2018: Schweikert Effectively Voted Against Prohibiting Legislation Forming FTC Mergers From Applying To Mergers That Would "Unreasonably" Increase Drug Prices. In May 2018, Schweikert voted against a motion to recommit that would have, according to Congressional Quarterly, "prohibit[ed] provisions in the bill from applying to mergers that would unreasonably increase the costs of pharmaceutical drugs." The underlying legislation would have, also according to Congressional Quarterly, "reconcile[d] differences in anti-trust injunction standards between the Federal Trade Commission and the Justice Department." The vote was on a motion to recommit. The House rejected the motion by a vote of 193 to 220. [House Vote 176, 5/6/18; Congressional Quarterly, 5/9/18; Congressional Quarterly, 5/9/18; Congressional Actions, H.R. 5645]
2019: Schweikert Voted For Requiring Pharmacy Benefit Managers To Disclose Information Related To Drug Rebate Negotiations. In October 2019, Schweikert voted for a bill that would, according to Congressional Quarterly, "require the Health and Human Services Department to make publicly available information disclosed by pharmacy benefit managers related to the negotiation of rebates and discounts for prescription drugs. It would require prescription drug plan sponsors to implement real-time benefit tools, integrated with electronic prescribing or health record systems, that would transmit information to patients related to the price and availability of alternative prescription drugs." The vote was on a motion to suspend the rules and pass the bill. The House agreed to the motion by a vote of 403-0. [House Vote 586, 10/28/19; Congressional Quarterly, 10/28/19; Congressional Actions, H.R. 2115]
2019: Schweikert Voted Against Health Care Legislation That Was Designed To Bring More Generic Drugs To The Marketplace, Restore Funding To Promote ACA Plans, Fund States To Create Their Own State-Based ACA Exchanges, And Stop A Trump Administration Rule Increasing Eligibility For Short-Term Insurance Plans That Do Not Comply With ACA Rules, Such As Protections For Pre-Existing Conditions. In May 2019, Schweikert voted against the MORE Health Education Act. According to Congressional Quarterly, "[t]his bill includes a number of provisions intended to lower the price of prescription drugs by helping to bring generic and biosimilar drugs to market more quickly, and it seeks to bolster enrollment in Affordable Care Act marketplaces by restoring funding to promote ACA health plans and help individuals find affordable plans while also providing funding for states to establish their own state-operated health insurance marketplaces (rather than relying on the existing federal marketplace). In addition, it revokes a Trump administration rule that expands the availability of short-term health plans that don't have to comply with ACA consumer protections, such as protections for individuals with preexisting conditions." The vote was on passage. The House passed the bill by a vote of 234 to 183. [House Vote 214, 5/16/19; Congressional Quarterly, 5/10/19; Congressional Actions, H.R. 987]
The Legislation Attempts To Make It Easier For Generic Drug Makers Obtain Samples Of A Potential Drug Company; Denying Samples Is A Tactic Some Drug Makers Use To Delay Generics Coming To Market. According to Congressional Quarterly, "One tactic brand name drug companies use to delay the development of generic versions of a drug is to deny access to the drug to the company seeking to make a generic version. The FDA requires manufacturers of generic drugs to demonstrate that their version is chemically identical to the branded drug and produces the same results in patients. In order to meet these requirements, generic drug companies sometimes need as many as 5,000 samples of a drug to meet the generic drug testing requirements. The bill establishes the right of a generic drug company to bring civil action against the license holder for a brand name drug if the license holder refuses to provide sufficient quantities of the drug to the generic manufacturer on commercially reasonable, market-based terms. Under the measure, the generic drug manufacturer must demonstrate that the drug in question is not subject to Risk Evaluation and Mitigation Strategy (REMS) with elements to assure safe use (ETASU) or, if the drug is REMS with ETASU, that the generic drug company has developed its own safety protocol that has been authorized by the FDA (see below). The generic drug company must also demonstrate that it has requested to purchase samples of the drug and that the brand name company did not provided sufficient quantities of the drug on commercially reasonable, market-based terms within 31 days of receiving the request." [Congressional Quarterly, 5/10/19]
The Bill Would Prevent Brand Name And Generic Drug Makers From Entering Into "Pay For Delay" Agreements Where Brand Name Companies Pay Generic Companies Not To Bring A Generic To Market. According to Congressional Quarterly, "One way brand name drug companies try to protect their drugs is to compensate other drug companies if they delay marketing generic versions of the drug. This tactic has been called 'pay for delay' and is also known as a reverse payment agreement. Drug companies that want to sell a generic version may challenge an existing patent; the brand name drug manufacturer can then sue for patent infringement. Often the companies decide to settle: the generic company delays marketing its version and the brand name company provides compensation (the 'reverse payment') to the generic company for the delay. The terms of these agreements are confidential, known only by the Federal Trade Commission. In 2013 the Supreme Court ruled that the FTC could scrutinize these pay-for-delay agreements and the FTC has been opposing them ever since. Consequently, drug companies no longer pay their competitors to delay marketing generic versions; instead, they offer compensation in different ways. The bill prohibits brand name and generic drug manufacturers from entering into agreements under which the brand name company pays the generic company to delay the entry of a generic drug or biosimilar into the market, and it charges the FTC with enforcement --- statutorily requiring the agency to investigate agreements between drug companies. Specifically, the measure makes it unlawful for a drug patent holder and a company that wants to make a generic version of the drug to enter into an agreement or settle a patent infringement claim by having the manufacturer of the generic drug receive, directly or indirectly, anything of value from the brand name manufacturer. Generic drug companies that enter into unlawful settlements would forfeit their 180-day market exclusivity for the generic version of the drug. Manufacturers would be permitted to enter into patent settlements if the payment of the settlement does not exceed $7.5 million for reasonable litigation expenses." [Congressional Quarterly, 5/10/19]
Legislation Would Attempt To Reverse A Process Known As "Blocking" Whereby Generic Drug Companies Nearly Finish An Application, But Delay Getting FDA Approval And Bring The Drug To Market, Which Prevents Other Generic Companies From Bringing The Drug To Market. Which According to Congressional Quarterly, "In recent years generic drug companies have engaged in a practice a practice known as 'blocking,' under which a company substantially completes the application for a generic drug and gains the right to 180 days of market exclusivity --- but delays in getting final FDA approval and bringing the generic to market, which blocks other manufacturers from marketing their generic versions because the commencement and completion of the generic exclusivity period is also delayed. A company may do this because it has a deal with the brand name manufacturer to delay introduction of the generic. The bill authorizes the FDA to give final approval for the generic version of a subsequent company under certain circumstances --- at which time the 180-day exclusivity period for the initial company would begin, even if that company is not yet ready to market its generic drug, with the subsequent company eligible to market its generic once the exclusivity period concludes. Specifically, under the measure the FDA could give final approval for a subsequent application for a generic version of a brand name drug and trigger the 180-day exclusivity period for the initial generic applicant if the following four conditions are met: the subsequent application is ready for full FDA approval; at least 30 months have passed since at least one company submitted an application for a generic version of the drug; any related patent litigation has been fully resolved; and no prior applicant has yet received final FDA approval." [Congressional Quarterly, 5/10/19]
2015: Schweikert Voted Against Requiring Companies That Produce Generic Drugs To Repay The Government If The Price Grows Faster Than Inflation As Part Of The Bipartisan Budget Act Of 2015. In October 2015, Schweikert voted against requiring generic drug producers to repay the government as part of a Medicaid drug repayment program if the price of generic drug exceeds inflation. According to Congressional Quarterly, "The measure expands the Medicaid additional rebate requirement to generic drugs, applicable to rebate periods beginning one year after the date of the enactment. Under current law, single-source and innovator multiple-source drugs pay an additional rebate if the price of the drug has increased faster than inflation, but that requirement does not now apply to generic drugs. CBO estimates that these provisions would reduce spending by $1 billion over 10 years." The measure was part of the Bipartisan Budget Act of 2015, which also "would suspend the debt limit until March 15, 2017 and increase[d] the discretionary spending cap for fiscal 2016 by $50 billion and for fiscal 2017 by $30 billion, with the increases split equally between defense and non-defense spending" among other provisions." The vote was on a motion to concur in the Senate amendment with an amendment. The House agreed to the motion by a vote of 266 to 167. The Senate later passed the bill and the president later signed it into law. [House Vote 579, 10/30/15; Congressional Quarterly, 10/30/15; Congressional Quarterly, 10/27/15; Congressional Actions, H.R. 1314]
2015: Martin Shkreli Attempted To Raise Prices On Daraprim By More Than 5,000 Percent. According to Vox, "Martin Shkreli is a greedy pharmaceutical executive. He's the one who raised the price of Daraprim --- a drug used by AIDS patients to fight infections --- by more than 5,000 percent last month, before bowing to pressure on Tuesday. He's also an American hero. We should be thanking him today. Pharmaceutical companies have been buying up generic drugs, jacking up their prices, and messing up patients' lives for years. Many, many chronically ill Americans have been forced to suddenly spend their savings on medical treatment because of overnight price hikes." [Vox, 9/23/15]
Loren Adler Via Vox: Budget Deal Targeted "Daraprim-Type Malfeasance." According to Loren Adler via Vox, "'This is at least the first time in recent history' that a budget deal has sought to cap generic drug prices, says Loren Adler, the CRFB's research director. 'And [it] very directly targets Daraprim-type malfeasance.'" [Vox, 11/2/15]
2021: Schweikert Voted Against Directing The Department Of Health And Human Services To Negotiate Lower Prescription Prices For Insulin And Certain Medicare-Eligible Drugs That Lack Generic Competition. In November 2021, Schweikert voted against the Build Back Better act which would, according to Congressional Quarterly, "require the Health and Human Services Department to negotiate a 'maximum fair price' for insulin and select Medicare-eligible, brand-name drugs that do not have generic competition." The vote was on passage. The House passed the bill by a vote of 220-213. [House Vote 385, 11/19/21; Congressional Quarterly, 11/19/21; Congressional Actions, H.R. 5376]
2021: Schweikert Effectively Voted Against A Manager's Amendment To The Build Back Better Act, Which Would Clarify That Negotiated Prescription Drug Prices Would Apply Nine Years After A Drug's Approval And Specify That Average Price Estimations Would Be Based On 2021 Prices. In November 2021, Schweikert voted against the adoption of the rule which would, according to Congressional Quarterly, "modify provisions related to maximum fair prices negotiations for prescription drugs, including to clarify that negotiated prices would apply nine years after a drug's approval, or 13 years after approval for biologics, and specify that average price calculations would be based on 2021 prices." The vote was on the adoption of the rule. The House adopted the rule by a vote of 221-213, thus the manager's amendment was automatically adopted. [House Vote 372, 11/6/21; Congressional Quarterly, 11/6/21; Congressional Actions, H.R. 5376; Congressional Actions, H.Res. 774]
2021: Schweikert Effectively Voted Against A Manager's Amendment To The Build Back Better Act, Which Would Clarify That Negotiated Prescription Drug Prices Would Apply Nine Years After A Drug's Approval And Specify That Average Price Estimations Would Be Based On 2021 Prices. In November 2021, Schweikert voted against the motion to order the previous question on the rule which would, according to Congressional Quarterly, "modify provisions related to maximum fair prices negotiations for prescription drugs, including to clarify that negotiated prices would apply nine years after a drug's approval, or 13 years after approval for biologics, and specify that average price calculations would be based on 2021 prices." The vote was on a motion to order the previous question. The House agreed to the motion by a vote of 221-213. [House Vote 371, 11/6/21; Congressional Quarterly, 11/6/21; Congressional Actions, H.R. 5376; Congressional Actions, H.Res. 774]
2021: Schweikert Voted For Requiring The Food And Drug Administration To Take Applications And Designate Five Higher Institutions As National Centers Of Excellence In Advanced And Continuous Pharmaceutical Manufacturing, And Providing $100 Million Through FY 2026 To Support Activities. In October 2021, Schweikert effectively voted for the National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2021 which would, according to Congressional Quarterly, "require the Food and Drug Administration, within a year of enactment, to solicit applications for and designate up to five institutions of higher education as National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing to support the research, development and implementation of advanced and continuous pharmaceutical manufacturing; develop related new technologies and information-sharing networks; and collaborate with the FDA to publish reports on and develop best practices for continuous manufacturing. It would authorize $100 million through fiscal 2026 for such activities." The vote was on passage. The House passed the bill by a vote of 368-56. [House Vote 318, 10/19/21; Congressional Quarterly, 10/19/21; Congressional Actions, H.R. 4369]
2019: Schweikert Voted Against The House Drug Price Negotiation Bill For Medicare Programs. In December 2019, Schweikert voted against a motion that would, according to Congressional Quarterly, "allow the Health and Human Services Department to negotiate prices for certain drugs under Medicare programs and would make a number of modifications to Medicare programs related to drug costs and plan benefits." The vote was on passage. The House passed the bill by a vote of 230-192. [House Vote 682, 12/12/19; Congressional Quarterly, 12/12/19; Congressional Actions, H.R.3]
The Bill Allowed HHS To Negotiate The Prices Of Prescription Drugs Covered By Medicare And Penalize Companies That Don't Comply. According to Vox, "Under current law, the Health and Human Services secretary is barred from engaging in negotiations for prescription drugs covered by Medicare [...] The final bill enables the HHS secretary to negotiate the prices of as many as 250 drugs annually. Additionally, it would penalize companies that do not negotiate with HHS with a fine starting at 65 percent of a drug's gross sales from the prior year. For every quarter that the company does not engage, the penalty goes up by 10 percentage points, until it hits 95 percent of a drug's gross sales." [Vox, 12/12/19]
The Bill Required Drugmakers To Issue Rebates To The Treasury If They Raise The Prices For Medicare Drugs Faster Than The Rate Of Inflation. According to Vox, "The proposal would also address pricing hikes that have been applied to different drugs covered by Medicare Parts B and D, requiring companies to either undo any increases that surpass the rate of inflation, or rebate the entirety of those hikes since 2016 to the Treasury. An amendment from Jayapal would also make sure that people covered by private plans could obtain rebates as well. Additionally, the bill would cap out-of-pocket prescription drugs costs for those covered by Medicare Part D to $2,000 annually. Currently, there is no cap." [Vox, 12/12/19]
CBO Estimated That The Bill Would Decrease Medicare Spending By Around $500 Billion Over The Next Decade. According to Congressional Quarterly, "The Congressional Budget Office estimates the bill would save the government around $500 billion over a decade, most of which the bill would spend on lowering cost-sharing for seniors in Medicare's drug benefit and expanding Medicare coverage to include dental, vision and hearing." [Congressional Quarterly, 12/12/19]
Republicans Opposed The Bill, Arguing That It Was The Beginning Of Nationalizing The Pharmaceutical Industry. According to Congressional Quarterly, "'The speaker wants to take us down the road of nationalizing an entire industry and impose Washington's stifling influence on the life sciences sector that produces lifesaving cures,' McConnell said." [Congressional Quarterly, 12/12/19]
CBO Estimated The Bill Would Result In 38 Fewer Drugs In The Next 20 Years. According to Congressional Quarterly, "The CBO estimated that the bill would result in approximately 38 fewer drugs over two decades because of the loss of pharmaceutical industry revenues from lower prices." [Congressional Quarterly, 12/12/19]
The Bill Was Unlikely To Be Taken Up In The Republican-Controlled Senate. According to Vox, "The Senate is expected to give the bill the same treatment it's given hundreds of others: it won't take it up. Because of this dynamic, the bill is widely seen as a values statement for Democrats seeking to put a stake in the ground." [Vox, 12/12/19]
The Bill Included Other Provisions That Increased Funding For NIH Research And Allowed HHS To Require Prices Be Included In Prescription Drug Advertisements. According to Congressional Quarterly, "Establish a $100 million grant program through fiscal 2025 at the National Institutes of Health to better enable the commercialization of products developed through government research [...] allow HHS to implement requirements to include prices in prescription drug advertisements [...] [and] increase funding for an NIH program that helps fund medical trials, and prohibit pharmacy benefit managers from charging state Medicaid programs more than the prices the benefit manager paid for the drugs." [Congressional Quarterly, 12/12/19]
2019: Schweikert Effectively Voted For Ensuring That The Drug Price Negotiation Bill Would Not Result In Fewer New Drugs In The Future. In December 2019, Schweikert voted for a motion that would, according to Congressional Quarterly, "recommit the Elijah E. Cummings Lower Drug Costs Now Act (HR 3) to the House Energy and Commerce Committee with instructions to report it back immediately with an amendment that would prohibit the provisions of the bill from going into effect unless the Health and Human Services Department certifies that the implementation of such provisions is not projected to result in fewer new drug applications in relation to unmet medical needs and potential cures." The vote was on a motion to recommit. The House rejected the motion by a vote of 196-226. [House Vote 681, 12/12/19; Congressional Quarterly, 12/12/19; Congressional Actions, H.R.3]
2019: Schweikert Voted For A GOP Substitute Amendment To The Lower Drug Costs Now Act. In December 2019, Schweikert voted for a substitute amendment that would, according to Congressional Quarterly, "make a number of modifications to payments and pricing structures under Medicare Parts B and D and Medicaid, including to place a $3,100 annual out-of-pocket cap on costs for Medicare Part D beneficiaries and to require insurance companies to establish a monthly post-deductible cap of $50 on insulin for Part D beneficiaries, starting in 2022. It would establish or modify a number of requirements related to availability of drug pricing information, payment systems, and availability of refunds from drug manufacturers. It would make a number of modifications to FDA regulations related to biosimilar drug products and generic drug exclusivity. It would expedite or simplify certain procedures for the approval and market entry of generic drugs, and it would prohibit generic and brand-name drug manufacturers from entering into agreements in which brand-name manufacturers pay to delay entry of a generic drug into the market. It would require Health and Human Services Department to establish a requirement that direct-to-consumer television advertisements for Medicare- or Medicaid-eligible prescription drugs or biological products include truthful information indicating the list price of the drug or product advertised. It would also reduce from 10% to 7.5% the threshold for medical expense tax deductions to allow taxpayers to deduct medical expenses exceeding 7.5% of their adjusted gross income." The vote was on adoption of a substitute amendment. The House rejected the amendment by a vote of 201-223. [House Vote 676, 12/12/19; Congressional Quarterly, 12/12/19; Congressional Actions, H.Amdt.711; Congressional Actions, H.R.3]
2021: Schweikert Voted Against Extending Requirements For Drugs To Qualify As An "Orphan Drug," Which Would Direct Drug Manufacturers To Demonstrate That There Is No Reasonable Expectation That The Sponsor Will Recover The Costs For The Development And Distribution Of The Drug In The U.S. In May 2021, Schweikert voted against the Fairness in Orphan Drug Exclusivity Act of 2021 which would, according to Congressional Quarterly, "extend certain requirements for drugs to qualify for 'orphan drug' status, which provides incentives for the development of drugs to treat rare diseases or conditions. Specifically, it would require drug manufacturers that are seeking or have previously received orphan drug status approval for a drug -- including approval to extend an existing status -- to demonstrate to the Health and Human Services Department that, at the time of approval, there is or was 'no reasonable expectation' that the manufacturer would recover the costs of developing and distributing the drug in the United States from U.S. sales within 12 years of first marketing the drug. It would require the department to deny or revoke such approval if a manufacturer does not meet the requirements." The vote was on passage. The House failed to pass the bill by a vote of 250-168, failing to meet 2/3 of the vote, but eventually was passed on May 19th, 2021 by a vote of 402-23. The Senate did not take substantive action on the bill. [House Vote 134, 5/11/21; Congressional Quarterly, 5/11/21; Congressional Actions, H.R. 1629]
2016: Schweikert Effectively Voted Against Exempting Mergers That Could Increase The Price Of Drugs "Unreasonably" From Rules Forcing The FTC To Comply By The Same Rules As The DOJ For Anti-Trust Cases. In March 2016, Schweikert voted against a motion to recommit that would have, according to Congressional Quarterly, "exempt[ed] mergers that would 'unreasonably' increase the cost of pharmaceutical drugs from the bill." The underlying legislation would have, also according to Congressional Quarterly, "require[d] the Federal Trade Commission (FTC) to comply with the same procedures as the Department of Justice under the Clayton Act (PL 63-212) for cases of antitrust laws that could 'substantially lessen competition' or 'tend to create a monopoly.'" The vote was on a motion to recommit. The House rejected the motion by a vote of 174 to 235. [House Vote 136, 3/23/16; Congressional Quarterly, 3/23/16; Congressional Quarterly, 3/23/16; Congressional Actions, H.R. 2745]
2021: Schweikert Voted Against Requiring Drug Manufacturers To Provide Rebates For Single-Source Drugs Under Medicare Parts B And D, And Cap Annual Out-Of-Pocket Limits At $2,000 Starting In 2024 For Medicare Part D. In November 2021, Schweikert voted against the Build Back Better act which would, according to Congressional Quarterly, "require manufacturers to provide rebates for single-source drugs under Medicare Parts B and D for which prices increase faster than inflation. For Medicare Part D, it would cap annual out-of-pocket limit at $2,000 beginning in 2024." The vote was on passage. The House passed the bill by a vote of 220-213. [House Vote 385, 11/19/21; Congressional Quarterly, 11/19/21; Congressional Actions, H.R. 5376]