Over the next year, HHS’ Office of the Inspector General (OIG) plans to investigate the US Food and Drug Administration’s (FDA) requirements for post-marketing studies for new drugs, the exchange of information between drug supply chain partners and FDA’s oversight of networked medical devices in hospitals, as well as three other programs linked to the regulation of food and tobacco.
Although the majority of OIG’s work is tied to the oversight of Medicare and Medicaid funds, the inspector general also offers independent and objective oversight that aims to promote economy, efficiency and effectiveness in the programs and operations of HHS agencies including FDA.
On the post-marketing end of drug development, OIG will try to determine the extent to which FDA requires post-marketing studies and clinical trials for new drug applications. OIG will also assess how FDA monitors post-marketing requirements (PMRs) and takes enforcement action against applicants that do not comply with them.
OIG points to one section of the Food and Drug Administration Amendments Act of 2007 (FDAAA) that provides the agency with new authority to require additional testing of an approved prescription drug or biologic to assess serious risks. Under this authority, FDA may require an applicant to conduct post-marketing reviews at the time of approval or after approval if FDA becomes aware of new safety information or an unexpected serious risk.
In addition, in FY2017, OIG plans to issue a report based on its review of drug supply chain trading partners’ (e.g., drug manufacturers, wholesale distributors, dispensers) early experiences in exchanging transaction information and transaction history as required by the Drug Supply Chain Security Act.
Most recently, FDA delayed until 1 March 2016 track and trace requirements for dispensers, which includes pharmacies, health systems and physician offices.
Transaction information includes basic information about the drug (e.g., the strength and dosage form of the product, the National Drug Code, etc.), and the history for every prior transaction for a drug back to the manufacturer.
“Together, this information forms the foundation of drug traceability and the security of the drug supply chain. We will interview trading partners about how they have successfully exchanged this information and what, if any, obstacles they have faced,” OIG says.
Hospital Medical Devices
Meanwhile, OIG in FY2016 plans to examine whether FDA’s oversight of hospitals’ networked medical devices is sufficient to effectively protect associated electronic protected health information (ePHI) and ensure the safety of beneficiaries.
OIG notes that some computerized medical devices, such as dialysis machines, radiology systems and medication dispensing systems that are integrated with electronic medical records (EMRs) and the larger health network, pose a growing threat to the security and privacy of personal health information.
Medical device manufacturers provide Manufacturer Disclosure Statement for Medical Device Security (MDS2) forms to assist health care providers in assessing the vulnerability and risks associated with ePHI that is transmitted or maintained by a medical device.
OIG also plans to look into FDA inspections of high-risk food facilities, the agency’s monitoring of food recalls and the establishment of the Family Smoking Prevention and Tobacco Control Act.
Fiscal Year 2016 Work Plan for HHS’ OIG