Good Day BIO: Congressional preview and USTR’s Special 301 Review

Starting the new week with a focus on what’s happening in Washington, D.C., including our exclusive look at the year ahead in Congress and BIO’s comments to USTR’s Special 301 Review. (781 words, 3 minutes, 54 seconds)

What to expect from Congress in 2022

We caught up with BIO’s Federal Government Relations Team to get an exclusive preview of what to expect on Capitol Hill in 2022.

The state of play: As most of 2021 focused on the Bipartisan Infrastructure Framework (BIF) and the Build Back Better Act (BBBA), the new year finds Congress with the challenges of an election year and several competing priorities. Can Congress pass some version of the BBBA (which includes some pretty terrible drug pricing ideas), keep the government open and funded, AND enact progressive priorities like voting rights, immigration reform, and climate response, all before November’s midterms?  

First thing’s first: funding the government. Congress will now pivot to legislation that must be passed before the end of the fiscal year. On February 18, the continuing resolution to fund the government expires. Congress needs to pass additional legislation, which will likely sustain the current funding levels through the end of the year.

FDA User Fee Programs: Congress must reauthorize the FDA User Fee Programs, which provide funding and program updates to the FDA review processes for branded, generic, biosimilar, and medical device applications. This effort typically attracts many ideas, good and bad, and the user fee bill quickly becomes a Christmas tree for these policy “ornaments.” Expect to see ideas related to expedited approval programs as well as clinical trial diversity and modernization.  

Intellectual property will continue to be a focus—and we expect to see bills dealing with pay-for-delay settlements, the Biologics Price Competition and Innovation Act (BPCIA), and so-called “product-hopping” practices. Congress and the Biden administration have also been very interested in antitrust issues. The Federal Trade Commission has an ongoing investigation into the pharmaceutical industry examining whether mergers and other practices may be anticompetitive. FTC Chair Lina Khan indicated the Commission would use its authority more aggressively in the future.

On China: The House is aiming to complete its version of a China competitiveness bill. The Senate passed the U.S. Innovation and Competition Act, which provides incentives for advanced manufacturing, in June; Speaker Nancy Pelosi and Senate Majority Leader Chuck Schumer announced a deal in November to find a way to get the bill through Congress. House Agriculture Committee Chair David Scott (D-GA) also plans to initiate farm bill negotiations in the coming weeks, since the current bill expires in 2023. 

The bottom line: 2022 is shaping up to be every bit as busy as 2021—so stay tuned.

BIO: Denying IP protection harms ‘the ability to innovate, invest, and create jobs’

BIO is submitting comments today to the Office of the U.S. Trade Representative (USTR) Special 301 Review—“a key opportunity” to share IP challenges that harm the innovative U.S.-based biotechnology research community. 

What is USTR’s Special 301 Review? The annual process “to identify countries that deny adequate and effective protection of intellectual property (IP) rights or deny fair and equitable market access to U.S. persons who rely on IP protection,” explains the Federal Register. 

The immediate impact is “the denial of equitable market access abroad for our biotech enterprises,” says BIO. “This directly harms their ability to innovate, invest and create jobs in the United States.”

We’re seeing this in several countries—notably Mexico, which has not approved a new biotech product in three years, as well as Canada, China, India, and Japan, as the comments detail.

Why IP matters: “IP-enabled innovations contribute to the robust strength of the U.S. economy and propel the quintessentially American entrepreneurial spirit, which is the hallmark of the biotech sector, promoting economic development across sectors and leading to inclusive and high-paying jobs for American workers,” BIO explains. 

What should the government do? “[T]ake appropriate and proportionate actions including enforcement of existing trade agreements and U.S. trade laws to efficiently remedy the IP issues detailed below with key trading partners and ensure a fair, rule-based system globally that provides market incentives for continued IP-driven innovation,” BIO concludes. In addition, IP should be “a cornerstone of the Build Back Better agenda.” 

Read BIO’s full comments.

More News:

National Geographic: Superbugs were already on the rise. The pandemic likely made things worse.
“In the U.S., for instance, more than half of the nearly 5,000 patients hospitalized between February and July 2020 were prescribed at least one antibiotic within the first 48 hours of admission.”

President Biden’s Monday: Hosting the National Governors Association at the White House this morning, then meeting with Sheikh Tamim Bin Hamad Al-Thani, Amir of the State of Qatar. 

What’s Happening on Capitol Hill: Congress returns from recess this week and tomorrow the House Rules Committee will mark up the America COMPETES Act of 2022, addressing China’s competitiveness. Dr. Robert Califf, Biden's nominee for FDA Commissioner, is being "unfairly attacked from the left and right," says the Wall Street Journal Editorial Board.