The Whole Truth And Nothing But the Truth
Lying to the FDA will always get you in trouble
by Les Schnoll
It usually starts as a little white lie. The worst case finale is a not so brief vacation at the federal penitentiary. The philosophy is usually the same: What they don't know won't hurt them. The truth is what they don't know (or what you don't tell them) will hurt you.
It is sometimes only the misguided beliefs of a single person in an organization; at times it is the result of the ill-advised values of an entire company. In any event, the action will invariably get you in trouble. The incident: lying to the Food and Drug Administration (FDA) about a medical device, pharmaceutical or food product your organization manufactures.
Potential consequences include those with which most of us in the field are familiar, ranging from a Form 483 to regulatory letters, fines, consent decrees and injunctions. At times, the organization and its employees can be prosecuted--and the conviction rate is pretty high.
"So what? I won't get caught," you say. Or, "That's why we have lawyers."
Not a good mantra. Those organizations and staff who think they can get away with lying are usually not aware of a good friend of the FDA, namely the Department of Justice. Let's not forget that FDA investigators are officers of the government and, as such, can rely on their fellow representatives to provide assistance. That's where Title 18 of the United States Code comes into play.
Title 18 is a broad set of regulations dealing with crimes and criminal procedures that are under the jurisdiction of the Department of Justice. Part one (crimes) includes chapter 47 on "Fraud and False Statements." You should keep in mind a couple of sections in chapter 47 if you decide to be less than honest with a representative of the U.S. government.
Section 1001 (Statement or Entries Generally) applies in any matter within the jurisdiction of the executive, legislative or judicial branches of the government, which about covers it all. It applies to anyone or any organization that knowingly and willfully:
Falsifies, conceals or covers up by any trick, scheme or device a material fact (participates in a cover-up).
Makes any materially false, fictitious or fraudulent statement or representation (doesn't tell the truth).
Makes or uses any false writing or document knowing the same to contain any materially false, fictitious or fraudulent statement or entry (falsifies data).
Conviction under section 1001 can lead to pretty steep fines and imprisonment up to five years.
Section 1031 (Major Fraud Against the United States) is an area in which you are best advised not to get involved. This section applies to anyone who knowingly executes (or attempts to execute) any scheme or artifice with the intent to defraud the United States or obtain money or property by means of false or fraudulent pretenses, misrepresentations or promises.
In other words, if an organization has a contract with a federal agency and, for example, falsifies information to obtain that contract, section 1031 kicks in. Now the government cuts a little slack here: To be prosecuted under section 1031, the organization must be a prime subcontractor (or subcontractor to a prime subcontractor) of the United States, and the contract has to be $1 million or more.
The penalties for conviction for this type of indiscretion can be a fine of up to $1 million and 10 years in prison. Then again, those penalties can be more (including fines up to $10 million) if the loss to the government or the gross gain to the guilty party is $500,000 or more or if the offense involves a "conscious or reckless risk" to public safety. The regulations also provide the courts an opportunity to impose additional sanctions.
Now that we're aware of the Department of Justice, another possible result of lying to the FDA or falsifying documentation provided to the agency is a process known as AIP, or Application Integrity Policy. The source of this policy is chapter 10 of the FDA Office of Regulatory Affairs' Regulatory Procedures Manual.
AIP focuses on the integrity of data and information in applications submitted to the FDA for review and approval. To put this into perspective, note that the original title of the regulation published in the Federal Register (56 FR 46191 on Sept. 10, 1991) was "Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities: Final Policy."
AIP describes the FDA's approach regarding the review of applications that may be affected by wrongful acts raising significant questions about data reliability. If an organization is placed on AIP status (and this is a very small fraternity), the FDA will defer scientific review of any applications submitted by the company until it is satisfied the information provided is reliable.
Generally, AIP is invoked after the observation of a pattern of falsified information (more than one instance) of material facts (a false statement, misstatement or omission of a fact). These instances are classified as wrongful acts and defined as "any act that may subvert the integrity of the review process."
Wrongful acts include (but are not limited to) submitting a fraudulent application, offering or promising a bribe or illegal gratuity, stating an untrue statement or material fact, submitting data that are otherwise unreliable due to patterns of errors, whether caused by incompetence, negligence, practice or systemwide failure to ensure the integrity of data submissions.
Once a company is placed on AIP status, it's not easy to get off. Revocation of AIP is based on the guilty organization's conducting a credible and adequate internal review to identify all instances of wrongful acts. The review typically involves a qualified outside consultant approved by the FDA and submission and execution of a corrective action plan that includes:
A commitment to ensure safety, efficacy and quality.
A description of corporate ethics and compliance programs.
A process for effective communication of the company's ethics, quality and compliance programs to personnel through written procedures and training.
Steps to address current wrongful acts.
In addition, the organization must withdraw any questionable applications and commit in writing not to refile or reactivate any application not included in the validity assessment until the FDA is satisfied with the reliability of the information. The organization is required to submit a new application when a validity assessment indicates an application contains unreliable data and the company wishes to replace the data.
It makes good business sense--and it's easier--to be honest. If you say you're following a certain procedure or process, you'd better not be fudging the truth. George Washington was right when he supposedly said, "I shall not tell a lie."
Note: If readers have any questions or concerns, they should contact their companies' legal counsels or member of their compliance hotline (such as compliance officer or ombudsman). This article is not intended as legal advice but is expected to make readers aware of the law and risks associated with prevaricating, dissembling or otherwise being less than candid with the FDA.
LES SCHNOLL is director, corporate regulatory management, Hill-Rom Co., Batesville, IN. He is a member of ISO/TC 176 and ISO/TC 210 with more than 25 years of experience in quality assurance and quality control, auditing, regulatory compliance, management and microbiology in medical, pharmaceutical, preclinical and clinical laboratory and food areas. Schnoll is the author of two books published by Paton Press: The Regulatory Compliance Almanac--A Guide to Good Manufacturing, Clinical and Laboratory Practices and The CE Mark: Understanding the Medical Device Directive.