[Congressional Record (Bound Edition), Volume 153 (2007), Part 12]
[Extensions of Remarks]
[Pages 17008-17009]
[From the U.S. Government Publishing Office, www.gpo.gov]




    INTRODUCING THE FAIR BALANCE PRESCRIPTION DRUG ADVERTISEMENT ACT

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                        HON. FORTNEY PETE STARK

                             of california

                    in the house of representatives

                        Thursday, June 21, 2007

  Mr. STARK. Madam Spearker, I rise today to introduce the Fair Balance 
Prescription Drug Advertisement Act. This bill would place long overdue 
restrictions on direct-to-consumer, DTC, prescription drug 
advertisements. All too often, these poorly regulated ads provide 
incomplete and misleading information about new pills, pushing 
unnecessary prescriptions and promoting drugs before doctors and 
scientists have time to learn enough about their dangers.
  Consumers, at whom these ads are targeted, don't realize that FDA 
approves drugs without confirming that they are safe for every 
treatment circumstance. As a result, many new drugs are widely marketed 
before the FDA discovers serious side effects and takes corrective 
action. Examples include drugs for conditions as common as arthritis 
and high blood sugar.
  As scientists have discovered, ``DTCA (direct to consumer 
advertising) is a successful method of generating prescriptions.'' 
Since ad restrictions were gutted in the U.S., drug advertising has 
grown at a startling rate, to a whopping $4.2 billion in 2005. No 
surprise, drug costs have grown dramatically as well, from 78 billion 
in 1997 to more than 2 trillion in 2005. Pharmaceutical companies spend 
billions of dollars trying to convince consumers their drugs will fix 
everything from bad sex lives to bad moods. These ads lead consumers to 
demand drugs that may not be medically necessary or appropriate for 
their condition.
  In many instances, DTC ads promote drugs that are later found to harm 
patients. In 2003, for example, Johnson & Johnson ran ads where Procrit 
seemed to rescue a cancer victim from disabling lethargy. Then new 
research came out showing cancer patients did no better on Procrit. In 
fact, some cancer patients actually did worse.
  The FDA has now given Procrit a black box warning cautioning against 
the use of this drug in certain circumstances. The agency has also 
warned Johnson & Johnson and Amgen that there is no evidence to support 
marketing efforts suggesting the drug reduces fatigue for patients in 
chemotherapy.
  By increasing demand for pricey new drugs when cheaper ones will do, 
DTC advertising also drives up the costs of prescriptions. Sadly when 
patients find they can't afford these expensive drugs, they skip doses 
or don't even start the treatment. Unbalanced ads for expensive pills 
therefore contribute to both higher costs and to poor control of 
chronic disease.
  The Fair Balance Prescription Drug Advertisement Act will empower the 
FDA to determine whether pharmaceutical companies present information 
about their products in a fair manner, balancing risks and benefits. 
Any advertisements found to violate this standard would be denied 
currently allowed business expense tax deductions for advertising 
costs.
  Based on recommendations from the Institute of Medicine, the bill 
goes one step further and eliminates the business exemption for all new 
medications for the first 2 years that they are in the marketplace. 
This provision would provide doctors and scientists the opportunity to 
learn more about drugs' effects on a general population before 
consumers are bombarded with marketing pitches. Had this regulation 
been in effect when Procrit was introduced, many people would be better 
off today.
  There are freedom of speech concerns with directly prohibiting 
advertising, accurate or not. This legislation therefore takes a 
different approach, hitting drug companies where it hurts them most, 
their bottom lines. While companies could continue running misleading 
ads, they would have to pay significantly more to do so. This will 
discourage drug companies from engaging in dishonest marketing 
practices.
  The Fair Balance Prescription Drug Advertisement Act sets forth new 
guidelines that will help the pharmaceutical industry appropriately 
educate the public, enabling consumers to make informed decisions based 
on a fair and balanced presentation of risks and benefits. Today's DTC 
ads simply don't meet that standard. Given rapidly rising health care 
and prescription drug costs, we need to take every step we can to make 
prescription drugs safer and more affordable. We have to make sure 
advertisements aid consumers in making informed decisions, rather than 
simply increasing demand for the newest drugs.
  Since the pharmaceutical industry already argues that their ads 
inform consumers, they should have nothing to fear from this bill. We 
should pass this bill immediately and take a concrete step to improve 
the safety and efficacy of prescription drugs for America's consumers. 
I urge all my colleagues to join me in support of the Fair Balance 
Prescription Drug Advertisement Act.

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