Advocate | NewYorkBIO

Advocate

As the leading association in New York dedicated solely to the issues of the bioscience industry, NewYorkBIO urges legislators to support the industry by creating a better business climate that supports companies at all stages of development to grow and succeed. NewYorkBIO is committed to policies that ensure patient access to the innovative therapies, devices and diagnostics that are being developed by bioscience companies across New York.

The bioscience industry has been a leading business sector in New York for over 150 years. From vaccines to protect against polio, diphtheria and smallpox, to life-saving antibiotics, to advanced DNA discoveries, companies located in New York continue to lead innovation in biosciences. Now more than ever, it is imperative for New York to encourage and promote the research and development of new life-saving medicines, agricultural products, diagnostics, and medical devices. The State must recognize and capitalize on the existing resources the bioscience industry provides to our state and work to grow this vital industry. With the right incentives and supportive policies, New York can strengthen its position as a leader in biotechnology and further develop the bioscience industry in the state to benefit patients worldwide.

Issues

NEWYORKBIO OPPOSES S.1913/A.6222

The Federal government created the 340B program in 1992 to help lower health care costs for underserved populations and to assist the healthcare providers that treat them. Since that time, 340B purchases have increased exponentially, and concerns have been raised not just by industry, but by the Congressional Budget Office. NewYorkBIO opposes legislation that would forbid companies from implementing methods of transparency within a rapidly expanding program like 340B. Manufacturers already face accountability for their actions under 340B, either through the Administrative Dispute Resolution process created by the 340B legislation, or through the courts. Enacting S. 1913/A.6222 has the potential to create problems in the marketplace that could impact patient access.

NEWYORKBIO SUPPORTS A.1296-B/S.1287-B - RARE DISEASE ADVISORY COUNCIL

NewYorkBIO strongly supports legislation to create a permanent Rare Disease Advisory Council in New York. Several years ago, the state recognized the importance of raising awareness of rare diseases and improving best practices, and it created a temporary Rare Disease Workgroup. This legislation would continue the important work done by that group.

NEWYORKBIO OPPOSES ROLLING BACK PROTECTIONS TO ENSURE THAT MEDICAID PATIENTS HAVE ACCESS TO BIOMARKER TESTING

This proposal is included in the Executive Budget (Health S.9007/A.10007, Part M, Section 12). It narrows eligibility for Medicaid patients to access biomarker testing to the sole discretion of the Department of Health, if it determines it is a “medical necessity.” Biomarker testing is critical for determining the most effective treatment for cancer and other diseases. NewYorkBIO strongly supported the original legislation that provided broad access to biomarker testing for patients based on several eligibility categories, (FDA approved, CMS covered, nationally recognized clinical practice guidelines or peer reviewed literature/studies). We oppose any rollback that could impact patients’ access to this critical treatment tool.

BOLSTERING BIOTECHNOLOGY

The Executive Budget Aid to Localities Appropriations Bill (S.9003/A.1003) proposes a Bolstering Biotechnology Initiative. NewYorkBIO supports these strategic investments that strengthen innovation, expand patient access to cutting-edge therapies, and enhance the state’s global competitiveness. These initiatives include establishing a Statewide Clinical Trial Consortium to leverage the collective strengths of New York’s research institutions and improve access to innovative treatments; leveraging public and private venture capital investments to support promising biotechnology startups and retain high-growth companies in New York; investing in fellowships and workforce development programs to prepare New Yorkers for high-demand roles across the biotechnology ecosystem; and creating a new performance-based Commercialization Grant Program, modeled on the successful Biodefense Commercialization Program, to help companies bring biotechnology innovations to market in targeted areas such as neurodegenerative diseases. Together, these proposals represent a comprehensive approach to strengthening New York’s biotechnology economy and ensuring that innovation developed in the state delivers benefits to patients and communities statewide.

NEWYORKBIO SUPPORTS FULL FUNDING FOR THE CENTERS OF EXCELLENCE AND CENTERS OF ADVANCED TECHNOLOGY PROGRAMS IN THEIR CURRENT CONFIGURATION

The Executive Budget Aid to Localities Appropriations Bill (S.9003/A.1003) proposes cuts to the Centers of Excellence and Centers of Advanced Technology programs. New York has long supported innovation, and two of its most successful programs have been these programs. Using two different business models, they encourage collaboration between industry and New York’s robust higher education sector. Each year, the Executive Budget proposes cuts in those programs. In the past, the legislature has negotiated to restore those cuts, and we urge them to do the same this year.

NEWYORKBIO OPPOSES S.371/A.4604 - WHOLESALE PRESCRIPTION DRUG IMPORTATION

This bill attempts to address the complex issue of drug pricing by creating a short-sighted importation program that will make our patients less safe. The World Health Organization estimates that the global counterfeit drug market could be as high as $75 Billion. It further estimates that 1 in 10 drugs in low- and middle-income countries are substandard or counterfeit. Even importing from Canada carries risk - an FDA evaluation “revealed that, while nearly half of imported drugs claimed to be Canadian or from Canadian pharmacies, 85% of such drugs were actually from different countries.” NewYorkBIO opposes this legislation.

NEWYORKBIO OPPOSES S.488-A/A.2289-A AND OTHER LEGISLATION THAT DISCOURAGES PATENT SETTLEMENT AGREEMENTS

These bills would interject the state into patent settlement agreements between drug manufacturers. Supporters of these policies argue that the purpose of litigation settlements in patent disputes is to delay the introduction of generic therapies into the marketplace. However, the Federal Trade Commission already has jurisdiction to ensure that agreements involving intellectual property related to drugs do not have this effect. It is not surprising that innovator companies and generic manufacturers often have disagreements about patent protection dates as a therapy is coming off patent. Often these disagreements lead to litigation and require courts to intervene. Creating additional standards of disclosure and review at the state level could disincentivize companies from reaching settlements and delay the introduction of competing generic therapies.

NEWYORKBIO SUPPORTS S.7025-A/A.5152-A - PHARMACY TECHNICIAN IMMUNIZATIONS

NewYorkBIO strongly supports policies that expand patient access to vaccines. This legislation would allow to administer vaccines and to perform other tasks under the direct supervision of licensed pharmacists.

NEWYORKBIO SUPPORTS S.2128/A.7142 - "SHARE THE SAVINGS"

We recognize that New Yorkers need relief regarding out-of-pocket costs when purchasing their medications at the pharmacy counter. Health insurance companies utilize PBMs to negotiate rebates and discounts on medications offered by drug manufacturers. Patients with commercial health plans are not seeing the intended lower price at the pharmacy counter because these savings are kept as profit by health insurance companies and PBMs and are not passed down to the patients they are meant to help. Therefore, we support this legislation to access medications affordable.

NEWYORKBIO SUPPORTS S.1578B/A.3676B - SICKLE CELL TREATMENT ACT

This legislation would designate sickle cell centers for excellence and outpatient treatment centers. NewYorkBIO supports policies such as this that would direct resources and attention to difficult to treat maladies for the benefit of patients in New York.