[Congressional Record Volume 171, Number 14 (Thursday, January 23, 2025)]
[Senate]
[Pages S336-S338]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
By Mr. DURBIN (for himself, Mr. Grassley, Mr. King, Ms. Ernst,
Ms. Smith, Mr. Welch, Mr. Blumenthal, Ms. Baldwin, and Mr.
Tuberville):
S. 229. A bill to amend title XI of the Social Security Act to
require that direct-to-consumer advertisements for prescription drugs
and biological products include an appropriate disclosure of pricing
information; to the Committee on Finance.
Mr. DURBIN. Mr. President, as President Trump begins his second term,
I am concerned about his immigration policy, pardons for violent
insurrectionists of January 6, and the grifters seeping into the White
House. In each of these areas, I am prepared to fight with every tool
at my disposal to stop abuses that harm Americans.
But I also believe we must find areas of agreement where we can, and
one of those areas could be addressing the astronomical cost of
prescription drugs, a real-life issue facing American families.
Thankfully, last week, President Biden announced 15 new drugs that
Medicare will now bargain for, to lower prices for seniors across the
America. Remember, those savings are only possible because of the
passage of the Inflation Reduction Act, which did not receive a single
Republican vote.
There is more work to do though. On average, patients in the United
States of America pay four times more--four times more--than people in
similar countries for the exact same drugs. What is going on here? A
drug is made in America and sold at four times the cost in America as
is charged by the same companies overseas.
Why is the United States such an outlier? One reason is advertising.
Have you noticed any ads for drugs on television lately? If you
haven't, you don't have a TV. The United States is one of only two
industrialized countries in the world that allows pharmaceutical
companies to advertise on television. What is the other country that
allows this? New Zealand--the United States and New Zealand.
You know these ads I am talking about--catchy jingles, flashy images;
patients rock climbing, swimming, dancing. Big Pharma spends--get this
now--$6 billion every year to flood the airwaves about the latest
wonder drug. Why do they spend so darn much money on drug ads? Because
it increases their profits. Big Pharma thinks, if they can pummel you
with enough ads, not only will you be able to spell Xarelto, but you
will be able to tell your doctor this is the blood thinner you have
been waiting for.
Don't take my word for it. Here is what the American Medical
Association says about these ads we are inundated with every single
darn day on our televisions:
Direct-to-consumer advertising inflates demand for new and
expensive drugs, even when these drugs may not be
appropriate.
So when President Biden announced a list of 15 drugs that will be
negotiated for discounts, I imagined most Americans already recognized
many of their names: Ozempic, Trelegy, Ibrance, and Otezla.
Manufacturers spend hundreds of millions of dollars encouraging you
to just ``ask your doctor'' about these drugs. The result? Medicare
spent $22 billion last year on those very same four drugs that were
heavily advertised medications.
A recent headline in the New York Times read:
Robert F. Kennedy Jr. Wants to Ban Drug Ads on TV. It
Wouldn't Be Easy.
It discussed the First Amendment challenges Pharma would raise as a
result of that.
While I have strong concerns with President Trump's health nominee, I
am glad this administration wants to join me to tackle these
promotional ads. We already have an incredible strategy on the table.
For the last 8 or 9 years, I have introduced bipartisan legislation
to crack down on these drug ads on TV and other places. Senator Chuck
Grassley, Republican of Iowa, has been my partner.
When you turn on the evening news--get this--one-third of all
commercial time is for prescription drugs. Do you think you are seeing
a lot of ads? One-third of all commercial time is for prescription
drugs.
Try to avoid it, if you wish. But the average American sees nine drug
ads a day. I will bet it is more. It seems like more.
With billions in targeted spending, patients are bombarded with
information. All of this information is being tossed at you, most of it
at a mile-a-minute gibberish. But they do keep in the darkness one
important factor: They never mention the cost, the price of the drug.
In 2023, Illinois company AbbVie spent $315 million on TV ads for
Rinvoq. I have an ad here. Rinvoq is an eczema and arthritis drugs.
However, in the commercial, they don't tell you one thing. The cost of
this drug is $6,100 per month. My staff just corrected me before I came
to the floor and said: You missed the latest increase. It is now up to
$6,400 a month for Rinvoq.
Hang on. I am sure you will see one of those ads in no time at all.
Senator Grassley and I think it is time to end the big secrecy on the
cost of these drugs. If they are going to advertise it and rattle off
gibberish--I love the one that says: Don't take Otezla if you are
allergic to Otezla.
That never would have dawned on me. That is part of their ad.
If you are looking at the ads and hearing the gibberish they throw at
us, they tell you everything under God's green Earth, except a basic
honest issue: How much does it cost?
That is why today we are introducing bipartisan legislation to
require price disclosures in direct-to-consumer drug ads.
Our plan is simple. It actually passed the Senate once before, in
2018, and 88 percent of the American people support this kind of
disclosure. In fact, after we worked to advance this measure, Donald
Trump, then President of the United States, said this, and I want to
make sure the quote is accurate. This is from his first term in office:
Big announcement today: Drug companies have to come clean
about their prices in TV ads. Historic transparency for
American patients is here. If drug companies are ashamed of
those prices--lower them!
I may disagree with the President on many things, but I certainly
agree with this statement there.
Big Pharma hates being honest with patients about the true prices of
their drugs. They fear it might cut into their colossal historic
profits. With the support of President Trump and Senator Grassley, I
believe this will be the year we finally pass bipartisan legislation to
bring sunshine to these ads and to actually lower health costs.
Mr. DURBIN. Mr. President, I ask unanimous consent that the text of
the bill be printed in the Record.
There being no objection, the text of the bill was ordered to be
printed in the Record as follows:
S. 229
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Drug-price Transparency for
Consumers Act of 2025'' or the ``DTC Act of 2025''.
SEC. 2. FINDINGS; SENSE OF THE SENATE.
(a) Findings.--Congress finds the following:
(1) Direct-to-consumer advertising of prescription
pharmaceuticals is legally permitted in only 2 developed
countries, the United States and New Zealand.
(2) In 2018, pharmaceutical ad spending exceeded
$6,046,000,000, a 4.8 percent increase over 2017, resulting
in the average American seeing 9 drug advertisements per day.
(3) The most commonly advertised medication in the United
States in 2020 had a list price of more than $6,000 for a
one-month supply.
(4) A 2021 Government Accountability Office report found
that two-thirds of all direct-to-consumer drug advertising
between 2016 and 2018 was concentrated among 39 brand-name
drugs or biologicals, about half of which were recently
approved by the Food and Drug Administration.
(5) According to a 2011 Congressional Budget Office report,
pharmaceutical manufacturers advertise their products
directly to consumers in an attempt to boost demand for their
products and thereby raise the price that consumers are
willing to pay, increase the quantity of drugs sold, or
achieve some combination of the two.
(6) Studies, including a 2012 systematic review published
in the Annual Review of Public Health, a 2005 randomized
trial published in the Journal of the American Medical
Association, and a 2004 survey published in Health Affairs,
show that patients are more likely to ask their doctor for a
specific medication, and the doctor is more likely to write
[[Page S338]]
a prescription for it, if a patient has seen an advertisement
for such medication, even if such medication is not the most
clinically appropriate for the patient or if a lower cost
generic medication may be available.
(7) According to a 2011 Congressional Budget Office report,
the average number of prescriptions written for newly
approved brand-name drugs with direct-to-consumer advertising
was 9 times greater than the average number of prescriptions
written for newly approved brand-name drugs without direct-
to-consumer advertising.
(8) The Centers for Medicare & Medicaid Services is the
single largest drug payer in the United States. Between 2016
and 2018, 58 percent of the $560,000,000,000 in Medicare drug
spending was for advertised drugs, and in 2018 alone, the 20
most advertised drugs on television cost Medicare and
Medicaid a combined $34,000,000,000.
(9) A 2021 Government Accountability Office report found
that direct-to-consumer advertising may have contributed to
increases in Medicare beneficiary use and spending among
certain drugs.
(10) The American Medical Association has passed
resolutions supporting the requirement for price transparency
in any direct-to-consumer advertising, stating that such
advertisements on their own ``inflate demand for new and more
expensive drugs, even when these drugs may not be
appropriate''.
(11) A 2019 study published in the Journal of the American
Medical Association found that health care consumers
dramatically underestimate their out-of-pocket costs for
certain expensive medications, but once they learn the
wholesale acquisition cost (in this section referred to as
the ``WAC'') of the product, they are far better able to
approximate their out-of-pocket costs.
(12) Approximately half of Americans have high-deductible
health plans, under which they often pay the list price of a
drug until their insurance deductible is met. All of the top
Medicare prescription drug plans use coinsurance rather than
fixed-dollar copayments for medications on nonpreferred drug
tiers, exposing beneficiaries to WAC prices.
(13) Section 119 of division CC of the Consolidated
Appropriations Act, 2021 (Public Law 116-260) requires the
Secretary of Health and Human Services to increase the use of
real-time benefit tools to lower beneficiary costs. However,
there still remains a lack of available pricing tools, so
patients may not learn of their medication's cost until after
being given a prescription for the medication. A 2013 study
published in The Oncologist found that one-quarter of all
cancer patients chose not to fill a prescription due to cost.
(14) The Federal Government already exercises its authority
to oversee certain aspects of direct-to-consumer drug
advertising, including required disclosures of information
related to side effects, contraindications, and
effectiveness.
(b) Sense of Congress.--It is the sense of Congress that--
(1) a lack of transparency in pricing for pharmaceuticals
has led to a lack of competition for such pharmaceuticals, as
evidenced by a finding by the Department of Health and Human
Services that ``Consumers of pharmaceuticals are currently
missing information that consumers of other products can more
readily access, namely the list price of the product, which
acts as a point of comparison when judging the reasonableness
of prices offered for potential substitute products'' (84
Fed. Reg. 20735);
(2) in an age where price information is ubiquitous, the
prices of pharmaceuticals remain shrouded in secrecy and
limited to those who subscribe to expensive drug price
reporting services, which typically include pharmaceutical
manufacturers or other health care industry entities and not
the general public;
(3) greater insight and transparency into drug prices will
help consumers know if they can afford to complete a course
of therapy before deciding to initiate that course of
therapy;
(4) price shopping is the mark of rational economic
behavior, and markets operate more efficiently when consumers
have relevant information about a product, including its
price, before making an informed decision about whether to
buy that product;
(5) providing consumers with basic price information may
result in the selection of lesser cost alternatives, all else
being equal relative to the patient's care, and is integral
to providing adequate competition in the market;
(6) the WAC is a factual, objective, and uncontroversial
definition for the list price of a medication, in that it is
defined in statute, reflects an understood place in the
supply chain, and is at the sole discretion of the
manufacturer to set;
(7) there is a governmental interest in ensuring that
consumers who seek to purchase pharmaceuticals for purposes
of promoting their health and safety understand the objective
list price of any pharmaceutical that they are encouraged
through advertisements to purchase, which allows consumers to
make informed purchasing decisions; and
(8) there is a governmental interest in mitigating wasteful
expenditures and promoting the efficient administration of
the Medicare program by slowing the growth of Federal
spending on prescription drugs.
SEC. 3. REQUIREMENT THAT DIRECT-TO-CONSUMER ADVERTISEMENTS
FOR PRESCRIPTION DRUGS AND BIOLOGICAL PRODUCTS
INCLUDE AN APPROPRIATE DISCLOSURE OF PRICING
INFORMATION.
Part A of title XI of the Social Security Act is amended by
adding at the end the following new section:
``SEC. 1150D. REQUIREMENT THAT DIRECT-TO-CONSUMER
ADVERTISEMENTS FOR PRESCRIPTION DRUGS AND
BIOLOGICALS INCLUDE AN APPROPRIATE DISCLOSURE
OF PRICING INFORMATION.
``(a) Requirement.--
``(1) In general.--Subject to paragraph (2), not later than
July 1, 2026, the Secretary shall require that each direct-
to-consumer advertisement for a prescription drug or
biological product for which payment is available under title
XVIII or XIX and that is required to include the information
relating to side effects, contraindications, and
effectiveness described in section 202.1(e)(1) of title 21,
Code of Federal Regulations (or any successor regulation)
also include an appropriate disclosure of pricing
information, as described in subsection (b), with respect to
such prescription drug or biological product.
``(2) Exemption.--The requirement under paragraph (1) shall
not apply to a prescription drug or biological product for
which the wholesale acquisition cost for a 30-day supply of
(or, if applicable, a typical course of treatment as set
forth in the approved label for the primary indication
addressed in the advertisement for) such prescription drug or
biological product is less than $35.
``(b) Appropriate Disclosure of Pricing Information.--For
the purposes of subsection (a), an appropriate disclosure of
pricing information, with respect to a prescription drug or
biological product--
``(1) shall clearly and conspicuously disclose the
wholesale acquisition cost for a 30-day supply of (or, if
applicable, a typical course of treatment for) such
prescription drug or biological product; and
``(2) may explain that a consumer may pay a different
amount for such prescription drug or biological product than
such wholesale acquisition cost depending on the health
insurance coverage of the consumer.
``(c) Rulemaking.--Not later than 1 year after the date of
enactment of this section, the Secretary shall promulgate
final regulations to carry out this section, including
establishing requirements for--
``(1) the visual and audio components, with respect to each
medium of direct-to-consumer advertisement, to communicate
the wholesale acquisition cost of the advertised prescription
drug or biological product; and
``(2) the amount of time for a manufacturer to update any
direct-to-consumer advertisement to reflect any change to the
wholesale acquisition cost of the advertised prescription
drug or biological product.
``(d) Sanctions.--Any manufacturer of a prescription drug
or biological product, or an agent of such manufacturer, that
violates the requirement of this section may be subject to a
civil money penalty of not more than $100,000 for each such
violation. The provisions of section 1128A (other than
subsections (a) and (b)) shall apply to civil money penalties
under the preceding sentence in the same manner as they apply
to a penalty or proceeding under section 1128A(a).
``(e) Public Reporting.--In order to enforce the
requirement under this section, the Secretary may use
information reported about manufacturers that fail to comply
with such requirement.
``(f) Definitions.--In this section:
``(1) Biological product.--The term `biological product'
means any biological product (as defined in section 351(i) of
the Public Health Service Act) that is licensed by the Food
and Drug Administration pursuant to section 351 and is
subject to the requirements of section 503(b)(1) of the
Federal Food, Drug, and Cosmetic Act.
``(2) Prescription drug.--The term `prescription drug'
means any drug (as defined in section 201(g) of the Federal
Food, Drug, and Cosmetic Act) that has been approved by the
Food and Drug Administration pursuant to section 505 of such
Act and is subject to the requirements of section 503(b)(1)
of such Act.
``(3) Wholesale acquisition cost.--The term `wholesale
acquisition cost' has the meaning given such term in section
1847A(c)(6)(B).
``(g) Authorization of Appropriations.--There are
authorized to be appropriated such sums as may be necessary
for the purposes of carrying out this section.''.
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