Commentary: Streamline drug approval process
By Peter J. Pitts, a former Food and Drug Administration associate commissioner and president of the Center for Medicine in the Public Interest, New York City When you're desperately ill, your chances of recovery improve as your access to treatme...
By Peter J. Pitts, a former Food and Drug Administration associate commissioner and president of the Center for Medicine in the Public Interest, New York City
When you're desperately ill, your chances of recovery improve as your access to treatment improves. That's why it's such good news that the Food and Drug Administration is working to speed up the process of getting new medications to patients.
The FDA has two critical missions. One is to ensure that medications approved for sale to patients are safe and effective. The other is to get treatments to patients as quickly as possible.
Unfortunately, the two missions can come into conflict.
Approve a drug too quickly, without a comprehensive review of safety and efficacy, and the example that haunts all regulators might come to pass yet again. That would be the thalidomide tragedy of the 1950s, when a treatment for morning sickness in Great Britain in pregnant women led to severe birth defects.
But taking too long to approve a safe and effective treatment also takes a toll: patients who could benefit from the new treatment don't get it in a timely fashion, sometimes with fatal consequences.
Nobody wants to be the regulator who approves a dangerous medicine, whereas delayed approval imposes costs visible to very few. Regulators therefore have an incentive to err on the side of more testing and delay.
The FDA has long been aware of this problem. The agency has looked for ways to streamline approvals where safety reviews have shown positive results. And they are starting to pay off.
In 2017, the FDA approved more than 1,000 generic drugs - 200 more than had ever been approved in a single year previously. It also approved 46 novel drugs - more than twice as many as it did in 2016.
The increase in the number of treatments on the market and the availability of generic medications are providing the competition that is the most effective way to keep drug costs down.
The sad fact is that more than one in 10 Americans declined to fill a prescription in 2016 due to cost concerns.
When Americans don't fill their prescriptions, their illnesses worsen, which drives up healthcare spending. It costs the country more than $300 billion annually to take care of people who have failed to get well or have grown sicker due to their inability to comply with their prescription drug regimen.
Speeding up generic approvals should reduce abandonment rates. That's because Americans abandon taking generics at a rate that's 266 percent lower than the rate for brand-name drugs. The difference, of course, is the lower cost of generics.
Speeding up approvals for brand-name drugs could also improve adherence. That's because competition between different treatment options drives costs down.
Consider the recent price drops for cholesterol medicines. In 2015, the FDA approved a new drug called Praluent. It's a breakthrough medication - one that's proven to decrease heart attacks and strokes.
Praluent initially went on the market at a list price of $14,600. Fortunately for patients, the FDA has since approved other breakthrough cholesterol drugs. To improve market share, Praluent's developer has offered rebates of between 45 and 69 percent.
The dilemma of the drug approval process hasn't gone away and never will. But the FDA's improvements show that it can be managed more effectively.