Secretary Azar, let FDA scientists do their jobs

October 2, 2020
So much for a slow Friday. Our thoughts are with President Trump, the First Lady, and their family, and we hope they experience a speedy recovery. Ahead of his testimony on Capitol Hill, BIO sent a letter to Health and Human Services Secretary Alex Azar urging him to…

So much for a slow Friday. Our thoughts are with President Trump, the First Lady, and their family, and we hope they experience a speedy recovery. 

Ahead of his testimony on Capitol Hill, BIO sent a letter to Health and Human Services Secretary Alex Azar urging him to release pending vaccine clinical trial guidance. We also explain why it’s important for policy to support plant and animal biotech innovation. Today’s news in about 1,000 words, 5 minutes.


Secretary Azar, let FDA scientists do their jobs


While scientists at the U.S. Food and Drug Administration (FDA) and within the biopharma industry have been working hard to try to defeat COVID-19, there has been increasing political pressure to deliver a vaccine as quickly as possible. This has had repercussions on public opinion about science and a future COVID-19 vaccine.

Ahead of Health and Human Services (HHS) Secretary Alex Azar’s testimony on Capitol Hill, BIO sent him a letter urging him to release pending vaccine guidance and let FDA scientists do their jobs.

As background, the FDA was set to release vaccine guidelines, “bringing the bar for emergency use of a coronavirus vaccine closer to the standard for a full approval,” reported POLITICO.

“But the guidance stalled last week when it reached the White House,” with President Trump and Secretary Azar reportedly expressing concerns about releasing it, POLITICO continued.

BIO sent a letter urging Secretary Azar to release the guidance, to “provide scientists and researchers greater regulatory clarity and strengthen public confidence in any future vaccine that may be authorized or approved.” 

“We cannot allow a lack of transparency to undermine confidence in the vaccine development process,” says the letter. “Releasing any additional guidance on granting emergency use authorization for a vaccine will go a long way in accomplishing this critical goal.” 

“Let the career scientists at FDA really do their jobs,” said BIO President and CEO Dr. Michelle McMurry-Heath in a video statement. “Let them pursue the scientific questions around the COVID vaccine and have confidence in their decisions.”

“Scientists and leaders at the FDA are always trying to juggle public opinion, political pressure, and the science at hand,” she concludes. “But the good news is they’re pros at it. They know their science inside and out. They’re dedicated to the patients they serve and the industry that they work with, and they really want to do the best job possible. So, I have all confidence that if we unshackle the FDA and let them do their great work, that we’ll have a wonderful vaccine before too long.”

Read more about BIO's letter in the New York Times.


Dr. Michelle on BIO's letter to HHS Secretary Azar

More Health Care News:

Cato Institute Regulation: The evergreening myth
“Claims that drug innovators extend their patents obscure a radical policymaking goal.” 

CNBC: Pfizer CEO says U.S. presidential debate was ‘disappointing’ in memo to employees that criticizes politicizing coronavirus vaccine process
“He told employees that vaccine development is moving ‘at the speed of science’ and that the company would not succumb to political pressure.”


Why biotechnology should be bipartisan


African swine fever continues to spread in Germany, reports Reuters, yet another example of the need for policy that supports the development of animal biotech. BIO’s Karen Batra takes a look at how the election could impact this kind of innovation—and the need for policymakers to continue to prioritize scientific progress, whatever the result.

As we’ve previously reported, African swine fever continues to devastate pigs and consequently farmers, but biotechnology is working on developing pigs that are resistant to the deadly disease.

But: The industry, including “academics, technology developers, farmers, and ranchers—especially livestock producers—are still waiting for some movement on regulation of animal biotechnology and gene-edited animals, currently under authority of the [Food and Drug Administration],” explains Karen

And with just a few weeks until Election Day, biotechnology developers are speculating about how innovation will be treated under various outcome scenarios, she says.

For more than a decade, scientific progress has largely been a bipartisan issue. The Trump administration has worked to modernize oversight of biotech plants, including pest-resistant plants, while the Obama administration released a National Bioeconomy Blueprint that included a plan to overhaul regulations that held back innovation.

We hope this remains the case, because there’s more work to do—especially on animal biotech.

What can we do in the meantime? In addition to our policy advocacy, BIO continues to work to grow trust in innovation—because regulatory reforms must be accompanied by meaningful education and outreach, too. 

Here are some resources to help:

  • The U.S. Department of Agriculture (USDA), Environmental Protection Agency (EPA), and FDA recently launched Feed Your Mind, a consumer education initiative to provide science-based information on genetically engineered foods. Feed Your Mind just added new resources including new videos, fact sheets, and a high school curriculum.
  • Innovature is a joint project of BIO and the American Seed Trade Association (ASTA) highlighting gene editing’s contributions to agriculture, food, and wellness. The content hub houses articles and resources while the accompanying social media platforms promote a dialogue about agriculture innovation, science, and nature.
  • GMO Answers, funded by the members of CropLife International, has used its online portal and pool of more than 200 experts to answer thousands of questions in real time about GMOs in food and agriculture. The program continues to add to its library of resources and drive a conversation on social media

Learn more at Growing Trust for Innovation.


More Agriculture and Environment News: 

BBC: Two-fifths of plants at risk of extinction, says report
“We're losing the race against time because species are disappearing faster than we can find and name them. Many of them could hold important clues for solving some of the most pressing challenges of medicine and even perhaps of the emerging and current pandemics we are seeing today.”

BIO Beltway Report

President Trump’s Friday: He’s in isolation after the White House physician announced that President Trump and the First Lady tested positive for COVID-19.

What’s Happening on Capitol Hill: House Democrats passed a $2.2 trillion coronavirus relief package, but it’s unlikely to get through the Senate. As of this writing, Speaker Nancy Pelosi and Treasury Secretary Steve Mnuchin are reportedly still trying to hammer out a bipartisan deal by the end of the day. Meanwhile, Health and Human Services Secretary Alex Azar is appearing before the House Select Subcommittee on the Coronavirus Crisis.

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