[Congressional Record Volume 153, Number 74 (Monday, May 7, 2007)]
[Senate]
[Pages S5631-S5632]
From the Congressional Record Online through the 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.
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
[[Page S5632]]
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.
____________________