Accelerating Access to Critical Therapies

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This report closely examines federal bill H.R.3537, also known as the Accelerating Access to Critical Therapies for ALS Act (Piuzzi et al., 2019). It is a recent addition to the legislative space of the United States that was enacted on December 23, 2021 (H.R.3537 – Accelerating Access to Critical Therapies for ALS Act, 2021). Due to the increasing number of neurodegenerative diseases, this project involves the opening of grant programs and the expansion of financial opportunities for treatment. However, at the same time, all information about the course of therapy and patients should be transmitted to state authorities. The purpose of this work is to assess stakeholders, as well as to conduct a SWOT analysis to identify the weaknesses and strengths of the bill.


From an economic point of view, there is a background that determines the need for a grant. The expensive treatment of neurodegenerative diseases under insurance programs makes the introduction of the bill a more effective way of financing. Regulatory processes that prompted the writing of the bill were related to illegal drug traffic. According to the law, administrative and even criminal liability is imposed for such trade. However, many still try to make money on demand, and unfortunately some doctors resort to such frauds as a way of additional earnings. The adoption of federal bill H.R.3537 can prevent such trade.

The legal background of federal bill H.R.3537 is related to the ongoing work on the modernization of the process of movement and use of medicines. The approval of the bill will facilitate the legal monitoring of the movement of medicines for use in the treatment of neurodegenerative diseases from the manufacturer to the end user using identification tools. Among the medicines used or methods of treatment of this group of diseases, there are falsified, substandard and counterfeit medicines. Therefore, the legal possibility of checking the legality of registered medicines in circulation will ensure the transparency of treatment.


Direct stakeholders in this case are doctors who will have a new responsibility to report on their actions during the treatment of patients. The analysis of the report on the activities of the neurological department will become more detailed than the main indicators of activity for the year, the dynamics of morbidity and the percentage of those cured (Swash, 2019). Direct stakeholders are also employees of government agencies whose duties, according to the bill, include control over medical institutions working with neurodegenerative diseases.

Indirect stakeholders in this case are patients undergoing treatment for neurodegenerative diseases. Despite the fact that they are not designated in the bill text as a controlled or controlling person, like doctors or employees of the government authorities, this initiative will also affect patients. According to the terms of the grant, treatment data, and therefore patient data, will be provided to third parties. Thus, information about patients that was previously completely confidential ceases to be so.

All stakeholders take a different position on the area of concern. Doctors and patients benefit from the adoption of this bill, as funding will allow treating patients with neurodegenerative diseases more effectively (Kiernan et al., 2020). At the same time, this bill will lead to a stricter form of control over doctors and disclosure of confidential patient data to third parties, which is a negative point. For government agencies, the ability to monitor the course of treatment is a purely positive outcome, as this will help prevent illegal trade in medicinal drugs.



The strengths of this bill include improving the effectiveness of the treatment of neurodegenerative diseases. Providing the main medical entities and industries with the funds necessary for the implementation of economic and social programs will have a positive impact on the level of health outcomes. The opportunity to purchase better equipment and medicines for treatment and diagnosis will benefit the health of patients.


Among the weaknesses of this bill, additional control over medical staff can be noted, which can affect the effectiveness of their work because they may be under stress due to new requirements. They will also have less time to work directly with patients, as it will be necessary to fill out new detailed reports. The combination of these factors can negatively affect the effectiveness of treatment of patients not only with neurodegenerative diseases, but also other patients who are engaged in doctors involved.


Among the possibilities of adopting this bill is the reduction of cases of illegal trade in medicines. The need to provide a detailed report on the course of treatment after receiving the grant will allow government agencies to track the movement of medical goods. The number of health outcomes will increase not only due to economic activity associated with the purchase of high-quality medicines. They will also grow due to the use of medicines only as prescribed by a doctor in the prescribed dosage.


Among the threats that bill poses is a violation of the principle of confidentiality of patient data. The subject of confidentiality is the diagnosis of the disease, data on the state of health, prognosis and all the information that the doctor receives as a result of the examination or when listening to the patient’s complaints. However, under the terms of the grant, this data must be provided to the state authorities. There may be situations when this information can be used to the detriment of the patient.

Effect on the Stakeholders

At the institutional level, issues in the bill will positively affect stakeholders. Due to the grant at the institute of health in general, and especially its local area related to the treatment of neurodegenerative diseases, qualitative changes will be noticeable. The measures taken will strengthen the effectiveness of providing medical care to citizens. At the local level, federal bill H.R.3537 may cause resistance among doctors due to the need for additional paperwork (Goutman et al., 2019). Maintaining documentation takes up most of the working day, so most likely the innovation will also be negatively perceived by patients. At the local level, there are not very many patients with neurodegenerative diseases, but the new requirements for medical reports will affect all other patients, since doctors will devote less time to them.

At the state level, this innovation will reduce the number of negative outcomes in patients with neurodegenerative diseases. Neurodegenerative diseases are characterized by progression, leading to degeneration of personality, complete loss of working capacity and legal capacity. However, with the implementation of high-quality treatment, when receiving a grant at the state level, there will be fewer people who will need care and maintenance due to the deterioration of the disease. This will be due to the ability to carry out more expensive treatment that prevents the disease from progressing.

At the federal level, bill H.R.3537 may accompany the monitoring of the movement of medicines. Reports on the use of grant funds will guarantee the authenticity and quality of medical drugs. The main task of this reporting system will be to increase the level of consumer safety, combat counterfeiting and low-quality analogues. The adoption of the law will partially eliminate the problem, which seriously affects the end users – patients.

Nurse as a Change Agent

The master’s prepared nurse leader can act as a change agent, contribute to the policy-making process, and advocate for quality, cost-effective care. The first way she can do this is by conducting educational work among the population. One of the main tasks of a medical professional is to convince a patient to consciously adopt a healthy lifestyle (Lynch & Bateman-House, 2021). Explaining the possible negative effects of taking medications outside of a doctor’s appointment, the nurse advocate for quality, cost-effective care. Convincing the patient of the need to follow the doctor’s prescriptions in out-of-hospital conditions, the nurse increases the effectiveness of the adopted program. The second way that a medical nurse can use is to write scientific papers and stand with them at conferences. Popularization of federal bill H.R.3537 and its outcomes will allow more medical institutions to learn how to get the benefit from it.


The code of medical ethics states among the duties of a doctor in relation to a patient that a doctor must maintain absolute secrecy in everything that concerns patients who trust them. However, the adoption of federal bill H.R.3537 requires medical staff to transfer confidential patient information to third parties – state authorities. The dilemma regarding this bill is to determine whether the positive result that will be obtained as a result of the grant election justifies the violation of the principle of confidentiality.


Goutman, S. A., Savelieff, M. G., Sakowski, S. A., & Feldman, E. L. (2019). Stem cell treatments for amyotrophic lateral sclerosis (ALS): A critical overview of early phase trials. Expert Opinion on Investigational Drugs, 28(6), 525-543.

Kiernan, M. C., Vucic, C., Talbot, K., McDermott, C. J., Hardiman, O., Shefner, J. M., … Turner, M. R. (2020). Improving clinical trial outcomes in amyotrophic lateral sclerosis. Nature Reviews Neurology, 17(13), 104-118.

Lynch, H. F., & Bateman-House, A. (2021). Facilitating both evidence and access: improving FDA’s accelerated approval and expanded access pathways. Journal of Law, Medicine & Ethics, 48(2), 365-372.

Piuzzi, N. S., Mitchell, N., Chughtai, M., Khlopas, A., Ramkumar, P. N., Harwin, S. F., … Muschler, G. F. (2019). Accelerated growth of cellular therapy trials in musculoskeletal disorders: an analysis of the NIH clinical trials data bank. Orthopedics, 4(8), 16-20.

Swash, M. (2019). Critical design considerations for time-to-event endpoints in amyotrophic lateral sclerosis clinical trials. Journal of Neurology, Neurosurgery & Psychiatry, 90(3), 1308-1309.

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1. NursingBird. "Accelerating Access to Critical Therapies." March 16, 2023.


NursingBird. "Accelerating Access to Critical Therapies." March 16, 2023.