The congressional push to crack down on Chinese biotech firms is extending to the trade association BIO and questions about whether it should register as a foreign agent for its advocacy on behalf of one of the targeted interests, Peter reports.

Why it matters: It shows how lobbying against a bill that would cut off taxpayer funding to the Chinese companies is itself becoming a target for China hawks in Congress.

What they're saying: House Select Committee on the CCP Chairman Mike Gallagher asked Attorney General Merrick Garland for a Justice Department review of BIO's lobbying against Gallagher's bill and whether such work merits changes to the Foreign Agents Registration Act, or FARA.

• Gallagher pointed to WuXi AppTec, one of the companies singled out in the Biosecure Act. The firm is a member of BIO and is listed in the bill as a "biotechnology company of concern" that poses a national security threat.
• "BIO's advocacy on behalf of WuXi Apptec — intended to protect the company's access and commercial ties in the United States despite the risk to U.S. national security — is aligned with the interests of the CCP and PRC government," Gallagher wrote.

The other side: BIO maintains that it's doing its job. "It is an advocacy organization's mission and duty to let Congress know the impacts of their potential policies on the American public and in our case on patients," CEO John Crowley said in a statement.

• Last month, BIO wrote a letter to senators raising "serious concerns" with a companion bill that was advanced out of the Homeland Security and Governmental Affairs Committee.
• BIO pointed to the intertwined nature of commercial interests in drug development, making it hard to target only Chinese companies without spillover to U.S. players.
• "In its current form, this legislation will do untold damage to the drug development supply chain both for treatments currently approved and on market as well as for development pipelines decades in the making," the letter stated.

Garland hasn't publicly commented on the matter.

Senate efforts to make biosimilars more easily interchangeable with the products they copy got a boost in President Biden's FY25 budget, when the FDA endorsed automatic swapping as part of a package of legislative proposals to boost competition, Axios' Adriel Bettelheim reports.

Why it matters: The idea was part of a primary care-health workforce package that Senate HELP Chairman Bernie Sanders sponsored, as well as stand-alone legislation that backers argue is needed as drug development moves toward more expensive biological products.

The FDA said separate standards now required to prove interchangeability have led to confusion and misunderstanding, and that the policy change would be "more consistent with current scientific understanding."

• It also would bring the U.S. in line with regulations in places like Europe, where biosimilars are deemed interchangeable upon approval.

Flashback: The Affordable Care Act envisioned expanded use of generic versions of complex biological products. But, as we've noted, adoption has been slow due to regulatory red tape and market incentives favoring brand-name treatments.

What's next: The move to scrap a biosimilar interchangeability standard is among a series of legislative reforms the FDA showcased during Monday's budget rollout under the heading "Facilitating Competition."

• Others include amending the three-year period of exclusivity that new drugs can qualify for that FDA said can delay generic competition, and creating a "skinny label" safe harbor from patent infringement liability for makers of human and animal generic drugs.

The House Energy and Commerce health subcommittee is marking up 19 bills today, including reauthorizations of Alzheimer's research and emergency services programs, as well as a measure that would ban discrimination in organ transplants, Victoria reports.

The legislation includes:

• The Charlotte Woodward Organ Transplant Discrimination Prevention Act, which was first introduced in the 117th Congress and would bar medical providers from discriminating against individuals with mental or physical disabilities who are candidates to receive organ transplants.
• Kidney PATIENT Act, which would delay the inclusion of oral drugs to treat end-stage renal disease being moved into the Medicare Part B ESRD prospective payment system. An amended version was approved out of the Ways and Means Committee last week.
• Seniors' Access to Critical Medications Act, which would make a pandemic-era CMS waiver permanent and allow seniors to receive medications prescribed by their doctor by mail, or allows a family member to pick them up.