This system has created a very unhealthy relationship between the industry and the FDA

BY SIMONE J. SMITH

During the pandemic, the public learned about the downside of one of the FDA’s industry-friendly workarounds — the Emergency Use Authorization (EUA), a shortcut that allowed the FDA to rush an unapproved vaccine in production, and then directly into the global community.

This was done even though there were early and widespread safety concerns. The infrastructure and capacity to review the available information so rapidly is due in large part to the funding from user fees. User fees are a viable way to shift some of the financial burden to manufacturers who stand to make money from the approval and sale of drugs in the lucrative U.S. market.

The FDA, obviously, has to work with the industry, and that’s good, but when the FDA starts getting taken over in many ways by the industry, that’s not good.

The FDA is an agency of the Public Health Service, and first and foremost, the FDA is in operation to help protect public health, primarily by ensuring that companies: prove the safety and efficacy of drugs/devices, manufacture them properly, and market them appropriately.

The FDA also has a secondary mandate to help foster innovation in healthcare by working with industry and academia to find better ways to evaluate safety and efficacy, and to respond to innovations in medicine.

What many of us are not aware of is that one has to be very cautious when — through a combination of being funded directly by the industry, which are pro-industry as opposed to pro-consumer — it starts moving in a way that is very favourable to the industry.

In short, the FDA effectively gets to decide who is even allowed to compete in the market. It is illegal to sell a drug or device with advertised medical claims without FDA approval, and insurance companies will typically not pay for their use. As a result, investors cannot afford to ignore the workings, or the prevailing mood, of the FDA when considering investments in this sector.

The pharmaceutical industry’s influence gets exerted in a number of ways. 10 years ago, their direct funding exerted the influence, paying cash right up front for FDA review [with the Prescription Drug User Fee Act (PDUFA)]. So, in many ways, the FDA started looking at industry as their client, instead of the public and the public health, who they should be protecting.

A second way in which the industry influence occurs is by having leaders in the drug division who refuse to take a stand. The attitude of leaders there is, “avoid conflict” and avoiding conflict means doing what the industry wants.

A third way in, which the industry’s influence has been allowed to grow considerably, is the absence of congressional oversight. Up until 12 years ago, whenever the FDA would make a mistake, they would have to explain what went wrong.

It appears that the FDA can, will and does change the rules on the fly when it feels that it must. Many companies have presented what they felt were complete data packages, designed in cooperation with the FDA and with the agency’s needs in mind, only for the FDA to tell them later that they need to perform additional studies. While these new studies are sometimes requested to answer questions raised by the clinical trial data, the FDA also sometimes appears to use them as a stalling tactic or a means of ruling out even far-fetched safety risks.

What has happened is the FDA has become weak and ineffective, unable to protect its citizens from the next dangerous drug. There are some signs that the pendulum may be swinging too far in the direction of the manufacturers.

This system has created a very unhealthy relationship between the industry and the FDA, where the FDA says, “We have to be nice to these people, because they are paying our bills.” It’s developed an unhealthy sort of client relationship between the government and the industry, which has resulted in some drugs (COVID-19 vaccine) getting approved that shouldn’t have.