We will determine the extent to which FDA conducts inspections of generic drug manufacturers. We will also describe the results of such inspections and the enforcement actions taken by FDA in response to shortcomings or deficiencies. FDA typically inspects drug manufacturing facilities before generic drug approval and conducts routine inspections of foreign and domestic manufacturers to monitor compliance with good manufacturing practices. Generic drugs are copies of FDA-approved brand-name drugs that must be equivalent to the original drugs with respect to conditions of use, active ingredient(s), route of administration, dosage form, strength, labeling, and performance characteristics. Pharmaceutical companies must receive FDA approval before marketing and manufacturing a new generic drug. (OEI; 01-13-00600; expected issue date: FY 2015)
FDA—Oversight of postmarketing studies of approved drugs
We will determine the extent to which FDA requires postmarketing studies and clinical trials (referred to as postmarketing requirements, or PMRs) for new drug applications. We will also assess how FDA monitors PMRs and takes enforcement action against applicants that do not comply with them. Section 505(o)(3) of the Food and Drug Administration Amendments Act of 2007 (FDAAA) provides FDA new authority to require additional testing of an approved prescription drug or biological product to assess serious risk related to its use. Under this authority, FDA may require an applicant to conduct PMRs at the time of approval or after approval if FDA becomes aware of new safety information or an unexpected serious risk associated with the use of the drug. (OEI; 01-13- 00390; expected issue date: FY 2015)
FDA—Review of information exchange in the drug supply chain
We will review drug supply chain trading partners' (e.g., drug manufacturers, wholesale distributors, dispensers) early experiences in exchanging transaction information and transaction history as required by section 202 of the Drug Supply Chain Security Act. 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 transaction history includes transaction information for every prior transaction for that drug back to the manufacturer. Together, this information forms the foundation of drug traceability and the security of the drug supply chain. Except for dispensers, trading partners must comply with the new exchange requirements by January 1, 2015, (dispensers have until July 1, 2015, to comply). We will interview trading partners about how they have successfully exchanged this information and what, if any, obstacles they have faced. (OEI; 05-14-00640; expected issue date: FY 2015)
FDA—Drug sponsors' compliance with clinical trial reporting requirements
In 2007, Congress passed the FDAAA (42 U.S.C. § 282(j)) which mandated that certain clinical trials be registered and their results be reported in the clinical trial registry and reporting data bank known as ClinicalTrials.gov. These reporting requirements are an important tool that enhances FDA' s ability to assess and monitor a drug's safety and efficacy. We will determine the extent to which clinical trials comply with the reporting requirements set forth by the FDAAA and the way in which FDA is ensuring that these requirements are met. (OEI; 02-14-00610; expected issue date: FY 2015)
