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Audit office says FDA 'is not meeting safety data obligations'

Criticised for not effectively tracking information about approved drugs
FDA

The US FDA has come in for criticism from a government watchdog for not tracking safety data effectively for already-marketed drugs.

The Government Accountability Office (GAO) says in a new report that the regulator is meeting its objectives for bringing new drugs to market quickly when there is an unmet medical need, but is falling down when it comes to post-marketing monitoring.

Between 2006 and 2014 the FDA received around 1,000 requests for quicker approval of drugs, and around a quarter of all approvals during that period referenced at least one expedited process ie fast-track, breakthrough status, priority review or accelerated approval.

Last year for example, the FDA approved 45 new molecular entities (NMEs) - including 16 first-in-class compounds - and more than 60% of the total relied on expected approval mechanisms.

The report notes that the FDA had missed its own deadlines in reviewing more than half the 1,400 post-marketing studies it had asked new drug developers to carry out as a condition of approval.

According to the GAO, the FDA "lacks reliable, readily accessible data on tracked safety issues and post-market studies needed to meet certain post-market safety reporting responsibilities".

While control standards for government agencies require information is recorded in a relevant time frame, the assessment of the FDA's Centre for Drug Evaluation and Research (CDER) has revealed "problems with the "completeness, timeliness, and accuracy" of post-market data.

Congresswoman Rosa DeLauro - who commissioned the GAO report - said the finding "confirms my greatest fear, that FDA lacks fundamental resources and leadership in ensuring that drugs brought quickly to market are truly safe and effective".

DeLauro says the GAO's conclusions suggest that the regulatory agency is "shifting more of the safety risk to consumers" by pursuing expedited approvals without the safety net of stringent oversight of post-market studies.

The FDA said in a statement that it has already started to take action to improve the "administrative tracking" of post-marketing trial data.

It also stressed that all drugs must meet the same regulatory standards - regardless of whether they are approved via expedited or standard pathways - and do not necessarily have different post-marketing study requirements.

Article by
Phil Taylor

19th January 2016

From: Regulatory

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