Statement of Principles on Drug Safety and Efficacy Standards

Background.  The Food and Drug Administration Amendments Act of 2007 (FDAAA) was signed into law in September 2007 with the aim to make prescription drugs safer.  The legislation allows the FDA to require drug companies to change labeling information if safety issues emerge, and provides necessary resources to the FDA in an effort to help promote innovation in biomedical research and better access to new therapies for physicians and patients.  Under the legislation, post-market surveillance is enhanced and will help to more accurately identify potential adverse effects of pharmaceutical products through the use of databases maintained by the Department of Veterans' Affairs, the Medicare program and other large insurers. 

The legislation also created the Reagan-Udall Foundation to establish a public-private partnership for the advancement of the FDA's Critical Path Initiative, and to help modernize product development, accelerate innovation and increase product safety.  Additionally, the bill establishes risk evaluation and mitigation strategies (REMS) and codifies the FDA's authority to require additional studies on the safety of a product once it has reached the market, and to determine whether it is appropriate to ensure the benefits of a drug outweigh its risks. 

Recent reports of adverse effects from approved prescription drugs have heightened awareness regarding the need for monitoring products' usage and to ensure that the highest standards of safety and efficacy are achieved.  National Patient Advocate Foundation welcomes the recent discussions about how we can make our drug approval process better, but we are mindful of the fact that patients with life-threatening and life-altering diseases like cancer are given hope because of the advantages of scientific discovery, and new product development.  We support reform that makes drugs safer for their intended populations, but caution against those actions whose unintended consequences might hinder the improvement of technologies for treatment, prevention, screening and detection - or that discourage their creation altogether.

As Congress continues to deal with this issue and considers options to strengthen our standards of prescription drug safety and efficacy, NPAF believes such reforms must be matched with efforts to enhance the FDA's level of efficiency, scientific expertise, and overall capacity to fulfill its numerous priorities and mandates.   

Where the Issue Stands.  Effective December 2007, the omnibus spending bill passed through Congress included language that would effectively block the FDA from transferring any funds to the Reagan-Udall Foundation, demonstrating a belief in alignment with a number of consumer groups that the Foundation might be too susceptible to industry influences. 

Any federal effort to improve national standards for drug safety and efficacy should be based on the following principles:

• Promote innovation in biomedical research and facilitate increased access to new therapies for physicians and patients.
• Expand the use of post-market surveillance to continuously observe the impacts of a given pharmaceutical product, recognizing the potential for unintended consequences, side effects or adverse effects, and ensuring that the relative benefits of a drug outweigh its risks.
• In the case of any new safety concerns, recommendations should be made for the appropriate adjustment of safety/warning information reflected in required labeling changes with patient safety/warning labels written in easy to understand/patient friendly language.
• Any and all efforts to improve drug safety should be transparent and independent of outside political pressures.

Where We Stand.  National Patient Advocate Foundation fully supports the implementation of practices to encourage the modernization, and advancement of drug safety priorities, and the improvement of the drug approval process.  However, we remain concerned that the appointments and staffing of the Foundation must be done in such a way as to maintain the critical transparency and independence to assure that the public has full faith and confidence in its work.  NPAF intends to closely monitoring the development and direction of the foundation in the coming months.

Statement of Principles on Association Health Plans

National Patient Advocate Foundation shares the concerns regarding the increasing difficulty for employers to provide comprehensive health insurance benefits for their employees due, in large part, to rising health insurance premium costs. We note this is especially true for owners and employees of small businesses and workers who are self-employed. There is increasing interest among employers to enroll in Association Health Plans (AHPs) to enable small businesses and the self-employed to purchase health insurance coverage through business, professional or civic associations. Proponents contend that, by collectively leveraging the number of insured workers in a risk pool, AHPs would result in more affordable health insurance premiums and enable additional workers, and particularly workers with lower wages, to purchase health insurance coverage for themselves and their families. In response to these concerns, members of Congress have proposed legislation that would further govern and regulate AHPs.

National Patient Advocate Foundation will carefully consider all legislative proposals that will assist in reducing the number of Americans who lack private health insurance coverage and do not qualify for other federal or state health coverage programs. As Congress develops legislative proposals regarding AHPs, we respectfully request that the following concerns be given careful consideration:

Coverage Guidelines. AHPs should be prohibited from excluding industries that have a history of higher claims experience. Congress should establish minimum health insurance benefit packages and provide incentives for employers who offer additional benefits. AHPs should be prohibited from offering different health plans based on the geographic location of the employer. This is particularly important for those who live in rural areas of our country. AHPs should be prohibited from charging higher premiums for industries with a history of high claims experience. Furthermore, AHPs should be prohibited from increasing premium rates during a given plan year.

Pre-emption of State Regulation. Many states have enacted legislation that would provide all covered workers with certain minimum health insurance benefits. These benefits include access to emergency care services, mandatory, timely internal and external grievance and appeals procedures for denial of benefits, parity for coverage for mental health benefits with those of medical and surgical benefits, breast and cervical cancer screening, direct access to OB/GYN services and other benefits and services. States have also established strong oversight regulations to establish minimum solvency standards and to protect consumers against unfair claims practices and false or misleading advertising. National Patient Advocate Foundation believes that all AHPs should be required, at a minimum, to adhere to state health care laws and regulations in the states in which they operate. Plans should be required to adhere to state laws of the state in which the beneficiary resides.

Federal Oversight. National Patient Advocate Foundation is concerned that new federal legislation and regulations regarding AHPs could weaken existing state standards. We are concerned that if AHPs elect to self-insure, they could be exempt from state solvency requirements designed to ensure that insurance companies have sufficient resources to avoid financial failure. We are concerned that current federal requirements only require financial reporting when a health plan is near insolvency and permit AHP actuaries to certify solvency. We encourage Congress to carefully consider strengthening the current solvency standards for AHPs.

Impact on Employers Currently Offering Health Insurance Coverage. According to the Congressional Budget Office, companies that currently provide health insurance benefits could migrate to AHPs, thereby having the unintended result of increasing health insurance premiums for those employers who continue to purchase health insurance through traditional means. National Patient Advocate Foundation encourages Congress to carefully consider the impact that the expansion of AHPs will have on health care costs for employers who provide health insurance through traditional health plans.

Consumer Protections Must be in Place. Escalating premium costs must be limited to an annual increase only at the time of open enrollment. Consumers must be assured a timely appeal process in their state of residency if an external appeal is required.

Statement of Principles on Stem Cell Research

National Patient Advocate Foundation (NPAF) is an organization whose mission is to seek improved access to, and reimbursement for, healthcare services through both policy and legislative reform at the state and federal levels. Our mission is shaped by the experience of the patients we serve through our companion organization, the Patient Advocate Foundation. The Patient Advocate Foundation professional team includes case managers, oncology nurses, coding and billing specialists, licensed social workers, and debt crisis counselors who mediate and negotiate with insurers, employers, and creditors to resolve access to care, job retention, and debt crisis problems that result from a diagnosis of a chronic, life-threatening, or debilitating disease.

As an advocate for America's patient community, NPAF recognizes that stem cell research is critical to the fight against many life-threatening diseases. National Patient Advocate Foundation strongly supports permitting federal funds to be used for all forms of stem cell research, including adult stem cell research.

NPAF is committed to ensuring that patients receive access to the highest quality of medical care, which entails access to the latest therapies. NPAF therefore supports scientific research for therapeutic purposes that open the door to medical advancements that could not only save lives, but also enhance quality of life and alleviate suffering for patients.