(a) "Drug" has the meaning given that term in ORS 689.005.
(b) "Health care facility" has the meaning given that term in ORS 442.015.
(c) "Health care service contractor" has the meaning given that term in ORS 750.005.
(d)(A) "Manufacture" means:
(i) The production, preparation, propagation, compounding, conversion or processing of a drug, either directly or indirectly by extraction from substances of natural origin or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis; and
(ii) The packaging or repackaging of a drug or labeling or relabeling of a drug container.
(B) "Manufacture" does not include the preparation or compounding of a drug by an individual for the individual’s own use or the preparation, compounding, packaging or labeling of a drug:
(i) By a health care practitioner incidental to administering or dispensing a drug in the course of professional practice;
(ii) By a health care practitioner or at the practitioner’s authorization and supervision for the purpose of or incidental to research, teaching or chemical analysis activities and not for sale;
(iii) By a health care service contractor for dispensing to a subscriber or delivery to a health care facility or outpatient clinic owned or operated by the health care service contractor or an affiliate of the health care service contractor;
(iv) By a centralized repackaging operation for distribution to subscribers of health care service contractors or to pharmacies, health care facilities or outpatient clinics operated by or affiliated with a health care service contractor; or
(v) By a health care facility for dispensing to a patient or other person.
(e) "Manufacturer" means a person that manufactures a prescription drug that is sold in this state.
(f) "New prescription drug" has the meaning prescribed by the Department of Consumer and Business Services by rule.
(g) "Patient assistance program" means a program that a manufacturer offers to the general public in which a consumer may reduce the consumer’s out-of-pocket costs for prescription drugs by using coupons or discount cards, receiving copayment assistance or by other means.
(h) "Prescription drug" means a drug that must:
(A) Under federal law, be labeled "Caution: Federal law prohibits dispensing without prescription" prior to being dispensed or delivered; or
(B) Under any applicable federal or state law or regulation, be dispensed only by prescription or restricted to use only by health care practitioners.
(i) "Price" means the wholesale acquisition cost as defined in 42 U.S.C. 1395w-3a(c)(6)(B).
(2) No later than March 15 of each year, a manufacturer shall report the information described in subsection (3) of this section to the department regarding each prescription drug for which:
(a) The price was $100 or more for a one-month supply or for a course of treatment lasting less than one month; and
(b) There was a net increase of 10 percent or more in the price of the prescription drug described in paragraph (a) of this subsection over the course of the previous calendar year.
(3) For each prescription drug described in subsection (2) of this section, a manufacturer shall report to the department, in the form and manner prescribed by the department:
(a) The name and price of the prescription drug and the net increase, expressed as a percentage, in the price of the drug over the course of the previous calendar year;
(b) The length of time the prescription drug has been on the market;
(c) The factors that contributed to the price increase;
(d) The name of any generic version of the prescription drug available on the market;
(e) The research and development costs associated with the prescription drug that were paid using public funds;
(f) The direct costs incurred by the manufacturer:
(A) To manufacture the prescription drug;
(B) To market the prescription drug;
(C) To distribute the prescription drug; and
(D) For ongoing safety and effectiveness research associated with the prescription drug;
(g) The total sales revenue for the prescription drug during the previous calendar year;
(h) The manufacturer’s profit attributable to the prescription drug during the previous calendar year;
(i) The introductory price of the prescription drug when it was approved for marketing by the United States Food and Drug Administration and the net yearly increase, by calendar year, in the price of the prescription drug during the previous five years;
(j) The 10 highest prices paid for the prescription drug during the previous calendar year in any country other than the United States;
(k) Any other information that the manufacturer deems relevant to the price increase described in subsection (2)(b) of this section; and
(L) The documentation necessary to support the information reported under this subsection.
(4) The department may use any prescription drug price information the department deems appropriate to verify that manufacturers have properly reported price increases as required by subsections (2) and (3) of this section.
(5) A manufacturer shall accompany the report provided under subsection (2) of this section with the following information about each patient assistance program offered by the manufacturer to consumers residing in this state for the prescription drugs described in subsection (2) of this section:
(a) The number of consumers who participated in the program;
(b) The total value of the coupons, discounts, copayment assistance or other reduction in costs provided to consumers in this state who participated in the program;
(c) For each drug, the number of refills that qualify for the program, if applicable;
(d) If the program expires after a specified period of time, the period of time that the program is available to each consumer; and
(e) The eligibility criteria for the program and how eligibility is verified for accuracy.
(6) No later than 30 days after a manufacturer introduces a new prescription drug for sale in the United States at a price that exceeds the threshold established by the Centers for Medicare and Medicaid Services for specialty drugs in the Medicare Part D program, the manufacturer shall notify the department, in the form and manner prescribed by the department, of all the following information:
(a) A description of the marketing used in the introduction of the new prescription drug;
(b) The methodology used to establish the price of the new prescription drug;
(c) Whether the United States Food and Drug Administration granted the new prescription drug a breakthrough therapy designation or a priority review;
(d) If the new prescription drug was not developed by the manufacturer, the date of and the price paid for acquisition of the new prescription drug by the manufacturer;
(e) The manufacturer’s estimate of the average number of patients who will be prescribed the new prescription drug each month; and
(f) The research and development costs associated with the new prescription drug that were paid using public funds.
(7)(a) After receiving the report or information described in subsections (2), (3), (5) or (6) of this section, the department may make a written request to the manufacturer for supporting documentation or additional information concerning the report. The department shall prescribe by rule the periods:
(A) Following the receipt of the report or information during which the department may request additional information; and
(B) Following a request by the department for additional information during which a manufacturer may respond to the request.
(b) The department may extend the period prescribed under paragraph (a)(B) of this subsection, as necessary, on a case-by-case basis.
(8) A manufacturer may be subject to a civil penalty, as provided in ORS 646A.692, for:
(a) Failing to submit timely reports or notices as required by this section;
(b) Failing to provide information required under this section;
(c) Failing to respond in a timely manner to a written request by the department for additional information under subsection (7) of this section; or
(d) Providing inaccurate or incomplete information under this section.
(9) Except as provided in subsection (10) of this section, the department shall post to its website all of the following information:
(a) A list of the prescription drugs reported under subsection (2) of this section and the manufacturers of those prescription drugs;
(b) Information reported to the department under subsections (3) and (5) to (7) of this section; and
(c) Written requests by the department for additional information under subsection (7) of this section.
(10)(a) The department may not post to its website any information described in subsection (9) of this section if:
(A) The information is conditionally exempt from disclosure under ORS 192.345 as a trade secret; and
(B) The public interest does not require disclosure of the information.
(b) If the department withholds any information from public disclosure pursuant to this subsection, the department shall post to its website a report describing the nature of the information and the department’s basis for withholding the information from disclosure.
(c) A person may petition the Attorney General, as provided in ORS 192.411, to review a decision by the department to withhold information pursuant to paragraph (a) of this subsection.
(11) In accordance with ORS 646A.694, the department shall provide to the Prescription Drug Affordability Board established in ORS 646A.693:
(a) Each calendar quarter, a list of prescription drugs included in reports submitted under subsections (2) and (6) of this section; and
(b) Access to pricing information submitted to the department under subsections (3), (6) and (7) of this section.
(12) The department shall make available to consumers, online and by telephone, a process for consumers to notify the department about an increase in the price of a prescription drug.
(13) The department may adopt rules as necessary for carrying out the provisions of this section, including but not limited to rules establishing fees to be paid by manufacturers to be used solely to pay the costs of the department in carrying out the provisions of this section.
(14) No later than December 15 of each year, the department shall compile and report the information collected by the department under this section to the interim committees of the Legislative Assembly related to health. The report shall include recommendations for legislative changes, if any, to contain the cost of prescription drugs and reduce the impact of price increases on consumers, the Department of Corrections, the Public Employees’ Benefit Board, the Oregon Health Authority, the Department of Human Services, the Oregon Educators Benefit Board and health insurance premiums in the commercial market. [2018 c.7 §2; 2018 c.7 §§6,7; 2021 c.598 §8]
Note: Section 7, chapter 598, Oregon Laws 2021, provides:
Sec. 7. (1) The Prescription Drug Affordability Board shall study the entire prescription drug distribution and payment system in this state and polices adopted by other states and countries that are designed to lower the list price of prescription drugs including but not limited to the following options:
(a) Establishing upper payment limits for all financial transactions in this state involving a drug and specifying the methodology used to determine the upper payment limit that does not undermine the viability of any part of the prescription drug supply chain;
(b) Using a reverse auction marketplace for the purchase of prescription drugs by state and local governments; and
(c) Implementing a bulk purchasing process for state and local governments to purchase prescription drugs.
(2) No later than December 31, 2022, the board shall complete the study described in subsection (1) of this section and report to the interim committees of the Legislative Assembly related to health in the manner provided in ORS 192.245:
(a) The board’s findings including findings for each option described in subsection (1) of this section; and
(b) Recommendations for policies to lower the list prices of prescription drugs sold in this state and for legislative changes necessary to implement the policies. [2021 c.598 §7]
Structure 2021 Oregon Revised Statutes
Volume : 16 - Trade Practices, Labor and Employment
Chapter 646A - Trade Regulation
Section 646A.030 - Definitions for ORS 646A.030 to 646A.042.
Section 646A.032 - Price list for health spa services.
Section 646A.034 - Contracts; contents.
Section 646A.038 - Moneys paid prior to facility opening; disposition; priority of claim; refund.
Section 646A.050 - Definitions.
Section 646A.052 - Form of purchase agreement.
Section 646A.060 - Purchase of used goods; records; application to pawnbrokers.
Section 646A.064 - Definitions for ORS 646A.064 to 646A.067.
Section 646A.066 - Applicability to local ordinances.
Section 646A.068 - Penalty for violating ORS 646A.065.
Section 646A.070 - Sale of telephonic equipment; disclosure requirements; enforcement; penalty.
Section 646A.072 - Exceptions to disclosure requirements.
Section 646A.075 - Required information prior to purchase of dog.
Section 646A.080 - Sale of novelty item containing mercury; penalty.
Section 646A.081 - Prohibition on sale or installation of mercury vapor outdoor lighting fixtures.
Section 646A.092 - Advertisements for sale or lease of motor vehicle; exceptions.
Section 646A.100 - Definitions for ORS 646A.100 to 646A.110.
Section 646A.104 - Information required in notice of intent.
Section 646A.108 - Prohibited conduct.
Section 646A.110 - Applicability of ORS 646A.100 to 646A.110 and 646A.112.
Section 646A.112 - Injunction of sham sale; evidence; attorney fees; defense; definitions.
Section 646A.120 - Definitions for ORS 646A.120 to 646A.134.
Section 646A.122 - Applicability of ORS 646A.120 to 646A.134.
Section 646A.124 - General disclosure requirements.
Section 646A.126 - Specific disclosure requirements.
Section 646A.128 - Provisions prohibited in lease-purchase agreements.
Section 646A.130 - Reinstatement of lease-purchase agreement by consumer; receipt for each payment.
Section 646A.132 - Renegotiation or extension of lease-purchase agreement.
Section 646A.134 - Disclosures required in advertisement for lease-purchase agreements.
Section 646A.140 - Definitions for ORS 646A.140 and 646A.142.
Section 646A.142 - Rental vehicle collision damage waiver notice.
Section 646A.150 - Applicability of ORS 646A.150 to 646A.172.
Section 646A.152 - Definitions for ORS 646A.150 to 646A.172.
Section 646A.156 - Required contents of service contracts.
Section 646A.158 - Prohibited conduct.
Section 646A.164 - Complaints and investigations confidential; exceptions.
Section 646A.166 - Refusal to continue or suspension or revocation of registration.
Section 646A.168 - Assessment fee; rules; purpose; registration fee.
Section 646A.172 - Rules; exemption of certain obligors.
Section 646A.200 - Definitions for ORS 646A.202 and 646A.204.
Section 646A.204 - Customer information.
Section 646A.214 - Verification of identity in credit or debit card transactions.
Section 646A.220 - Credit card solicitation; required disclosure; definitions.
Section 646A.222 - Charge card solicitation; required disclosure; definitions.
Section 646A.230 - Action by Attorney General or district attorney; civil and criminal penalties.
Section 646A.274 - Definitions for ORS 646A.276 and 646A.278.
Section 646A.278 - Requirements for sale of gift card that expires.
Section 646A.280 - Definitions for ORS 646A.280 to 646A.290.
Section 646A.282 - Simulated invoices prohibited.
Section 646A.284 - Cause of action by Attorney General; judgment; attorney fees.
Section 646A.286 - Cause of action by private party; judgment; attorney fees.
Section 646A.288 - Presumptions in cause of action brought under ORS 646A.284 or 646A.286.
Section 646A.290 - Construction; other remedies.
Section 646A.293 - Definitions for ORS 646A.293 and 646A.295.
Section 646A.295 - Prohibited actions; requirements; timing; failure to obtain consent; exceptions.
Section 646A.300 - Definitions for ORS 646A.300 to 646A.322.
Section 646A.306 - Repurchase of inventory by supplier; effect of new retailer agreement.
Section 646A.308 - Civil action for supplier’s failure to pay; venue.
Section 646A.310 - Prohibited conduct by supplier.
Section 646A.314 - New or relocated dealership; notice; area of responsibility.
Section 646A.316 - Warranty claims; payment; time for completion.
Section 646A.318 - Warranty claims; processing.
Section 646A.320 - Retailer’s improvements to products.
Section 646A.322 - Remedies; arbitration; cause of action; attorney fees; injunctive relief.
Section 646A.340 - Definitions for ORS 646A.340 to 646A.348.
Section 646A.342 - Prohibited conduct; required verifications and notice.
Section 646A.344 - Bond or letter of credit; action; exceptions.
Section 646A.360 - Unsolicited facsimile machine transmissions.
Section 646A.370 - Definitions for ORS 646A.370 to 646A.374.
Section 646A.372 - Limits on usage of automatic dialing and announcing device.
Section 646A.374 - Prohibited actions.
Section 646A.400 - Definitions for ORS 646A.400 to 646A.418.
Section 646A.402 - Availability of remedy.
Section 646A.404 - Consumer’s remedies; manufacturer’s affirmative defenses.
Section 646A.414 - Limitations on actions against dealers.
Section 646A.416 - Limitation on commencement of action.
Section 646A.430 - Definitions for ORS 646A.430 to 646A.450.
Section 646A.432 - Applicability of ORS 646A.430 to 646A.450; applicability of other law.
Section 646A.434 - Sale of vehicle protection product; conditions and requirements.
Section 646A.436 - Warrantor registration; requirements; expiration; fees; rules.
Section 646A.438 - Reimbursement insurance; requirements; insurer qualifications.
Section 646A.440 - Required provisions of reimbursement insurance policy; cancellation; notice.
Section 646A.444 - Recordkeeping requirements for warrantor; record retention.
Section 646A.446 - Prohibited conduct for warrantor.
Section 646A.448 - Prohibited activities.
Section 646A.450 - Rules; investigative powers of department.
Section 646A.460 - Definitions for ORS 646A.460 to 646A.476.
Section 646A.462 - Express warranty; duration.
Section 646A.464 - Repair of assistive device.
Section 646A.466 - Replacement or refund after attempt to repair.
Section 646A.468 - Procedures for replacement or refund.
Section 646A.470 - Sale or lease of returned assistive device.
Section 646A.472 - Dispute resolution.
Section 646A.476 - Civil action for damages; attorney fees; limitation on actions.
Section 646A.480 - Definitions for ORS 646A.480 to 646A.495.
Section 646A.482 - Estimate required before beginning work; contents; evaluation.
Section 646A.490 - Additional prohibited actions; reassembly required; copies.
Section 646A.495 - Owner designee; waiver of authorization requirement.
Section 646A.500 - Legislative findings; declaration of purpose.
Section 646A.504 - Definitions for ORS 646A.500 to 646A.514.
Section 646A.506 - Prohibited conduct.
Section 646A.510 - Exemptions.
Section 646A.525 - Definitions for ORS 646A.525 to 646A.535.
Section 646A.540 - Definitions; labeling and packaging requirements; preemption.
Section 646A.542 - Requirement to document compliance.
Section 646A.544 - Local government enforcement; notice required; penalties.
Section 646A.560 - Legislative findings.
Section 646A.562 - Definitions for ORS 646A.560 to 646A.566.
Section 646A.564 - Standards for mercury content in electric lamps; exceptions.
Section 646A.575 - Definitions for ORS 646A.575 to 646A.590.
Section 646A.577 - Limited license required; application; fee; renewal; prohibited representations.
Section 646A.582 - Written disclosure requirements.
Section 646A.585 - Exceptions to license requirement; prohibited representations; acts of employees.
Section 646A.592 - Enforcement.
Section 646A.602 - Definitions for ORS 646A.600 to 646A.628.
Section 646A.606 - Security freeze; requirements; proof of authority; effect.
Section 646A.610 - Fees not permitted.
Section 646A.612 - Conditions for lifting or removing security freeze.
Section 646A.614 - Effect of security freeze on use of consumer reports or protective records.
Section 646A.624 - Powers of director; penalties.
Section 646A.628 - Allocation of moneys.
Section 646A.640 - Definitions.
Section 646A.643 - License requirement to engage in debt buying; exemptions.
Section 646A.652 - Required notices.
Section 646A.655 - Compliance with director’s standards; rules.
Section 646A.658 - Prohibited practices.
Section 646A.664 - Enforcement actions; penalties.
Section 646A.667 - Preemption.
Section 646A.683 - Requirement to report increase in drug price; exemptions.
Section 646A.692 - Civil penalty.
Section 646A.695 - Annual fees assessed against drug manufacturers; rules.
Section 646A.702 - Definitions for ORS 646A.702 to 646A.720.
Section 646A.705 - Persons that are not foreclosure consultants.
Section 646A.710 - Foreclosure consulting contract; requirements; void provisions.
Section 646A.720 - Prohibited acts of foreclosure consultant.
Section 646A.725 - Definitions for ORS 646A.725 to 646A.750.
Section 646A.730 - Persons that are not equity purchasers.
Section 646A.735 - Written contract; requirements; void provisions; power of attorney prohibited.
Section 646A.745 - Required and prohibited acts.
Section 646A.755 - Acts not precluded.
Section 646A.770 - Definitions.
Section 646A.773 - Applicability of Insurance Code; statement of costs; exemptions.
Section 646A.781 - Cancellation and expiration; refunds; effect of sale, assignment or transfer.
Section 646A.784 - Reimbursement insurance policies for guaranteed asset protection waivers.
Section 646A.787 - Fiduciary responsibilities.
Section 646A.800 - Late fees on delinquent cable service accounts; amount; disclosure; notice.
Section 646A.808 - Obtaining personal information by false representation via electronic media.
Section 646A.813 - Security requirements for Internet-connected devices; exemptions; penalty.