[Congressional Record (Bound Edition), Volume 153 (2007), Part 8]
[Senate]
[Pages 11361-11362]
[From the U.S. Government Publishing Office, www.gpo.gov]




                            DRUG ADVERTISING

  Mr. ROBERTS. Mr. President, I thank Chairman Kennedy, Ranking Member 
Enzi and all of my colleagues for accepting my amendment to improve the 
drug advertisement provisions included in S. 1082, the Food and Drug 
Administration Revitalization Act.
  My amendment, replaces the drug advertisement provisions in the 
underlying bill with what I believe is a more commonsense approach to 
dealing with prescription drug advertisements.
  During the markup of this bill in the HELP Committee a few weeks ago, 
the chairman and Ranking Member Enzi committed to working with me to 
address my concerns on this issue. This amendment represents the result 
of our efforts to achieve an outcome that is acceptable to all of us.
  I also want to thank Senators Harkin, Burr, and Coburn for their 
leadership on this issue and for cosponsoring my amendment.
  Chairman Kennedy and Ranking Member Enzi, I want to say that I truly 
appreciate the hard work you both have done in putting together this 
bill. I know you and your staff have put in many long months of work to 
get us to this point.
  I specifically want to thank David Bowen of Chairman Kennedy's staff 
and Amy Muhlberg of Senator Enzi's staff for working so closely with me 
and my office on finding a resolution on the drug advertising issue. 
David and Amy, I appreciate your commitment and professionalism in 
helping us to achieve this compromise.
  While I strongly support the goals of this legislation to ensure drug 
safety and to renew some very important prescription drug and medical 
device programs, I have serious concerns with provisions in the 
underlying bill regarding drug advertising. I believe these provisions 
would infringe on our first amendment rights to free speech.
  Of most concern to me is a provision in the underlying bill to give 
the Secretary the discretion to institute a 2-year ban on advertising 
for new drugs and related restrictions on drug advertising.
  As a former editor and reporter for several newspapers, I feel that 
these provisions violate the first amendment and would do nothing to 
address concerns that have been expressed with drug advertising. 
Instead, we would have a situation where the Secretary would become the 
editor for all prescription drug advertisements and could ban drug 
advertising for up to 2 years.
  This would certainly put us on a slippery slope to restricting 
advertisements in other industries, and I don't think that is a 
responsible approach.
  The freedom that is guaranteed to us under the first amendment 
demands that we carefully consider any proposal that would impose a ban 
or other limitation on speech. The first amendment says, ``Congress 
shall make no law . . . abridging the freedom of speech . . . .'' For 
more than three decades, this protection has been extended to speech in 
the form of advertising, or commercial speech.
  The U.S. Supreme Court has set down an explicit four-part test--known 
as the Central Hudson test--to determine if a speech restriction 
violates the first amendment.
  I believe the advertising provisions in the underlying bill fail the 
key parts of that test and my view is supported by constitutional 
experts, including the American Civil Liberties Union--ACLU, the 
Washington Legal Foundation and several other constitutional experts.
  However, I understand that there are strong concerns with drug 
advertising. I agree that we have a legitimate interest in ensuring 
these advertisements are not false or misleading. This is why my 
amendment takes a reasonable and commonsense approach to deal with drug 
advertisements.
  My amendment stresses the importance of assuring that advertising is 
accurate and balanced and recognizes that companies should be held 
accountable if their ads are false or misleading.
  My amendment strikes the 2-year moratorium on advertising in the 
underlying bill and instead allows the Secretary to assess civil 
monetary penalties--up to $150,000 for the first violation and $300,000 
for subsequent violations--on drug companies that produce false or 
misleading ads.
  This will ensure that patients will know truthful and accurate 
information about new prescription medications in a timely manner, 
rather than having to wait until 2 years after their arrival in the 
marketplace.
  My amendment also allows the Secretary to require the disclosure of a 
serious risk or date of approval of the drug in the advertisement if he 
or she believes the ad would be false or misleading without the 
disclosures.
  My amendment requires that major statements about a drug's side 
effects, contraindications and effectiveness in television or radio ads 
be presented in a clear and conspicuous manner so as not to mislead the 
public.

[[Page 11362]]

  My amendment also does not change the current language in the 
underlying bill which allows the Secretary to review direct-to-consumer 
ads before a drug company disseminates these ads to the public.
  This will allow the FDA to comment and provide constructive feedback 
to companies to ensure their ads are appropriate and not misleading. 
Many companies are already submitting their ads to the FDA for review.
  Truthful and accurate prescription drug ads do provide a benefit to 
the public. Research has shown that people are more likely to go to the 
doctor, ask thoughtful questions and discuss sensitive health issues 
with their doctors as a result of DTC ads.
  My amendment ensures these positive aspects of advertising will 
continue, but also gives the FDA the tools they need to protect the 
public from false or misleading prescription drug ads.
  The agreement that was accepted today is a fair compromise that 
addresses the concerns of all of the Members involved.
  Again, I thank the chairman and Ranking Member Enzi for their efforts 
to work on this important issue, and I thank all of my colleagues for 
accepting my amendment.
  I ask unanimous consent to add Senator Webb as a cosponsor of the 
Drug Safety Act.
  The PRESIDING OFFICER. Without objection, it is so ordered.

                          ____________________