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State legislatures remain busy across the country—especially when it comes to healthcare policy. As Q1 wraps up and we move into the mid-year, the Biotechnology Innovation Organization (BIO) is focusing on four priority legislative advocacy efforts in the states.
“Divisiveness in Congress is causing states to step into the void and become even more active on prescription drug pricing, 340B, vaccines, and consumer data privacy and AI.” says Patrick Plues, Senior Vice President for State Government Affairs at BIO.
So what is going on in state healthcare policy, and how does it affect patients?
Prescription drug pricing
BIO continues to advocate against many of the drug pricing proposals under consideration in the states, particularly bills to establish Prescription Drug Affordability Boards (PDABs). PDABs continue to be a hot issue in state legislatures despite pushback from many patient groups and biotech advocates.
Sixteen bills related to PDABs have been introduced so far in 11 states for this year’s legislative sessions.
PDABs are state boards that aim to cap, control, and dictate the price of drugs that manufacturers can charge. Originally conceived to hypothetically lower drug costs, these boards have instead posed a serious barrier for patients when it comes to getting access to certain drugs.
“One big issue with PDABs is that no two are the same, so when trying to tackle this issue from state to state, advocates and policy professionals are often faced with a many-headed hydra,” says Plues. “Another problem with these boards is that they oversimplify a highly complex healthcare system while simultaneously sticking their head in the sand when it comes to diving deep into how certain drugs become unaffordable for certain patients.”
As Bio.News reported last year, “The reality is that no two patients pay the same price for a drug, so what is affordable to one patient is not affordable to another. A Medicaid patient will get different coverage than a private insurance patient. A patient paying at a hospital pharmacy during an emergency will pay a different price for a drug than what they would pay at their local pharmacy in a different situation.”
Additionally, these boards do not address the issue of drug costs as a result of pharmacy benefit managers (PBMs), which drive up the cost of drugs for insured patients and then go on to pocket those incurred costs. The fact of the matter is that patients and insurers don’t buy drugs directly from manufacturers; they buy them from pharmacies and wholesalers, so PDAB policy does not attack the drug pricing issue at its source.
PDABs are currently established in eight states: Colorado, Maine, Maryland, Minnesota, New Hampshire, New Jersey, Oregon, and Washington. Colorado’s PDAB has proven to be particularly active, with Maryland following the lead after Colorado completed its first round of review and determination of upper payment limits (UPL).
Yet, as Plues explains, PDABs in these states have not done much. “As a matter of fact, there is a bill under consideration in New Hampshire to repeal its PDAB because it’s costing the state money and not doing anything,” he says.
This year, a bill in Virginia to establish a PDAB was vetoed by Gov. Glenn Younkin, while a bill in Maryland to expand the scope of its PDAB law passed the legislature and is awaiting action by Gov. Wes Moore. Bills are still under consideration in Connecticut, Illinois, Iowa, Kansas, and Michigan.
However, the Illinois and Iowa bills are currently considered “dead” for session. The Illinois bill did not meet deadlines, and the Iowa bill did not receive a hearing. Similarly, in Michigan, while their PDAB bill passed the Senate with a Democratic majority, it now sits in the House with no hearings having been scheduled, and it is not expected to advance. In Kansas, their PDAB bill is currently waiting on a hearing.
Connecticut’s PDAB legislation, however, is rolled into a larger comprehensive drug pricing bill that also includes a 340B manufacturer mandate provision, maximum fair price (MFP) reference pricing for certain bulk purchasing negotiations, an excessive price penalty, importation, and patent settlement language.
Maine’s PDAB legislation aims to change the composition of the Board to include a representative from industry. It also directs the Board to study what other states are doing to control drug prices and make recommendations to the board on ways to control costs, including setting UPLs.
340B Legislation
State efforts related to the federal 340B Drug Discount Program have reached an all-time high in 2025, with 63 bills active in 32 states. There are 39 bills including a contract pharmacy manufacturer mandate. Other bills include claims modifier provisions and other 340B-related changes at the state level. The BIO state team is heavily engaged in pushing back on these bills.
Yet, the scope of 340B legislation varies from state to state, with some states pushing for more transparency while others look to expand the program (sometimes trying to do both at the same time).
“I envision the proliferation of state 340B legislation continuing as Congress considers drastic funding cuts to Medicaid. 340B entities, hospitals in particular, will look to other revenue sources, and the 340B program is a major one for them,” says Plues.
As Bio.News reported in 2022, “The program was started in 1992 with the goal of allowing hospitals and clinics that work with underserved communities to provide outpatient prescription drugs to patients at deep discounts. Now, after 30 years, the program has ballooned—and morphed into a system that is proving anathema to its original intent.”
Participants in 340B programs are taking their savings on deeply discounted drugs, but not necessarily passing them on to patients.
Bio.News reported: Despite the growth of the program, there is little oversight. Academic research has repeatedly shown that 340B hospitals are not leaders in providing charity care.
- There is strong data, gathered by AIR340B, to suggest that 340B profits exceed charity care spending at large nonprofit hospitals.
- Other analyses, such as this Health Affairs paper and this analysis by Health Capital Group, have found that the charity care provided by nonprofit hospitals doesn’t grow when profits expand.
While misuse of the program continues, there is an increase in 340B transparency bills compared to previous years. Last year, the first 340B transparency measure passed in Minnesota, and this year four bills are active across the states. Transparency bills, as the name suggests, aim to make the operations of 340B entities more transparent—often through oversight and reporting, in order to ensure that these entities are acting consistently with the intent of the program.
For example, Colorado’s 340B transparency bill aims to establish hospital transparency provisions and requirements for the use of 340B revenues. However, this bill is politically attached to another bill in the state that would expand the program by prohibiting the limiting of the acquisition of drugs to 340B entities unless otherwise stated by the federal Department of Health and Human Services. The combination of the two bills together in Colorado is notable given their vastly different goals.
Idaho passed its 340B transparency bill, and Indiana’s 340B transparency bill passed the House and Senate and is returning to the Senate for concurrence. This bill is expected to pass and head to the governor’s desk. However, in Kentucky, their 340B transparency bill found itself killed on the House floor after verbiage was amended in the House committee.
Vaccines
Vaccine-related bills that weaken immunization programs in states are still extremely prevalent in state legislatures. But while COVID-related vaccine bills are on the decline somewhat, a larger number of bills seeking to dismantle school and childcare immunization requirements, as well as an uptick in bills related to mRNA technology, are being introduced.
Other bills would curtail employer vaccine mandates, prohibit requirements for vaccines available through emergency use authorization, target vaccine manufacturers’ liability protections, and/or target vaccine clinical trial design. Overall, there are a projected 252 vaccine bills on the move in 40 states. Four states, Idaho, Iowa, Montana, and Missouri, had filed legislation addressing mRNA vaccines.
In Idaho, there were attempts to pass two bills targeting mRNA vaccines: one that would have placed a statewide moratorium on the use of “human gene therapy products,” which would include mRNA-based technologies and certain cell and gene therapies; and another that would have required labeling of blood products from recipients of mRNA vaccines and COVID vaccines. Both bills are considered dead for the year.
In Iowa, legislation was filed to prohibit the administration of “gene-based vaccines” by healthcare providers, but it died after it was heard in the Senate subcommittee. Montana also saw failure of a bill banning mRNA vaccines for humans.
In Missouri, a bill that would have initially included establishing labeling requirements for various food products, including: food derived from animals treated with an mRNA vaccine, food containing genetically engineered ingredients, and certain food additives, was filed. However, when it went to subcommittee, it was amended to include only the GE labeling provision; the mRNA food labeling requirement was removed.
There is little doubt that there is more work to be done in the states to advocate for vaccines and responsible public health policy in the coming months and years.
Other areas of note
While PDABs, 340B, and vaccines continue to be big ticket issues on the state level when it comes to healthcare, there are a couple of other topics of note floating around various state legislatures.
Data privacy, for example, is seeing more action on the state level than on the federal level, as their seems to be a preference for states to continue to take the lead on consumer and health data privacy legislation. With the rise of artificial intelligence and its effects on current technology and data, this is understandable, but the need for clear distinctions between consumer and health data continues to be important.
In particular, data privacy bills need to have the proper amendments and allowances that will allow biotechs to continue conducting clinical trials and post-approval confirmatory studies required by regulators; this includes exemptions for HIPAA-covered information, HIPAA business associates, FDA/public health reporting, research and clinicals trials and de-identified data.
There are many other health-related issues in addition to the topics listed here, proving that advocacy and policy engagement on the state level will be anything but boring in 2025.
