The consumer watchdog group, Public Citizen, garnered significant attention this week when they raised an alarm against an FDA proposal that would enable pharmaceutical companies to distribute new drug safety data from clinical trials directly to doctors, prior to FDA review, for a potential label change. Their concern is that this proposal would allow pharmaceutical companies to publicize medications as ‘more safe’ than what the FDA approval process had previously revealed.

We agree that allowing pharma to continue to self-regulate drug safety is a dangerous practice. But we also find the FDA’s original proposal troubling for another reason.

As noted in a Reuters article covering Public Citizen’s protest, “Last June the Food and Drug Administration proposed allowing the distribution of new risk information about approved drugs, saying that a drug's safety profile "evolves" as exposure to the product increases.” And yet the article states, “Companies would not be allowed to distribute literature about newly identified risks or information that shows an already identified risk is more serious than stated on the label. Such information would need to be reviewed by the FDA and potentially included in the label.”

Huh? Why would FDA acknowledge that as new information emerges it changes the safety profile of a drug (which it does – See Table 1), but that those data should only be conveyed if drugs are presenting as more safe than expected? Isn’t that totally counter-intuitive. More safe is like an added bonus, a surprise treat in the cereal box. Less safe? As in new, unanticipated side effects, isn’t that what people really need to know about? And quickly? Isn’t the FDA’s primary goal to ensure the safety of the public at-large? How could keeping dangerous side effects a secret be a good thing for anyone?


Related Read: Should Adverse Drug Event Reporting by Healthcare Providers be Mandatory?


Reported adverse events

AdverseEvents’ mission has been to open a window onto the previously secretive world of drug safety, where once pharmaceutical companies maintained control over the information funnel. AdverseEvents focuses on finding key post-marketed safety risks, especially those that haven’t previously been identified in clinical trials or stated on the label. Our RxSignal analytic was designed specifically to serve as a pre-FDA action warning system. Using Eliquis as an example, you can see from the screen-shot below that there are serious, not labeled side-effects that are occurring at elevated rates. Shouldn’t managed care organizations and prescribers have the ability to take this into account when deciding on a treatment? Don’t patients have a right to believe that their doctors, insurers and hospitals have complete, up-to-date and accurate information regarding the prescriptions prescribed to them?


AdverseEvents Explorer Platform - Eliquis Drug Safety Profile


Everyday our clients are using that information to make better purchasing and prescribing choices, which lessens their downstream costs and improves patient outcomes.

While we agree that seeing improved safety data for drug post-approval is “nice to see,” it is the data that shows threats to patient outcomes that are “must haves,” and it is why we see the FDA proposal as completely nonsensical.


Related Read: Monitoring the Safety of Biosimilars by Managed Care Organizations: A Practical Approach


We believe that Big Pharma via this proposal is attempting to provide more refined label data (biased though it may be) concerning risks that are already disclosed. And while it is true that just because a risk is on a drug’s label, this labeling does not tell you how rare that risk is or whether one drug has a greater association with that risk than another drug. All this points to however, is the increasing need for more data, not less. For example, AdverseEvents’ RxOutcome dashboard provides our clients with a look at the real-world adverse event incidence rates from the entire population and compares those risks across disease groups or drug classes. It is a powerful and complete way of understanding the true risk profile of a series of drugs. It is also an independent view point. The pro-Big Pharma proposal would achieve the exact opposite – the biased selection and limitation of drug safety data available to those who require it the most, the public.


Related Read: RxOutcome - A New Paradigm in Drug Safety





I applaud Public Citizen for calling attention to this matter and encourage the FDA to ensure that the movement is to more independent data, not less. To learn more about the drug safety data, analytics and insight that AdverseEvents provides click here.

To see a sample of how independent data can reveal safety variances between drugs please view our Comparative Safety Review of Hepatitis C drugs: HARVONI, SOVALDI, VIEKIRA PAK



Sign Up Now! RxOutcome

Brian Overstreet

Brian Overstreet


Brian Overstreet Linkedin Brian Overstreet Twitter

Brian Overstreet

Written by Brian Overstreet