2018: Fitzpatrick Effectively Voted Against Prohibiting Legislation
Forming FTC Mergers From Applying To Mergers That Would "Unreasonably"
Increase Drug Prices. In May 2018, Fitzpatrick 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: Fitzpatrick Voted For Requiring Pharmacy Benefit Managers To
Disclose Information Related To Drug Rebate Negotiations. In October
2019, Fitzpatrick 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: Fitzpatrick Voted For 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, Fitzpatrick
voted for 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]
2021: Fitzpatrick 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, Fitzpatrick 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: Fitzpatrick 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, Fitzpatrick 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: Fitzpatrick 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, Fitzpatrick 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: Fitzpatrick 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, Fitzpatrick 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: Fitzpatrick Voted For The House Drug Price Negotiation Bill For
Medicare Programs. In December 2019, Fitzpatrick voted for 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: Fitzpatrick Effectively Voted For Ensuring That The Drug Price
Negotiation Bill Would Not Result In Fewer New Drugs In The Future. In
December 2019, Fitzpatrick 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: Fitzpatrick Voted For A GOP Substitute Amendment To The Lower
Drug Costs Now Act. In December 2019, Fitzpatrick 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: Fitzpatrick Voted To Extend 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, Fitzpatrick voted for 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]
2021: Fitzpatrick 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, Fitzpatrick 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]