Good Day BIO: Updates on Build Back Better and animal biotech

Capitol Hill’s a bit quiet this week, so we update you on the outlook for Build Back Better and give more reasons why drug price controls should not be included. Plus, a new study says what we’ve been saying all along: we need to modernize animal biotech regulations. (710 words, 3 minutes, 33 seconds)

Update on Build Back Better—and why drug price controls still aren’t the answer

While things are relatively quiet on Capitol Hill, we’re still watching Build Back Better—and seeing more reasons why drug price controls should not be included in the social spending plan.

ICYMI: After the House passed Build Back Better, the Senate has been unable to agree on the social and climate spending bill. Now, reports indicate they might land on “smaller” and “scaled back” bills, with the outlook for drug price controls TBD. 

Senate Finance Republicans want to eliminate “innovation-killing” drug price controls from the package,according to a letter they sent last week to their colleagues. 

Here’s why: “Americans would see fewer new treatments and vaccines, greater inflation pressures, and reductions in health care quality and access for years to come. The bill would substantially undermine incentives for biomedical innovation, as unaccountable federal officials would compel a growing number of manufacturers each year to partake in a mandatory price-setting program,” they explain. 

And brand-name drug prices actually fell last year—“the fourth consecutive year of declines for list prices,” said BIO’s Chief Policy Officer John A. Murphy III. 

Meanwhile, pharmacy benefit managers (PBMs) increased the number of drugs excluded from formularies,writes Drug Channels’ Dr. Adam J. Fein. “Exclusions are one of the key factors behind the large gap between list and net prices for brand-name drugs” and can “affect a patient’s out-of-pocket costs and access to a particular therapy.” 

Why it matters: Instead of limiting discussions about cost of health care to pharmaceutical companies and innovation-killing drug pricing proposals, we need to look at the entire picture of health care costs and spending, including PBMs.   

More Health Care News:

FDA: FDA limits use of certain monoclonal antibodies to treat COVID-19 due to the Omicron variant
“FDA revised the authorizations for two monoclonal antibody treatments—bamlanivimab and etesevimab (administered together) and REGEN-COV (casirivimab and imdevimab)—to limit their use to only when the patient is likely to have been infected with or exposed to a variant that is susceptible to these treatments.” 

The Wall Street Journal (Opinion): The Alzheimer’s death panel
“Under CMS’s proposal, Medicare will only pay for them if patients enroll in duplicative trials in which they could get assigned a placebo instead of the drug. Yet Alzheimer’s patients won’t be able to enroll in these trials unless they live near large health-care centers that have the resources to conduct them.” 

Study: Animal biotech regulations must be ‘scaled to the particular level of risk involved’

A new study published in Transgenic Research touts the benefits of genome editing for agricultural animals—and the need for modernized regulatory oversight for animal biotechnology.

We’ve been selectively breeding animals for centuries—yielding “huge benefits” for agricultural animals as well as “significant, measurable changes to the genomes of those animal species and breeds,” says the study authored by scientists from Virginia Tech, USDA, and international agricultural institutions.   

Now: “Genome editing techniques may now be applied to achieve targeted DNA sequence alterations,” which can help us achieve disease resistance, improve animal welfare, and reduce environmental impact. 

We have the science—what else do we need to do? “[Define] regulatory approaches for genome edited animals,” and share “approaches and experiences to institute progressive policies in which regulatory oversight is scaled to the particular level of risk involved,” the researchers say. 

Why it matters: The successful transplant of the heart of a genetically engineered pig into a human is exciting—and “also a stark reminder of the lack of a clear path to commercialization for animal biotechnology products intended for agriculture,” said Rep. Vicky Hartzler (R-MO) during a House Agriculture hearing last week. 

Agriculture Secretary Tom Vilsack said he understands the “necessity of having clarity” around animal biotech. As soon as the FDA Commissioner is confirmed, USDA plans to work closely with them to “make sure there is ongoing discussion and negotiation” around new proposed framework for oversight (which BIO commented on)—read more.


More Agriculture & Environment News:
Real Clear Policy: Gene Editing: A 21st Century Tool to Combat Climate Change
In the 21st century, agriculture is more technologically sophisticated than ever. And yet, the core challenge for the world's farmers is the same as it has always been: How to maximize the quality and quantity of our food supply while minimizing waste and environmental damage. Enter gene editing.

President Biden’s Tuesday: Speaking at the Families USA health care conference, where POLITICO says he’s expected to push Congress to pass Build Back Better. 

What’s Happening on Capitol Hill: “A bipartisan group of senators met via Zoom on Monday to try to figure out a path forward on Russia sanctions legislation,” per The Hill. The House is in recess.