[Congressional Record Volume 169, Number 66 (Thursday, April 20, 2023)]
[Senate]
[Pages S1297-S1298]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. DURBIN (for himself, Mr. Grassley, Mr. King, Mr. Braun, 
        Mr. Blumenthal, Mr. Vance, and Ms. Baldwin):
  S. 1250. A bill to amend title XI of the Social Security Act to 
require that direct-to-consumer advertisements for drugs and 
biologicals include an appropriate disclosure of pricing information; 
to the Committee on Finance.
  Mr. DURBIN. Madam President, most Americans spent more time at home 
watching television during the pandemic. I know I did. And what was one 
of the most common commercials we saw? Direct-to-consumer drug ads. You 
know, those fancy commercials with catchy music, celebrity actors, and 
swinging golf clubs? Even before COVID, Americans saw an average of 
nine ads per day. Every year, the pharmaceutical industry spends more 
than $6 billion on ads--$6 billion. That is the same as the entire 
budget of the Food and Drug Administration. In fact, we know that most 
top Pharma companies spend more on their advertising budget than on 
drug research and development.
  It turns out, the United States is one of only two countries in the 
world that even allows these commercials. Can you guess the other? New 
Zealand.
  Do you want to know why Pharma spends so much money promoting their 
drugs? Because it increases their profit margins. Pharma pushes these 
ads because they steer patients to specific, expensive medications--
whether a patient actually needs the drugs or not. And sometimes it is 
easier in a 10-minute meeting for the doctor to just write the 
prescription than to take the time to explain why the drug may not be 
needed or a less expensive, generic version might be a better choice. 
Pharma thinks if they pummel you with enough ads that you finally learn 
how to spell Xarelto, you will insist to your doctor that this is the 
blood thinner you need though a less expensive option would be just as 
effective.
  With billions in targeted spending, patients are bombarded with 
information--don't take Xarelto if you are allergic to Xarelto--but 
kept in the dark on one crucial factor--the price.
  Take Rinvoq, which is manufactured by Illinois-based AbbVie for 
eczema and arthritis. It is now the most-advertised drug on 
television--replacing two other AbbVie medications, Humira and Skyrizi. 
AbbVie spent $315 million last year on TV ads for Rinvoq alone. But 
nowhere in the ad do they tell you it costs $6,100 per month.
  Well, Senator Grassley and I think it is time for Big Pharma to end 
the secrecy. If they are advertising a drug, they should disclose the 
price right up front. It is a basic transparency measure for patients. 
Consumer protection 101. So today, we are reintroducing bipartisan 
legislation to require price disclosures in direct-to-consumer drugs 
ads, or DTC ads. Our plan is simple, and it has actually passed the 
Senate once before.
  Here is why we think this transparency in drug ads is so important. 
Earlier this year, a study found that more than two-thirds of drugs 
advertised on television were considered, quote, ``low-value.'' Those 
pricey drugs that show you whitewater rafting or rock climbing? They 
are often no better than other, more affordable drugs.
  One-in-five Americans do not take their medications as prescribed 
because of the cost. They cut their pills in half or skip doses because 
they can't afford to take their medications as prescribed. So don't you 
think it is worth knowing right away that Rinvoq could run you $6,100 
per month rather than waiting for that moment of truth at the pharmacy 
counter?
  Don't just take my word for it. These advertisements often urge you 
to ``ask your doctor if it is right for you.'' Well, we asked those 
doctors. The American Medical Association says: ``Direct-to-consumer 
advertising inflates demand for new and expensive drugs, even when 
these drugs may not be appropriate.''
  As Democrats are working in Washington to avoid default and prevent 
our economy from crashing and to preserve the solvency of Medicare, we 
asked the Government Accountability Office, GAO, to look at the impact 
of these DTC ads on Medicare's budget. The GAO found that between 2016 
and 2018, drugs advertised on television accounted for 58 percent of 
Medicare's spending. These DTC ads ballooned Medicare spending on a 
small handful of drugs, costing the Medicare Program $320 billion over 
3 years. Humira topped the list with $500 million in advertising in 
2018, which contributed to $2.4 billion in Medicare costs.
  I used this chart in 2017 when I first introduced this legislation, 
and when the monthly cost of Humira was $3,700 per month. But as you 
can see, the cost of Humira is now $6,900 per month. Shouldn't AbbVie--
makers of Humira--disclose that price to you so you can use this 
information when making treatment decisions? If they did, AbbVie may 
think twice before raising the price.
  Our DTC bill is supported by Democrats and Republicans, the AARP, 
American Medical Association, American Hospital Association, and 88 
percent of Americans. President Trump supported our bill. This bill has 
passed the Senate before. And several Republicans have included this 
provision in larger packages they have supported. The only opposition 
comes from one place: Pharma. They hate the idea of being honest with 
patients about the price of their drugs and they are looking for 
Senators to help keep their secret.
  So when the Senate considers drug pricing legislation in the coming 
weeks, I will ask for a vote on this bipartisan policy. Senator 
Grassley has been a great partner in this effort; and we will work to 
bring this dose of sunshine to the airwaves. It is about time Americans 
catch a break when it comes to the cost of drugs.
  Madam 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. 1250

       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 2023'' or the ``DTC Act of 2023''.

     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's 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

[[Page S1298]]

     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 for the doctor to write 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 DRUGS AND BIOLOGICALS 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 DRUGS AND BIOLOGICALS 
                   INCLUDE AN APPROPRIATE DISCLOSURE OF PRICING 
                   INFORMATION.

       ``(a) Requirement.--
       ``(1) In general.--Subject to paragraph (2), the Secretary 
     shall require that each direct-to-consumer advertisement for 
     a drug or biological for which payment is available under 
     title XVIII or XIX and which 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 drug or biological.


 =========================== NOTE =========================== 

  
  On page S1298, April 20, 2023, in the second column, the 
following appears: ``(1) IN GENERAL. . . . Code of Federal 
Relations (or any successor regulation) also include . . .
  
  The online Record has been corrected to read: ``(1) IN GENERAL. 
. . . Code of Federal Regulations (or any successor regulation) 
also include . . .


 ========================= END NOTE ========================= 


       ``(2) Exemption.--The requirement under paragraph (1) shall 
     not apply to a drug or biological for which the wholesale 
     acquisition cost for a 30-day supply of (or, if applicable, a 
     typical course of treatment for) such drug or biological 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 drug or biological, 
     shall--
       ``(1) disclose of the wholesale acquisition cost for a 30-
     day supply of (or, if applicable, a typical course of 
     treatment for) such drug or biological; and
       ``(2) be presented clearly and conspicuously.
       ``(c) Rulemaking.--Not later than 1 year after the date of 
     enactment of this section, the Secretary, acting through the 
     Administrator of the Centers for Medicare and Medicaid 
     Services, shall promulgate final regulations to carry out 
     this section, including--
       ``(1) the visual and audio components required to 
     communicate the wholesale acquisition cost in the appropriate 
     manner for the medium of the advertisement;
       ``(2) the reasonable amount of time a manufacturer has to 
     update any direct-to-consumer advertisement to reflect any 
     change to the wholesale acquisition cost of the advertised 
     drug or biological; and
       ``(3) the way in which a manufacturer may include a brief 
     statement explaining that certain consumers may pay a 
     different amount depending on their insurance coverage.
       ``(d) Sanctions.--Any manufacturer of a drug or biological, 
     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 System.--In order to enforce the 
     requirement under this section, the Secretary may establish a 
     public reporting system--
       ``(1) to build awareness of such requirement; and
       ``(2) allow for reporting of manufacturers that fail to 
     comply with such requirement.
       ``(f) Definitions.--In this section:
       ``(1) Drug and biological.--The terms `drug' and 
     `biological' have the meaning given such terms in section 
     1861(t).
       ``(2) 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.''.
                                 ______