GAO Report Uncovers Drug Safety Issues at FDA

FDA has failed to address multiple gaps in its process for monitoring drug safety issues, according to a new Government Accountability Office report released Thursday, AP/Modern Healthcare reports (AP/Modern Healthcare, 1/14).

Report Details

Between October 2006 and December 2014, about one-quarter of the drugs FDA approved went through at least one of the agency's expedited programs, the report noted.

Some experts say the fast-track approval system compromises patient safety by allowing drug companies to delay safety and efficacy evidence until after a drug is already on the market. On the other hand, supporters of the expedited approval process do not believe the system increases safety risks and is necessary, considering a shift in more drugs being developed for specialized populations.

Once FDA approves a drug, it is required to monitor its:

• Safety; and
• Drugmaker efforts to study the medication once it has reached the market.

Most of the potential safety issues identified by FDA were not tracked in its computer database for drug safety tracing, GAO investigators found. GAO attributed the tracking gap to a policy change that made it more difficult to enter the data. FDA staff members entered about two-thirds fewer issues into the system after the policy took effect (Tavernise, New York Times, 1/14).

The GAO report said, "Given the high workload of its review staff it had prioritized identifying, assessing and addressing potential safety issues over administrative tracking."

The report also found that between 2008 and fall 2013 FDA failed to complete a timely review of more than half of the 1,400 follow-up studies it had requested or required (AP/Modern Healthcare, 1/14).

The report also found FDA's computer system was cumbersome and did not allow for sorting by:

• Disease type;
• FDA action; or
• Patient population.

GAO said, "FDA's data on post-market safety issues and studies were found to be incomplete, outdated, to contain inaccuracies, and to be stored in a manner that made routine, systematic analysis difficult." (New York Times, 1/14).

GAO recommended that FDA develop in-depth plans to overhaul its database so it can be more easily updated (AP/Modern Healthcare, 1/14).  

FDA said it has looked into some of the issues noted in the report and has already taken steps to correct the problems (New York Times, 1/14). HHS said FDA is conducting internal evaluations to upgrade its computerized tracking system.

Reaction

Rep. Rosa DeLauro (D-Conn.), who commissioned the report, said the findings suggest FDA is "shifting more of the safety risk to consumers," noting, "The GAO report clearly highlights that FDA is not doing its due diligence in tracking drug safety issues and post-market studies that are critical in ensuring patient safety" (AP/Modern Healthcare, 1/14).

Diana Zuckerman, president of the National Center for Health Research, said, "We are shortcutting an important part of the approval process in the hope that we get the information later, but now we're finding out that's not happening" (New York Times, 1/14).