Policy Tracker

The DPL Policy Tracker keeps tabs on federal policy proposals that address US drug pricing issues. To begin, select filter options.

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Accountability and Oversight

Allow government to regulate/require disclosure of patient assistance

[Improving Access to Affordable Prescription Drugs Act; Introduced 03/29/2017] Require independent charity assistance programs to disclose to the IRS the total amount of patient assistance provided to patients who are prescribed drugs manufactured by any contributor to the independent charity assistance program.

[Fair Care Act of 2020; Introduced 10/05/2020] Allow the Secretary of HHS to establish a mechanism to regulate drug manufacturers' financial contributions to patient out-of-pocket costs, such as copays.

Ensure 340B program is providing care for the low-income patients it is intended to serve

[U.S. Budget FY 2019; Introduced 02/12/2018] Modify the 340B drug discount program to reward hospitals that provide significant charity care and reducing payment through the program to hospitals that provide little charity care.

[Fair Care Act of 2020; Introduced 10/05/2020] Require DSH hopsital covered entities to report on low-income utilization rates of outpatient hospital services under 340B.

[Closing Loopholes for Orphan Drugs Act; Introduced 02/04/2021] Revise the 340B drug discount program to exclude discounting orphan drugs that are not being used to treat rare conditions.

Ensure biosimilars cannot be paid more than their reference biologic product

[Lower Costs, More Cures Act of 2019; Introduced 12/09/2019] Ensure biosimilars cannot be paid more than their reference product during the initial period.

[Lower Costs, More Cures Act of 2021; Introduced 04/21/2021] Limit the payment amount for biosimilars during the initial period.

Establish drug pricing review board/committee

[Prescription Drug and Medical Device Price Review Board Act of 2018; Introduced 05/09/2018] Establish an Interagency Drug and Device Price Review Board to collect data on drug and device prices and manufacturing costs, and if necessary, take enforcement action against manufacturers that charge consumers excessive prices.

[Prescription Drug and Medical Device Price Review Board Act of 2018; Introduced 05/09/2018] Establish a Medical Device Price Review Board under the Department of Health and Human Services to regulate the prices of qualifying prescription drugs and medical devices. The Board will require manufacturers to report the price charged and the costs to produce and market the drug and the board can prescribe a formula to determine whether the average manufacturer price is an excessive price and the manufacturer will be prohibited against charging that excessive price.

[We Protect American Investment in Drugs Act; Introduced 07/31/2019] Establish contract with National Academy of Medicine to study drug manufacturers' justifications for drug prices and develop framework for determining fairness of prices. Establish nonprofit corporation known as the Drug Affordability and Access Committee.

[Prescription Drug Affordability and Access Act; Introduced 01/08/2020] Establish an independent bureau within HHS devoted to obtaining lower prescription drug costs for patients, decrease government spending on such drugs, and ensure adequate access. Bureau will regularly conduct reviews of prescription drug prices including certain price increases.

Establish evidence based measures of quality

[Prescription Drug Pricing Reduction Act of 2020; Introduced 07/02/2020] Establish evidence-based measures of pharmacy quality to ensure that the incentive payments or price concessions that are paid by a pharmacy to a PDP sponsor for covered part D drugs focus on aspects of patient health outcomes that the pharmacy has an impact on.

[Lower Costs, More Cures Act of 2021; Introduced 04/21/2021] Establish pharmacy quality measures under part D.

[Elijah E. Cummings Lower Drug Costs Now Act; Introduced 04/22/2021] Establish pharmacy quality measures under part D.

[Medicare Prescription Drug Savings and Choice Act of 2019; Introduced 10/21/2019] Establish role of AHRQ to assess the clinical benefit of covered Part D drugs and make recommendations to the Secretary regarding negotiated prices of covered drugs.

Health Plan Transparency

[PBM Transparency in Prescription Drug Costs Act; Introduced 12/04/2019] Amend title XXVII of the Public Health Service Act to require health plan oversight. Prohibit a group health plan or PBM from entering into a contract with a manufacturer, distributor, wholesaler, or any other third party that limits the disclosure of information for production of reports that increase transparency.

[Prescription Drug Pricing Reduction Act of 2020; Introduced 07/02/2020] Requires the reporting of any potential fraud, waste, and abuse to the Secretary of Health and Human Services by Prescription Drug or Medicare Advantage Prescription Drug plans.

[A bill to increase transparency and access to group health plan and health insurance issuer reporting, and for other purposes.; Introduced 12/21/2020] Require all group insurance plans or insurers (excluding Church Plans) to report information on the past year's pharmacy benefits and drug costs to the Secretary of Labor and the Secretary of the Treasury.

[Lower Costs, More Cures Act of 2021; Introduced 04/21/2021] Require PDPs and MA-PD plans to report fraud, waste, and abuse to HHS.

Limit influence of branded manufacturers on patient decision-making

[Responsibility in Drug Advertising Act of 2016; Introduced 02/12/2016] Amend the Federal Food, Drug, and Cosmetic Act to restrict direct-to-consumer drug advertising.

[Protecting Americans from Drug Marketing Act; Introduced 03/03/2016] Amend the Internal Revenue Code to deny a tax deduction for the cost of direct-to-consumer advertising of prescription drugs.

Manufacturer Transparency

[Prescription Drug Affordability Act of 2015; Introduced 09/10/2015] Require drug companies to report not only the price information charged to federal payers, but also requires companies to submit prices, profits, and sale information in other countries in which those products are sold.

[Prescription Drug Affordability Act of 2015; Introduced 09/10/2015] Require pharmaceutical companies to publicly report information that affects drug pricing, including the total costs incurred for research and development and clinical trials, as well as the portion of drug development expenses offset by tax credits or paid by federal grants.

[Fair Accountability and Innovative Research Drug Pricing Act of 2017; Introduced 05/16/2017] Require manufacturers to notify HHS and submit a report 30 days before raising price of certain products by more than 10%. The report should contain justification and costs for manufacturing, R&D, along with net profits, and marketing and advertising.

[Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017; Introduced 06/13/2017] Amend title XI of the Social Security Act to require drug manufacturers to submit justification of drug price increases within 60 days of determination of applicability of rule.

[Improving Access To Affordable Prescription Drugs Act; Introduced 03/29/2017] Require the HHS Office of the Inspector General (HHS OIG) to monitor changes in drug prices and take steps to prevent drug manufacturers from engaging in price gouging. If price of a drug increases beyond medical inflation, the manufacturer would be subject to a graduated excise tax that depends on the size of the price increase, with prior assessment of the extent to which the price increase was due to changes in a drug’s supply chain or for other justifiable reasons.

[Improving Access To Affordable Prescription Drugs Act; Introduced 03/29/2017] Require drug manufacturers to disclose costs of research, development, manufacturing, marketing, and acquisitions, as well as federal investments, revenues and sales, and other factors that influence drug prices, by product, to the Secretary of the Department of Health and Human Services (HHS), to be made publicly available in a searchable format.

[Preserve Access to Affordable Generics Act; Introduced 01/12/2017] Require brand name manufacturers and generic manufacturers to submit to the Federal Trade Commission any other agreements the parties enter into within 30 days of entering into an agreement related to the manufacturing, marketing, sale, or exclusivity period of a drug.

[U.S. Budget FY 2019; Introduced 02/12/2018] Require manufacturers to better report ASP for accurate payment rates.

[CURE High Drug Prices Act; 12/13/2018] Allows the Secretary of HHS to notify a manufacturer of its potential price gouging and require a justification of the increase.

[Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019; Introduced 02/13/2019] Amend title XI of the Social Security Act to require drug manufacturers that increase their wholesale cost beyond a certain threshold to submit a written justification of that increase to CMS. This justification will be summarized and published on the CMS website. Manufacturers that do not abide by this bill will be fined.

[Right Rebate Act of 2019; Introduced 01/24/2019] Amend the Social Security Act to stop the misclassifications of drugs that are a part of the Medicaid drug rebate program.

[Affordable Medications Act; Introduced 09/05/2018] Propose to increase transparency by requiring drug manufacturers to submit reports outlining the revenue and incurred cost of a drug.

[Drug-price Transparency in Communications (DTC) Act; Introduced 05/13/2019] Amend title XI of the Social Security Act to require direct-to-consumer advertisements for prescription drugs and biologicals to include truthful and non-misleading pricing information.

[More Efficient Tools to Realize Information for Consumers Act; Introduced 04/12/2019] Amend Title III of the Public Health Service Act to require manufacturers to justify certain drug price increases. Report for justification required when qualifying drug increases 10 percent or more within a single calendar year or 25 percent or more within three consecutive calendar years.

[More Efficient Tools to Realize Information for Consumers Act; Introduced 04/12/2019] Amend the Social Security Act to require prescription drug marketing sample information reported by manufacturers to be available to oversight agencies, researchers, and payers.

[Prescription Drug Price Reporting Act; Introduced 05/23/2019] Require manufacturers to report a prescription drug price's wholesale acquisition cost, average net price, and rebates to health insurance plans or PBMs with respect to covered individuals.

[Prescription Drug STAR Act; Introduced 04/08/2019] Amend titles XI and XVIII of the Social Security Act to require manufacturers to justify certain drug price increases. Publicly disclose discounts and price concessions passed through to plan sponsors on the HHS website. Require certain manufacturers to report drug pricing information related to drugs covered under the Medicare program.

[Empowering States to Address Drug Costs Act; Introduced 07/24/2019] Amend title XIX of the Social Security Act to review AMP, best price, and rebate calculation data to establish State all-payer prescription drug rate setting entities or State multi-payer purchasing tools.

[The Prescription Drug Pricing Reduction Act (PDPRA) of
2019; Introduced 07/25/2019] Require manufacturers that do not have a Medicaid drug rebate agreement to report ASP information to the HHS to help establish Medicare payment rates.

[The Prescription Drug Pricing Reduction Act (PDPRA) of
2019; Introduced 07/25/2019] Amend the Social Security Act to require manufacturers to report to HHS information and supporting documentation needed to justify price increases for prescription drugs and biological products as measured by wholesale acquisition cost (WAC) or changes in WAC that exceed certain thresholds.

[The Prescription Drug Pricing Reduction Act (PDPRA) of
2019; Introduced 07/25/2019] Amend the Social Security Act to require HHS Secretary to audit price and drug product information reported by manufacturers to ensure accuracy and timeliness. Allow Secretary to impose civil monetary penalties on wholesalers, manufacturers, or direct sellers if entities refuse to provide pricing information.

[CURE High Drug Prices Act; Introduced 08/02/2019] Allow the Secretary of HHS to notify a manufacturer of its potential price gouging and require a justification of the increase.

[Prescription Drug Price Reporting Act; Introduced 11/21/2019] Require manufacturers to report on each drug marketed in the U.S. their current wholesale acquisition cost, average wholesale acquisition cost during the previous calendar year, average net price, as well as total rebates during the previous calendar year or time that the drug has been marketed. Require manufacturers to report increases or decreases in wholesale acquisition cost of a prescription drug no later than 30 days before the price change takes effect.

[Lower Costs, More Cures Act of 2019; Introduced 12/09/2019] Require manufacturers to report drug pricing information with respect to drugs under Medicare. Require HHS to report on accuracy of ASP information submitted by manufacturers to Congress.

[Lower Costs, More Cures Act of 2019; Introduced 12/09/2019] Ensure the accuracy of the manufacturer price and product information under Medicaid by conducting audits and surveys.

[Lower Costs, More Cures Act of 2019; Introduced 12/09/2019] Require manufacturers to justify certain drug price increases.

[Prescription Drug Pricing Reduction Act of 2020; Introduced 07/02/2020] Improvement of manufacturer reporting of ASP in order to set more accurate payment rates.

[Matt's Act; Introduced 07/29/2021] Require manufacturers of insulin drugs to publish the average net price of each insulin product on a quarterly basis.

[Prescription Drug Pricing Reduction Act of 2020; Introduced 07/02/2020] Require drug manufacturer price transparency for drugs with a large price increase, high spending, or high launch price (for new drugs).

[Fair Accountability and Innovative Research Drug Pricing Act of 2021; Introduced 03/23/2021] Require manufacturers to report on justification for certain drug price increases.

[Lower Costs, More Cures Act of 2021, Introduced 04/21/2021] Require manufacturers to report on justification of certain drug price increases.

[Lower Costs, More Cures Act of 2021, Introduced 04/21/2021] Make prescription drug marketing sample information available to oversight agencies, researchers, payers, and the public.

[Lower Costs, More Cures Act of 2021, Introduced 04/21/2021] Conduct audits and surveys of manufacturer price and drug product information under the Medicaid Drug Rebate Program.

[Elijah E. Cummings Lower Drug Costs Now Act; Introduced 04/22/2021] Require manufacturers to justify to HHS certain drug price increases.

PBM Transparency

[Prescription Drug Price Transparency Act; Introduced 02/07/2019] Establish standards for pharmacy benefits manager under the Medicare prescription drug program and Medicare Advantage program to further transparency of payment methodologies to pharmacies, and for other purposes.

[More Efficient Tools to Realize Information for Consumers Act; Introduced 04/12/2019] Amend the Social Security Act to make publicly available PBMs' ability to negotiate rebates, discounts, remuneration fees, administrative fees, and price concessions as well as the amounts passed on to plan sponsors.

[Public Disclosure of Drug Discounts and Real-Time Beneficiary Drug Cost Act; Introduced 04/08/2019] Amend titIes XI and XVIII of the Social Security Act to require public disclosure of rebates, discounts, remuneration fees, administrative fees, and price concessions and the amounts passed through to plan sponsors.

[Creating Transparency to Have Drug Rebates Unlocked (C–THRU) Act of 2019; Introduced 02/13/2019] Amend titles XI and XVIII of the Social Security Act to increase transparency of discounts provided by drug manufacturers by publicly disclosing PBMs' ability to negotiate rebates, discounts, and price concessions and the amounts passed through to plan sponsors.

[Phair Relief Act of 2019; Introduced 07/24/2019] Amend titles XI and XVIII of the Social Security Act to make PBMs' ability to negotiate rebates, discounts, and price concessions as well as their amounts publicly available through the HHS website.

[The Prescription Drug Pricing Reduction Act (PDPRA) of
2019; Introduced 07/25/2019] Require HHS to publicly report information on aggregate price concessions, difference between what insurer pays PBM and what PBM pays pharmacies, and number of prescriptions dispensed while still preventing disclosure of price concessions for specific plans or drugs. Require Part D insurers to conduct financial audits of data related to their PBM contracts. Require Part D insurers to report to pharmacies' post-point-of-sales adjustments for price concessions or incentive payments for covered Part D drugs. Require Part D insurers to report actual and projected direct and indirect remuneration amounts in bids for Part D coverage.

[Prescription Drug Pricing Reduction Act of 2020; Introduced 07/02/2020] Establishes audits of PBM managers and data

[Prescription Drug Pricing Reduction Act of 2020; Introduced 07/02/2020] Strengthen pharmacy benefit managers’ transparency requirements. 

[Prescription Drug Pricing Reduction Act of 2020; Introduced 07/02/2020] Requires disclosure of pharmacy price concessions for covered part D drugs

Provide evidence of clinical superiority to receive financial rewards

[Improving Access To Affordable Prescription Drugs Act; Introduced 03/29/2017] Add a requirement that products awarded the 3-year New Clinical Investigation Exclusivity must show significant clinical benefit over existing therapies manufactured by the applicant in the 5-year period preceding the submission of the application.

[Lower Costs, More Cures Act of 2019; Introduced 12/09/2019] Clarify that in order to get new exclusivities, all orphan drugs must prove clinical superiority to a previous version of the drug already on the market.

Provider Transparency

[Ensuring the Value of the 340B Program Act of 2018; Introduced 02/27/2018] Require hospitals to provide information of drug acquisition costs for 340B drugs along with information on the hospital's revenues received for such drugs.

[Prescription Drug Pricing Reduction Act of 2020; Introduced 07/02/2020] Improving claims data that is provided to prescription drug plans to encourage appropriate use of medications and improve health outcomes.

Foster Competition

Drug importation for noncompetitive markets

[Pharmaceutical Supply and Value Enhancement Act; 09/28/2016] Allow for the expedited approval and temporary importation of generic prescription drugs in the case of noncompetitive drug markets (fewer than five holders of approved applications for brand or generic versions of the drug, drug has been approved for at least 10 years, or patents on the active ingredient of a drug have expired).

[Short on Competition Act; Introduced 01/20/2017] Allow for the expedited approval and temporary importation of generic prescription drugs in the case of noncompetitive drug markets (fewer than five holders of approved applications for brand or generic versions of the drug, drug has been approved for at least 10 years, or patents on the active ingredient of a drug have expired).

[Pharmaceutical Supply and Value Enhancement Act; Introduced 09/28/2016] Allow for importation of prescription drugs in the case of noncompetitive drug markets or drug shortages.

[Executive Order on Increasing Drug Importation to Lower Prices for American Patients; Introduced 07/24/2020] Permitting the importation of prescription drugs from other countries in order to create more competition in domestic pricing and lower the cost of prescription drugs for Americans.

Ensure competitive access to drug samples

[FAST Generics Act of 2017; Introduced 04/06/2017] Amend the Federal Food, Drug, and Cosmetic Act to ensure that eligible product developers have competitive access to approved drugs and licensed biological products.

[FAST Generics Act of 2015; Introduced 06/18/2015] Amend the Federal Food, Drug, and Cosmetic Act to ensure that eligible product developers have competitive access to approved drugs and licensed biological products, so as to enable eligible product developers to develop and test new products, and for other purposes.

Incentivize generic and biosimilar entry

[Making Pharmaceutical Markets More Competitive Act; Introduced 05/11/2017] Prioritize the review of, and act within 240 calendar days of the date of the submission of, an original abbreviated new drug application submitted for review under this subsection, or on a supplement to such an application, that is for a drug for which there are not more than 3 approved drugs listed.

[Pharmaceutical Supply and Value Enhancement Act; Introduced 09/28/2016] Allow for the expedited approval and temporary importation of generic prescription drugs in the case of noncompetitive drug markets (fewer than five holders of approved applications for brand or generic versions of the drug, drug has been approved for at least 10 years, or patents on the active ingredient of a drug have expired).

[Improving Access To Affordable Prescription Drugs Act; Introduced 03/29/2017] Modify the New Chemical Entity (NCE) exclusivity period to allow generic drug application for the branded product after three years rather than five, but maintain market exclusivity for five years.

[Increasing Competition in Pharmaceuticals Act; Introduced 02/02/2017] Create a new “generic priority review voucher” that would be awarded to the sponsor of a successful application for a medical shortage or sole-source drug that makes it to market.

[SAVINGS Act; Introduced 09/22/2016] Require the FDA to expedite the review of second generics and make a final decision within 150 days of receiving these Priority Review Abbreviated New Drug Applications.

[Lower Drug Costs through Competition Act; Introduced 01/30/2017] Revise provisions for the FDA to prioritize review of generic drug applications allowing for expedited inspection.

[U.S. Budget FY 2019; Introduced 02/12/2018] Give FDA greater ability to bring generic drugs to market quicker by granting power to approve a subsequently filed generic application for 180-day exclusivity when the first-to-file is not yet approved due to deficiencies.

[President's Blueprint; Introduced 05/01/2018] Allow the FDA to publish a list of drug names that have no competitors to encourage generic competitors to enter the market and bring prices down.

[CREATES Act of 2019; Introduced 02/05/2019] Promote the competition in the drug market by facilitating the entry of lower-cost generic and biosimilar versions of drugs.

[Fair Care Act of 2019; Introduced 02/25/2019] Expedite development and priority review for generic complex drug products.

[Competition Prescription Act of 2019; Introduced 07/24/2019] Expedite development and priority review for complex generic drugs.

[BIOSIM Act; Introduced 09/20/2019] Amend title XVIII of the Social Security Act to temporarily increase payment under Medicare program for certain biosimilars to incentivize biosimilar development.

[Lower Costs, More Cures Act of 2019; Introduced 12/09/2019] Change the conditions of first generic exclusivity to spur access and competition.

[Lower Costs, More Cures Act of 2019; Introduced 12/09/2019] Streamline biosimilars approval process by providing clarity for applicants that they can include information in their application showing the proposed conditions of use have been previously approved for the reference product.

[Lower Costs, More Cures Act of 2019; Introduced 12/09/2019] Require prescription drug marketing sample information reported by manufacturers to be available to certain individuals and entities.

[Fair Care Act of 2020; Introduced 10/05/2020] Expedite development and priority review for generic complex drugs.

[Short on Competition Act; Introduced 03/23/2021] Allow for the expedited approval and temporary importation of generic prescription drugs in the case of noncompetitive drug markets (fewer than five holders of approved applications for brand or generic versions of the drug, drug has been approved for at least 10 years, or patents on the active ingredient of a drug have expired).

Incentivize use of biosimilars and generics

[FAST Generics Act of 2019; Introduced 02/05/2019] Amend the Federal Food, Drug, and Cosmetic Act to allow sponsors interested in developing generic drugs and biosimilars to have competitive access to currently approved drugs and licensed biological products.

[The Prescription Drug Pricing Reduction Act (PDPRA) of
2019; Introduced 07/05/2019] Increase add-on payment for a biosimilar under Medicare Part B from 6% of reference product's ASP to 8% for a period of five years.

[Star Rating for Biosimilars Act; Introduced 10/08/2019] Amend title XVIII of the Social Security Act to implement new set of measures in the 5-star rating system under the Medicare Advantage program to encourage increased access to biosimilar products. Measures include coverage on plan formularies, tier placement, utilization management tools, and utilization relative to the reference biological product.

[Prescription Drug Pricing Reduction Act of 2020; Introduced 07/02/2020] A temporary increase in Medicare Part B payments for biosimilars.

Limit anticompetitive behaviors by manufacturers

[FAIR Generics Act; Introduced 01/08/2015] Disqualify from being a “first applicant” (which grants 180 days of market exclusivity) any ANDA applicant (for a generic drug) that has entered into a “pay for delay” agreement.

[Preserve Access to Affordable Generics Act; Introduced 01/12/2017] Prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market.

[EPI Act; Introduced 09/28/2016] Prohibit a company that holds the patent for a brand-name pharmaceutical product from also introducing an authorized generic.

[Improving Access To Affordable Prescription Drugs Act; Introduced 03/29/2017] Make it illegal for brand-name and generic drug manufacturers to enter into agreements in which the brand-name drug manufacturer pays the generic manufacturer to keep more affordable generic equivalents off the market. Take away 180 day exclusivity period for generic manufacturers entering into such an agreement.

[Prescription Drug Affordability Act of 2015; Introduced 09/10/2015] Prohibit anti-competitive arrangements between brand and generic drug makers where the brand name drug manufacturers pays the generic manufacturer to delay bringing their generic alternative to market.

[Preserve Access to Affordable Generics Act; Introduced 01/12/2017] Authorize the Federal Trade Commission to initiate proceedings against parties to any agreement that resolves or settles a patent infringement claim in connection with the sale of a drug.

[U.S. Budget FY 2019; Introduced 02/12/2018] Discourage generic manufacturers use of their 180-day exclusivity as the first generic to prevent other generic manufacturers from entering the market. Propose to start a drug company's 180-day exclusivity clock in cases when another generic application is waiting for approval, but is blocked by the first applicant's 180-day exclusivity.

[Preserve Access to Affordable Generics and Biosimilars Act; Introduced 01/09/2019] Prohibits brand name drug companies from paying generic drug companies for delaying the entry of a generic drug in the market. Similarly, prohibits biological product manufacturers from paying biosimilar companies to delay entry of biosimilar products

[Affordable Medications Act; Introduced 09/05/2018] Introduce measures to block unfair and anticompetitive drug monopoly practices to allow for generic competitors to come to market

[Prescription Drug Price Relief Act of 2019; Introduced 01/10/2019] End government-granted monopolies for drug manufacturers who charge prices that are higher than the median price charged in other countries.

[Affordable Prescriptions for Patients Act of 2019; Introduced 05/09/2019] Amend the Federal Trade Commission Act to prohibit anticompetitive behaviors by drug manufacturers, including "product hopping."

[PACED Act; Introduced 02/12/2019] Amend title 35 to prohibit patent owners from asserting sovereign immunity as a defense before the U.S. Patent & Trademark Office to prevent the production of generics.

[Stop STALLING Act; Introduced 04/29/2019] Deter the filing of sham citizen petitions that attempt to interfere with the approval of a competing generic drug or biosimilar.

[Affordable Prescriptions for Patients Through Promoting Competition Act of 2019; Introduced 09/19/2019] Amend the Federal Trade Commission Act to prohibit anticompetitive behaviors by drug manufacturers, including "product hopping."

[Lower Costs, More Cures Act of 2019; Introduced 12/09/2019] Allow for actions against bad actors who delay generics and biosimilars coming to market by withholding drug samples.

[Lower Costs, More Cures Act of 2019; Introduced 12/09/2019] Prevent manufacturers from gaming the system by receiving additional exclusivity periods once they are deemed biologics.

[Further Consolidated Appropriations Act, 2020; Introduced 03/25/2019] Promote competition by applying limitations on branded biologic exclusivity and not granting additional exclusivity through deeming. Prevent drug manufacturers from abusing REMS and restricting generic and biosimilar competition.

[Lowering Prescription Drug Prices for America’s Seniors and Families Act of 2020; Introduced 03/03/2020] Preserve access to affordable generics and biosimilars by allowing the Commission to initiate a proceeding against agreements presumed to have anticompetitive effects.

[Fair Care Act of 2020; Introduced 10/05/2020] Prohibit agreements that would prevent generic applicants from commercial marketing upon approval.

[Fair Care Act of 2020; Introduced 10/05/2020] Prohibit civil petitions with the intent of delaying generic entry.

[Protecting Consumer Access to Generic Drugs Act of 2021; Introduced 01/04/2021] Prohibit branded manufacturers from compensating generic manufacturers for delaying the entry of a generic drug into the market, and prohibit biologic manufacturers from compensating biosimilar and interchangeable product manufacturers for delaying entry of a biosimilar or interchangeable product.

[Lower Costs, More Cures Act of 2021; Introduced 04/21/2021] Prohibit pay-for-delay agreements.

Reduce market monopoly

[Improving Access To Affordable Prescription Drugs Act; Introduced 03/29/2017] Reduce the biological product exclusivity from 12 years to 7 years.

[Improving Access To Affordable Prescription Drugs Act; Introduced 03/29/2017] Reduce the biological product exclusivity from 12 years to 7 years.

[PRICED Act; Introduced 06/23/2016] Amend the Public Health Service Act to shorten the exclusivity period for brand name biological products from 12 to 7 years.

[PRICED Act; Introduced 07/26/2018] Amend the Public Health Service Act to shorten the exclusivity period for brand name biological products from 12 to 7 years.

[Prescription Drug Price Relief Act of 2019; Introduced 01/10/2019] End government-granted monopolies in regards to manufacturers who price drugs higher than the median in other countries

[Fair Care Act of 2019; Introduced 02/25/2019] Limit exclusivity periods for drugs that treat rare diseases and conditions.

[Lowering Prescription Drug Costs and Extending Community Health Centers and Other Public Health Priorities Act; Introduced 05/14/2019] Incentivize low-cost drug options by changing the conditions of first-filer generic exclusivity to encourage competition.

[PRICED Act; Introduced 06/20/2019] Amend the Public Health Service Act to shorten exclusivity period for brand name biological products from 12 to 5 years.

[Lower Costs, More Cures Act of 2019; Introduced 12/09/2019] Limit potential for "evergreening" by restricting manufacturers from obtaining new exclusivities on previously approved clinical entities.

[To amend the Biologics Price Competition and Innovation Act of 2009 to make improvements with respect to the transition of biological products, and for other purposes.; Introduced 03/09/2020] Amend the Biologics Price Competition and Innovation Act of 2009 by listing certain insulin products as interchangeable biosimilars.

[Fair Care Act of 2020; Introduced 10/05/2020] Consolidate exclusivity periods for drugs treating rare diseases by not allowing the Secretary to approve a different applicant or issue a license for the same drug for the same disease until the original exclusivity period expires.

[Fair Care Act of 2020; Introduced 10/05/2020] Protect access to biologics by limiting additional exclusivities.

Incentivize innovation

Direct financial incentives

[Affordable Medications Act; Introduced 09/05/2018] Encourage innovation by setting aside a prize fund for the development new antibiotics and drugs

Establish a new FDA approval pathway

[Promising Pathway Act; Introduced 05/13/2021] Establishment of an approval pathway for drugs and biologics for the treatment of serious diseases and conditions. Approval pathway would provide early, short-term approval for drugs and biologics that provide substantial evidence of safety and positive therapeutic benefit. Expands the evidence requirements to allow for use of "scientifically-substantially-surrogates" or surrogate endpoints to predict clinical benefit.

[Promising Pathway Act; Introduced 05/13/2021] Provisional approval granted under the Promising Pathway can be up to a maximum of 2 years, renewable every 2 years, for up to 6 years. Full approval is granted when the drug or biologic has at least a 15% improvement in an important endpoint as compared to other therapies.

Increase price awareness throughout the supply chain

Disclosure of pricing information to beneficiaries at decision-making

[Know the Lowest Price Act of 2018; Introduced 03/14/2018] Amend the Social Security Act to ensure that health plans and pharmacy benefit managers cannot restrict pharmacies from providing individuals information on the differential price of the drug under the plan and without health-insurance coverage.

[COST Act; Introduced 07/31/2018] Amend the Public Health Service Act and Social Security Act to prevent health insurers, group health plans, Medicare Advantage organizations and prescription drug plan sponsors from restricting drug pricing information given to consumer.

[More Efficient Tools to Realize Information for Consumers Act; Introduced 04/12/2019] Amend the Social Security Act to require prescription drug plan sponsors to include real-time benefit information as part of the sponsor's electronic prescription program under Medicare. Information should include clinically-appropriate alternatives to drugs in formulary, cost-sharing information, and applicable utilization management requirements.

[Public Disclosure of Drug Discounts and Real-Time Beneficiary Drug Cost Act; Introduced 04/08/2019] Require prescription drug plan sponsors to include real-time benefit information as part of sponsor's electronic prescription program under Medicare.

[Transparent Drug Pricing Act of 2019; Introduced 04/01/2019] Amend the Social Security Act to require disclosure of drug prices at point of sale, including customer's out-of-pocket cost in context of current health plan a well as cost without using any health plan. HHS required to make this information publicly available through a database that allows consumers to subscribe to price change notifications for prescription drugs.

[The Prescription Drug Pricing Reduction Act (PDPRA) of
2019; Introduced 07/25/2019] Modify transparency tool provision to require comparable information for services that can also be furnished in a physician office.

[The Prescription Drug Pricing Reduction Act (PDPRA) of
2019; Introduced 07/25/2019] Require Part D insurers to provide for a "real-time benefit tool (RTBT)" that enables electronic transmission formulary and benefit information to each enrollee's prescribing clinician.

[Lower Costs, More Cures Act of 2019; Introduced 12/09/2019] Require prescription drug plan sponsors to include real-time benefit information as part of sponsor's electronic prescription program under Medicare.

[Lowest Price for Patients Act; Introduced 12/16/2019] Amend title XXVII of the Public Health Service Act and title XVIII of the Social Security Act to require pharmacies to disclose any differential between the cost of a prescription drug based on whether certain individuals use prescription drug coverage to acquire the drug.

[Prescription Drug Pricing Reduction Act of 2020; Introduced 07/02/2020] Requiring Medicare Advantage Organizations and Prescription Drug Plans to increase the use of real-time benefit information and tools for prescribers by incorporating such tools into electronic health record systems.

Public disclosure of pricing information

[Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017; Introduced 03/15/2017] Amend titles XI and XVIII of the Social Security Act to provide public disclosure of information on rebates, discounts, and price concessions with respect to an individual drug or an individual plan on the HHS website. To allow patients and employers to compare PBMs negotiating capacity.

[Improving Access To Affordable Prescription Drugs Act; Introduced 03/29/2017] Require drug manufacturers to disclose costs of research, development, manufacturing, marketing, and acquisitions, as well as federal investments, revenues and sales, and other factors that influence drug prices, by product, to the Secretary of the Department of Health and Human Services (HHS), to be made publicly available in a searchable format.

[Drug-Price Transparency in Communications Act; Introduced 11/16/2017] Require drug manufacturers to disclose the prices of prescription drugs in any direct-to-consumer advertising and marketing to practitioners of a drug.

[Transparent Health Care Pricing Act of 2018; Introduced 01/16/2018] Require entities that offer or furnish health care related products or services to the public to disclose the price for those products and services at the point of purchase or on the internet. The entities must disclose all prices, including wholesale, retail and discounted prices that are accepted as payment in full for products and services furnished to individual consumers.

[Drug-Price Transparency in Communications Act; Introduced 07/26/2018] Require drug manufacturers to include prescription drug prices on any DTC advertising and any marketing to practitioners of a drug.

[Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017; Introduced 03/15/2017] Allow patients and employers to compare PBMs' ability to negotiate rebates, discounts, and price concessions passed through to plan sponsors by making this information publicly available on the internet.

[Lower Costs, More Cures Act of 2019; Introduced 12/09/2019] Require public disclosure of drug discounts on the internet in order to allow comparison of PBMs' ability to negotiate rebates, discounts, remuneration fees, concessions, etc.

[Lower Costs, More Cures Act of 2019; Introduced 12/09/2019] Codify recent HHS regulations to require pharmaceutical companies to list prices of their prescription drugs in direct-to-consumer advertisements.

[Transparency in Prescription Drug Advertising Act; Introduced 02/13/2020] Urge the Secretary of HHS to require the list prices of drugs to be included in advertisements.

[Transparency and Accountability in Health Care Costs and Prices Act of 2020; Introduced 02/27/2020] Amend title XXVII of the Public Health Service Act to require the Secretary of Health and Human Services to establish a grant program facilitating State efforts to establish or maintain an all-payer claims databases (APCD) in order to increase transparency. APCD data allows for users to track trends in health care prices, check price and quality, and aid employers and health plans in making informed decisions when developing health plans.

[Prescription Drug Pricing Reduction Act of 2020; Introduced 07/02/2020] Make PBM provisions and drug discounts available on the internet in order to allow patients and employers to compare PBMs' ability to negotiate rebates, discounts concessions, etc.

[Prescription Drug Pricing Reduction Act of 2020; Introduced 07/02/2020] Establish prescription drug pricing dashboards to be publicly available on the internet for beneficiaries, clinicians, researchers, and the public to view information on utilization and spending on prescription drugs and biologics covered under Medicare parts B, D, and Medicaid. 

[Prescription Drug Pricing Reduction Act of 2020; Introduced 07/02/2020] Increasing the transparency of the Medicare website by expanding the information published to include the amount paid to the physician for an item or service and the estimated amount of that the beneficiary pays for the item or service.

[Prescription Drug Pricing Reduction Act of 2020; Introduced 07/02/2020] Requires that the results of remuneration reports be disclosed to the public online for all prescription drug plans.

[Lower Costs, More Cures Act of 2021; Introduced 04/21/2020] Require public disclosure of drug discounts to allow comparison of PBMS' ability to negotiate rebates, discounts, remuneration fees, etc.

[Lower Costs, More Cures Act of 2021; Introduced 04/21/2020] Require that DTC advertisements for drugs and biologics include truthful pricing information.

Limit Price Inflation

Adjusting payments for inflation

[Competition Prescription Act of 2019; Introduced 07/24/2019] Allow Secretary of HHS to alter payments for prescription drugs provided through Medicare Part B by paying rates that are adjusted for inflation.

Implement inflation cap

[U.S. Budget FY 2019; Introduced 02/12/2018] Propose an inflation limit for reimbursement of Medicare Part B drugs.

[CURE High Drug Prices Act; Introduced 12/13/2018] Prohibit the gouging of drug prices by setting limit in drug price increase of a certain percent or more within a time period.

Impose a financial disincentive on manufacturers for drug prices that are increasing faster than inflation. Examples include excise taxes and rebates.

[Stop Price Gouging Act; Introduced 02/07/2019] Impose an excise tax on pharmaceutical companies that sell prescription drugs subject to price spikes that exceed rates of inflation.

[Protecting Medicare from Excessive Price Increases Act of 2018; Introduced 03/01/2018] Amends the Social Security Act to require drug manufacturers to pay a Medicare part B rebate for qualifying drugs if the price of the drug increases faster than inflation.

[CURE High Drug Prices Act; Introduced 12/13/2018] In the event that drug prices increase beyond the listed percentage or more within a certain time period, the Secretary has the power to restore any excessive amount paid from the price increase to the consumer.

[Stop Price Gouging Act; Introduced 02/07/2019] Subject pharmaceutical companies to an excise tax if drug prices exceed the annual percentage increase in the Chained Consumer Price Index.

[Stop Drug Companies from Overcharging Seniors in Medicare Part B Act of 2019; Introduced 07/10/2019] Amend title XVIII of the Social Security Act to require manufacturers to provide rebates for drugs covered under Medicare Part B if growth in average sales price exceeds inflation.

[The Prescription Drug Pricing Reduction Act (PDPRA) of
2019; Introduced 07/25/2019] Require drug manufacturers to pay a rebate to Medicare for the amount their Part B drugs increase above the rate of inflation.

[The Prescription Drug Pricing Reduction Act (PDPRA) of
2019; Introduced 07/25/2019] Establish a mandatory rebate if a pharmaceutical manufacturer increases their list price for certain covered Part D drugs above inflation.

[CURE High Drug Prices Act; Introduced 08/02/2019] Grant the Secretary the power to also restore any excessive amount paid from the price increase to the consumer or the payer.

[Elijah E. Cummings Lower Drug Costs Now Act; Introduced 04/22/2021] Enact inflation rebate if drug company has raised the price of a drug in Medicare Part B or D above rate of inflation since 2016.

[Pharmaceutical REPAI Act; Introduced 10/08/2019] Amend title XVIII of the Social Security Act to require drug manufacturers to pay a Medicare Part D rebate for certain drugs if the price increases above the rate of inflation.

[Prescription Drug Pricing Reduction Act of 2020; Introduced 07/02/2020] Establishment of Medicare Part B rebates for drugs and biologics with prices that are increasing faster than inflation.

[Prescription Drug Pricing Reduction Act of 2020; Introduced 07/02/2020] Amendment to the Social Security Act that requires manufacturer rebates for Medicare Part D drugs with prices that are increasing faster than inflation.

[Elijah E. Cummings Lower Drug Costs Now Act; Introduced 04/22/2021] Enact Medicare part B rebate for drugs with prices increasing faster than the rate of inflation.

[Elijah E. Cummings Lower Drug Costs Now Act; Introduced 04/22/2021] Enact Medicare part D rebate for drugs with prices increasing faster than the rate of inflation.

[Prescription Drug Affordability Act of 2015; Introduced 09/10/2015] Require generic drug manufacturers to pay an additional rebate to Medicaid if their drug prices rise faster than inflation, mirroring the current requirements for brand name drug makers.

Reduce period of exclusivity

[FLAT Prices Act; Introduced 02/06/2019] Reduce the period of exclusivity of prescription drugs if there is an increase in the wholesale acquisition cost beyond a set threshold.

Reduce costs and improve access for patients

Allow for the importation of FDA-approved drugs from other countries

[Improving Access To Affordable Prescription Drugs Act; Introduced 03/29/2017] Allow wholesalers, licensed U.S. pharmacies, and individuals to import qualifying prescription drugs manufactured at FDA-inspected facilities from licensed Canadian sellers and, after two years, from OECD countries that meet standards comparable to U.S. standards. Imported drugs must have the same active ingredient, route of administration, and strength as drugs approved in the U.S., and the Secretary has suspension authority when sellers do not meet standards.

[Prescription Drug Affordability Act of 2015; Introduced 09/10/2015] Allow individuals, pharmacists, and wholesalers to import prescription drugs from licensed Canadian pharmacies.

[Safe and Affordable Drugs from Canada Act of 2017; Introduced 01/009/2017] Amend the Federal Food, Drug, and Cosmetic Act to allow personal importation of safe and affordable drugs from approved pharmacies in Canada.

[Affordable and Safe Prescription Drug Importation Act; Introduced 02/28/2017] Introduce regulation that allows wholesalers, pharmacies, and individuals to import prescription drugs from a list of certified foreign sellers, published on a dedicated website, and permit importation from OECD countries with standards for approval and sale of prescription drugs comparable to those in the United States.

[Affordable and Safe Prescription Drug Importation Act; Introduced 02/28/2017] Allow individual importation of qualifying prescription drugs from Canada or another licensed foreign pharmacy.

[Personal Drug Importation Fairness Act of 2017; Introduced 02/07/2017] Allow importation by persons other than a drug's manufacturer if the drug has the same active ingredients, route of administration, and strength as an approved drug, is imported or re-imported from a qualified country in which it is lawfully marketed, is dispensed by a licensed pharmacist, is shipped directly to, or is imported by, the ultimate consumer, in quantities that do not exceed a 90-day supply, is accompanied by a copy of a valid prescription, and is not a controlled substance.