August 6, 2024
Kamala Harris in the spotlight (and now Tim Walz): How do these moves re-shape the presidential campaign’s health policy debate?
With Vice President Kamala Harris securing enough Democratic delegates to be the official Democratic Party nominee for president, attention has turned to her long-standing record on various health care issues. And with today’s addition of Minnesota Governor Tim Walz to the ticket, there’s even more to absorb. While the Vice President has been most vocal on the issue of abortion, her health care track record is relatively broad. Let’s unpack the basics: Harris’ record as California attorney general and U.S. senator reveals strong support for progressive proposals such as her co-sponsorship of Sen. Bernie Sanders’ (I-VT) “Medicare for All” proposal. A strong advocate of more government involvement in the U.S. health care system, she has also supported aggressive drug pricing controls, restrictions on patents for drugs with prices deemed “unaffordable” (e.g. “March-In Rights”) and expansion of the Affordable Care Act (ACA) subsidies, which are scheduled to expire in 2025. Much of what Harris may be able to accomplish in a broader health care agenda likely depends on which party controls the U.S. House and Senate. Divided control will make any bold proposals more difficult (if not impossible) to achieve. Minnesota Governor Tim Walz (D) brings similar left-leaning health care policy perspectives to the ticket. A vocal critic of the biopharmaceutical community, Walz advocated for and secured passage of a 2023 law establishing one of the most aggressive Prescription Drug Affordability Boards (PDABs) in the nation. While there is little difference between President Biden’s position on major health care policy issues, Harris is expected to lean in to certain health care issues more strongly than Biden, using the her potential bully pulpit to pressure Congress to move aggressively on progressive priorities. It’s expected that the Harris-Walz campaign will release its more detailed health care platform after the Democratic Convention in Chicago August 19-22.
Advocates of existing “Right to Try” law outline plans for potential expansion
As former president Donald Trump touts the Right to Try law in his campaign for a second presidential term, the organization behind the 2018 law is aiming to expand it to allow more patients to access unapproved treatments created based on a patient’s genetic code, including cell and gene therapies for rare diseases. The expanded Right to Try is already the law in several states and could soon come to the federal level. But there’s limited evidence of uptake for the original Right to Try law. The libertarian Goldwater Institute has published a model law and several states have considered or passed similar language. Goldwater argues that the 2018 Right to Try law “laid the groundwork for medical autonomy and for allowing patients who are under proper medical guidance to seek treatments that might benefit them, when there is a manufacturer able and willing to make that treatment available and all parties are in agreement that it is the right approach.” The group argues that with the rise of personalized medicine, and approval of new therapies that target patients with specific genetic characteristics (e.g. cell and gene therapies), the 2018 law should be revised and expanded. Expanded Right to Try bills have become law in Arizona, Nevada, North Carolina, Louisiana and Maryland. A spokeswoman for the Goldwater Institute said while she doesn’t know specifics of which manufacturers are open to providing individualized treatments in those states, “it’s my understand that there are companies at least working towards this.” The original Right to Try bill became law in 2018 and was popular with lawmakers, passing the Senate with unanimous consent and the House with a vote of 250-169. The current Right to Try program is open to patients who have been diagnosed with a life-threatening disease or condition, have exhausted all approved treatment options and are unable to participate in a clinical trial for the unapproved drug they are seeking access to. Eligible drugs are those which are the subject of an investigational new drug application at FDA but have not been approved for any use, for which a Phase 1 clinical trial has been completed and which are in active development or production and have not been placed on a clinical hold by FDA. Companies are forbidden under federal law from profiting on treatments that are not FDA-approved but can recover costs directly associated with a patient’s treatment. Trump has stated on the campaign trail that the current law has saved “thousands of lives”, a claim that the FDA’s numbers seem to refute. FDA requires only limited information from sponsors of drugs that are accessed through Right to Try. Its webpage for that information states that four drugs were reported for 2023 and 12 were reported from 2018-2022; clinical outcomes data from Right to Try was not used in a marketing application for any of those drugs. Several major pharmaceutical companies, including Pfizer and Janssen, have stated they will not participate in Right to Try because of the lack of FDA oversight. Expanding the Right to Try program by giving incentives to companies to participate has also been raised as an idea to increase participation, an idea Trump has said he would be open to if elected for a second term.
BIOSECURE Act Update: Congress requests information on clinical trials conducted in China
The House Select Committee on the Chinese Communist Party may be expanding the breadth of its inquiry into the biopharmaceutical industry’s relationships with certain Chinese entities. Last week, congressional offices allegedly contacted the industry’s two largest trade groups, BIO and PhRMA, regarding clinical trials at Chinese hospitals with ties to the People’s Liberation Army. This outreach comes as the committee is also allegedly planning to send a letter to the FDA on the topic. China, with its large patient population, has long been a hotbed for clinical trials. According to a new report from IQVIA, China’s share of clinical trials is now third behind North America and Western Europe with massive growth reported in the last five years. Reports indicate that the House committee isn’t examining all clinical trials in China but is focused on sites affiliated with the People’s Liberation Army. The name of the military wing is included in hospital centers that have hosted studies from companies like Pfizer, Eli Lilly and J&J, according to a review of the ClinicalTrials.gov database, a federal registry of trials and reported by Endpoints. The same congressional committee initiated the proposed BIOSECURE Act which would essentially force US companies to cut ties with WuXi AppTec and other Chinese medical contractors by 2032. House Speaker Mike Johnson has promised movement on some version of BIOSECURE before the end of the year, but it remains unclear as to whether the House and Senate could agree on language in that busy (and short) timeframe, despite bipartisan agreement on the general issue.
2024 Elections: What’s on tap and how will it impact access to innovative medicines? Schedule your presentation now
While many Americans can’t wait for the November elections to be behind us, this election’s ramifications for health care policy, especially for the patient access and the biotech and biopharma communities, will be enormous. With slim majorities in both the House and Senate, and a race for the White House that takes fascinating turns every hour of the day, Gridiron’s crystal ball is somewhat murky (but gaining some clarity) as we exit the summer months. The departure of Biden from the race and the Kamala Harris’ apparent ability to energize the Democratic base has changed the dynamic. However, the candidates’ specific plans and policy visions will come into focus in the last three months and the top-of-the-ticket impact on Senate, House and state legislative races will likely be substantial. It’s important for companies and organizations to prepare for the various scenarios and the issues that will likely be front-and-center if those scenarios become reality. It’ll also be important to absorb and analyze the results after November 6. Book your time for a Gridiron Public Affairs presentation (either before, after or both) on Election 2024 today, before the calendar fills up. Email Greg at greg@gridironpublicaffairs.com for more information.
Health Policy Snippets:
- House Republicans introduce legislation to allow biopharma companies to provide support to patients undergoing treatment. Congressman Brett Guthrie (R-KY), Chairman of the House Energy & Commerce’s Health Subcommittee, introduced H.R. 9184, the Patient Access Act, in early August to help provide greater access to life-saving therapies. Many of these therapies require comprehensive care delivery in specialized health care facilities certified by the FDA that may be limited in number and location throughout the country and require extended monitoring by the team of specialized health care providers to track a patient’s progress or to address adverse health events. Right now, the federal Anti-Kickback Statute (AKS) prohibits the “knowing and willful payment of remuneration, or a kickback, to incentivize or reward patient referrals for a service provided to a patient by federal health care programs.” The legislation would allow manufacturers to cover the costs of travel and incidentals for a patient and up to two caregivers throughout the duration of these treatments. Guthrie, who would likely become chair of the House Energy & Commerce Committee if the GOP retains its majority, is also an advocate for other changes to the AKS, including the ability of gene therapy companies to cover the costs of fertility preservation for patients, a major issue for the sickle cell disease community.
- Congress is home for break: What are the main issues left to be addressed? It’s campaign season for members of Congress (with parades, debates, corn boils and county fairs on the to-do list) but the future of several health policy issues remain uncertain. Here’s a quick look at top priorities that need to be addressed before the end of the year: 1) Telehealth extension. Both sides of the aisle generally agree that the extension of telehealth reimbursement in Medicare (which was originally covered during COVID) is a good idea, but the price tag is high. Congress needs to find a middle ground fast or coverage will end on December 31. 2) Pharmacy Benefit Manager Reform. Another issue both sides generally agree on: something needs to be done to rein in PBMs. The issue has new momentum after a scathing FTC report issued in July accusing PBMs of profiting at the expense of patients and small pharmacies. Whether some policy (likely more limited in scope than what many PBM critics would like) can come together between now and January remains debatable.
