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PRINCIPLES REGARDING PHARMACEUTICALS AND MEDICAL DEVICES

The American Medical Student Association:

1.             Regarding Government Policy:

a.             URGES increased funding and regulatory power for the Food and Drug Administration (FDA) to enable it to ensure that pharmaceutical, diagnostic and other medical products are of the highest quality and safety; (2006)

b.             SUPPORTS legislation that provides for the classification, testing and pre-market clearance of medical devices and encourages the development and use of new, approved devices; (2006)

c.             SUPPORTS the incorporation of the National Drug Code into various drug compendia, SUPPORTS the mandatory utilization of the National Drug Code, its imprintation with bar codes on all drug containers and solid dosage forms, and ENCOURAGES the increased use of automated bar code systems at point of dispensation to reduce drug errors; (2006)

d.             URGES adequate funding of the FDA or a federal agency to be charged with:

1.             coordinating and reviewing evaluative testing of bioequivalence and bioavailability of products and requiring it where indicated; (2006)

2.             requiring and reviewing comparative testing between new products and existing products in addition to placebo when such products already exist within the same class to determine if the new product is superior or equivalent to existing therapy; (2006)

3.             publishing lists of products it judges to be bio-equivalent or comparatively efficacious; (2006)

4.             receiving and evaluating challenges to previous bio-equivalency and comparative efficacy decisions. (2006)

e.             URGES the FDA and pharmaceutical manufacturers to make widely available to physicians and pharmacists definitive reports on bioavailability and therapeutic equivalence and bulletins indicating current trends where studies are not yet conclusive;

f.              OPPOSES efforts to allow the use of uncertified or unapproved drugs in the treatment of a medical condition without emergency approval; (2006)

g.             SUPPORTS government programs or legislation to encourage innovation of new pharmaceutical products especially new molecular entities (NME), biologics, and medical devices, particularly for neglected, communicable, or life-threatening diseases in the United States and worldwide. (2006)

2.             Regarding physician/industry interaction:

a.             SUPPORTS the concept that the physician’s role in pharmaceutical product selection remain primary;

b.             ENDORSES the objective sources of therapeutic information on pharmaceuticals, such as the “Medical Letter of Drugs and Therapeutics,” “Facts and Comparisons,” “The American Hospital Formulary,” and ENCOURAGES all institutions to provide independent sources, rather than relying upon industry sponsored sources such as the Physician’s Desk Reference;

c.             OPPOSES the use of promotional gimmicks and inappropriate gifts serving no educational or informational purpose to influence medical students or physicians; (1992)

d.             OPPOSES the process by which the AMA’s guidelines on gifts to physicians from industry were adopted by members of the medical community and its related industries; (1992)

e.             OPPOSES the policy of giving training institutions sole control over the allocation of industrial funds for the purpose of physicians’-in-training participation in extracurricular educational activities; (1992)

f.              ENCOURAGES the pharmaceutical industry, in cooperation with AMSA and other organizations representing physicians-in-training, to begin a continuing dialogue on the role of industry in medical education and in supporting legitimate medical education activities; (1992)

g.             BELIEVES that practicing physicians should maintain an independent financial posture vis-à-vis the pharmaceutical industry to avoid the potential of conflict of interests in prescribing for and treating their patients; (2002)

h.             URGES all physicians, residents and medical students not to accept as end recipients any promotional gifts from the pharmaceutical industry. (2002)

i.              URGES all hospitals and residency programs to discontinue the practice of pharmaceutical company-funded lectures and lunches. (2002)

j.              URGES all hospitals and residency programs to discontinue the practice of disseminating information about off-site drug-company sponsored events. (2002)

k.             OPPOSES granting CME credit for pharmaceutical company-sponsored events.  (2002)

l.              URGES all physicians not to accept honoraria on behalf of pharmaceutical companies for speaking at educational conferences and not to accept compensation for token consulting or advising. (2002)

m.            OPPOSES the tracking of prescriptions by commercial entities and SUPPORTS legislation to limit access to individual prescription patterns of physicians by the sales and marketing departments of pharmaceutical companies. (2006)

n.             SUPPORTS including curricula in medical school education concerning the ethics of physician-industry interactions, particularly in relation to pharmaceutical research and marketing. This curriculum may include: (2004)

1.             the research and development process for new drugs, including the cost of creating new medications and the role for physician-researchers; (2004)

2.             the decision-making process for prescribing medications, as it relates to the economics and bioequivalence of using brand name versus generic drugs; (2004)

3.             the impact of direct-to-consumer and direct-to-physician marketing  practices employed by the pharmaceutical industry, as they relate to the physician-patient relationship; (2004)

4.             a review of the various guidelines concerning gifts from the pharmaceutical industry, including those issued by AMSA, AMA, and the Pharmaceutical Researchers and Manufactures of America (PhRMA). (2004)

o.             Strongly ENCOURAGES physicians and physicians-in-training to refuse pharmaceutical samples in cases in which equally effective, low-cost alternatives exist and utilize samples only in cases in which other lower cost therapies have been unsuccessful or are contraindicated. (2007)

3.             Regarding Pharmaceutical and Medical Device Pricing:

a.             SUPPORTS efforts to reduce the cost of medications and medical devices for patients. Possible mechanisms to achieve lower prices include: (2006)

1.             Bulk purchasing by federal and state governments to allow the negotiation of lower prices;  (2006)

2.             Compulsory licensing of pharmaceuticals and devices under patent protection;  (2006)

3.             Re-importation of medications from industrialized countries, when the medications are approved for use in the United States ;  (2006)

4.             Maximum Allowable Cost (MAC) programs, only if all the following provisions are met:

a.             that the physician be able to get a brand-name drug simply by certifying that it is his/her opinion that a specific product is needed;  (2006)

b.             that the pharmacist be reimbursed for a prescribed brand name-drug if he/she cannot reach the physician for permission to substitute;  (2006)

c.             that stringent quality controls be instituted regarding all substituted products to ensure they are, indeed, as safe and efficacious as the standard product.  (2006)

5.             Mechanisms to encourage research and development through government grants and awards, including rewards for innovation with one-time monetary compensation in exchange for open patents on novel medications.  (2006)

b.             AMSA OPPOSES any limitations on bulk purchasing, especially for public healthcare agencies. (2006)

c.             SUPPORTS legislation to require physicians to prescribe pharmaceutical products by generic name and then to note in parentheses the name of a specific brand name or company whenever the physician will not allow substitution, and which requires pharmacists to pass along to the consumer any wholesale price differences between generic and brand-name drugs when the generic drug is dispensed;

d.             ENCOURAGES physicians to consider and make students aware of cost-effectiveness when recommending or prescribing commonly used drugs and to educate about affordable alternative therapies for patients who have financial limitations to pharmaceutical access; (2006);

e.             SUPPORTS legal action against pharmaceutical companies to mandate fair pricing in cases where essential medications are unaffordable to the general public and pricing is disproportionate compared with other national or international prices. (2006)

4.             Regarding pharmaceutical advertisement:

a.             URGES that the advertising of all pharmaceutical and OTC products be maximally educational for both the public and physicians and meet the following criteria:

1.             medications should be portrayed as medicines with a specific purpose and not as cure-all panaceas;

2.             the advertising should not define a need that does not exist in a medical sense nor create a new need;

3.             the advertising should be factual and without pictorial or verbal representations which appeal to emotions rather than intellectual reasoning;

4.             patients and providers should be portrayed in a respectful and humane manner and not in a stereotyped or demeaning fashion with respect to age, sex, sexual orientation and gender identity, race and disability;

5.             the promotional content should be clearly identifiable as such and be as separate from the educational content as possible;

6.             a suggested retail price should be included in all detail advertisements;

7.             the statement, “If you are presently taking any other medicines, consult your pharmacist or doctor before using our product,” should be included in all OTC drug advertisements. (2006)

b.             SUPPORTS required labeling of all cosmetic ingredients;

c.             OPPOSES drug industry-sponsored direct-to-consumer (DTC) advertisements. (2005)

5.             Regarding pharmaceuticals and international health:

a.             CONDEMNS pharmaceutical companies that produce and export dangerous and controlled drugs to countries in quantities much greater than is used in those countries, and other parties contributing to illicit smuggling and sale of these drugs. (2006)

b.             SUPPORTS the use of the World Health Organization (WHO) Model List of Essential Drugs as a reference base which countries may use in developing national essential drug policies, while recognizing that what medicines are considered essential should be determined on a country-by-country basis by national authorities and that this may include medications not found on the WHO Model List of Essential Drugs. (2008)

c.             URGES the pharmaceutical industry to adopt policies of research, development, manufacture and pricing that support developing countries in making essential drugs and vaccines available to their peoples, without promoting use of drugs and vaccines not included on the WHO List of Essential Drugs. (2006)

d.             STRONGLY CONDEMNS any efforts by the pharmaceutical industry to reduce access to essential medications including by means of intimidation or boycott when a country uses flexibilities found in international trade agreements (such as compulsory licensing) to generically produce medications essential to that country’s public health; (2008)

e.             SUPPORTS worldwide efforts, such as the Global Fund, to increase access to essential medicines to all people of the world suffering morbidity or mortality due to  treatable life-threatening or disabling diseases without discrimination due to gender, race, nationality, sexual orientation and gender identity, age or socioeconomic status. (2006)

6.             Regarding research, intellectual property and access to essential medicines in resource-poor settings:

a.             RECOGNIZES that Universities, as intellectual property holders, play a crucial role in the development of new medicines and medical technologies, and that how they patent and license these technologies can help determine whether individuals in developing countries have access to the end products of university research. (2003)

b.             URGES Universities to utilize the following Principles, suggested by the institutional ethos of universities, when making patenting and licensing decisions that have potential impacts on access to essential medicines and medical technologies worldwide:

1.                    University research is intended to advance the common public good, a primary element of which is the advancement of health.

2.                    Global public health concerns need to be an important part of patenting and licensing decisions.

3.             The success of patenting and licensing programs should be measured according to their impact upon public health.

4.             University intellectual property policies should be implemented in a manner supportive of developing countries’ right to protect public health and, in particular, to promote access to medicines for all.

5.             Technology transfer to develop capacity in developing countries is an important part of universities’ mandate to advance knowledge and the social good. (2003)

c.             URGES Universities to consider different strategies to implement these Principles, including not patenting or allowing their licensees to patent in developing countries, and issuing non-exclusive licenses for developing country markets. (2003)

d.             RECOGNIZES that changes in University practices, with regards to intellectual property, will require collective action and leadership amongst Universities worldwide.  (2003)

e.             URGES Universities to act together to establish norms and implement strategies and best practices to promote access to essential medicines in developing countries. (2003)

f.              URGES the pharmaceutical and medical device industry to respect the scientific process of research and discovery, including the following:

1.             SUPPORTS the right of researchers to freely publish their results without prior approval from sponsoring entities; (2006)

2.             OPPOSES publishing partial and incomplete results of studies, using ghostwriters and otherwise bypassing the peer-review process; (2006)

3.             OPPOSES the use of Contract Research Organizations (CRO) to conduct research outside of academic institutions; (2006)

4.             STRONGLY OPPOSES attempts by industry to retaliate against and/or intimidate individuals and groups working to improve pharmaceutical safety or government pharmaceutical policies. (2006)

7.             Regarding Prescription Drug Reimportation: (2004)

a.             BELIEVES that Canadian pharmacies, which are subject to similar quality control and chain of custody standards as the United States , have the ability to ensure the safety of prescription drugs. (2004)

b.             RECOGNIZES that the reimportation of drugs from Canada is a temporary step towards improving access to affordable drugs from pharmaceutical companies within the United States . (2004)

c.             SUPPORTS the reimportation of drugs from Canada as a temporary solution, until equivalent pharmaceuticals are available at equal or lower prices in the United States through bulk purchasing and price negotiation. (2006)

8.             Regarding Liability of Pharmaceutical Companies:

a.             SUPPORTS increasing the enforcement of pharmaceutical regulation and penalties on pharmaceutical companies for failing to disclose to the FDA any information concerning harmful effects of their products. (2006)

b.             OPPOSES legislation that would exempt pharmaceutical manufacturers from legal liability stemming from known harmful effects of their products. (2005)

9.             Regarding Neglected Tropical Diseases:

a.             SUPPORTS increasing the priority of the so-called neglected tropical diseases on the global public health agenda. (2008)

b.             CALLS UPON governments, non-governmental organizations, and industry to create a need-based drug research and development model for the neglected tropical diseases which could include, but shall not be limited to, the following interventions: (2008)

1.             Provide long-term, committed funding for basic science research into the neglected tropical diseases (2008)

2.             The use of transferable intellectual property rights (2008)

3.             Implementation of advanced purchase commitments  (2008)

4.             The introduction of prize funds for drugs effective against the neglected tropical diseases (2008)

5.             Providing start-up monies for pharmaceutical research and development in developing countries. (2008)

6.             Providing start-up capital for small biotechnology firms both in developing countries and in the West whose business models aim to address neglected tropical diseases  (2008)

7.             Development and implementation of “corporate social responsibility” policies by multinational pharmaceutical companies to address the need for a need-based model of pharmaceutical research and development  (2008)

8.             The creation of Product Development Public-Private Partnerships  (2008)

9.             The creation of open compound libraries (2008)

c.             SUPPORTS the efforts of the Drugs for Neglected Diseases Initiative (DNDi) and the Institute for One World Health (IOWH) toward creating effective drugs against the neglected tropical diseases. (2008)

d.             URGES monetary investment from governments, non-governmental organizations, and charitable giving to programs and initiatives working toward creating treatments for neglected tropical diseases. (2008)

e.             URGES monetary investment from governments, non-governmental organizations, and charitable giving to programs and initiatives working toward developing public health initiatives for prevention of neglected tropical diseases. (2008)