Health & Lifestyle

Less than a third of FDA drug regulation changes are actually backed by science

Less than a third of US Food and Drug Administration (FDA) drug regulation changes are backed by research, a study has warned.

This means either the FDA is taking action based on evidence that is not public, or more thorough decision-making is needed, researchers from Yale University said.

The FDA Adverse Event Reporting System (FAERS) is a database of adverse events – negative outcomes patients have experienced after taking a drug, such as a rash.

It also holds details of medication errors, including mistakes in the prescribing, taking or providing advice on medicines.

The database helps the FDA check all drugs that it has approved are safe after they have hit the shelves. 

The FDA gets over two million adverse event reports every year through its FAERS and reviews all information on adverse events that could be caused by a medicine and need further investigations, known as safety signals.

These FAERS drug safety concerns in children have previously included risks of cancer, birth defects, and deaths.

Regulatory actions the FDA may take include public communications, letters to healthcare providers, changes to drug labeling, including boxed warnings, and the withdrawal of drugs.

But only 30 per cent of FDA regulatory actions were supported by at least one relevant published research study, and none were verified with a public assessment, the study found.

The researchers said the findings ‘highlight the continued need for rigorous post-market safety studies to strengthen the quality of evidence available at the time of regulatory action’.

The researchers found 76 drug safety concerns in 2014, 57 of which included relevant, published evidence. But less than a third of those 57 had evidence which supported the course of action taken by the FDA. Furthermore, the evidence used was often a follow-up of an individual patient

The researchers found 76 drug safety concerns in 2014, 57 of which included relevant, published evidence. But less than a third of those 57 had evidence which supported the course of action taken by the FDA. Furthermore, the evidence used was often a follow-up of an individual patient

Do they know something we don’t? US stocks up on $300m worth of radiation sickness drug

The US has stocked up on radiation sickness drugs just weeks after Vladimir Putin threatened to use nuclear weapons against the West.

Officials said the deal — worth $290million — was ‘part of ongoing work’ and ‘has not been accelerated’ by the Kremlin leader’s escalating rhetoric.  

The US Health and Human Services (HHS) – whose motto is to ‘improve the health, safety, and well-being of America – announced the purchase of romiplostim Tuesday.

Sold under the brand name Nplate, it is used to reduce bleeding caused by acute radiation syndrome (ARS), also known as radiation sickness.

Putin issued a chilling warning late last month that he was prepared to use Russia’s nuclear arsenal to protect Ukrainian territory annexed after sham referendums.

But the US Health and Human Services (HHS) said the drug order was ‘part of ongoing work’ and ‘has not been accelerated’ by Putin’s warning.

However, the timing will likely raise questions given that this is the first time the US Government has bought Nplate.

It is unclear how many doses the order covers, but the drug normally fetches between $1,000 and $2,500 per dose.

Researchers analyzed 603 drug safety concerns identified from the FAERS and reported to the FDA from 2008 to 2019.

The researchers referred to the concerns as ‘resolved’ if the FDA had taken regulatory action or judged that none was necessary.

About 70 per cent were deemed resolved, with 78 per cent of those leading to regulatory action.

Some 77.2 per cent of the actions were changes to drug labeling and 14.3 per cent were public communication from the FDA.

The researchers made a separate detailed analysis of 82 drug safety concerns identified in 2014 and 2015.

Of the 76 of those that were resolved, 57 had at least one relevant study that had been identified alongside it.

But most of the studies were case reports – a follow-up of an individual patient – or case series – a group of case reports with patients who were given similar treatment.

And less than a third of the 57 (29.8 per cent), had at least one relevant published research study which supported the course of action taken by the FDA.

None were verified with a public assessment.

13 of the 82 signals led to drug safety communications, all solely due to information from FAERS.

The 2007 FDA Amendments Act means the FDA must publish quarterly reports of drug safety concerns identified in FAERS, but the reasons for the FDA’s different regulatory actions, or lack of action, after safety signals, is not clear.

If drug safety communications to the public are required, the FDA regularly provides supporting evidence, but when changes are made to product information, no such information is normally given.

The researchers suggested that an FDA action might be decided on the basis of information that is not publicly available, meaning the public will be left in the dark as to why rules on their medicine have changed.

The researchers noted limitations of their study, including that they did not consider regulatory actions taken in other countries off the back of the drug safety concerns, which could have affected the FDA’s decisions.

The findings were published in The BMJ.

But in a document attached to the study, other researchers from the University of Sydney questioned if concerns that the researchers deemed ‘resolved’ truly were.

They cited an a separate study analyzing FDA warnings on the sleeping pill zolpidem which found only minor reductions in average dose, and with women taking the drug largely unaware that they were more at risk.

They said the FDA’s actions need to be evaluated for their effectiveness.

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