A 9248: Enacts the New York state pharmaceutical drug manufacturer and wholesaler disclosure act; requires pharmaceutical drug manufacturers and wholesalers to annually report to the New York department of health, for disclosure to the general public, all of its gifts to health care practitioners that prescribe drugs when such gifts have a value of seventy-five dollars or more; authorizes the commissioner of health to impose penalties and promulgate necessary rules and regulations.

  
  STATE OF NEW YORK ________________________________________________________________________ 9248 2025-2026 Regular Sessions  IN ASSEMBLY November 7, 2025 ___________ Introduced by M. of A. DiPIETRO -- read once and referred to the Commit- tee on Health AN ACT to amend the public health law, in relation to disclosure of certain gifts provided by drug manufacturers or wholesalers to health care providers The People of the State of New York, represented in Senate and Assem- bly, do enact as follows: 1 Section 1. Article 2 of the public health law is amended by adding a 2 new title 3-A to read as follows: 3 TITLE III-A 4 NEW YORK STATE PHARMACEUTICAL DRUG MANUFACTURER AND 5 WHOLESALER DISCLOSURE ACT 6 Section 245. Legislative intent. 7 245-a. Definitions. 8 245-b. Disclosure requirements. 9 245-c. Annual consumer guide on pharmaceutical drug manufacturer 10 and wholesaler gifts to health care providers. 11 245-d. Penalties. 12 245-e. Rules and regulations. 13 § 245. Legislative intent. The legislature finds that the cost of 14 prescription drugs in the United States has grown dramatically. Accord- 15 ing to the Centers for Disease Control, spending on retail prescription 16 drugs in the United States more than tripled from fifteen billion 17 dollars in nineteen hundred eighty-two to forty-eight billion two 18 hundred million dollars in nineteen hundred ninety-two, then more than 19 tripled again to one hundred sixty-two billion four hundred million 20 dollars in two thousand two. In per capita terms, retail prescription 21 drugs spending increased from sixty-four dollars in nineteen hundred 22 eighty-two to five hundred sixty-nine dollars in two thousand two. In 23 two thousand five, spending on pharmaceuticals rose to two hundred EXPLANATION--Matter in italics (underscored) is new; matter in brackets [ ] is old law to be omitted. LBD13456-01-5 
 A. 9248 2 1 fifty-one billion eight hundred million dollars. While the availability 2 of useful new drugs to treat chronic conditions such as heart disease, 3 hypertension and depression accounts for much of the increased spending, 4 there is widespread concern about the impact aggressive marketing by 5 drug manufacturers and wholesalers has had on drug costs and prescribing 6 patterns. In addition to the explosive growth in direct-to-consumer 7 advertising, these marketing efforts are often directed at health care 8 providers and include gifts, paraphernalia, trips and travel, food and 9 entertainment. A Competitive Media Reporting Study found that drug 10 companies provided seven billion two hundred million dollars worth of 11 free samples to physicians' offices in nineteen hundred ninety-nine. The 12 drug industry sponsored more than three hundred fourteen thousand physi- 13 cian "events" in two thousand one, ranging from catered lunches in 14 hospital conference rooms to weekend getaways at resorts, nearly double 15 the number four years earlier. Drug companies spent some twenty-two 16 billion dollars in marketing in two thousand three. According to the 17 Journal of the American Medical Association, ninety percent of drug 18 company marketing is directed at physicians. Esteemed medical publica- 19 tions such as the Journal of the American Medical Association and the 20 British Medical Journal produced studies that suggest these marketing 21 activities do influence health care providers' decisions on prescription 22 drugs, and in ways that are not the best for patients or the health care 23 system itself. The legislature recognizes that drug manufacturers and 24 wholesalers are free to use any legal sales and marketing techniques to 25 promote their products. But the legislature also finds that the consum- 26 ers have a right to know what gifts, if any, their health care providers 27 are receiving from manufacturers and wholesalers, in order that they 28 might make informed and cost-effective decisions about their 29 prescription drug expenditures. 30 § 245-a. Definitions. As used in this title, the following terms shall 31 have the following meanings: 32 1. "Approved clinical trial" means a clinical trial that has been 33 approved by the U.S. Food and Drug Administration (FDA) or has been 34 approved by a duly constituted Institutional Review Board (IRB) after 35 reviewing and evaluating it in accordance with the human subject 36 protection standards set forth at 21 C.F.R. Part 50, 45 C.F.R. Part 46, 37 or an equivalent set of standards of another federal agency. 38 2. "Bona fide clinical trial" means an approved clinical trial that 39 constitutes "research" as that term is defined in 45 C.F.R. § 46.102 40 when the results of the research can be published freely by the investi- 41 gator and reasonably can be considered to be of interest to scientists 42 or medical practitioners working in the particular field of inquiry. 43 3. "Clinical trial" means any study assessing the safety or efficacy 44 of drugs administered alone or in combination with other drugs or other 45 therapies, or assessing the relative safety or efficacy of drugs in 46 comparison with other drugs or other therapies. 47 4. "Drugs" shall have the same meaning as set forth in subdivision 48 seven of section six thousand eight hundred two of the education law. 49 5. "Health care provider" means any physician or other person who is 50 legally authorized to prescribe drugs. 51 6. "Pharmaceutical drug manufacturer" means a person who compounds, 52 mixes, prepares, produces and bottles or packs drugs for the purpose of 53 distributing or selling to pharmacies or to other channels of distrib- 54 ution. 55 7. "Pharmaceutical drug wholesaler" means a person whose primary busi- 56 ness purpose is to bottle, pack or purchase drugs for the purpose of 
 A. 9248 3 1 selling or reselling to pharmacies or to other channels as provided in 2 this title. 3 8. "Pharmacy" shall have the same meaning as set forth in subdivision 4 one of section six thousand eight hundred two of the education law. 5 9. "Unrestricted grant" means any gift, payment, subsidy, or other 6 economic benefit to an educational institution, professional associ- 7 ation, health care facility, or governmental entity which does not 8 impose any restrictions on the use of the grant, such as favorable 9 treatment of a certain product or an ability of the marketer to control 10 or influence the planning, content, or execution of the education activ- 11 ity. 12 § 245-b. Disclosure requirements. 1. Any pharmaceutical drug manufac- 13 turer or pharmaceutical drug wholesaler, including any employee or agent 14 of such manufacturer or wholesaler, that makes any gift whether in the 15 form of money, service, loan, travel, entertainment, hospitality, thing 16 or promise, or in any other form, to a health care provider shall report 17 the gift to the commissioner in the manner set forth in subdivision two 18 of this section. 19 2. Any pharmaceutical drug manufacturer or pharmaceutical drug whole- 20 saler who makes at least one gift under subdivision one of this section 21 shall file with the commissioner an annual report, due no later than 22 June first of each year, beginning in two thousand twenty-six, of all 23 gifts made by the manufacturer or wholesaler to health care providers. 24 3. Such annual report shall contain: (a) the name, address and tele- 25 phone number of the pharmaceutical drug manufacturer or wholesaler; (b) 26 an itemized list containing a description of each gift falling under 27 subdivision one of this section and the name, address and telephone 28 number of the health care provider who received each gift; (c) the mone- 29 tary value of each gift; and (d) such other information as deemed neces- 30 sary by the commissioner for compliance with this article. 31 4. The following shall be exempt from disclosure: 32 (a) the payment of reasonable compensation and reimbursement of 33 expenses in connection with bona fide clinical trials; 34 (b) any gift the value of which is less than seventy-five dollars; 35 (c) scholarship or other support for medical students, residents and 36 fellows to attend a significant educational, scientific, or policy-mak- 37 ing conference of a national, regional, or specialty medical or other 38 professional association if the recipient of the scholarship or other 39 support is selected by the association; 40 (d) unrestricted grants for continuing medical education programs; 41 (e) prescription drug rebates and discounts; and 42 (f) free samples of drugs. 43 § 245-c. Annual consumer guide on pharmaceutical drug manufacturer and 44 wholesaler gifts to health care providers. 1. No later than September 45 first of each year, beginning in two thousand twenty-six, the commis- 46 sioner shall publish and make available, free of charge to the public, a 47 consumer guide on gifts provided by pharmaceutical drug manufacturers 48 and wholesalers to health care providers. Such guide shall contain all 49 of the information provided in the annual report required by section two 50 hundred forty-five-b of this title and the information shall be written 51 in plain language in a clear and understandable format. 52 2. The commissioner shall provide for the adequate distribution and 53 availability of the consumer guide on pharmaceutical drug manufacturer 54 and wholesaler gifts to health care providers. Appropriate copies of 55 the guide shall be transmitted to the office for the aging for distrib- 56 ution at every office for the aging in the state, to every county office 
 A. 9248 4 1 for the aging in the state and to the commissioner of education for 2 distribution to every public library in the state where copies of the 3 guide shall be made available free of charge to the public. The commis- 4 sioner shall also post the guide on the department's internet website. 5 § 245-d. Penalties. 1. The commissioner may impose a civil penalty 6 for failure to file a timely report as required by section two hundred 7 forty-five-b of this title in an amount up to fifty dollars a day until 8 such report is filed or three thousand dollars, whichever is less. 9 2. Any person who violates any other provision of this title shall be 10 subject to a civil penalty in an amount not to exceed three thousand 11 dollars for each violation. The commissioner is authorized to assess the 12 civil penalty under this section pursuant to section twelve of this 13 chapter. 14 § 245-e. Rules and regulations. The commissioner is authorized to 15 promulgate rules and regulations as deemed necessary to carry out and 16 enforce the provisions of this title. 17 § 2. This act shall take effect on the first of January next succeed- 18 ing the date on which it shall have become a law.