Regulatory Focus™ > News Articles > FDA's Regulation of Generic Manufacturers, Clinical Trials Comes Under Scrutiny

FDA's Regulation of Generic Manufacturers, Clinical Trials Comes Under Scrutiny

Posted 05 November 2014 | By Alexander Gaffney, RAC

FDA's Regulation of Generic Manufacturers, Clinical Trials Comes Under Scrutiny

Federal oversight officials are once again poised to take a close look at actions being taken by the US Food and Drug Administration (FDA) to protect consumers.

In a new Work Plan posted by the US Department of Health and Human Services' (DHHS) Office of the Inspector General (OIG)—the division in charge of auditing DHHS agencies—federal auditors say they plan to hone in on five separate areas of FDA regulation.

Generic Drugs

OIG says it's interested in determining "the extent to which FDA conducts inspections of generic drug manufacturers." Inspections, especially of generic manufacturers, have received ample attention in recent years both from FDA and legislators, who gave FDA additional resources in 2012 under the Generic Drug User Fee Act (GDUFA)—part of the sprawling Food and Drug Administration Safety and Innovation Act (FDASIA). The legislation was intended to give FDA the funding it needed to inspect generic drug manufacturing facilities, which are often based outside the US and are therefore more difficult to inspect.

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.

OIG said it is also interested in seeing how FDA deals with "shortcomings or deficiencies" it finds at generic drug manufacturing facilities both prior to approval and after a drug is approved. Findings should be released to the public by the end of 2015.

Postmarketing Studies

OIG is also set to look at FDA's requirements for postmarketing studies and clinical trials. Many drugs are now approved along with conditions—namely, that the companies conduct trials meant to uncover potential problems with the drugs. For example, many recently approved obesity drugs were approved on the condition that their sponsors conduct trials to determine if use of the drugs led to increased cardiovascular adverse events.

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.

OIG's report said it is also interested in studying how FDA deals with companies that do not complete the studies.

Drug Supply Chain

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.

While the drug identification system is still in its infancy, OIG said it wants to review the implementation of the program so far as it relates to drug supply chain "trading partners" like drug manufacturers and wholesale distributors, who will be required to exchange information about their transactions with one another.

The law's transaction requirements come into effect on 1 January 2015, and OIG said it wants to hear about their "early experiences" with the requirements.

Clinical Trials Reporting

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 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."

All work items are expected to be completed by the end of 2015.


OIG Fiscal Year 2015 Work Plan

Categories: Regulatory News

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