By Brooks Lockett and Justin Evans

 

 

Two recent developments are dramatically altering the biotechnology industry. First, there have been vast increases in the amounts of chemical herbicides used on genetically modified crops, and still further increases are scheduled to occur in the next few years. Second, the World Health Organization’s International Agency for Research on Cancer (IARC) has classified glyphosate, the herbicide most widely used on GM crops, as a “probable human carcinogen” and classified several other herbicides, including 2,4-dichlorophenoxyacetic acid (2,4-D), as “possible human carcinogens.”

 

These policy changes were fueled by litigation taken against agribusiness giants like Monsanto following hundreds of accusations of their products being toxic. For instance, Monsanto’s top-selling weed-killer RoundUp that was approved in the early 1970’s has recently faced claims by a man who testified that using the product for many years as a school groundskeeper caused him to develop terminal non-Hodgkin’s lymphoma.

 

The 46-year old’s case is one of the hundreds of others taken against biotech companies and their products. Despite prolific litigation, regulatory bodies have been slow to clearly define and differentiate their roles on the continuum of federal oversight. For this reason, cases like glyphosate distort public opinion of the biotechnology industry and misrepresent the incredible wave of innovation and scientific discovery it’s brought to our society. Furthermore, glyphosate-based products like RoundUp whose toxicity profiles have been widely debated make the regulation process considerably more difficult.

What does this mean for regulation of biotech products? Industry shifts call for regulatory bodies to adapt – quickly. This article will explore what steps are being taken by federal regulatory authorities to modernize our regulatory system in alignment with the currently shifting biotechnology landscape.

 

Our current regulatory system does its job protecting the health of our society and environment. However, oftentimes there is uncertainty about agency jurisdiction, leading to a lack of predictability of timeframes for review of new and marketed products. These problems result in avoidable costs that slow economic growth and stifle innovation.

 

In an attempt to mitigate these inconsistencies, the EPA updated the coordinated framework for the regulation of biotechnology in 2017, which stated that the EPA would regulate pesticides, herbicides, and pollutants, the FDA would regulate food, medical devices, and human drugs, and the USDA would regulate any products of biotechnology that may pose a risk to agricultural health or animal health.

 

Looking back at glyphosate, there are a few questions to address concerning which federal agency will have direct oversight. Since glyphosate is an herbicide, it falls under the umbrella of the EPA – but the USDA is responsible for the testing of crops, which herbicides are applied to. In glyphosate’s case, both agencies have specific supervision over different parts of the regulatory process. Not to mention, the FDA has the authority to enforce penalties for non-compliance.

 

We can see there is a large amount of overlap between the boundaries of oversight each regulatory authority has. This requires careful coordination among health authorities to minimize the room for interpretation when it comes to approving biotech products. The goal here is to seek out regulatory strategies that protect human and environmental health without stigmatizing emerging biotechnologies and diminishing public confidence in the oversight of products. In order to do so, there needs to be more predictable practices among regulatory authorities with overlapping jurisdiction.

 

What’s the next step?

 

Agencies should establish a regulatory model that is exceedingly predictable. In essence, the agencies practices should be so transparent that other health authorities should be able to accurately forecast how they will respond to certain situations.

 

This highly-predictive model will illustrate a plan for frequent, formal horizon-scanning assessments of new biotech and agricultural products to ensure that agencies are prepared for future products before federal regulation is required. Regulatory authorities should be able to ensure that every product evaluation is risk-based and grounded in the best science available. With this, regulatory activities will be able to be adjusted based on experiences with specific products and the environments into which they have been introduced. Theoretically, these practices would improve agencies’ abilities to assess the risks arising from future products of biotechnology. Had this been done for Monsanto’s glyphosate-based product RoundUp, the FDA, EPA, and USDA may have been able to better coordinate their responses to the World Health Organization’s 2015 announcement that glyphosate was heavily linked to cancer – and perhaps avoided the whirlwind of negative media attention it brought to the biotech sector.

 

Now that we have outlined several key issues regarding the federal regulatory efforts with respect to the biotechnology industry, what are ways to potentially improve this system and alleviate any unnecessary difficulties?

 

For a better understanding of the potential solutions to gaps in the United States’ regulatory system and how to fill them in, it is useful to draw comparisons to European regulatory practices.

 

European health authorities take an approach of austere caution when dealing with the approval and implementation of biotechnology products in its countries, whereas the United States’ approach is highly permissive. This is further supported by the varied responses by the two regions to the World Health Organization report on glyphosate. When contradictory findings on the potential risks of the use of glyphosate first surfaced, the European Union (EU) responded by delaying its renewal of the glyphosate license until it could conduct further scientific studies. The delay is largely a response to the disapproval of politicians, regulators, and researchers in the EU.

 

Contrastingly, agencies in the United States like the Environmental Protection Agency (EPA), have failed to evaluate the human health risks arising from glyphosate including carcinogenicity, as well as the environmental risks. The Europeans approach is considered the precautionary principle, whereas the United States approach is that of substantial equivalence. Between these two modes of regulation, there are several critical differences to acknowledge.

 

The precautionary principle aims to prohibit products that may cause severe or irreversible damage to humans, animal and plant health, as well as the environment. European health authorities have not gone as far as banning all genetically modified products but instead established guidelines that should be used to constructively scrutinize the products being introduced. Many are skeptical of the United States’ approach because it is not believed that this approach was fueled from a place of consideration for the American citizens, but rather a push from the industry to approve its products more quickly.

 

Regulation of biotechnology products should be overseen by the coordinated efforts of one agency.

 

Another way to harmonize our regulatory system is to establish a single governmental agency that is responsible for the oversight of biotechnology products like glyphosate and genetically engineered organisms. This agency would eliminate the patchwork regulation done by the current 16 agencies. That way there is less room for error and for critical information regarding regulatory decisions to fall through the cracks. Having a more centralized structure would allow for a normalized standard, which would promote more clear guidelines for product compliance initiatives.

 

The efforts of this single agency should mirror the FDA’s actions in relation to drug screening. It should dedicate its resources to reviewing newly developed products of biotechnology and request studies, similar to clinical trials to test the safety of the products over time. I believe an agency dedicated strictly to food will help relieve the burden of the FDA so that it can focus on drugs exclusively. Many of the sixteen agencies are responsible for more than food safety, which increases the burden on the entity, by having to divide their efforts between responsibilities.

Because regulations fluctuate and inspections are done at different points, it is often difficult to respond to outbreaks. Proponents could argue that by having a staggered visitation, the sixteen agencies are visiting the company more than what a centralized entity would. Starting a new agency means that the entity will be starting over and will create a delay in the inspection process and would take years to get the point of flowing properly. The new agency may be affected by the same growing pains as the FDA. Even the FDA has struggled with its duties as of recent after the Congress passed the Food Safety Modernization Act. FDA learned very quickly that it could not take on food safety alone and would need help. It realized that it did not have the proper manpower nor the funding to properly train those running food facilities and inspectors. This could be a reason why a centralized entity might be the way to go. If the FDA needs to form alliances with the other 15 agencies to properly protect food safety, why not create a single entity?

 

Governmental agencies should separate its interest from that of the industry

 

This section goes without saying, but it is important to emphasize (governments should care more about people, not profits).

 

A prime example of why Americans have a lack of trust in government agencies comes from its revolving door policy with biotechnology and pharmaceutical companies. Governmental agencies should no longer allow for life science companies to place its employees into prominent positions of the government. For example, the FDA’s substantial equivalence policy, which justifies the use of genetically engineered products without extensive testing or labeling, was created by Michael Taylor, the FDA’s Deputy Commissioner of Food at its passing. Taylor began his career as a staff attorney with the FDA, before leaving to join King & Spalding’s food and drug practice, where he represented Monsanto. Decades later, he would return to the FDA as their Deputy Commissioner for Policy and thereafter become Monsanto’s vice president for public policy.

 

To provide an example from the pharmaceutical industry; Alex Michael Azar II, like Taylor, worked for a private firm before taking a prominent position in the government as the General Counsel of the United States Department of Health and Human Services during the Bush Administration. With the election of Obama, Azar left the Department of Health and Human Services to work as Eli Lilly’s top lobbyist and spokesman as its Senior Vice President of Corporate Affairs and Communications. As you may have guessed, with the election of Trump, Azar is back in government as the United States Secretary of Health and Human Services.

Taylor and Azar are just two out of hundreds of instances of this ‘revolving door’ that exists between the government and the life sciences industry. Experts say the convenient relationships don’t necessarily mean congressional staffers do favors for lobbyists they know, but the access doesn’t hurt. High-level appointees job-hopping between regulatory agencies and bioscience companies is an issue that goes much deeper than discussed, but nonetheless, it plays a factor in government regulation that leads people to believe that ‘business relationships’ are taking priority over what is best for patients.

 

To recap, federal regulatory bodies might benefit from establishing a single agency to oversee all aspects of the regulation of biotechnology – possibly resulting in better coordination of responses to situations like Monsanto, where a product that was previously thought to be non-toxic turns out to be toxic. This might help remedy the seemingly bad reputation of life science companies who are attempting to establish a culture of transparency among the government and also the general public. And above all else, putting the patient first.