The National Consumers League supports policies that ensure access to safe, effective, and affordable prescription drugs for all Americans while supporting continued innovation. They advocate for robust FDA funding to review new drugs and ensure generics approval. The League also supports vigilant post-market drug surveillance, enforcement of pharmaceutical oversight, and transparency in drug advertising. The needs of patients should be central to the pharmaceutical system.

1. Where We Stand
The following are the official policy statements, adopted by the Board of Directors, the
governing body of the National Consumers League, which guide the advocacy work of the
organization.
NCL Health Policy
Government at all levels must act to insure access to affordable quality health care for all citizens.
As a matter of public policy, the government’s role in health care must not be limited to the
reimbursement of health care practitioners and facilities for the treatment of the diseased or
injured. Rather, government must assume its responsibility to further the total health of consumers,
including the quality of their environment, the promotion of healthy lifestyles, their nutritional needs,
occupational health and safety, and right to comprehensive preventive health care. An increase in
research on the causes of diseases, which eventually could lead to prevention, is critically needed.
While medical care itself is inevitably technical and therefore must be left to physicians and other
qualified health care providers, it is important that consumers be genuine participants in their own
care and have a significant role in shaping public policies which affect them and their families.
There is also a critical need for coordinated, pluralistic, and cost-effective health care delivery
systems to deliver high-quality services that are accessible to all people without regard to age, sex,
race, disability, sexual orientation, social or economic condition, or residence.
Towards these ends, the League supports:
1. Primary care as the foundation of a system that provides consumers a full range of quality
providers, including physicians, nurses, pharmacists, dentists, nutritionists, and mental
health workers;
2. Attention to populations with special needs such as children, pregnant women, the poor,
people with HIV and AIDS, the elderly, people with mental and physical disabilities, and non-
English speakers;
3. Strong emphasis on the development of physician practice guidelines and nursing research
based on health outcomes;
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2. 4. A network of care available to persons living in underserved urban and rural areas to
coordinate fragmented delivery systems, often complicated by inadequate communications
and transportation; and development of more effective methods to correct the shortage of
medical and health personnel in medically underserved areas–both rural and urban;
5. Long-term care integrated with acute health care services and available in the most
appropriate setting;
6. Progressive health care financing based on a uniform payment system with community rating.
Deductibles, co-insurance, and co-payments are obstacles to full access to the health care
system and should be eliminated or at least held to a minimum;
7. Specific published prices for health care services and the prohibition against providers
requiring consumers to pay additional fees;
8. Consumer access to comprehensive and accurate information and education about the range
and implications of available health care options;
9. Managed care organizations, including health maintenance organizations, as a choice for
consumers with participation on a voluntary basis;
10. Requirement for a safe environment in workplaces, including the proper disposal of industrially
related toxics and research on occupational health hazards. Workplaces that are dangerous or
expose employees to long-term health risks impose substantial burdens on the system;
11. The requirement that when new medical technologies are disseminated that there be
adequate assessment of the effectiveness and requirements for training and teaching so that
these technologies do not harm quality of medical care and possibly greatly add to the cost;
12. Careful monitoring and regulating of promotion and advertising of prescription drugs;
13. Consumers’ right to an appeals process to contest unfair administrative or medical decisions;
14. Unrestricted access of consumers to their medical records, and their right to correct inaccurate
information and control dissemination of confidential information; and
15. Consumer representation in either an administrative, advisory, or advocacy capacity at every
level and in every sector of health care.
In addition, NCL:
1. Endorses the concept of comprehensive health care as a universal right and joins with other
groups in health coalitions to support a national health plan. Proposals should include dental
care, prescription drugs, psychiatric care, and long-term care to the extent that it is medically
necessary;
2. Calls for health-care cost containment policies, both state and federal, as well as voluntary
efforts to restrain health costs through broad community coalitions,
labor/management cooperation, and collective bargaining negotiations;
3. Opposes cuts in Medicare and Medicaid which are of vital importance to the elderly, disabled,
and poor; and supports all efforts to make these programs more responsible to the health-care
needs of these groups by expanding covered services, and, in Medicaid, expanding eligibility to
all the poor and indigent;
4. Supports expanding Medicare services to include eyeglasses, hearing aids, foot care,
preventive care, and long-term care in all appropriate settings, including home health care,
assisted living, hospices, and intermediate and skilled nursing homes. Financial barriers to
participation in Medicare, such as high deductibles, coinsurance, and premiums should be
reduced or eliminated;
5. Calls for expanding Medicare to include a voluntary, comprehensive, affordable, and
guaranteed prescription drug benefit available to all beneficiaries;
6. Expresses concern about the rapid takeover by giant, for-profit conglomerates of health care
services of all kinds – hospitals, nursing homes, home health care, HMOs, managed care
organizations, and other health care services – and calls for financial and other support for
continuing, strong, and community-oriented non-profit health care institutions;
7. Urges, in response to the misdistribution of primary care physicians and other health
personnel, substantially increased federal assistance to medical, public health, and allied health
professional schools and to economically disadvantaged students, in order to encourage better
distribution of health professionals to meet consumer demand; and
8. Believes health professionals should adhere to a high standard of ethical behavior. This
includes avoiding conflict of interest or undue influence by marketing appeals in decision-

3. making.
—Adopted December 13, 2000
1. Right to Privacy — An individual has a right to privacy with respect to individually identifiable
health information. The individual should have the right to decide to whom, and under what
circumstances, their individually identifiable health information will be disclosed.
2. Informed Consent and Notice — Health information that identifies a specific individual should not
be disclosed without that individual’s explicit consent, unless authorized by law. Individuals should
be notified about how their medical records are used and when their individually identifiable health
information is disclosed to third parties.
Informed consent is a process, which ensures that patients understand a proposed treatment or
procedure, and can intelligently share in responsible decision making. Implicit in this principle is
the right of a patient to decline the proposed treatment or procedure. Included among the basic
elements of informed consent must be a statement describing the extent to which the
confidentiality of the patient’s medical records will be maintained. Use or disclosures without
informed consent should be permitted only under exceptional circumstances; for example, if a
person’s life is endangered, if there is a threat to the public health, or if there is a compelling
law- enforcement need. Disclosure of individually identifiable health information to someone
other than the patient or the caregiver solely for marketing or commercial purposes should
never be permitted without informed consent.
Individuals should be given written, easy-to-understand notice of how information will be used,
so that they can make informed, meaningful decisions about uses and disclosures of their health
information.
3. Security Safeguards and Penalties — Safeguards, including computerized “walls” and electronic
audits, should be utilized to prevent the unauthorized release and possession of computerized
medical information.
The increased use of electronic health record data storage creates opportunities for greater
protection of health information through a number of computer security methods, many of which
already are utilized by other industries. Providers, health plans, and other users of health
information should seek to incorporate electronic security measures, such as passwords,
electronic audits, and encryption, to avoid unnecessary access and possible misuse of health
information. There should be penalties for violation and private right of action for individuals
harmed by a breech in the security of their health information. States should adopt common
operating standards for data security and patient privacy protection, including clearly
established penalties for violations not covered by HIPAA (such as identity theft), and an
accountable means for monitoring, enforcement, and prosecution of violations.
4. Individual Right to Access–Health care consumers should have access to their medical record
and the ability to propose corrections or amendments to the record.
In order to be an active participant in health care, consumers should be able to obtain,
inspect, and, if necessary, offer corrections or amendments to their medical record.
Erroneous information contained in the medical record can result in discrimination with
respect to insurance and employment.
No personal health information should be available to a provider or health professional
that is not also available to the patient (with exception for cases of danger to the patient).
Unreasonable or unaffordable fees should not impair the ability of each person to access,
review or supplement their personal health information.
People must be able to receive complete paper copies of any of their information.
Health Information Privacy

4. 5. Right to Private Action — For violations of the right to privacy and security of health information,
consumers should have a right to private action.
6. Research Access — Certain needs for health information, such as research and public health
interests, should be recognized and met to the extent possible through access to unidentifiable
data. Access to identifiable health data for properly constituted institutional review board (IRB)-
approved studies should be available, when necessary.
Research that will improve the health and reduce health risks of all Americans should be
supported. In certain research settings, medical information should be made available to
researchers without prior written authorization, under certain conditions. Such conditions should
include a determination by a properly constituted IRB that the research involves minimal risks to
participants, the absence of consent would not adversely affect the rights or welfare of
participants, the research could not practicably be carried out if consent were required.
Researchers should be responsible for removing the personal identifiers and for providing the
IRB with assurances that the information will be protected from improper use and unauthorized
additional disclosures. In a GAO report published in February 1999 (GAO/HEHS-99-55, Medical
Records Privacy), it was stated “IRB review does not ensure the confidentiality of medical
information used in research because the provisions of the Common Rule related to
confidentiality have limitations.” It is suggested in the report that organizational policies be in
place, which restrict access to personally identifiable information to authorized individuals, and
that organizations impose data security safeguards and encryption policies to ensure
confidentiality.
7. Education–The public and users of health information should be educated about the need to
maintain the confidentiality of medical record information (See NCL Consumer Education policy).
As overwhelming opportunities exist for the public, health professionals, clinicians, insurers,
employers, and other users of health information to access private medical records, it is
important that there be a national, systemic approach to educating these users about the
importance of protecting medical records.
8. Consumer Information Programs–NCL supports pharmaceutical care and pharmacy programs,
which provide useful information to consumers about their prescription drugs; however, health
information privacy must be protected (See NCL Consumer Education policy). Inappropriate or
suboptimal uses of prescription medicines result in needless deaths and suffering, as well as
billions of dollars of added hospitalization costs and loss of productivity. Armed with greater and
better knowledge about the medicines they take, consumers will be empowered to make more
informed decisions about their health and health care. NCL strongly supports programs to provide
consumers with truthful and accurate information on prescription drugs. NCL participated in
developing and supports HHS’s “MedGuide Action Plan,” which calls for uniformly structured,
“consumer friendly” information about the risks and uses of a prescription drug, to be provided to
the patient by the pharmacist, at the time a drug is dispensed.
NCL has also actively supported the concept of pharmaceutical care and pharmacy programs
which provide information about appropriate medication regimes, self-monitoring and self-
reporting, refill reminders, disease state information programs, and drug therapy education,
including information about alternative therapies to help the consumer understand treatment
and to assure better health.
Any consumer information programs should provide the consumer, at the outset, with a
complete description of the program, its potential benefits, and an explanation of how the
program works. If possible, this information should be provided by the physician or other health
care provider. At a minimum, this information should be provided by the pharmacist before the
patient becomes involved in the program. Pharmacies, to the best of their knowledge, should
fully inform consumers about the intended use of any confidential health care information in
pharmacy records at the time they receive their prescription. Participation in these programs
should be entirely voluntary, and consumers should have easy-to-exercise options to withdraw
from any information program at any time.
––Adopted December 9, 2005

5. The National Consumers League supports access to prescription drugs that are safe, effective, and
affordable for all. While there is a plethora of proposed policy solutions to reduce drug prices and
ensure that Americans get the prescriptions they need, one of the most effective strategies is
increasing the availability and usage of generic drugs. The FDA requires generic drugs to have the
same active ingredient, strength, dosage, and route of administration as their brand-name
equivalents. They are just as safe and effective as their brand-name counterparts, and far
cheaper.
Generic drugs can enter the market once the patent protections for brand-name drugs expire, and
when multiple options exist on the market, competition drives prices down. They are sold at much
lower prices because they can utilize the data collected from the previous clinical trials for the
brand-name drug in their development process. To be approved, generic drugs need to show that
they are “bioequivalent” to the brand-name drug, meaning that they must contain the same active
ingredient and act the same way in the body. The FDA conducts rigorous testing to ensure that
generics meet these standards. When multiple generics enter the market, they are typically 85
percent cheaper than brand-name drugs and more generics are produced now than ever, with
2019 setting a record for having the most new generics approved.
Similarly, biosimilars represent a cheaper, yet high-quality alternative to biologics, a typically
expensive class of drugs which are most often injectables. In fact, biologics and other specialty
drugs comprise nearly half of all prescription drug spending, yet only a small number of patients
use them. Biosimilars are not completely identical to their brand-name counterparts, but they do
work in the same way and have no meaningful difference. Due to the often high costs of biologics,
increasing the usage and availability of biosimilars is a very effective solution for reducing drug
costs and increasing access to innovative medicines for all patients.
Although generics already comprise 90% of all prescriptions filled in the US, there is still room to
expand their availability- especially for new drugs. We support the good work the FDA has done
with drug companies to move drugs to a generic equivalent when the patent expires on the brand.
We also encourage the FDA to work with manufacturers to speed up the process of developing
and approving new generics. NCL is constantly working to raise awareness with patient and
consumer communities about the high quality of generic drugs and their overall affordability.
We believe that expanding the use of generics and biosimilars is a far better option for making
drugs more affordable than, say, drug importation, which is a cumbersome, unrealistic, and unsafe
policy some have proposed to keeping drug costs down.
—Adopted July 2021
Generic Drugs and Biosimilars
NCL supports the enactment of policies that will ensure the safety and efficacy of prescription
drugs and expand access to all Americans, while ensuring that the United States can continue to
be a leader in developing groundbreaking new pharmaceuticals. As a nation, we must continue to
maintain integrity within the drug supply chain and support research and development on cutting-
edge pharmaceuticals, while engaging in stringent regulation of new and existing drugs to ensure
their safety and efficacy.
Approval from the U.S. Food and Drug Administration (FDA) is recognized around the world as the
gold standard for guaranteeing the safety and efficacy of new drugs. In order to ensure that all
pharmaceutical products on the market are proven safe and effective, and continue to undergo
rigorous inspections, NCL believes that we need a robust and well-funded FDA. A well-funded FDA
Pharmaceuticals

6. will support the operations needed to deliver new drugs and generics to consumers in a timely
manner. The FDA is also in a unique position to promote increased diversity in clinical trials, which
would bring about greater efficacy for treatments administered to racial and ethnic minority
communities, aiding in the fight against systemic health inequities.
Vigilant post-market surveillance and continuous monitoring of pharmaceuticals on the market
further ensures that they are safe and manufactured in the proper manner. This oversight is
essential for protecting American consumers and guaranteeing that they are always getting the
highest quality medications. To uphold its mission to preserve the fidelity of the American
pharmaceutical market, the FDA must be given the powers necessary to exercise enforcement of
its oversight authority.
Every aspect of the drug sector must consider the needs of the patients who ultimately rely upon
these prescriptions. Consumers should be central to the American pharmaceutical system. The
pharmaceutical industry needs to educate consumers about where to report adverse side effects,
and advertisements should be compelled to provide consumers with transparent information about
the risks and benefits of the product. Federal regulatory action needs to have oversight of drug
manufacturers’ advertising practices to eliminate deceptive efficacy and safety claims.
Consumers want to make informed decisions about their prescriptions with advice from their
doctors, pharmacists, and other relevant healthcare professionals based on their medical needs.
We call on drug companies to work with health care providers to ensure patients are properly
educated about the medicines they take, and raise awareness of the pharmaceutical development
process.
Pricing transparency is critical to lowering prescription drug prices in the United States. Excessive
prescription drug costs are directly linked to poor medication adherence and contribute to health
disparities when patients cannot afford the medicines they need. We understand the drug
manufacturing system relies on rebates to Pharmacy Benefit Managers (PBMs), policymakers need
to ensure those discounts are being passed to consumers and not siphoned away from them by
PBMs. Americans can only truly benefit from pharmaceutical products if they can afford them.
—Adopted August 2021
The National Consumers League believes that all Americans should have access to safe and
effective prescription medications and supports sensible efforts to lower drug costs for patients.
We do not believe drug importation is a safe and effective strategy. Drug importation has long
been considered a risky policy for lowering costs. Among the problems with drug importation is
that implementing such a program would require significant federal funding to effectively mitigate
risks to public safety. Drugs imported from abroad intended to be sold in foreign markets would not
have gone through the rigorous inspection and certification process in order to meet U.S.
standards, making the U.S. prescription drug market vulnerable to dangerous counterfeit products.
Four former FDA heads, two who served during the Obama administration — Robert Califf and
Margaret Hamburg — and two who served under former president George W. Bush — Andrew
von Eschenbach and Mark McClellan oppose drug importation for just these reasons.
Any prescription drug importation program authorized by the Food and Drug Administration should
ensure that the system poses no additional risk to the public’s health and safety, while achieving a
reduction in the cost of covered products. Currently, the FDA itself has said that it does not have the
capacity to inspect a multitude of imported medicines and the cost for doing so would offset most
of the promised savings from a program.
The influx of poorly inspected drugs to the U.S. could also create a two-tiered prescription drug
market where the poorest and most vulnerable consumers would face the health hazards from
such drugs, while more affluent Americans would have access to the more reliable drugs. Such a
system would exacerbate the health inequities already present in our society. Alternative solutions
to high drug prices exist – like approving more generic drug options more quickly – which are far
Prescription Drug Importation

7. more effective at lowering drug costs without posing risks to the health and safety of American
consumers.
—Adopted June 2021
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