The FDA has faced its fair share of criticism over side effect reporting for drugs, with some claiming that the agency's system is outdated and misses important safety information. Now, the agency is looking to make improvements.
The FDA has set up at least one partnership with a tech firm to update its monitoring systems, and it's eyeing more. In its latest move, the agency is talking to tech giant Google ($GOOG) about teaming up to identify previously unknown side effects.
As Bloomberg reports, FDA officials recently met with a senior Google researcher who co-wrote a 2013 paper about using search query data to identify adverse drug reactions. FDA spokesman Chris Kelly told the news outlet that the meeting was a chance "for the agency to begin a discussion on how we might collaborate with Google on identifying adverse event data, using Google's technologies and data." Other FDA officials and a Google spokesman declined to comment to Bloomberg.
For the 2013 paper, Google senior staff scientist Evgeniy Gabrilovich and his co-author sifted 176 million Yahoo! queries, finding that search data can help flag previously undiscovered drug reactions. It could be a fruitful system for the FDA to step up its side effect monitoring. Gabrilovich's paper looked at the differences between searches for common symptoms such as "cramps" and "weight gain" and those that also included the name of a drug. The search analysis uncovered reactions that usually appear much later after a patient starts treatment, and so their link to the drug is often overlooked.
Even though the FDA gets more than a million reports of adverse drug reactions a year, critics say the system probably misses events and is slow to detect safety problems, the Bloomberg article notes. And before the drugs are approved, they only go out to carefully selected groups of patients in clinical trials.
This is not the first time the FDA has approached a tech company about improving its side effect reporting system. Microsoft ($MSFT) has also been working informally with the agency for several years on pinpointing drug side effects, Bloomberg reports. The company's researchers, along with FDA colleagues, authored a 2013 paper that found Web search data could have flagged the adverse interaction between antidepressant Paxil and cholesterol med pravastatin.
|PatientsLikeMe President Ben Heywood|
Last month, the FDA said it would join forces with PatientsLikeMe to use the company's patient information to improve drug-safety monitoring. PatientsLikeMe boasts data from a network of 350,000 patients, and its information on drug tolerance and adherence could help regulators pinpoint a drug's risks and benefits sooner than the FDA's existing surveillance program.
"We want to find not only new signals or new signals faster. We are endeavoring to take the patient voice and capture it and quantify it in a scalable way," PatientsLikeMe co-founder and president Ben Heywood told FiercePharma at the time. "It's a huge opportunity to bring the patient voice into regulatory risk and benefit."
- read the Bloomberg story