Good Day BIO: CBO's H.R. 3 numbers, USDA's new guidance

A report from the Congressional Budget Office (CBO) finds fewer drugs will come to market if price controls—like H.R. 3 go into effect.

H.R. 3 would require drug manufacturers to negotiate prices with the government based on an international price index of prices paid in several other countries—here’s Speaker Nancy Pelosi’s fact sheet explaining what’s in the bill. 

Read: H.R. 3 is back 

CBO released a report last week simulating the impact of price control models on new drug development—read it here. 

The Key Finding: CBO estimates that a policy like H.R. 3 “is associated with a 0.5 percent average annual reduction in the number of new drugs entering the market in the first decade under the policy, increasing to an 8 percent annual average reduction in the third decade.” That’s nearly 60 forgone medicines in the first three decades alone.

Proponents of bills like H.R. 3 are likely to say that doesn’t sound like too many drugs—but we say that’s not acceptable. 

What are these lost drugs over the next decade? Are they drugs for people living with rare diseases, who may never see a cure in their lifetime as a result? Are they antibiotics or antivirals to treat the growing scourge of antimicrobial resistance? Or are they vaccines for the next pandemic?

So, what’s next? We’re gearing up for a fight on H.R. 3 this fall, so stay tuned to learn more about how you can engage. BIO has been—and remains—committed to working with lawmakers on patient-centered reforms that boost access to lifesaving medicines and treatments without compromising the next generation of lifesaving cures. 

Read: Tiny biotechs fear ‘nuclear winter’ from Pelosi’s drug pricing bill

More Health Care News: 

The Wall Street Journal: U.S. COVID-19 hospitalizations approach a peak as Delta variant spreads
“Patients are younger, and disparities across race and ethnicity persist as hospitalizations soar.”

The agency’s Animal and Plant Health Inspection Service (APHIS) proposed draft guidance aimed at determining when genetically engineered plants need USDA approval for commercialization—here’s what we know.

In May 2020, USDA released a much-needed update to ag biotech regulations (7 CFR Part 340), which said certain genetically engineered organisms for which USDA has a great deal of experience or are similar to traits that could have been developed through conventional breeding do not require pre-market review.   

Read: BIO Issue Brief on USDA’s Modernized Plant Biotech Regulations 

For plants not in these categories, USDA would issue a permit for importation, interstate movement, or environmental release, OR conduct a “regulatory status review” (RSR) to determine whether the plant should be subject to regulations.   

Last week, APHIS released draft guidance on the RSR process—read about it here. 

The timeline: The RSR process has been implemented for six crops (corn, soybean, cotton, potato, tomato, alfalfa) as of April 5, 2021; it will be fully implemented for all crops on October 1, 2021. 

BIO’s take: “This is guidance we’ve been waiting for for quite some time, because I think how it looks will be a key determinant in how well the new rule is going to look,” Clint Nesbitt, BIO’s Senior Director of Science and Regulatory Affairs for Food & Agriculture, told Agri-Pulse. 

The next steps: USDA is accepting comments on the proposed rule until October 25. Meanwhile, on September 21, APHIS will hold a technical webinar to discuss the RSR process and guide.

President Biden’s Monday: A tough August continues today as he deals with two crises: the looming withdrawal deadline in Afghanistan (tomorrow) and Hurricane Ida. 

What’s Happening on Capitol Hill: Back in recess.