Regulatory Focus™ > News Articles > Government Report Details FDA's Progress, Failures in Implementing Improvements

Government Report Details FDA's Progress, Failures in Implementing Improvements

Posted 06 December 2012 | By Alexander Gaffney, RAC

The Department of Health and Human Services' (DHHS) Office of the Inspector General (OIG)is many things: an investigator of programs, a finder of fraud and a recommender of program improvements. A new OIG report makes the case that another superlative might belong on that list: ignored.

The agency puts out dozens of reports each year documenting what it sees as program inefficiencies, problems and weaknesses. In 2012, for instance, the agency has issued reports on the regulation of dietary supplements, the security of the US Food and Drug Administration's (FDA) food facility registry (also used to register dietary supplement manufacturers), the agency's medical device review process, and the amount of fines levied against regulated businesses.

But while these reports may address serious issues in great detail, OIG's recommendations aren't always implemented, sometimes leaving vulnerabilities even more exposed than they were before the reports were issued.

In a new report, OIG seeks to track down those omissions and draw even more attention to them in the hopes that someone-the agencies or other federal or legislative officials-will take notice and make the requested changes.

Numerous program areas overseen by FDA were identified as being deficient in their implementation of OIG's recommendations.

A 2009 report regarding the transparency of clinical investigator's financial interests, for instance, recommended that investigators be required to disclose all financial ties that might cloud their objectivity, particularly ties with pharmaceutical or medical device companies. While FDA has made some progress in requiring such disclosures-a 2009 directive, a May 2011 draft guidance and a May 2011 compliance guide for its staff-not all of OIG's recommendation were implemented. Specifically, OIG requested that clinical investigators' financial ties be disclosed to FDA as part of the pretrial application process-usually seen in the form of an Investigational New Drug (IND) application or an Investigational Device Exemption (IDE) application.

In another instance, OIG said FDA had failed to fully implement its recommendations on how to "use adverse event reports to detect and address safety concerns." The problem, as explained by OIG, is that FDA did not document its follow-up on adverse events and did not consistently analyze adverse events in a "timely manner." Neither did it consistently act to penalize facilities that failed to report adverse events in a timely manner.

OIG called for a "clear protocol" to support timely reporting of adverse events, and while FDA has made strides to implement some of its recommendations through the creation of the FDA Adverse Event Reporting Systems (FAERS), it has still failed to demonstrate that it is working to reduce under- or late-reporting by facilities and manufacturers.

OIG also spent a great deal of space in the report detailing the numerous failings of FDA's regulation of food-producing facilities, which it said remained deficient on a number of levels. The agency's reliance on state regulators to conduct inspections, for instance, has left it with inconsistent data regarding just how many inspections have actually taken place. "Two state agencies have informed OIG of discrepancies between the number of inspections reported in FDA data systems and that in State records," OIG explained. In other instances, FDA had been chided for exercising lax oversight over food production facilities, which are at least in theory required to register with FDA. Many still have not done so, and OIG noted that FDA's efforts in this area are part of an on-going process.

FDA is also mentioned in the report under several other semi-related program areas. The agency's National Drug Code (NDC) Directory, for instance, is often used by state and federal Medicaid officials as a means to verify whether drugs have been approved and are thus eligible for reimbursement. FDA has called that analysis problematic, as it is "neither fully accurate nor complete [because] drug manufacturers do not always submit the required information," OIG explained. Neither does inclusion in the NDC denote agency approval, leading to Medicaid programs paying as much as $20 million for unapproved drugs. FDA, OIG wrote, is now working more closely with CMS to make sure unapproved drugs do not get reimbursed, but more work remains to be done. 


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