POSITION STATEMENTS
75.000 DRUGS AND MEDICATIONS
75.000 DRUGS AND MEDICATIONS
75.964 340B Regulations
The Medical Society of the State New York supports greater transparency of health care entities participating in the 340B Drug Discount Program including a publicly available report of covered entities’ 340B savings and the percentage of 340B savings used directly to care for underinsured patients and lower-income patients; and that the Medical Society of the State of New York work with the AMA to advocate for an alternative to the 340B program that ensures that discount medications are directed to underinsured and lower-income patient populations. (HOD 2024 – 50)
75.965 Rapid Response to Medication and Device Shortages
The Medical Society of the State of New York will provide information on the MSSNY website on how to report drug shortages to the Food and Drug Administration.
MSSNY will work with the American Medical Association on its efforts to help mitigate drug Shortages, and these efforts will be posted to the MSSNY website. (HOD 2023-162)
75.966 Medical Use of Psilocybin and 3, 4-Methylenedioxymethamphetamine (MDMA)
MSSNY awaits FDA evaluation of psilocybin and MDMA clinical trials completed and underway so that scientific data informs judgments about risks and benefits of treatment.
MSSNY will advocate that New York State wait for the FDA to approve psilocybin and MDMA as safe medications with guidance on how they should be prescribed rather than enact legislation to permit their use as medications.
MSSNY supports decriminalization of possession of psilocybin and MDMA for personal use. (HOD 2023-157)
75.967 Appropriate Warning Labels and Signs for Vape and Marijuana
MSSNY will advocate for clear and legible warnings on products containing THC and/or nicotine regardless of the vehicle in which they are contained.
MSSNY will also advocate for clear, legible warning signs to be posted in businesses that sell products containing THC and/or nicotine. (HOD 2023-153)
75.968 Medication Not Approved by FDA For Use in Humans
The Medical Society of the State of New York (MSSNY) will advocate for New York State legislation stating that insurance companies and other related entities must never be required to pay for substances not approved by FDA for use in humans.
MSSNY will urge the American Medical Association (AMA) to advocate for federal legislation stating that insurance companies and other related entities must never be required to pay for substances not approved by FDA for use in humans. (HOD 2023-254)
75.969 Medicare Coverage of OTC Nicotine Replacement Therapy
MSSNY will advocate for OTC nicotine replacement therapies, excluding vaping products, to be carved out from the non-coverage by Medicare of OTC products and be specifically covered when prescribed by physicians who care for patients with Medicare, Medicare Part D, or Medicare Part C coverage.
MSSNY will forward this resolution to the AMA for advocacy on the national level. (HOD 2023-255)
75.970 Patient Medication Safety
The Medical Society of the State of New York will continue to advocate together with the American Medical Association in support of efforts to ensure that the FDA has all the resources necessary to perform necessary inspection and testing of the manufacturing of medications, as well as preventing against drug shortages. (HOD 2023-68)
(See also Abortion and Reproductive Rights, 5.000; Drug Dispensing, 70.000; Home Health Care, 135.000; Pharmaceutical Advertising, 227.000; Public Health & Safety, 260.000; Reimbursement, 265.000; Sports and Physical Fitness, 290.000)
75.971 Pharmacy Benefit Managers
The Medical Society of the State of New York will urge the NYS Department of Financial Services to ensure that medications used in the hospital to stabilize palliative and hospice patients for pain and delirium continue to be covered by pharmacy benefit plans after patients are transitioned out of the hospital. This resolution will be transmitted to the American Medical Association for consideration at its next House of Delegates meeting. (HOD 2019-75)
75.972 Pharmaceutical Shortages of IV Bags
The Medical Society of the State of New York will ask the American Medical Association to urge legislation and/or regulatory flexibility to allow for the safe expansion of purchasing medical supplies, equipment and pharmaceuticals from various countries abroad at a time of shortage. (HOD 2018-103)
75.973 Appeals Process for Medications with Proscribed Dosing
The Medical Society of the State of New York will seek regulation and/or legislation to ensure that Medicare, Medicaid and insurance plans in New York State allow physicians to make dosing adjustments for approved medications to allow the patient to achieve therapeutic levels regardless of their body mass index, as well as differing metabolic considerations. The dose administered should be within the purview of the treating practitioners based on clinical parameters, documented in the medical record. (HOD 2015-263, referred to Council, substitute resolution adopted 1/21/2016)
75.974 Pharmaceutical Practices
All pharmaceutical insurers must operate with complete transparency so as not to monopolize the industry. MSSNY shall take action to immediately refer to the New York State Attorney General any evidence of collusion within the pharmaceutical supply chain. (HOD 2015-103)
75.975 Availability of Pharmaceuticals
The Medical Society of the State of New York will work with the New York State Department of Health and the American Medical Association to ensure that the Food and Drug Administration (FDA) appropriately uses its statutory power to aggressively investigate, remediate and prevent drug shortages, including imposing significant penalties on pharmaceutical manufacturers who fail to timely report shortages or discontinuances of medications. (HOD 2015-50; Reaffirmed HOD 2023-68)
75.976 Cannabis for Seriously Ill Patients
The Medical Society of the State of New York (MSSNY) adopts as policy the following principles:
1) That the use of cannabis may have a role in treating patients who have been diagnosed with serious, debilitating illnesses, when all other treatments have failed; or when clinical trials have shown to demonstrate comparable efficacy to currently accepted treatments.
2) The Medical Society of the State of New York recognizes the risk of smoking cannabis and encourages the use of alternate delivery systems.
3) Physicians who recommend cannabis for patient use, subject to the conditions set forth above, shall not be held criminally, civilly or professionally liable.
The Medical Society of the State of New York supports continued high quality clinical trials on the use of cannabis for medical purposes. (HOD 2014-161; Reaffirmed HOD 2024)
75.977: Reducing Cost of Prescription Drugs to Low Income Seniors
AMA should engage in a dialogue with appropriate stakeholders (i.e., state medical associations, national specialty societies, consumer organizations, patient advocacy groups, etc.) in support of the concepts in the “Senior Protection Plan” that would reduce excessive costs of prescription drugs incurred by low-income seniors. (HOD 2013-270; Reaffirmed HOD 2023)
75.978: Oppose Legislature Approval of Smoked Medical Marijuana
MSSNY reaffirms the process in which medications in the USA are regulated and approved by the FDA and not by state legislative action; opposes any process that entrusts the state legislature with the function of approving medications; reaffirms the fact that medication preparation needs to be strictly regulated by the FDA to assure safety, purity and effectiveness; and opposes, except for the terminally ill, any smoking formulation for medical marijuana as a delivery system for medication unless the FDA approves that delivery system. (HOD 2013-157; Reaffirmed HOD 2019 in lieu of res 172)
75.979 Medical Marijuana:
MSSNY will take a leadership role in the development of any regulations resulting from the passage of state legislation pertaining to medical marijuana and also request the American Medical Association’s assistance in seeking a reversal of the Executive Order pertaining to the prosecution of physicians who prescribe or advise medical marijuana, legally under state statute. (HOD 2009-173; Reaffirmed with amendment HOD 2019)
75.980 Inappropriate Incentives for Recommending Generic Drugs over Brand Name Drugs:
MSSNY will introduce a resolution at the June 2009 Annual Meeting of the American Medical Association (AMA) calling upon the Centers for Medicare & Medicaid Services to abolish the provision of providing incentives for pharmacists to “push” generic drugs over brand name drugs; and, through the AMA, to urge the Centers for Medicare & Medicaid Services to assure that there be greater transparency between the use of generics vs. brand name medications so as to enable patients to make informed and intelligent decision. Also, MSSNY to seek passage of legislation similar to that passed in Maine in 2003 and, subsequently, in other states, that would allow for the regulation of Pharmacy Benefit Management plans by imposing contract transparency and conflict of interest requirements and would require that savings based on drug volume discounts be passed on to client health plans and consumers. (HOD 2009-103; Reaffirmed HOD 2019)
75.981 “Pay for Delay” Arrangements by Pharmaceutical Companies:
MSSNY will forward a resolution to the American Medical Association exhorting that organization to support the Federal Trade Commission in its efforts to stop these “pay for delay” arrangements. (HOD 2008-207; Reaffirmed HOD 2018)
75.982 Extend Phase-out Period for Proven CFC Inhalers: (HOD 2008-170; SUNSET HOD 2018)
75.983 Limiting Coverage for Psychiatric Drugs:
MSSNY will urge the appropriate state agency and/or State Legislature to prohibit the practice of health insurance companies restricting access to psychiatric drugs by (1) requiring failure of a generic drug prior to permitting coverage for a non-generic drug; (2) limiting doses by number of pills per day; or (3) limiting coverage to certain formulations.
MSSNY also will seek legislation or other appropriate remedies to assure that patients who switch insurance companies be able to continue on their existing chronic drug therapies. (HOD 2008-54; Reaffirmed HOD 2018)
75.984 Medical Use of Marijuana/Synthetic Cannabinoids:
MSSNY encourages additional research on the use of cannabinoid products in the treatment of illness and the relief of human suffering without penalty. (HOD 2007-151; Modified and Reaffirmed HOD 2017; Reaffirmed HOD 2018 in lieu of res 166; Reaffirmed HOD 2019 in lieu of res 172)
75.985 Availability of Nicotine Replacement:
MSSNY supports the sale of nicotine replacement products in settings where cigarettes are sold and will work with the NYS Department of Health to make free nicotine replacement products available in physicians’ offices. (HOD 2006-161; Amended HOD 2016; Reaffirmed HOD 2019 in lieu of res 250)
75.986 Herbal Supplements:
(1) MSSNY will work with the American Medical Association to educate physicians and the public to report potential adverse events associated with dietary supplements and herbal remedies to help support FDA’s database of adverse event information on these forms of alternative/complementary therapies;
(2) MSSNY, in conjunction with the AMA, supports efforts to modify the Dietary Supplement Health and Education Act to require that (a) dietary supplements and herbal remedies including the products already in the marketplace undergo FDA approval for evidence of safety and efficacy; (b) meet standards established by the United States Pharmacopeia for identity, strength, quality, purity, packaging, and labeling; (c) meet FDA post-marketing requirements to report adverse events, including drug interactions; and (d) pursue the development and enactment of legislation that declares metabolites and precursors of anabolic steroids to be drug substances that may not be used in a dietary supplement;
(3) MSSNY will work with the AMA to support enforcement efforts based on the FTC Act and current FTC policy on expert endorsements;
(4) That the product labeling of dietary supplements and herbal remedies contain the following disclaimer as a minimum requirement: “This product has not been evaluated by the Food and Drug Administration and is not intended to diagnose, mitigate, treat, cure, or prevent disease.” This product may have significant adverse side effects and/or interactions with medications and other dietary supplements; therefore it is important that you inform your doctor that you are using this product;
(5) That in order to protect the public, manufacturers be required to investigate and obtain data under conditions of normal use on adverse effects, contraindications, and possible drug interactions, and that such information be included on the label; and
(6) MSSNY will continue its efforts to educate patients and physicians about the possible ramifications associated with the use of dietary supplements and herbal remedies. (HOD 2004-151; Modified and reaffirmed HOD 2014; Reaffirmed HOD 2024)
75.987 Medical Marijuana: SUNSET HOD 2020
75.988 Medicare and ‘Off Label’ Uses of Drugs:
MSSNY confirms its strong support for the autonomous clinical decision-making authority of physicians to prescribe medications for ‘off-label” use. (HOD 2004-67; Modified and reaffirmed HOD 2014; Reaffirmed HOD 2015-53; Reaffirmed HOD in lieu of 2022-55)
75.989 Unregulated Sympathomimetic Amines: SUNSET HOD 2023
75.990 Opposition to Bill Mandating Electronic Submission of Prescriptions: SUNSET HOD 2021
75.991 Herbal Substances: SUNSET HOD 2014
75.992 Prohibition of Inappropriate Pill Splitting:
It is the position of MSSNY that the New York State Insurance Department and all other appropriated state agencies prohibit insurance companies from requiring pill splitting. (HOD 2000-160; Reaffirmed HOD 2014; Reaffirmed HOD 2024)
75.993 Schedule I Drug Butyrolactone (GBL or 2G3H)-furanone dihydro): SUNSET HOD 2014
75.994 Enhanced Funding for ADAP (Aids Drug Assistance Program), including Drug Availability and Post Exposure Prophylaxis): SUNSET HOD 2014
75.995 Payment for Medications Containing Estrogen and Progesterone: SUNSET HOD 2014
75.996 Use Of Marijuana For Treatment of Glaucoma: SUNSET HOD 2014
75.997 Serialized Prescriptions: SUNSET HOD 2014
75.998 Diet Pills:
MSSNY endorsed the banning of over-the-counter diet pills entirely until such times as there is sufficient proof of their safety and effectiveness. (Council 12/13/84; Reaffirmed HOD 2013; reaffirmed HOD 2023)
75.999 Amphetamines: SUNSET HOD 2013
Position Statements
