Report Finds Gaps in FDA Drug Safety Oversight
Posted on behalf of Gordon & Partners on Feb 08, 2016 in Consumer Alerts
The Government Accountability Office (GAO) released a new report in January that reveals an unsettling lack of oversight in the Food and Drug Administration's method of tracking possible safety issues with drugs currently on the market.
Fast-Track Drug Approval
The Food and Drug Administration (FDA) currently has four separate programs for expediting drug reviews. These programs were put in place to make effective new drugs available to the people who could benefit from them as soon as possible.
However, upon closer inspection into the programs, the GAO found that companies were applying to more than one program at a time in some cases, submitting applications to all four programs to increase their chances of having their drug approved more quickly.
The report also noted that the FDA's record-keeping of approved drugs was inadequate. Incomplete and inaccurate records revealed that the FDA fails to keep up on follow-up studies that have been requested or required for approved drugs.
Of the 1,400 studies requested between 2008 and 2013, the agency was late in reviewing more than half. It also revealed that most of the potential safety issues that had been identified, were not uploaded into the system.
These studies are an important part of identifying safety concerns for patients taking these medications.
The report recommends that the FDA put in place new systems that will cross reference applications in order to prevent overlap of acceptance through more than one expedited program. It also recommends the agency keep adequate records of post-market studies once a drug has been approved to make sure that it is not harming consumers.
With 45 unique drugs approved and placed on the market in the last year, the chances of unforeseen negative effects for patients taking a drug that has not had thorough follow-up has increased.
If you feel that you or someone you love could have been affected by a bad drug, you should seek experienced legal counsel. The class action lawyers at Gordon & Partners will be able to assist you in asserting your rights as a consumer.