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.
Sponsor: MAZIARZ Committee: HEALTH
Law Section: Public Health Law
Law: Add Art 2 Title VI SS266 - 266-e, Pub Health L
Law Section: Public Health Law
Law: Add Art 2 Title VI SS266 - 266-e, Pub Health L
- Jan 4, 2012: REFERRED TO HEALTH
- Jan 5, 2011: REFERRED TO HEALTH
BILL NUMBER:S212 TITLE OF BILL: 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 PURPOSE: To require the state Department of Health to collect information on pharmaceutical company expenditures incurred in the marketing of prescription drugs and to create a free guide on pharmaceutical drug manufacturer and wholesaler gifts to health care providers in order to inform consumers. SUMMARY OF PROVISIONS: This bill would add a new Title VI to the Public Health Law, which would require the commissioner of the Department of Health (DOH) to create a consumer guide on the advertising and promotional activities associated with the provisions of prescription drugs in New York State. In performing this function, the commissioner is directed to collect information from pharmaceutical companies (and pharmaceutical companies are directed to provide such information) related to funds spent on health care professionals, hospitals, clinics, pharmacy benefits management employees and managed care employees on education materials, food and entertainment, gifts, trips and travel, seminars and income, This guide must be made available to the public at no cost no later than September 1st of each year. Exempt from the reporting requirements are: legitimate expenses associated with clinical trials; scholarships for medical students, residents, and fellows to attend genuine educational, scientific, or policy-making conferences of a medical or professional association as long as the recipient is chosen by said association; wire stricted grants; gifts of less than $75 in value; prescription drug rebates and discounts; and free drug samples. JUSTIFICATION: Prescription drug costs represent a growing component in health care expenditures. According to the Centers for Disease Control, spending on retail prescription drugs in the US more than tripled from $15 billion in 1982 to $48.2 billion in 1992, then more than tripled again to $162.4 billion in 2002. That is a per capita increase from $64 in 1982 to $569 in 2002. From 1985 to 2001, Medicaid spending on drugs increased 10-fold, and New York had the second highest Medicaid expenditures on Prescription drugs in the nation. Some observers see that as a positive trend, arguing that effective drug regimens prevent inpatient admissions and other costly procedures, and that marketing to medical professionals is necessary to inform health care practitioners about products. Critics of the practices, however, believe that the rise in prescription drug spending correlates with the amounts pharmaceutical companies are spending on marketing, advertising and "detailing" drugs directly with health care professionals, and point to some troubling trends with implications for both the quality and cost of health care: * The pharmaceutical industry spent more than $22 billion in 2003 on marketing, the lion's share of it on direct marketing to health care providers; * The number of sales representatives employed by drug companies nearly doubled since 1996, rising from 41,000 to between 90,000 and 100,000 in 2004. The number of marketers has seen similar increases, growing from 55,348 in 1995 to 87,810 in 2000; * The drug industry sponsored more than 314,000 physician "events" in 2001, ranging from catered lunches in hospital conference rooms to weekend getaways at resorts, nearly double the number four years earlier; and * Of the drugs responsible for the nearly 1996 rise in spending for pharmaceuticals in 2001, the four top sellers were among the top ten most heavily marketed drugs. Between 2000 and 2004, the prices of the top selling pharmaceuticals have increased almost 25%. * Leading medical schools including Stanford University, Yale University and the University of Pennsylvania have enacted policies banning their physicians from accepting of gifts, even those of only nominal value, from pharmaceutical companies. Some observers contend that the massive amounts spent on these promotional activities has led to inappropriate use of some drugs with serious consequences for health care quality, underutilization of less costly generic drugs, conflicts of interest for providers and added and unnecessary health care costs. A January 2001 study by the Journal of the American Medical Association (JAMA) found that marketing directly influences the drugs that doctors prescribe. A 2006 JAMA study reiterated that position, indicated that drug companies spend approximately $13,000 per physician annually and went so far as to call for a ban on such gifts. Furthermore, many groups fear that advertising promotes newer, less tested drugs aver older, more trusted drugs and fear an increased emphasis on treatment over prevention. While both the pharmaceutical industry and providers have established voluntary guidelines to limit gifting, the practice continues extensively. The purpose of this bill is to authorize the commissioner of health to collect data on the promotional activities of drug companies, and report these findings to consumers. Furnishing pharmaceutical consumers with this information may help them make better decisions about their medical care. LEGISLATIVE HISTORY: S.3217/A.6615 of 2009-2010; Referred to Senate Health Committee S.2971-C/A.7468-A of 2007-2008; Referred to Senate Health Committee S.696-E/A.5574-E of 2005-2006; Referred to Senate Finance Committee S.505A of 2003-2004; Referred to Senate Finance Committee S.4191 of 2001-20D2; Referred to Senate Finance Committee FISCAL IMPLICATIONS: None. EFFECTIVE DATE: This act shall take effect January 1st next succeeding the date on which it shall have become a law.
S T A T E O F N E W Y O R K ________________________________________________________________________ 212 2011-2012 Regular Sessions I N SENATE (PREFILED) January 5, 2011 ___________ Introduced by Sen. MAZIARZ -- read twice and ordered printed, and when printed to be committed to the Committee 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:
Section 1. Article 2 of the public health law is amended by adding a new title 6 to read as follows:
TITLE VI NEW YORK STATE PHARMACEUTICAL DRUG MANUFACTURER AND WHOLESALER DISCLOSURE ACT SECTION 266. LEGISLATIVE INTENT. 266-A. DEFINITIONS. 266-B. DISCLOSURE REQUIREMENTS. 266-C. ANNUAL CONSUMER GUIDE ON PHARMACEUTICAL DRUG MANUFACTURER AND WHOLESALER GIFTS TO HEALTH CARE PROVIDERS. 266-D. PENALTIES. 266-E. RULES AND REGULATIONS. S 266. LEGISLATIVE INTENT. THE LEGISLATURE FINDS THAT THE COST OF PRESCRIPTION DRUGS IN THE UNITED STATES HAS GROWN DRAMATICALLY. ACCORD- ING TO THE CENTERS FOR DISEASE CONTROL, SPENDING ON RETAIL PRESCRIPTION DRUGS IN THE UNITED STATES MORE THAN TRIPLED FROM FIFTEEN BILLION DOLLARS IN NINETEEN HUNDRED EIGHTY-TWO TO FORTY-EIGHT BILLION TWO HUNDRED MILLION DOLLARS IN NINETEEN HUNDRED NINETY-TWO, THEN MORE THAN TRIPLED AGAIN TO ONE HUNDRED SIXTY-TWO BILLION FOUR HUNDRED MILLION DOLLARS IN TWO THOUSAND TWO. IN PER CAPITA TERMS, RETAIL PRESCRIPTION DRUGS SPENDING INCREASED FROM SIXTY-FOUR DOLLARS IN NINETEEN HUNDRED EIGHTY-TWO TO FIVE HUNDRED SIXTY-NINE DOLLARS IN TWO THOUSAND TWO. IN EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets [ ] is old law to be omitted. LBD01691-01-1 S. 212 2 TWO THOUSAND FIVE, SPENDING ON PHARMACEUTICALS ROSE TO TWO HUNDRED FIFTY-ONE BILLION EIGHT HUNDRED MILLION DOLLARS. WHILE THE AVAILABILITY OF USEFUL NEW DRUGS TO TREAT CHRONIC CONDITIONS SUCH AS HEART DISEASE, HYPERTENSION AND DEPRESSION ACCOUNTS FOR MUCH OF THE INCREASED SPENDING, THERE IS WIDESPREAD CONCERN ABOUT THE IMPACT AGGRESSIVE MARKETING BY DRUG MANUFACTURERS AND WHOLESALERS HAS HAD ON DRUG COSTS AND PRESCRIBING PATTERNS. IN ADDITION TO THE EXPLOSIVE GROWTH IN DIRECT-TO-CONSUMER ADVERTISING, THESE MARKETING EFFORTS ARE OFTEN DIRECTED AT HEALTH CARE PROVIDERS AND INCLUDE GIFTS, PARAPHERNALIA, TRIPS AND TRAVEL, FOOD AND ENTERTAINMENT. A COMPETITIVE MEDIA REPORTING STUDY FOUND THAT DRUG COMPANIES PROVIDED SEVEN BILLION TWO HUNDRED MILLION DOLLARS WORTH OF FREE SAMPLES TO PHYSICIANS' OFFICES IN NINETEEN HUNDRED NINETY-NINE. THE DRUG INDUSTRY SPONSORED MORE THAN THREE HUNDRED FOURTEEN THOUSAND PHYSICIAN "EVENTS" IN TWO THOUSAND ONE, RANGING FROM CATERED LUNCHES IN HOSPITAL CONFERENCE ROOMS TO WEEKEND GETAWAYS AT RESORTS, NEARLY DOUBLE THE NUMBER FOUR YEARS EARLIER. DRUG COMPANIES SPENT SOME TWENTY-TWO BILLION DOLLARS IN MARKETING IN TWO THOUSAND THREE. ACCORDING TO THE JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, NINETY PERCENT OF DRUG COMPANY MARKETING IS DIRECTED AT PHYSICIANS. ESTEEMED MEDICAL PUBLICA- TIONS SUCH AS THE JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION AND THE BRITISH MEDICAL JOURNAL PRODUCED STUDIES THAT SUGGEST THESE MARKETING ACTIVITIES DO INFLUENCE HEALTH CARE PROVIDERS' DECISIONS ON PRESCRIPTION DRUGS, AND IN WAYS THAT ARE NOT THE BEST FOR PATIENTS OR THE HEALTH CARE SYSTEM ITSELF. THE LEGISLATURE RECOGNIZES THAT DRUG MANUFACTURERS AND WHOLESALERS ARE FREE TO USE ANY LEGAL SALES AND MARKETING TECHNIQUES TO PROMOTE THEIR PRODUCTS. BUT THE LEGISLATURE ALSO FINDS THAT THE CONSUM- ERS HAVE A RIGHT TO KNOW WHAT GIFTS, IF ANY, THEIR HEALTH CARE PROVIDERS ARE RECEIVING FROM MANUFACTURERS AND WHOLESALERS, IN ORDER THAT THEY MIGHT MAKE INFORMED AND COST-EFFECTIVE DECISIONS ABOUT THEIR PRESCRIPTION DRUG EXPENDITURES. S 266-A. DEFINITIONS. AS USED IN THIS TITLE, THE FOLLOWING TERMS SHALL HAVE THE FOLLOWING MEANINGS:
1. "APPROVED CLINICAL TRIAL" MEANS A CLINICAL TRIAL THAT HAS BEEN APPROVED BY THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) OR HAS BEEN APPROVED BY A DULY CONSTITUTED INSTITUTIONAL REVIEW BOARD (IRB) AFTER REVIEWING AND EVALUATING IT IN ACCORDANCE WITH THE HUMAN SUBJECT PROTECTION STANDARDS SET FORTH AT 21 C.F.R. PART 50, 45 C.F.R. PART 46, OR AN EQUIVALENT SET OF STANDARDS OF ANOTHER FEDERAL AGENCY. 2. "BONA FIDE CLINICAL TRIAL" MEANS AN APPROVED CLINICAL TRIAL THAT CONSTITUTES "RESEARCH" AS THAT TERM IS DEFINED IN 45 C.F.R. S 46.102 WHEN THE RESULTS OF THE RESEARCH CAN BE PUBLISHED FREELY BY THE INVESTI- GATOR AND REASONABLY CAN BE CONSIDERED TO BE OF INTEREST TO SCIENTISTS OR MEDICAL PRACTITIONERS WORKING IN THE PARTICULAR FIELD OF INQUIRY. 3. "CLINICAL TRIAL" MEANS ANY STUDY ASSESSING THE SAFETY OR EFFICACY OF DRUGS ADMINISTERED ALONE OR IN COMBINATION WITH OTHER DRUGS OR OTHER THERAPIES, OR ASSESSING THE RELATIVE SAFETY OR EFFICACY OF DRUGS IN COMPARISON WITH OTHER DRUGS OR OTHER THERAPIES. 4. "DRUGS" SHALL HAVE THE SAME MEANING AS SET FORTH IN SUBDIVISION SEVEN OF SECTION SIX THOUSAND EIGHT HUNDRED TWO OF THE EDUCATION LAW. 5. "HEALTH CARE PROVIDER" MEANS ANY PHYSICIAN OR OTHER PERSON WHO IS LEGALLY AUTHORIZED TO PRESCRIBE DRUGS. 6. "PHARMACEUTICAL DRUG MANUFACTURER" MEANS A PERSON WHO COMPOUNDS, MIXES, PREPARES, PRODUCES AND BOTTLES OR PACKS DRUGS FOR THE PURPOSE OF DISTRIBUTING OR SELLING TO PHARMACIES OR TO OTHER CHANNELS OF DISTRIB- UTION. S. 212 3 7. "PHARMACEUTICAL DRUG WHOLESALER" MEANS A PERSON WHOSE PRIMARY BUSI- NESS PURPOSE IS TO BOTTLE, PACK OR PURCHASE DRUGS FOR THE PURPOSE OF SELLING OR RESELLING TO PHARMACIES OR TO OTHER CHANNELS AS PROVIDED IN THIS TITLE. 8. "PHARMACY" SHALL HAVE THE SAME MEANING AS SET FORTH IN SUBDIVISION ONE OF SECTION SIX THOUSAND EIGHT HUNDRED TWO OF THE EDUCATION LAW. 9. "UNRESTRICTED GRANT" MEANS ANY GIFT, PAYMENT, SUBSIDY, OR OTHER ECONOMIC BENEFIT TO AN EDUCATIONAL INSTITUTION, PROFESSIONAL ASSOCI- ATION, HEALTH CARE FACILITY, OR GOVERNMENTAL ENTITY WHICH DOES NOT IMPOSE ANY RESTRICTIONS ON THE USE OF THE GRANT, SUCH AS FAVORABLE TREATMENT OF A CERTAIN PRODUCT OR AN ABILITY OF THE MARKETER TO CONTROL OR INFLUENCE THE PLANNING, CONTENT, OR EXECUTION OF THE EDUCATION ACTIV- ITY. S 266-B. DISCLOSURE REQUIREMENTS. 1. ANY PHARMACEUTICAL DRUG MANUFAC- TURER OR PHARMACEUTICAL DRUG WHOLESALER, INCLUDING ANY EMPLOYEE OR AGENT OF SUCH MANUFACTURER OR WHOLESALER, THAT MAKES ANY GIFT WHETHER IN THE FORM OF MONEY, SERVICE, LOAN, TRAVEL, ENTERTAINMENT, HOSPITALITY, THING OR PROMISE, OR IN ANY OTHER FORM, TO A HEALTH CARE PROVIDER SHALL REPORT THE GIFT TO THE COMMISSIONER IN THE MANNER SET FORTH IN SUBDIVISION TWO OF THIS SECTION. 2. ANY PHARMACEUTICAL DRUG MANUFACTURER OR PHARMACEUTICAL DRUG WHOLE- SALER WHO MAKES AT LEAST ONE GIFT UNDER SUBDIVISION ONE OF THIS SECTION SHALL FILE WITH THE COMMISSIONER AN ANNUAL REPORT, DUE NO LATER THAN JUNE FIRST OF EACH YEAR, BEGINNING IN TWO THOUSAND THIRTEEN, OF ALL GIFTS MADE BY THE MANUFACTURER OR WHOLESALER TO HEALTH CARE PROVIDERS. 3. SUCH ANNUAL REPORT SHALL CONTAIN: (A) THE NAME, ADDRESS AND TELE- PHONE NUMBER OF THE PHARMACEUTICAL DRUG MANUFACTURER OR WHOLESALER; (B) AN ITEMIZED LIST CONTAINING A DESCRIPTION OF EACH GIFT FALLING UNDER SUBDIVISION ONE OF THIS SECTION AND THE NAME, ADDRESS AND TELEPHONE NUMBER OF THE HEALTH CARE PROVIDER WHO RECEIVED EACH GIFT; (C) THE MONE- TARY VALUE OF EACH GIFT; AND (D) SUCH OTHER INFORMATION AS DEEMED NECES- SARY BY THE COMMISSIONER FOR COMPLIANCE WITH THIS ARTICLE. 4. THE FOLLOWING SHALL BE EXEMPT FROM DISCLOSURE:
(A) THE PAYMENT OF REASONABLE COMPENSATION AND REIMBURSEMENT OF EXPENSES IN CONNECTION WITH BONA FIDE CLINICAL TRIALS; (B) ANY GIFT THE VALUE OF WHICH IS LESS THAN SEVENTY-FIVE DOLLARS; (C) SCHOLARSHIP OR OTHER SUPPORT FOR MEDICAL STUDENTS, RESIDENTS AND FELLOWS TO ATTEND A SIGNIFICANT EDUCATIONAL, SCIENTIFIC, OR POLICY-MAK- ING CONFERENCE OF A NATIONAL, REGIONAL, OR SPECIALTY MEDICAL OR OTHER PROFESSIONAL ASSOCIATION IF THE RECIPIENT OF THE SCHOLARSHIP OR OTHER SUPPORT IS SELECTED BY THE ASSOCIATION; (D) UNRESTRICTED GRANTS FOR CONTINUING MEDICAL EDUCATION PROGRAMS; (E) PRESCRIPTION DRUG REBATES AND DISCOUNTS; AND (F) FREE SAMPLES OF DRUGS. S 266-C. ANNUAL CONSUMER GUIDE ON PHARMACEUTICAL DRUG MANUFACTURER AND WHOLESALER GIFTS TO HEALTH CARE PROVIDERS. 1. NO LATER THAN SEPTEMBER FIRST OF EACH YEAR, BEGINNING IN TWO THOUSAND THIRTEEN, THE COMMISSIONER SHALL PUBLISH AND MAKE AVAILABLE, FREE OF CHARGE TO THE PUBLIC, A CONSUMER GUIDE ON GIFTS PROVIDED BY PHARMACEUTICAL DRUG MANUFACTURERS AND WHOLESALERS TO HEALTH CARE PROVIDERS. SUCH GUIDE SHALL CONTAIN ALL OF THE INFORMATION PROVIDED IN THE ANNUAL REPORT REQUIRED BY SECTION TWO HUNDRED SIXTY-SIX-B OF THIS TITLE AND THE INFORMATION SHALL BE WRITTEN IN PLAIN LANGUAGE IN A CLEAR AND UNDERSTANDABLE FORMAT. 2. THE COMMISSIONER SHALL PROVIDE FOR THE ADEQUATE DISTRIBUTION AND AVAILABILITY OF THE CONSUMER GUIDE ON PHARMACEUTICAL DRUG MANUFACTURER AND WHOLESALER GIFTS TO HEALTH CARE PROVIDERS. APPROPRIATE COPIES OF S. 212 4 THE GUIDE SHALL BE TRANSMITTED TO THE OFFICE FOR THE AGING FOR DISTRIB- UTION AT EVERY OFFICE FOR THE AGING IN THE STATE, TO EVERY COUNTY OFFICE FOR THE AGING IN THE STATE AND TO THE COMMISSIONER OF EDUCATION FOR DISTRIBUTION TO EVERY PUBLIC LIBRARY IN THE STATE WHERE COPIES OF THE GUIDE SHALL BE MADE AVAILABLE FREE OF CHARGE TO THE PUBLIC. THE COMMIS- SIONER SHALL ALSO POST THE GUIDE ON THE DEPARTMENT'S INTERNET WEBSITE. S 266-D. PENALTIES. 1. THE COMMISSIONER MAY IMPOSE A CIVIL PENALTY FOR FAILURE TO FILE A TIMELY REPORT AS REQUIRED BY SECTION TWO HUNDRED SIXTY-SIX-B OF THIS TITLE IN AN AMOUNT UP TO FIFTY DOLLARS A DAY UNTIL SUCH REPORT IS FILED OR THREE THOUSAND DOLLARS, WHICHEVER IS LESS. 2. ANY PERSON WHO VIOLATES ANY OTHER PROVISION OF THIS TITLE SHALL BE SUBJECT TO A CIVIL PENALTY IN AN AMOUNT NOT TO EXCEED THREE THOUSAND DOLLARS FOR EACH VIOLATION. THE COMMISSIONER IS AUTHORIZED TO ASSESS THE CIVIL PENALTY UNDER THIS SECTION PURSUANT TO SECTION TWELVE OF THIS CHAPTER. S 266-E. RULES AND REGULATIONS. THE COMMISSIONER IS AUTHORIZED TO PROMULGATE RULES AND REGULATIONS AS DEEMED NECESSARY TO CARRY OUT AND ENFORCE THE PROVISIONS OF THIS TITLE. S 2. This act shall take effect on the first of January next succeed- ing the date on which it shall have become a law.