FDA Approval Processes For Therapeutic Drugs Must Be Improved

The Food and Drug Administration’s glacial pace at reviewing and approving new drugs has an enormous opportunity cost for society in terms of lives lost and illnesses prolonged.

For instance, while the FDA has received much praise for its ability to approve a vaccine for Covid within eight months of the pandemic, its inability to move with a similar urgency to approve a home flu test—ostensibly because they were not quite accurate enough—meant that no such tests were available until after vaccinations were widely available. Preventing people from easily discerning whether they had COVID made life enormously more complicated and confining for Americans.

One thing that served to lessen the severity of the Covid pandemic was the rapid development of various monoclonal antibodies for treating people with the illness. However, their future utility for treating new iterations of the virus—as well as other afflictions—are contingent upon the FDA coming to grips with the nature of this treatment and creating a sensible regulatory pathway for similar therapies.

Monoclonal antibodies—or mAbs—provide a short-cut for helping a body fight off a virus: Instead of stimulating antibody production via a vaccine, a lab biotechnologically engineers antibodies in a form that the body will recognize, which will spur it to create an accelerated response against a virus in infected patients.

mAbs were originally approved in the 1980s for the treatment of specific cancers, and they represent a way to provide possible treatments for a variety of maladies besides Covid. For instance, earlier this year researchers reported that they developed a treatment with mAbs that can significantly reduce respiratory syncytial virus (RSV)-related infections and hospitalizations in children under 5.

For mAbs to be worthwhile it is important that they be engineered to combat the current genetic makeup of an illness. For instance, the Covid virus has mutated rapidly since its inception: this has, of course, forced vaccine producers to change their products to reflect these changes, and they’ve managed to do so and get the modified vaccines to the market. Monoclonal Antibody treatments also have to be updated in a timely manner as well.

Early in the pandemic the FDA permitted several mAb therapies to be used on an Emergency Use Authorization, recognizing that it was important to have some therapeutic treatments available quickly and that the timeline for full FDA approval would take years and preclude these from reaching the market. However, those authorizations have expired and there are currently no mAb treatments for Covid available.

The expiration in and of itself is not a disaster: there are, thankfully, other effective treatments available. And it no longer made sense for the FDA to use its Emergency Use Authorization to hasten these treatments to the market, since there is not currently an emergency need for this.

However, it is clear that the very nature of mAb means that we need some sort of regulatory pathway to allow manufacturers to quickly pivot to rapidly provide new treatments in a timely manner. An environment where each new mAb treatment must go through the typical stages of drug approval would preclude these treatments from ever getting to the market in time for them to be effective for Covid, given how quickly the virus changes.

The answer—as my colleague Tony Lo Sasso and I noted—would be for the FDA to create some sort of expedited pathway for mAbs that would approve the platform for creating them so that variations could be quickly approved without a drawn-out FDA regulatory process. This might resemble the FDA’s current approach with vaccines for the seasonal flu, which change each year.

The FDA’s delay in accomplishing such a thing is, unfortunately, par for the course when it comes to getting new drugs to patients. While we all value the fact that the FDA goes to great lengths to ensure the safety and efficacy of new drugs, the process can often drag on for over a decade, depriving people of live-saving drugs.

At an Energy and Commerce hearing last month (I was once the committee’s economist) Congressman Dan Crenshaw took the FDA commissioner to task for an approval process that he averred was stifling innovation. Commissioner Robert Califf took exception to his remarks, and observed (correctly) that technology has become advanced at creating a library of therapeutic antibodies, which he said heartens his belief in the industry. Califf also noted that the FDA needs to work closely with industry to “make it worth their while to work in this field.” It begs the questions: is there an open and regular dialogue with manufacturers and if so, why are there no mAbs currently on the market given the undeniable need?

The length of time it takes for such therapeutics to reach patients effectively limits their value to us, and without changes to the approval process the benefits we get from these therapeutics will be limited. While the FDA’s insistence upon ensuring that drugs and medical devices are safe and effective is an appropriate standard, there are real costs to patients when the FDA fails to act in a timely manner, and these costs are not fully considered in its calculus.