An open letter from biopharma leaders

Science is the way out of the pandemic—and America’s researchers are working hard to bring COVID-19 vaccines, therapeutics, and diagnostics to the public, ASAP. But ensuring the public’s trust in those new medical products is essential. In an open letter to industry colleagues, BIO leaders explain what everyone involved needs to do. 

BIO leaders released an open letter to their biopharmaceutical colleagues articulating principles to ensure the “integrity, transparency, and objective assessment” of COVID-19 clinical data and secure public trust in new medical products developed in response to the pandemic. (Here’s the letter.)

These are the five core principles:

1. Clinical trials should be conducted according to best practices to assure credibility of the data, as well as the ethical participation of a diverse population of subjects.
2. Companies should disclose important clinical data via well-respected scientific meetings or rigorous, independent peer review journals. Companies that need to release data in advance of publication should do so thoughtfully and not through press release alone.
3. The U.S. Food and Drug Administration (FDA) should maintain its historic independence as the gold-standard international regulatory body, free from external influence.
4. The appropriate use and distribution of any new products should be data-driven, including through data collected during longer-term studies.
5. Political considerations should be put aside by leaders of both parties and they should “reassure the public that politics will not influence the development and approval of new medicines.”

“We urge all parties involved in the development, review, approval, and distribution of COVID-19 therapeutics and vaccines to commit themselves to these principles,” write the eight signatories, including BIO Chair Dr. Jeremy M. Levin, Chairman and CEO of Ovid Therapeutics; BIO Vice Chair Paul Hastings, President and CEO of Nkarta Therapeutics, Inc.; BIO President and CEO Dr. Michelle McMurry-Heath; and several past BIO leaders.

Why it matters: “As data begin to emerge from clinical trials of an array of vaccines and therapeutics, we believe that it is important for us in the biopharmaceutical industry to articulate the principles we see as essential for assessing these data and determining their potential value,” they continue. “We believe that public health, and the public’s trust in new medical products, are dependent upon the integrity, transparency, and objective assessment of new data as they emerge.” 

What they're saying: "We want the public to believe and to trust what we are doing," Dr. Levin told STAT News. "This is not just the current administration of BIO. This is the totality of decades of the industry speaking at this moment saying we believe that science and medicine need to stand out." 

View from BIO's Chairman, Jeremy Levin: "At this moment in time there is nothing more important or critical for the American public than to fully trust the manner in which our industry explores new scientific frontiers and analyzes data from critical clinical trials. Our nation should never have to worry that politics interferes with rational data and fact-driven scientific process, and the exploration and validation of clinical trial data. Even the appearance of political intrusion is detrimental. It undermines public confidence in our industry. It also offers an opportunity for those that already need a reason not to believe in our intent and commitment to science and medicine to doubt us further. That is why we made this declaration at this moment."

Learn more about what the biotech industry is doing to combat COVID-19.

On Tuesday, the U.S. Environmental Protection Agency (EPA) proposed a rule that will benefit America’s farmers and rural economies while making crops more sustainable. Here’s our take. 

The rule,Exemptions of Certain Plant-Incorporated Protectants (PIPs) Derived from Newer Technologies, “will streamline the regulation of certain plant-incorporated protectants (PIPs) that pose no risks of concern to humans or the environment,” according to EPA’s press release. 

What are PIPs? “[P]esticidal substances produced by plants and the genetic material necessary for the plant to produce the substance,” as the EPA puts it—in other words, natural, plant-derived resistance to pests.

What kind of PIPs do they want to exempt? Ones “based on sexually compatible plants created through biotechnology.” Or, to put it another way, these PIPs could happen naturally or through traditional breeding techniques but can be produced more efficiently with technology like genetic engineering.

BIO’s take: “An efficient, risk-based regulatory system fosters innovation and paves the way for global solutions such as crops that require fewer chemical inputs and tolerate extreme weather,” said Dr. Clint Nesbitt, BIO’s Senior Director of Science and Regulatory Affairs for Food & Agriculture.

What’s next: EPA will open a 60-day public comment period. BIO will submit comments in support.  

Read our statement on the proposed rule.

Learn more about how we can modernize plant biotech regulations and grow solutions to the climate crisis.

More Agriculture and Environment News:

Agri-Pulse: EPA moves to ease regulation of pest-resistant crops
"The agency’s proposal follows implementation of a broader rule finalized by the Agriculture Department in May to streamline its oversight of biotech plants."

The Washington Post: Where fashion is fungal
“[S]cientists are using mycelium, the threadlike vegetative roots of fungus, to create everything from plastics to packaging materials to plant-based meats, even scaffolding to grow new organs. And now, mycelium is starting to show up in closets as a nature-based material for clothes, shoes, and bags slung over shoulders.”