Trial Results and the Misleading Press Release

A pharmaceutical clinical trial statistician reviewing a misleading press release may recognize the gap between the study’s endpoints and the benefit the company claims. InterMune’s Actimmune resolution, which included a deferred prosecution agreement in the criminal case, shows how trial representations can reach government reimbursement.

In its October 2006 announcement, the Department of Justice described civil allegations concerning uncovered Actimmune prescriptions. The representations about a clinical trial of the drug, which those prescriptions followed, come from InterMune’s deferred prosecution agreement. In the announcement’s account of that agreement, the trial did not meet its primary or secondary endpoints. InterMune agreed to $30.2 million in federal civil payments over prescriptions the government alleged it should not have covered.

We examine that comparison with the insider who understands it: what the trial measured, what the analysis showed and what the company said the results meant. The next connection is how the representation reached prescribing and payment.

Omitted Drug Safety Reports and What Doctors Were Told

Safety information can matter to a false claims case when a company misrepresents a drug’s risks in obtaining government payment. GlaxoSmithKline’s 2012 resolution included a $657 million civil settlement concerning alleged Avandia safety misrepresentations.

For a regulatory affairs employee who knows of an omitted drug safety report, the underlying finding and the account given outside the company are the comparison we explore. What did the company know about the drug, and what did it tell the people making treatment or payment decisions?

A 2012 literature review identified misrepresented research results and hidden harm data among the practices it examined. A shorter version appeared in the BMJ. Its finding gives the safety employee a concrete reason to look at both accounts: the harm described internally and the risk described outside the company.

Quality Records and What the FDA Was Told

Manufacturing records can expose a direct contradiction between a company’s internal findings and its explanation to the FDA. The Cidra whistleblower complaint against GlaxoSmithKline alleged that product mix-ups discovered inside the plant did not match what the company told the regulator.

The complaint identifies the whistleblower as a former manager of global quality assurance. Her work included quality management across manufacturing sites, preparing sites for Food and Drug Administration pre-approval inspections and developing responses to regulatory problems.

The whistleblower’s third amended complaint alleged:

The complaint alleged that the plant found mix-ups inside its own operation, then told the Food and Drug Administration they must have happened somewhere else. The assurance went out even though the investigation pointed back into the plant.

GlaxoSmithKline’s October 2010 civil settlement was $600 million over allegations that government programs paid for adulterated drugs made at Cidra. Taxpayers paid for the medicine while the company allegedly concealed what was wrong with it.

REMS Controls, Prior Authorization and Patient Assistance

Aegerion allegedly distributed Juxtapid to patients without the diagnosis its approval required and falsified paperwork used to obtain government payment. Its $28.8 million civil False Claims Act settlement connected a drug approved for a rare disease to a business promoting it for high cholesterol regardless of that diagnosis.

Juxtapid was approved to treat high cholesterol in patients with a rare genetic disease called homozygous familial hypercholesterolemia. In the Justice Department’s September 2017 announcement, the government alleged that employees, including senior managers, made false and misleading statements that Juxtapid was appropriate for patients with high cholesterol regardless of whether they had that diagnosis, even when information pointed against it.

The civil allegations also reached the paperwork. Employees allegedly altered or falsified statements of medical necessity and prior authorizations submitted to federal healthcare programs. The diagnosis represented to the payer was part of what got the drug paid for.

Juxtapid’s Risk Evaluation and Mitigation Strategy set safety requirements for its use. Aegerion also agreed to a civil agreement with the Food and Drug Administration addressing failures to comply with those REMS requirements and labeling that lacked adequate directions for all the uses the company intended.

Patient assistance supplied another payment connection. The government alleged that Aegerion funneled funds through Patient Services, Inc. to cover copays for patients who otherwise would have received free medicine. That alleged copay kickback arrangement put the assistance program inside the reimbursement story. The alleged arrangement turned free medicine into a prescription someone else could be billed for.

Compliance Certifications and What Employees Actually Did

Aegerion’s corporate integrity agreement required measures covering promotion and interactions with patient-assistance programs, independent reviews, and compliance certifications from executives and board members.

A certification about promotional activity sits beside what employees actually told prescribers. A control over patient assistance sits beside how the company funded and interacted with the assistance program. The person reviewing those activities may understand whether the assurance reflects the operation.

What Is Considered Off-Label Promotion?

Off-label promotion means a manufacturer promotes an approved drug for a use outside its FDA-approved labeling. For a clinical or regulatory insider, the approved use, the company’s intended use and the use presented for government payment are separate comparisons.

For Medicaid, a medically accepted use includes an approved use or one supported by a citation in certain drug reference works, known as compendia. Citations approved for inclusion count too. A scientific claim can therefore matter again when it enters a reference work used for coverage decisions.

What Evidence Is Needed to Prove Fraud?

Study results, safety communications, manufacturing investigations and payment records can show different parts of the same alleged fraud. We work out with you how the records and your inside knowledge connect the company’s conduct to government claims.

For a trial representation, the study results and the public claim show what changed between analysis and promotion. For a safety concern, the finding and the communication about risk show what the company conveyed. For a manufacturing problem, the investigation and the FDA response show whether the outward explanation fits what employees found.

The payment records complete the picture. A medical-necessity statement or prior authorization can show the diagnosis presented for coverage. A claim for medicine made at a particular plant connects the supplied product to government money. The Cidra complaint went as far as identifying examples of government claims for Avandamet alongside its allegations of false statements to the FDA.

An insider’s account can explain the decision within those records: who understood the finding, who chose the wording and why the company used it. We bring the scientific, regulatory and payment questions together with you, so the significance of a technical discrepancy is clear.

A whistleblower case under the False Claims Act can pay 15% to 30% of what the government recovers.

When You Know What the Data Actually Said

If you can explain where a study finding, safety concern or quality investigation disappeared from the company’s outward account, speak with our whistleblower experts about that decision. We work beside you to build your strongest pharmaceutical whistleblower case, connecting the technical evidence to the company’s representations and government payment. We bring in pharmaceutical whistleblower lawyers who understand clinical evidence and reimbursement, and remain your partners through the case.