House rebukes pharma’s China ties

Sep 10, 2024

With Erin Schumaker

Driving The Day

A researcher at Protein Sciences works in a lab for a biotech company researching a vaccine for COVID-19

The BIOSECURE Act, passed in the House on Monday, would ban federal money from being used to procure or use products or services offered by Chinese biotech firms. | Jessica Hill/AP

HOUSE PASSES CHINA BIOTECH BILL — The House late Monday passed legislation that would effectively prohibit Chinese biotech companies from doing business in the U.S. in a bipartisan 306-81 vote Monday, bolstering prospects for the measure to become law later this year as part of the few must-pass legislative vehicles in play.

The opposition was mostly Democratic — 79 of the 81 votes against it. That included Rep. Jim McGovern (D-Mass.), ranking member of the Rules Committee, who argued the bill didn't give enough due process to companies, and House Minority Leader Hakeem Jeffries and others in leadership. However, Democratic leadership didn’t whip for or against the bill.

The BIOSECURE ACT bans federal money from being used to procure or use products or services offered by “companies of concern” — including five Chinese or Chinese-owned companies named in the text. It also would extend the prohibition to any drugmaker that uses equipment or services from those companies.

“Members of Congress understand the threat posed by [BGI Genomics], [WuXi AppTec] & their subsidiaries,” the House Select Committee on the Chinese Communist Party posted on X in the hours ahead of the vote. “We must pass this bill.”

How we got here: The legislation began gathering momentum earlier this year as intelligence agencies and lawmakers expressed growing concern about China’s biotechnology dominance and the country’s ability to access U.S. genomic data.

Companies like WuXi AppTec contract with major pharma companies to help develop or manufacture drugs. The legislation’s proponents argue that Beijing could use those firms to obtain intellectual property or sensitive information like Americans’ genomic data.

The drug industry says the bill could force an overhaul of clinical trial operations and change how companies bring products to market.

Lobbying groups on both sides have had to tread lightly in their advocacy, as support could provoke business retaliation from China, and lawmakers could interpret opposition as a lack of concern about national security.

Not unanimous: McGovern had expressed his concern about sufficient due process for companies days earlier in a letter to colleagues.

WuXi AppTec announced plans in January to build a major manufacturing facility in Worcester, a city in McGovern’s district, but they were put on hold.

What’s next: Lobbyists and industry analysts expect the bill to move as part of the annual defense bill, even though it wasn’t included on the list of amendments green-lit for votes on the House floor this summer.

IT’S TUESDAY. WELCOME BACK TO PRESCRIPTION PULSE. How is this “back to school” season treating you? Tell us over coffee! We won’t judge you for selecting the pumpkin spice option.

Reach out with tips to David Lim (dlim@politico.com or @davidalim) and Lauren Gardner (lgardner@politico.com or @Gardner_LM).

Eye on the FDA

A man is silhouetted against lights reflected in the waters

Even though the FDA rejected an application for psychedelic therapy to treat PTSD, some health officials contend that existing treatments aren't being used to their full capacity. | Robert F. Bukaty/AP

ACCELERATING PTSD TREATMENTS — Federal health officials feel good about the future of post-traumatic stress disorder treatments despite a recent FDA decision rejecting a psychedelic therapy, Erin writes.

Officials said Friday during a panel discussion — hosted by the FDA and the independent nonprofit Reagan-Udall Foundation for the FDA — that, while new treatments and drug approvals are needed, existing treatments aren’t being used to their full capacity.

The group included Elyse Katz from the DOD, Dr. Leith States from HHS, Dr. Neeraj Gandotra from SAMHSA, Marta Sokolowska from the FDA and Paula Schnurr and Miriam Smyth, both from the VA.

While some advocates, veterans and legislators think the approval process for new treatments moves too slowly, States said he felt encouraged. “We’re pushing forward in an incremental way,” he said.

By the numbers: In 2021, an estimated 14.5 million American adults had at least one major depressive episode and about 13 million people had PTSD, according to federal data. No new drug has been approved for the condition in decades, and existing drugs don't work for everyone, advocates for psychedelic therapy say.

State of play: Proponents of using psychedelic drugs to treat mental illness took a hit last month when the FDA rejected Lykos Therapeutics’ application for MDMA, also known as ecstasy, and therapy as a PTSD treatment. Lykos can resubmit its application if it conducts an additional Phase III clinical trial to study MDMA’s safety and efficacy further. The company has said it plans to appeal the FDA's decision.

Dr. Michael Mithoefer, senior medical director for medical affairs at the Multidisciplinary Association for Psychedelic Studies — Lykos’ nonprofit arm — said during a separate virtual meeting Friday that he thought the federal panelists overstated the efficacy of existing PTSD therapies.

2024 ELECTION

PASS PULSE THE MIC — There are many important pharma policy questions that we won’t likely get answers to tonight during the presidential debate between former President Donald Trump and Vice President Kamala Harris.

If we were in ABC’s David Muir’s and Linsey Davis’ shoes, here’s what we would ask each candidate and why:

Harris:

— Medicare drug price negotiations are allowed under the Inflation Reduction Act. You’ve promised to expand the negotiation program, but that would require Congress. How would you convince lawmakers to expand the number of drugs negotiated and broaden the program to private insurance?

Why: Republicans haven’t shown a willingness to expand the drug price negotiations, and many have argued they are government price-setting.

— Medicare for All is no longer on your agenda. What changed?

Why: During her short-lived 2020 presidential bid, Harris offered a modified Medicare for All plan, which would significantly shake up the health care system. It’s unclear what changed in her thinking between now and then.

Trump:

— Drug prices were a major focus during your first term. How would your administration handle Medicare negotiation? What changes would you want to make? Would you try to incorporate international reference pricing?

Why: Trump hasn’t specified how he’d administer the new Medicare program.

Both Harris and Trump:

— Telehealth prescribing of controlled substances has taken off since both of your administrations enacted pandemic-era rules allowing drugs like Adderall, testosterone and ketamine to be prescribed virtually. Those rules expire at the end of the year. What should be allowed to be prescribed without an in-person visit?

Why: The HHS and the DEA are at a stalemate over the fate of the regulations, which impact how millions of patients can receive medication.

— The opioid crisis continues to ravage the country. What would you do differently to change the course?

Why: Fatal overdoses climbed more than 50 percent during the pandemic and remain at more than 100,000 a year.

Pharma Moves

RxBenefits is joining the Pharmaceutical Care Management Association, the pharmacy benefit manager trade group, as its newest member. RxBenefits is an Alabama-based pharmacy benefits “optimizer” for employee benefits consultants.

Jody Hatcher, CEO of Morris & Dickson Co., and Debbie Weitzman, a CEO at Cardinal Health, are now chair and vice chair, respectively, of the Healthcare Distribution Alliance’s board of directors.

WHAT WE'RE READING

POLITICO’s Jordain Carney and Olivia Beavers write that the GOP spending bill faces significant opposition from conservative Republicans in the House, jeopardizing its passage.

A new study found that hair and skin care products like lotions and conditioners expose children to higher levels of hormone-disrupting chemicals called phthalates, NPR’s Maria Godoy reports.

Illnesses linked to mushroom-laced candy illustrate the limitations of the FDA’s power to regulate food and dietary supplement ingredients, Christina Jewett at The New York Times writes.

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