Companies that violate good manufacturing practices (“GMPs”) and/or good clinical practices, as well as the respective FDA 21CFR Sections 201, 211 and 312, 314 regulations, may be in violation of federal and state False Claims Acts when the resulting substandard or adulterated products are paid for by US government-funded programs (Medicare, Medicaid, TRICARE).
Government program billings for adulterated drugs (drugs produced in violation of FDA cGMP, cGCP, and Section 21CFR requirements) are considered “false claims.” Pharmaceutical companies or medical device manufacturers who sell adulterated products, or who receive funding from government programs to research or produce substandard products may violate the False Claims Act.
False Claims Act violations may be claimed for drug products regulated by FDA under the Investigational New Drug (“IND”) Regulations, for both research drugs not yet approved and drug products which have been FDA-approved for marketing and sales in the USA, and which are based on FDA’s IND and NDA/sNDA regulations.
Furthermore, for publically-traded Pharmaceutical Companies on the US Stock Exchange, deviations and violations of 21 CFRs for manufacturing and/or clinical trials which are minimized or omitted as risks from Investor disclosures may also violate Securities and Exchange Commission regulations. This may lead to additional claims of fraud and abuse, which is also a significant area of experience and prosecution of SEC laws by our attorneys and experts.
Common examples of FDA cGMP, cGCP, and 21CFR violations that may be False Claims Act liable include:
- Omitting or altering raw data and summary reports of safety and/or efficacy in clinical trial records
- Failing to report all Serious Adverse Events (“SAEs”) within 7 or 15 days of occurrence and first report to the Sponsor
- Altering or failure to include (or concealment) of required and original documents and supporting evidence in IND and NDA/sNDA applications by the Pharmaceutical Sponsor and/or their Contract Research Organization (“CRO”)
- Failure of the Sponsor and/or CRO to employ qualified medical and research personnel, and external investigators, in the conduct and reporting of IND and NDA studies, as well as the inclusion of persons on the FDA Debarment List and HHS OIG Exclusion List.
- False and misleading testimony by the Pharmaceutical Sponsor, CROs, investigators, and company-retained experts in FDA-conducted Advisory Committee meetings.
- Off-label marketing claims (promotion of uses and safety & efficacy data not contained in the FDA-approved Prescribing Information), by sales representatives, management and marketing, and medical affairs personnel.
- Adding, omitting or altering raw data and summary reports in manufacturing batch and controls records
- Allowing significant deviations in drug component manufacture and bulk drug substance, and not reporting to FDA in Annual Reports
- Adding, omitting or altering Analytical and Quality data
- Failure to examine batches / products related to other spec failures and failure to investigate out of spec batches
- Failure to prevent or investigate recurring contamination
- Failure to maintain valid computer systems and controls
- Failure to take corrective action and ensure no repeated incidents
- Failure to validate manufacturing processes and equipment
Remember, a drug doesn’t have to be less effective or impure to violate the False Claims Act. It only has to have been sold, produced, or investigated under conditions that violate FDA cGMP, cGCP and 21 CFR regulations (leading to the regulatory and legal definition of an “adulterated drug”). These infractions can occur within the USA, or internationally, as long as the research and/or marketed drug product is FDA-regulated (under an IND and/or NDA/sNDA) and eventually commercially-sold in the US.