What USTR and HHS said on Capitol Hill

Happy Friday. A busy week on Capitol Hill concludes with hearings covering key issues including Mexico’s biotech corn ban, expanding the COVID IP waiver, and upholding the purpose of Bayh-Dole—we have a quick recap. (641 words, 3 minutes, 12 seconds)

USTR grilled on Mexico corn ban, TRIPS waiver

Senate Finance Committee members pushed U.S. Trade Representative (USTR) Ambassador Katherine Tai for action on Mexico’s biotech corn ban and raised concerns about further WTO intellectual property giveaways in a hearing yesterday. 

Regarding Mexico: Sen. Chuck Grassley (R-IA) said USTR has been too patient with Mexico’s plans to ban U.S. imports of biotech corn. On March 6, USTR requested technical consultations under the U.S.-Mexico-Canada (USMCA) agreement, and Sen. Grassley demanded a formal dispute settlement be filed on the first day possible, April 7.

Others agreed, including Ranking Member Mike Crapo (R-ID): “What the Administration proposes as a trade negotiations and enforcement agenda is strikingly limited.”

Regarding expansion of the WTO’s waiver COVID IP protections to include diagnostics and therapeutics, Sen. Thom Tillis (R-NC) said the current and proposed waivers threaten U.S. innovation and leadership in the life sciences. Senator Crapo added, “...instead of working to strengthen U.S. intellectual property rules, the Administration actually waived U.S. intellectual property rights for COVID vaccines under the…TRIPS agreement and is even now considering expanding that waiver to diagnostic and therapeutic products. And while we all agree that one of China’s most pernicious, mercantilist policies is the theft of American intellectual property, the Administration does not pursue any IP rules in IPEF or elsewhere that could help ensure China could not benefit from its theft through sales to other countries.”

The administration is still considering the extension, said Ambassador Tai, noting they asked the International Trade Commission to collect public input and advise USTR.

What’s next: Ambassador Tai testifies before the House Ways and Means Committee today, where these issues could come up again.

HHS Secretary on price controls, PBMs, accelerated approval

Drug price controls, pharmacy benefit managers (PBMs), accelerated approval, and antimicrobial resistance came up during this week’s Senate Finance and Appropriations hearings with Health and Human Services (HHS) Secretary Xavier Becerra.

On drug prices:Price controls are already reducing research, said Ranking Member Mike Crapo (R-ID), while Sen. Thom Tillis (R-NC) said small-molecule drug research will suffer. However, Secretary Becerra and Chairman Ron Wyden (D-OR) supported expanding drug price controls.

On PBMs: Sens. Tom Carper (D-DE), James Lankford (R-OK), and Joe Manchin (D-WVA) said PBMs drive up drug prices. Secretary Becerra said he supports PBM transparency in a new bill but anticipates legal challenges.

On accelerated approval: Interference in accelerated approval by the Centers for Medicare & Medicaid Services (CMS) was criticized by Crapo and Appropriations’ Susan Collins (R-ME), who said CMS is blocking access to vital drugs. Becerra said that “the process FDA uses is different from the process CMS uses to make their decisions. As soon as CMS collects the evidence, or if FDA were to give standardized approval to the drug, they could broaden the scope of access.” However, as BIO has previously pointed out to CMS, its recent decision on anti-amyloid monoclonal antibody treatments not only severely inhibits access to these important innovative therapies, but suppresses enrollment in clinical trials, making it even harder to complete confirmatory trials required by the FDA when it approved of these accelerated approval drugs.


On antimicrobials: Five of the 27 drugs facing penalties for price increases are new antimicrobials, which are hard to support in the market, said Sen. Todd Young (R-IN). Becerra backed support like what’s in the PASTEUR Act.

What’s next: Biden’s budget plan faces opposition in the House, where Becerra testifies next week before the Ways and Means and Appropriations Committees and Energy and Commerce Health Subcommittee.

For Bayh-Dole, a week of good news and bad news

The “march-in rights” in the Bayh-Dole Act made headlines this week, with some good news for innovation and potentially bad news about the future use to control drug prices.

First, the good news: NIH rejected a petition to grant Bayh-Dole march-in rights on the prostate cancer drug Xtandi, saying marching in “is not warranted” and the drug is “widely available to the public on the market.”

Remind me, what’s Bayh-Dole? The 1980 law supercharges drug development by letting drug companies commercialize drug discoveries supported by NIH grants. If the private sector doesn’t commercialize a useful drug, however, the government can “march in” and give the patent to another company under limited circumstances, like a public health crisis.

But: Health and Human Services (HHS) and the Department of Commerce plan to investigate using march-in rights to control drug prices, even though march-in petitions based on price have previously been rejected.

The plan was criticized during Wednesday’s Senate Finance hearing—when Sen. Thom Tillis (R-NC) told HHS Secretary Xavier Becerra the plan counters innovation. Sen. Tillis submitted a column from Sens. Bayh and Dole, saying “they never intended their bill to be weaponized.” 

Read more about why we need to protect Bayh-Dole.

President Biden’s Friday: Continuing meetings with Canadian Prime Minister Justin Trudeau in Ottawa, where an announcement of a deal to stop asylum seekers at unofficial crossings is expected today, according to Reuters. 

What’s Happening on Capitol Hill: The Ways and Means Committee will hold the above-mentioned trade hearing—we’ll be watching.