Areas like generic drug regulation, drug supply chain and clinical trials reporting may be in need of some revamping by the Food and Drug Administration, according to a new Work Plan from the U.S. Department of Health and Human Services’ Office of the Inspector General. All items will be examined by the end of next year.
Alexander Gaffney over at RAPS nicely broke down the different elements flagged by the regulators of the regulators, but here’s an overview:
Generic Drugs
The OIG will figure out “the extent to which FDA conducts inspections of generic drug manufacturers,” and evaluate what the FDA does in retaliation to “shortcomings or deficiencies.” It’ll release findings by the close of 2015. Gaffney elaborated why this is becoming a mounting concern:
Recent inspections of manufacturing facilities in India and China have also unearthed serious issues. As explained in Focus’ data integrity tracker, Indian companies alone have been accused of falsifying data 12 separate times since May 2013, and one Indian generics company, Ranbaxy, paid $500M in fines over claims it falsified generic drug data.
Postmarketing studies
The level of postmarketing study required by the FDA is variable. Many drugs are studied after they hit the market to uncover whether or not they have negative longterm effect – but the OIG will take a look at the FDA’s level of monitoring and, if a company fails to comply with requirements, how it’s disciplined. Gaffney says:
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
The problem, as reported in recent years, is that companies don’t always complete these studies. Some companies have said they find it difficult to enroll patients in the proposed studies since patients can avoid the studies entirely and obtain the drugs from their physician.
Drug Supply Chain
The OIG is taking a look at “drug traceability and the security of the drug supply chain,” with plans to interview trading partners about how they’ve successfully exchanged information. Gaffney says:
Another interesting addition to OIG’s work load is a look at FDA’s implementation of the Drug Supply Chain Security Act (DSCSA), passed in 2013 as part of the Drug Quality and Security Act (DQSA). The law’s provisions call for the creation of a national system to track all pharmaceutical products, allowing for them to be traced throughout the supply chain. The intent is that counterfeit drugs will have a harder time reaching customers, and that legally marketed but unsafe drugs can be tracked down more easily.
Clinical Trial Reporting
A number of clinical trial reporting mechanisms are in place, but the OIG is taking a look at whether clinical trials are actually in compliance. Gaffney says:
Various reports over the last few years have noted that despite requirements passed into law by the Food and Drug Administration Amendments Act of 2007 (FDAAA), many companies are not reporting top-line clinical trial results to the ClinicalTrials.gov website in the required timeframes.
“These reporting requirements are an important tool that enhances FDA’s ability to assess and monitor a drug’s safety and efficacy,” OIG noted. “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.”
