According to an analysis by BioMedTracker that was commissioned by Forbes Magazine, 89% of drugs that were submitted for approval to FDA were given the green light this year.
That means FDA has only rejected three uses for new chemical entities. This activity follows an 88% approval rate in 2014.
This is an astonishing approval rate, especially when considering that in 2008 only half the drugs submitted to FDA were approved. Of course, there are a lot of explanations for why this is occurring, but to us and others in our industry the most striking reason is that the current political environment seems to be resulting in FDA approving drugs it shouldn't.
If this is an accurate portrayal of what is occurring it means we are entering into a new era where post-approval drug safety surveillance will be more important than ever. Warning sirens should be going off throughout every managed care organization, integrated delivery network and payer globally (hereafter I'll refer to these entities as managed care organizations, or MCOs) who bear the brunt of the financial risk. They are being forced into a position in which they will not only need to conduct initial comparative effectiveness research to determine formulary placement and utilization, but also need to invest in, and establish significant in-house post-marketing safety surveillance to avoid, and preempt costly adverse events.
This kind of rampant approval rate, in combination with the lack of FDA resources and funding, means there is no possible way the agency itself can be relied on by MCOs for comprehensive post-marketing safety surveillance and reviews. By the time FDA identifies an issue and the manufacturer and FDA negotiate the label change or other safety action, millions of dollars in adverse event related downstream medical costs have already been accrued by the MCO, not to mention the significant patient harm that could be avoided. In addition, even though FDA is focused on investing in big data capabilities and complicated active signal detection technology such as Sentinel, there are significant drawbacks and limitations to these efforts that will not be quickly resolved, and surely not in time to deal with the influx of new drugs hitting the market.
The costs of establishing a post-marketing surveillance program within a MCO do not have to be egregious. There are software platforms available like Advera's which use analytic technology to identify future label changes up to five years prior to FDA communication. This preemptive warning is vital in this new paradigm.
Bringing new drugs to market to treat disease is a great thing, and drug companies are getting better at research and producing better drugs, which is certainly one of many factors driving up approval rates. But this does not belie the fact that more drugs—expensive drugs—are flooding the market each year and these drugs are not being properly monitored, independent of FDA and the manufacturers. Without adapting their workflow to account for the new era of drug safety concerns that we have entered, MCOs are putting themselves, and patients at risk.
Jim Davis believes that an environment of transparency and evidence based decision making in healthcare that is based on improved data, analytics, and applications will reduce healthcare costs and improve patient outcomes. He has over 15 years of experience in commercial strategy, global sales management and execution, business development, and product development and over 12 years of specific domain expertise in healthcare market research, intelligence, and data. Jim can be reached at jim@adverahealth.com
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