Regulatory Focus™ > News Articles > Several FDA Programs to be Investigated in 2013 Under Proposed OIG Work Plan

Several FDA Programs to be Investigated in 2013 Under Proposed OIG Work Plan

Posted 03 October 2012 | By Alexander Gaffney, RAC 

The US Department of Health and Human Services' (DHHS) Office of the Inspector General (OIG), an investigative body charged with overseeing program performance and integrity, plans to devote part of its time and resources to investigating several programs run by the US Food and Drug Administration (FDA) during 2013.

OIG's plans were revealed on 2 October in the release of its Fiscal Year 2013 Work Plan, a 123-page document detailing the basic outline of its investigative plans for the upcoming year.

Four FDA programs will get special scrutiny from OIG: its complaint investigation process, its oversight of investigational new drug applications (INDs), implementation of Risk Evaluation and Mitigation Strategies Programs (REMS) and the 510(k) substantial equivalence pathway for medical devices.

Many of these programs have been the target of previous OIG investigations. A 2012 report into FDA's scientific dispute process, for instance, found broad issues within FDA's Center for Devices and Radiological Health (CDRH) and called for FDA to reassess its complaint resolution procedures. Instead of just focusing on CDRH, OIG said its investigation would expand to all complaint investigative processes at FDA.

For INDs, used to gain approval to conduct studies on an investigative drug, OIG said it will assess the timeliness of the IND review process and whether it meets the 30-day required review deadline.

REMS, instituted under the 2007 FDA Amendments Act, are add-on programs intended to make sure potentially dangerous products are used safely and that consumers are adequately informed of their risks. OIG said it plans to investigate the compliance of manufacturers with mandated REMS plans and their effectiveness at promoting desired behavior.

Finally, OIG said it will evaluate FDA's 510(k) process, which is used to clear devices that are substantially equivalent to earlier predicate devices already shown to be safe and effective. The investigation will focus on how FDA documents its decisions to clear devices through this process and when it determines that a more stringent Premarket Approval process is necessary.

With the exception of the IND investigation, all studies are expected to be completed in 2013.

OIG also said it would be investigating patient safety aspects of Medicare Part B and Part D patients prescribed off-label drugs, which it said is typically not allowed unless there is, "Sufficient evidence that the drug is safe and effective for treating the condition." The Centers for Medicare and Medicaid Services' (CMS) oversight mechanisms will be the target of this particular investigation, said OIG.

Drug shortages will also be investigated. OIG said it is concerned about the effects of rationing, delayed treatments and drug substitution, all of which could have a material impact on patient safety and could lead to providers turning to less-than-reputable sources to obtain supplies of drugs. OIG said it expects to complete these studies in 2014 after collecting information in 2013.

Finally, OIG said it will investigate FDA's oversight of Laboratory-Developed Tests (LDTs), which are often used as in-lab diagnostic tools and may not be subject to approval by regulators. "Because of this limited use, FDA has chosen to use regulatory discretion with respect to these tests and does not oversee them, explained OIG.  The agency said it plans to make recommendations in 2014 regarding whether FDA should exercise its regulatory authority, granted under the Medical Device Amendments Act of 1976, to more closely regulate the products.

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