State & Federal Policy Priorities
State Policy Priorities
As the statewide trade association for Pennsylvania’s life sciences community, Life Sciences PA is committed to ensuring the Commonwealth is the most attractive location in the United States to open and operate a life sciences company and invest in the research, development and manufacturing of medicines and technologies.
Life Sciences PA works with its State Policy Committee and various stakeholders in our diverse life sciences community to develop a shared set of recommendations and strategies that will support and catalyze Pennsylvania’s life sciences ecosystem – from the lab bench to the patient’s bedside.
These State Policy Priorities are revisited monthly and adjustments to their level of priority are made as warranted.
Questions about our State Policy Priorities?
If you have any questions on the State Policy Priorities, please contact Kurt Imhof, Senior Vice President, Policy & Public Affairs.
Education on the Value of Innovation
Successfully healing patients or providing them with an enhanced quality of life is the passion behind life sciences innovation. However, the process by which new medicines and technologies are created is time- and resource-intensive. Studies have shown it takes more than 10 years and $2 billion to move an innovative new drug through the research-and-development and clinical trial process to approval by the U.S. Food and Drug Administration (FDA).
This process is fraught with failure as fewer than 12 percent of medicines entering clinical trials are ultimately approved by the FDA. This failure is one of the reasons biopharmaceutical companies need to recoup some of those costs through the few products that make it to the market. Recouping those dollars allows companies to pursue further basic, translational, clinical, and manufacturing research needed to turn basic science into a safe, usable and effective therapy for patients.
In fact, the biopharmaceutical industry regularly invests more of its revenues in R&D than any other industry. As a recent Congressional Budget Office report highlights, for many years the number averaged 18-20 percent, but in recent years that number has exceeded 25 percent.
Life Sciences PA works to ensure the Pennsylvania General Assembly and the Governor’s administration understand this process and that patient access to groundbreaking therapies and cures through appropriate reimbursement in our market-based system are responsible for the Commonwealth’s leadership in life sciences innovation.
Education on the Complex Drug Pricing System
The process by which new medicines are priced is due in large part to the work outlined above; however, the cost borne by patients is the result of the complex drug pricing supply chain in the United States. While much attention is focused on the cost of prescription medicines, which account for approximately 10-14% of nationwide health care costs – a number that’s remained consistent for decades – the real issue remains out-of-pocket costs which are the result of insurance benefit design.
The price of medicines is the cause of much debate by the public and elected officials, and determining who pays for what medicines – and at what cost – is an important discussion to have. Life Sciences PA believes all actors – pharmacy benefit managers (PBMs), health insurance companies, pharmacies, healthcare providers, distributors and manufacturers – of our complex drug pricing system have a role to play in this debate. It is incumbent upon all of us to ensure that all parts of the prescription drug supply chain are acting in good faith and working to keep costs, especially those out-of-pocket costs borne by the patient, at an accessible level.
Life Sciences PA is committed to educating legislators on how insurance benefit design and various actors in the drug pricing supply chain can affect the out-of-pockets costs patients pay at the pharmacy. As noted above, the drug pricing, payment and distribution system is complex and includes many stakeholders. Life Sciences PA believes all stakeholders must be included in discussions around lowering the cost of prescription medicines and is opposed to proposals such as Prescription Drug Affordability Boards (PDAB) that focus solely on the role of biopharmaceutical manufacturers in this convoluted system.
Patient Access
Patients provide critical testimony on the effects of policies and regulations on their treatment and quality of life. Remaining focused on the voice of the patient is at the core of all innovations in the life sciences. Especially as medicines have become more individualized, the role of the patient in researching and developing new medicines has become increasingly important. Through Rare Disease Day and in working with our more than 50 patient advocacy group members, Life Sciences PA amplifies the voice of the ultimate beneficiary of our members’ research and development – patients.
The novel cures and treatments being developed by our member organizations mean little if the patients they are meant to serve face barriers in accessing them. Life Sciences PA is opposed to policies that inhibit patient access to medicines and technologies such as nonmedical switching and copay accumulators that undermine the physician-patient relationship. Life Sciences PA was pleased to see Senate Bill 88, which expands the coverage of Act 1 of 2023, and further enhances coverage for breast cancer screening signed into law in 2025. Additionally, LSPA was pleased to see the sunset on Pennsylvania’s Rare Disease Advisory Council (PARDAC) extended to 2028, giving this important entity more time to ensure it can appropriately continue to serve patients, caregivers and physicians facing rare disorders.
Finally, Life Sciences PA stands in support of policies that create the most inclusive access for patients, including: non-medical switching, copay accumulators (SB 268 and HB 2226), and legislation to address prior authorization for mental health medications (HB 1519).
Right to Repair Legislation
Medical devices, like most complex equipment, need periodic maintenance and repair. Proper servicing of these lifesaving and life-sustaining devices is vital to their safe and effective functioning and the safety of patients and device users. As part of their commitment to patient safety, original equipment manufacturers (OEMs) dedicate extensive resources to establishing comprehensive servicing programs to ensure their devices are properly maintained and continue to meet safety and effectiveness requirements determined by the Food and Drug Administration (FDA).
Legislation is being adopted in states throughout the country that would allow third-party repair servicers to attempt to repair these complex devices and no longer rely on OEMs. This legislation is known as “Right to Repair.” Giving unregulated third-party servicers unlimited access to service manuals and other proprietary OEM information would serve to put patients and device users at greater risk. Access to the latest manuals is no substitute for the extensive training, knowledge and expertise provided by the OEM. Life Sciences PA stands firmly opposed to any Right to Repair legislation in Pennsylvania that would allow third-party servicers to interfere with medical devices.
Life Sciences PA also closely monitors legislative activity in the Pennsylvania General Assembly for bills that are largely focused on consumer digital electronic equipment but may inadvertently capture FDA-approved medical technologies in their broadly written legislative language.
Developing the Life Sciences
Pennsylvania’s life sciences ecosystem is a key driver in the Commonwealth’s economy and provides more than 100,000 direct, family-sustaining jobs to Pennsylvanians. However, the industry is largely start-up in nature. Of the more than 3,000 life sciences establishments in Pennsylvania just over 65% of those entities are made up of ten employees are fewer. Life Sciences PA is supportive of expanding existing programs and creating new policies that play to one of the Commonwealth’s economic strengths, while also helping to catalyze the time- and resource-intensive process of researching, developing and commercializing life sciences innovations.
Life Sciences Pennsylvania was pleased to see Governor Shapiro’s administration put forth a comprehensive, ten-year economic development plan in 2024 – the first in the state in nearly 20 years. This plan includes the life sciences as one of the sectors of strength for the Commonwealth’s economy and LSPA looks forward to working with its state and regional partners on enhancing Pennsylvania’s innovation economy. Life Sciences PA is specifically supportive of the Governor’s $100 million investment in the life sciences and innovation economy along with additional programs listed below:
‘Innovate in PA’ 2.0 Program
Based on a program passed in 2013 under a Republican Governor, Pennsylvania launched an innovation fund through the sale of insurance premium tax credits. Building off that legacy, this budget creates the Innovate in PA 2.0 program to deploy nearly $100 million into the state’s innovation economy. This funding will provide incentives for companies to invest in the Commonwealth’s life sciences and innovation economies. It will fund initiatives that differentiate Pennsylvania as a unique ecosystem in which to start and grow research and development focused companies. These initiatives include a clinical trials network, venture studios, federal matching program, and a workforce and education pipeline to help these companies succeed.
With our world-class research institutions, historic economic engines like agriculture and energy, and thriving sectors in life sciences, robotics and technology, and manufacturing, Pennsylvania has the tools to drive economic growth throughout the state. However, without strategic investment, Pennsylvania risks falling behind states like New Jersey, New York, North Carolina, Ohio, and many others that have prioritized strategic investments in these growth industries.
These states are leveraging their economic strengths to attract talent and companies to accelerate statewide economic growth. Establishing a statewide innovation initiative as proposed by the Governor is a necessary and transformative step to ensure every Pennsylvanian— rural, suburban and urban—share in the benefits of a robust innovation economy.
Pennsylvania ranks 4th in the nation in higher education R&D expenditures, investing almost $5 billion in 2020. However, that spending fails to translate into widespread economic growth – particularly in the state’s innovation economy where early-stage companies drive job growth and economic development. For instance, Pennsylvania ranked 11th in venture capital investment in 2023, 43 in rate of startup density and 48 in rate of new entrepreneurs.
Recognizing those limitations but being fully aware of Pennsylvania’s strengths – Pennsylvania is home to more than 3,009 life sciences establishments employing just over 100,000 individuals – its entrepreneurial spirit, and the determination of its workforce, we believe this investment will spur innovation and bring significant returns to Pennsylvania’s economy. Studies estimate that for every advanced industry job, an additional 2.2 jobs are created in supporting industries like manufacturing, logistics, and retail.
Life Sciences PA supports this investment in Pennsylvania’s innovation economy, particularly the life sciences. These investments are critical to maintaining the Commonwealth’s leadership in innovation and, most important, bringing biomedical breakthroughs to patients throughout the world.
Tax Policies Incentivizing Research & Development
In addition to the Governor’s proposed investment in Pennsylvania’s innovation ecosystem, Life Sciences Pennsylvania strongly supports several other tax provisions to incentivize investment in the research and development necessary to fuel economic growth. These provisions include:
- R&D Tax Credits
The Research and Development Tax Credit Program is vital for innovation as this program rewards investment increases in research and development. A business can apply for a ten percent credit equal to its increase in its three-year average of its research and development expenditures with qualified small businesses eligible for a twenty percent credit. An especially important part of this program is that these tax credits are tradeable for those companies not yet commercial and in the life sciences industry, because the path to commercialization can last more than a decade, the tax credit may be just enough for a firm to make it to the next milestone and continue important product development. Life Sciences PA was pleased that the R&D Tax Credit Program was expanded to $60 million in 2022 and is supportive of increasing the cap, especially considering it is annually oversubscribed in applications by approximately $100 million. Specifically, Life Sciences PA is supportive of expanding the Research & Development Tax Credit from $60 million to $120 million, and appreciates the leadership of Life Sciences Caucus Co-Chairs, Representative Tim Briggs and Representative Valerie Gaydos to expand this program (HB 1004), as well as Senate Life Sciences Caucus Co-Chair, Senator Frank Farry and Senator Steve Santarsiero (SB 792) who have led the legislation to expand the program.
- Repeal R&D Decoupling
The 2025-26 budget decoupled Pennsylvania’s tax code from the Internal Revenue Code under Section 174. This will require Pennsylvania companies to continue amortizing R&D expenses over multiple years. In previous years, companies were allowed to deduct 100 percent of their R&D expenses in the expense year. That changed in 2022 due to the Tax Cuts and Jobs Act, passed in 2017, which required companies to amortize their R&D expenses over five years at 20 percent per year. While this flawed policy was reversed at the federal level in 2025, Pennsylvania state officials decided to keep the amortization in place. This policy is sure to reduce economic growth and penalize investments by companies in R&D-intensive industries such as manufacturing, technology, and life sciences. Additionally, it will have a disproportionate impact on small, innovative companies significantly affected by cash flow. As it stands, it has also made Pennsylvania a national outlier on R&D amortization. Life Sciences PA and our member companies support repealing this tax change.
- Net Operating Loss Tradability
Life Sciences PA is supportive of HB 1129. This legislation, which passed the House January 28, 2026 allows early-stage businesses to sell their net operating losses and unused research and development tax credits to unrelated companies, converting their losses to capital. Based on New Jersey law, this bill will permit monies received from these sales to be used to build and grow the operating business here in Pennsylvania, investing in high paying jobs within the Commonwealth. Qualifying businesses would be provided a valuable source of non-dilutive capital during the most vulnerable period of their development. Bolstering these new and innovative businesses supports the creation of good jobs within in-demand industries and serves to strengthen Pennsylvania’s economy now and into the future.
Pennsylvania’s Life Sciences Greenhouses
The Life Sciences Greenhouses capture the innovation potential of the life sciences industry and nurture
that potential with critical early-stage funding and sector-specific business expertise. With locations in Pittsburgh, Harrisburg and Philadelphia, citizens from every part of Pennsylvania benefit directly as new companies are formed, jobs are created, additional capital is attracted to the Commonwealth, and life-saving technologies reach patients. Life Sciences PA is supportive of the Governor’s 2025 – 2026 proposed budget to fund the Life Science Greenhouses at their annual level of $3 million.
Keystone Innovation Program
The Keystone Innovation Zones (KIZ) are a great option for start-up life sciences firms to establish an office location as they provide tax credits against the company’s tax liability with unused credits available for up to five years. KIZs are in strategic locations statewide. Life Sciences PA is supportive of the Governor’s 2026 – 2027 proposed budget to fund the Keystone Innovation Program at its annual level of $15 million.
Ben Franklin Technology Partners
The Ben Franklin Technology Partners (BFTP) is one of the nation’s longest-running technology-based economic development programs. Started in 1983 and positioned strategically throughout the state with regional headquarters in the Lehigh Valley, Philadelphia, Pittsburgh and State College, BFTP has provided funding to early-stage and established companies – including life sciences companies – as well as business and technical expertise and access to a network of innovative, expert resources. Life Sciences PA was pleased Ben Franklin Technology Partners received a $2.5 million increase in the 2022 – 2023 budget and is supportive of the Governor’s 2026 – 2027 proposed budget to maintain funding for the Ben Franklin Technology Partners at $17 million dollars.
Additionally, Life Sciences PA is supportive of the following economic development proposals:
Small Business Innovation Research (SBIR) Matching Grants
Innovative research and the development of groundbreaking medicine, therapeutics and diagnostics is a top priority for life science companies throughout Pennsylvania. These innovations require an abundance of resources, which is why support at both the federal and state levels is important. Many of these companies rely on SBIR (Small Business Innovation Research) funds as a critical component to moving their work forward. Because these federal funds are critical to innovation many states have created a matching program to provide additional, dedicated funds to further diffuse these costs. It is our goal at LSPA to bring a state matching program to SBIR funding to further support our life sciences ecosystem in Pennsylvania. Life Sciences PA is supportive of utilizing a portion of the Governor’s proposed ‘Innovate in PA 2.0’ funding for this program, along with the legislative vehicle that has been but forth by Rep. Paul Takac in the PA House of Representatives and the legislation put forth by Life Sciences Caucus Co-Chairs, Senators Frank Farry and Art Haywood (SB 811).
Dispersed by the Department of Health, the CURE Program awards grants to Pennsylvania-based
organizations for biomedical research, clinical investigations, and health services research. Studies funded by the grants aim to improve the delivery of health care, promote health, prevent disease and injury, and translate research advances to community health care practice. Life Sciences PA is supportive of increasing the percentage of annual Tobacco Settlement payments for health research grants.
Neurodegenerative Disease Research Program
As part of the 2025-2026 budget $5 million was included for a new neurodegenerative disease research program. This funding will be distributed through competitive grants to qualifying institutions conducting research on neurodegenerative diseases, such as Alzheimer’s disease, Amyotrophic Lateral Sclerosis (ALS), Parkinson’s disease, and related disorders. Life Sciences PA is thankful to State Representative Kyle Mullins for his leadership on this program that is now open to applicants.
Strengthening the Commonwealth
The Commonwealth of Pennsylvania is a destination for Americans to start and grow business, raise families, attend secondary schools, and obtain post graduate degrees, among many other reasons. Maintaining and expanding Pennsylvania’s economic competitiveness and creating a business environment that builds upon the Commonwealth’s existing economic strengths is critical for a robust life sciences ecosystem. Life Sciences Pennsylvania and its member companies are committed to fostering a policy and business climate that incentivizes company growth while bolstering and diversifying the life sciences workforce:
Creating Jobs and Growing the Economy
Pennsylvania’s Life Sciences industry is a backbone of the Commonwealth’s economy. From 2015 to 2020, direct Life Sciences industry employment in Pennsylvania grew to 102,000 direct jobs, which is a 51% increase over a five-year period. Additionally, the industry was responsible for another 230,000 jobs through business purchases and household expenditures. All told, the industry generated a total state economic output of $105.6 billion – comprised of a direct economic impact of $61.9 billion and indirect economic impact of $43.7 billion.
One caveat to these strong numbers that were outlined above is that of the Commonwealth’s more than 3,000 life sciences establishments, more than half of those are comprised of fewer than 10 employees. These companies require specific investments in life sciences and innovation (list above) but also require broad economic incentives to grow and thrive. Life Sciences PA is supportive of:
Association Health Plans
Starting and running a life sciences company comes with significant costs for our member companies. These costs can be a defining factor for startups in the life sciences as to whether they flourish or collapse. One of the largest expenses for these small companies is health insurance. In fact, health insurance costs are the second highest expense after employee salaries. Offering competitive benefits packages is a key factor in both attracting and retaining top talent. Unfortunately, small companies are often left with few and expensive options for insurance coverage. One thing that could drastically improve these options is the adoption of Association Health Plans (AHP). Association Health Plans are a type of group medical insurance for employers that allows smaller companies to access the health insurance savings associated with large group medical coverage. By adopting an Association Health Plan at Life Sciences PA, our members could improve their purchasing power by pooling all enrollees throughout the Association. Life Sciences PA is supportive of Representative Gaydos’ legislation on this issue as well as Senator Brooks’ policy proposal (SB 608).
Expanding the Virtual Manufacturing License
In 2024, HB 2084 passed the House and Senate and was signed into law as Act 101 by Governor Shapiro. This legislation created a “Virtual Manufacturer License” in the Commonwealth of Pennsylvania. A virtual manufacturer is a company that sells their own prescription drug products and/or medical devices but contracts out the manufacturing and distribution operations. Virtual manufacturers never take possession of the product.
Prior to Act 101, the Commonwealth of Pennsylvania issued a “Certificate of Record” for virtual manufacturers. The Certificate of Record is not a license, and therefore, Pennsylvania virtual manufacturers cannot distribute prescription drugs in states such as New York and Ohio, which do not accept certificates of record. This limited the ability of Pennsylvania companies to do business throughout the United States and put them at a disadvantage when trying to distribute pharmaceutical or medical device products. States such as Massachusetts, North Carolina and Maryland have language specific to virtual manufacturers, which makes the distribution of prescription drug products and/or medical devices more efficient in the 34 states requiring licensure of virtual manufacturers.
Life Sciences PA supports HB 2162 and SB 1206 which would update this law and amend the definition of a “Virtual Manufacturer” to include companies that have applied for approval to the U.S. FDA for a drug or device. The purpose of this change is to ensure companies that are on the verge of obtaining FDA approval of a drug or device do not have to wait for state approval of a virtual manufacturer license after receiving FDA approval. If a company can obtain a license prior to FDA approval of a drug or device, they can begin to distribute that product as soon as it receives FDA approval. This makes the planning process more efficient for companies on the verge of FDA approval.
Favorable Business Tax Policy
Pennsylvania has one of the least competitive corporate tax environments in the country. In 2023, the Commonwealth ranked 41st out of 50 states in the Tax Foundation’s Corporate Tax Rank. This ranking is due to two main contributing factors: PA is one of the few states that caps the usage of net operating
losses and Pennsylvania previously had the highest non-graduated Corporate Net Income (CNI) tax rate in the country, at 9.99 percent, though that is on a downward trajectory and will be 7.49 percent in 2026.
Life Sciences PA is pleased that the 2022 tax code bill included a reduction in the CNI from 9.99% to 4.99% over a period of nine years. Life Sciences PA will continue to collaborate with other stakeholders throughout the Commonwealth to expedite the CNI reduction, which makes the state a more attractive place to start, operate and grow life science companies.
Public Health Benefits of Prevention
Though much of Life Sciences PA’s work is focused on facilitating a business and policy climate focused on bringing novel treatments and cures to patients, it is important to note that our Commonwealth is a robust manufacturer of vaccines and is a leader in public health and pandemic preparedness. Vaccines have virtually eradicated diseases like polio, whooping cough, and typhoid fever. Unfortunately, recent movements – none of which are grounded in hard science – have led people to believe vaccinations are unhealthy, or have alternative health consequences, hence the recent rise in cases of mumps, measles, and other easily preventable diseases. This has been significantly exacerbated by uncertainty around vaccines and the U.S. vaccine infrastructure coming from the federal government.
Life Sciences Pennsylvania will continue to advocate for policies that ensure children, and adults, have access to vaccines that prevent a wide range of debilitating, and sometimes deadly, diseases. Life Sciences PA will also ensure legislators are educated on the incredible research, development and manufacturing efforts of our members working on vaccines, diagnostics, and therapeutics to address future public health crises. Life Sciences PA is supportive of Governor Shapiro’s efforts to ensure continued access to vaccinations amid federal uncertainty including Executive Order 2025-02 (Oct. 1); State Board of Pharmacy approving guidance from ACOG, AAP, AAFP and FDA; and the PA Department of Health expanding authorities health care providers can rely on. Additionally, Life Sciences PA is supportive of Pennsylvania House and Senate bills that ensure insurance coverage for recommended vaccines (HB 1828 and SB 989) and expand pharmacists practice authority (HB 1881 and SB 1055).
Advocacy Updates
Be the first to know the latest in advocacy news from LSPA!
Join the LSPA Network
LSPA is not geographically restricted to PA. Join more than 960+ companies across the country and get the latest updates from LSPA!
Federal Policy Priorities
Pennsylvania is a global leader in researching and developing new therapies, cures, and devices that help patients live longer, healthier lives. This innovation is due in part to the policy and regulatory ecosystem we enjoy in the United States.
Life Sciences PA works with its Federal Policy Committee and national partners to develop a set of policy issues and recommendations that will support and enhance the country’s life sciences ecosystem and maintain Pennsylvania’s leadership in life sciences innovation.
As the statewide trade association for the life sciences, our public policy advocacy engages and educates the Pennsylvania Congressional Delegation on those policy priorities that incentivize innovation and protect patient access.
Questions about our Federal Advocacy Priorities?
If you have any questions on the Federal Advocacy Priorities, please contact Lara Flynn, LSPA’s Senior Director of Federal Policy & Public Affairs.
Education on the Value of Innovation
Successfully healing patients or providing them with an enhanced quality of life is the passion behind innovation. However, the process by which new medicines and technologies are created is time and resource intensive. Studies have shown it takes more than 12 years and $2.6 billion to move an innovative new drug through the research-and-development and clinical trial processes to approval.
This process is fraught with failure as fewer than 12 percent of medicines entering clinical trials are ultimately approved by the U.S. Food and Drug Administration. This failure is one of the reasons biopharmaceutical companies need to recoup some of those costs through products that make it to the market. Recouping those dollars allows companies to pursue further basic, translational, clinical and manufacturing research needed to turn early scientific discoveries into safe, usable and effective therapies for patients.
In fact, the biopharmaceutical industry regularly invests more of its revenues in R&D than any other industry. As a recent Congressional Budget Office report highlights, for many years, the number averaged 18-20 percent, but in recent years that number has exceeded 25 percent.
Life Sciences PA works to ensure the Pennsylvania Congressional Delegation, comprised of two senators and seventeen members of the House of Representatives, understand this process and that patient access to groundbreaking therapies and cures through appropriate reimbursement in our market-based system are responsible for the United States’ leadership in biopharmaceutical innovation.
In addition to bringing successful FDA approved treatments and cures to patients, this ecosystem also delivers an economic benefit to the Commonwealth. In September of 2022, Life Sciences Pennsylvania released an Economic Impact Report compiled by KPMG. This report identified that the industry directly employed more than 100,000 in Pennsylvania during 2020. When considering the indirect and induced contributions of the industry, the industry is estimated to be responsible for supporting an additional 230,000 jobs. The economic driver that the Life Sciences community represents must be considered. This ecosystem, across the Commonwealth of Pennsylvania includes a diverse workforce which includes direct and indirect jobs, service providers, etc.
Improving Patient Access
Patients should be able to access innovative therapies and medical technologies without unnecessary delays. As science advances, policies governing coverage and reimbursement must keep pace.
Life Sciences Pennsylvania supports efforts to improve coordination between the Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) to help patients access approved therapies more quickly. Life Sciences PA continues to build support among the delegation for Ensuring Patient Access to Critical Breakthrough Products Act (H.R. 5343), which can help reduce gaps between regulatory approval and reimbursement.
Additionally, At the end of April, CMS and FDA announced the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway, a new pathway designed to expedite access to certain FDA-designated Class II and Class III Breakthrough Devices for people with Medicare.
Accelerated approval pathways are also critical for patients facing serious or life-threatening conditions. These pathways can help patients access promising therapies sooner while additional data continues to be collected and reviewed. Drugs approved by the FDA under Accelerated Approval still undergo typical FDA standards that require adequate and well-controlled trials and full FDA safety reviews. The FDA also reviews manufacturing processes, and other core scientific elements and requires that a confirmatory study be conducted after accelerated approval is received. In short, drugs approved under the FDA Accelerated Approval pathway are considered approved by the FDA for use in patients. Life Sciences PA supports the Accelerated Approval pathway and opposes policies that alter or undermine patient access to medicines receiving Accelerated Approval.
Patient affordability remains a significant challenge. While prescription medicines account for a relatively small share of overall healthcare spending, insurance design, cost-sharing requirements, and supply chain dynamics can still create barriers for patients.
LSPA believes all stakeholders including pharmacy benefit managers (PBMs), insurers, manufacturers, providers, and distributors, must be part of solutions that improve affordability and access. Greater transparency and accountability throughout the system are important steps toward lowering patient costs.
LSPA also opposes policies such as drug importation that could weaken the safety and reliability of the U.S. supply chain. Policies that disrupt supply stability create unnecessary and potential additional risks for patients. Maintaining a resilient supply chain and predictable policy environment is essential to ensuring continued access to medicines, diagnostics, and medical technologies.
In early April, LSPA sent an advocacy alert to our membership directing them to the White House Fact Sheet: President Donald J. Trump Bolsters National Security and Strengthens U.S. Supply Chains by Imposing Tariffs on Patented Pharmaceutical Products. Significant questions remain regarding implementation of this policy as the industry relies on global supply chains to bring treatments and therapies to patients in Pennsylvania and around the world.
Life Sciences Pennsylvania has expressed our concerns to the PA delegation that imposing sweeping tariffs on medical devices or pharmaceutical ingredients, risks delaying patient access to critical treatments and undermining decades of American leadership in life sciences innovation.
Robust Research and Development
Sustained investment in research and development is essential to maintaining U.S. leadership in life sciences innovation. Federal agencies such as the National Institutes of Health (NIH), National Science Foundation (NSF), and Department of Defense (DOD) support early-stage research that drives scientific discovery and future medical breakthroughs.
Currently, the NIH is investing over $2.5 billion in more than 4,300 research projects across the Commonwealth. This level of investment drives the innovation and life sciences ecosystem in Philadelphia, Pittsburgh, the Lehigh Valley and beyond. It is crucial to our membership that stable and predictable funding allows academic research institutions, small biotech, and manufacturers to continue developing new therapies and technologies. Life Sciences PA supports robust investment in the NIH and opposes Administration proposals to reduce the overall NIH budget.
Life Sciences PA advocated for the reauthorization of the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs as play an essential role in helping early-stage companies translate research into real-world applications. The legislation received strong bipartisan support from Pennsylvania’s congressional delegation. S. 3971, the Small Business Innovation and Economic Security Act restores a critical source of early-stage capital for the life sciences industry. The program is now authorized through September 30, 2031. The legislation follows a lapse that began on September 30, 2025, which halted new awards and created significant uncertainty across the ecosystem. With this reauthorization, LSPA will continue supporting smaller companies, reliant on SBIR/STTR funding as they advance research and enter clinical development.
As part of the reauthorization, several programmatic changes will be enacted. Life Sciences Pennsylvania will closely monitor implementation to ensure the programs continue to effectively serve our members.
Developing new therapies requires substantial time, capital, and scientific expertise. Public and private investment work together to support this process and help move discoveries from the laboratory to patients.
LSPA supports policies that strengthen the research and development ecosystem, including competitive tax treatment, strong reimbursement systems, and continued federal investment in scientific research. Policies that undermine investment incentives or reduce support for innovation may limit future medical progress and patient access to new treatments.
Intellectual Property (IP)
Strong intellectual property protections are the foundation for innovation in the life sciences. The U.S. patent system maintains important protections for companies researching and developing new medicines and technologies. In March of 2026, in remarks on the U.S. Chamber of Commerce International IP Index, John Squires, Under Secretary of Commerce for Intellectual Property and Director of the USPTO acknowledged the “centrality of IP to economic resilience.” These protections are especially important for the many small life sciences companies that call Pennsylvania home, and for the technology transfer offices that many of our academic institutions operate to move inventions from the lab to widely available treatments and cures for patients.
The University and Small Business Patent Procedures Act Of 1980 more commonly called the Bayh-Dole Act, provides recipients of federal research funding the right to retain ownership of the inventions that were conceived or first actually reduced to practice under their federal funding agreements. Intended to promote utilization of inventions arising from federally supported R&D and increase the number of inventions that progressed from the laboratories into the marketplace.
More than four decades on, changes to these policies would dramatically disrupt the already fragile ecosystem of academic research institutions, industry partners as well as private investment into treatments that have the potential to extend life expectancy in patients. This does not accurately account for the significant time and resources private investment organizations and companies make to research and develop safe, effective, and usable medicines.
Life Sciences Pennsylvania and the academic research institutions as well as R&D based companies that call Pennsylvania home, understand the importance of the strong intellectual property protections that we have in the U.S. Exercising proposals like “march-in rights” will significantly disrupt an innovation ecosystem that already faces challenging odds developing novel therapies and technologies for unmet medical needs.
Life Sciences Pennsylvania works collaboratively with the Bayh-Dole Coalition to educate Members of Congress, and their staff, on the origins and necessity of this foundation of American Innovation and the need to protect it.
Additionally, Life Sciences Pennsylvania joins the Partnership for the U.S. Life Science Ecosystem (PULSE) in sharing the unique nature of mergers and acquisitions (M&A) within our membership. To successfully bring cutting edge breakthroughs from bench to bedside—from the earliest NIH funded research in the academic setting through large scale manufacturing, mergers and acquisitions are a cornerstone of the American success of innovation. The Department of Justice DOJ and Federal Trade Commission (FTC) regulatory changes should be nuanced in this space.
Rare Disease Research and Development
Although rare disorders individually affect relatively small patient populations, they collectively impact millions of Americans. Developing therapies for rare diseases presents unique challenges, including limited clinical data, smaller patient populations, and high research and development costs.
The Orphan Drug Act has been instrumental in encouraging investment in rare disease research by providing incentives such as market exclusivity and tax credits. Since its enactment, the number of approved therapies for rare diseases has increased significantly. Life Sciences Pennsylvania strongly supports the Orphan Drug Act and opposes efforts to weaken the incentives that have helped drive progress for patients with rare conditions.
Since the expiration of the Pediatric Rare Disease Priority Review Voucher (PPRV) program in December of 2024, Life Sciences PA has worked with allied organizations such as NORD, Everylife,Patient Advocacy Groups within our membership, and other stakeholders to encourage the development of therapies for children with rare diseases by providing additional regulatory incentives.
Continued legislative and regulatory support is critical to advancing research, supporting innovation, and ensuring patients with rare diseases have access to life-saving treatments.
In February of 2026, Life Sciences PA was pleased to see the Mikaela Naylon Give Kids a Chance Act signed into law, which restores and extends the PPRV through September 30, 2029. This is a vital incentive for the development of therapies for rare pediatric diseases and provides long-needed certainty for innovators and patients.
FDA
A predictable and transparent regulatory environment is essential to both innovation and patient access. The Food and Drug Administration (FDA) plays a central role in reviewing new therapies and providing guidance that shapes the development process.
Clear and consistent regulatory standards help reduce uncertainty for companies developing medicines, diagnostics, and medical technologies. Predictability throughout the review process allows innovators to plan effectively, invest with confidence, and bring products to patients more efficiently.
User fee agreements such as the Prescription Drug User Fee Act (PDUFA) and Medical Device User Fee Amendments (MDUFA) provide important resources that help the FDA maintain timely and science-based reviews. Timely reauthorization of these agreements is important to avoid disruptions in the regulatory process. Negotiations are currently underway for MDUFA and will soon be underway for PDUFA in 2027. Life Sciences PA works closely with our national trade association collaborators including MDMA, AdvaMed, BIO, and others in supporting final language for these agreements that provide regulatory stability and predictability to those companies pursuing FDA approval of devices and therapeutics. Pennsylvania’s leadership in the research, development, and manufacturing of breakthrough medicines and technologies is strengthened by a trusted gold standard FDA. Life Sciences Pennsylvania supports policies that promote transparency, consistency, and early engagement between regulators and innovators. Maintaining a stable and predictable FDA will help ensure safe and effective therapies continue reaching patients as efficiently as possible.
Thank you to our Policy & Public Affair Sponsors!
Get Updates
from LSPA
Stay up-to-date on the latest news and events from Life Sciences PA, insights from the life sciences industry, and so much more!
Life Sciences Pennsylvania was founded in 1989 by a biotech scientist at Penn State University. Today it has grown to represent the entire life sciences industry – biotechnology and diagnostic companies, medical device companies, pharmaceutical companies, investment organizations, research institutions, and myriad service industries that support the life sciences in Pennsylvania.