[Congressional Record (Bound Edition), Volume 153 (2007), Part 8]
[Senate]
[Pages 11356-11357]
[From the U.S. Government Publishing Office, www.gpo.gov]




                        RULES GOVERNING THE FDA

  Mr. BROWN. Today, we are likely to wrap up consideration of 
legislation that modifies the rules governing the FDA, an agency that 
oversees all of the medical products we use and most of the food we 
eat. FDA came into being about a century ago because Americans were 
being sold medicines that caused injury, that caused birth defects, 
that even caused death; and Americans were consuming food products that 
too often were not safe. Those kinds of medicines were being sold as 
cures, but they didn't cure anything.
  FDA's first responsibility--first responsibility--is to safeguard the 
health of American consumers. But because the products under FDA's 
authority account for 25 cents out of every dollar U.S. consumers 
spend, there is a pull on the agency that has nothing to do with 
patient safety and everything to do with drugs, both brand name and 
generic, and medical device industry profits.
  I remember a few years ago, when I served as ranking member of the 
Commerce Committee's Health Subcommittee in the House of 
Representatives, a representative from FDA started his testimony to us 
in front of that subcommittee by showing us a chart that tracked the 
U.S. drug industry's global market share.
  As I told that representative, FDA is not the marketing arm of the 
drug industry. It is the patient safety arm of the Federal Government, 
to guarantee safe products for Americans who consume medicine, food, 
and the like.
  But FDA's drug industry dog and pony show is emblematic of the key 
problem this bill is designed to address. FDA has strayed from its 
public health mission, and this legislation will help to get us back on 
track.
  S. 1082 requires FDA and drugmakers to work together to assure the 
safety of medicines before and after a new drug is approved for 
marketing. It gives FDA more authority to prevent misleading drug ads 
and limit patient exposure to drug risks that may still be emerging.
  S. 1082 is intended to realign FDA's actions with its public safety 
mission. While there are aspects of the bill that I wish were stronger, 
I believe S. 1082 will improve patient safety and ultimately the bill 
will save lives.
  Chairman Kennedy and Ranking Member Enzi, their staff members, and 
Ellie Dehoney on my staff, literally worked night and day on this 
legislation. Other Senators have been there right along with them 
working to incorporate other key consumer health and safety provisions 
into this bill.
  As a result, this legislation will not only help us prevent drug 
safety crises, it will help prevent the exploitation of the ``citizen 
petition'' process, which delays access to lower priced medicines.

[[Page 11357]]

  Prescription drug affordability is a patient safety issue. What 
medicines cost determines who can afford them and who must forego them. 
That is a patient safety issue.
  Thanks to the hard work of Senators Hatch and Stabenow, among others, 
this bill also responds to the problem of antibiotic resistance. It 
takes steps to spur innovation and reduce costs in that market.
  Thanks to the hard work of Senators Dodd, Clinton, and others, this 
bill will help ensure children receive the right medicine at the right 
dosage and that they can benefit from medical devices tailored to their 
special needs.
  S. 1082 is an important bill, and it will be a better bill if this 
body passes the Dorgan amendment to enable the safe importation of 
prescription drugs and rejects Senator Cochran's amendment to prevent 
safe reimportation.
  Consumers are importing prescription drugs today. Seniors in Ohio are 
taking bus trips to Canada to buy their prescriptions in Windsor. It is 
happening in border States throughout our country because our country 
pays the highest prices in the world for prescription drugs.
  Our Government isn't doing anything about that. Too many members of 
Congress--House and Senate--are, frankly, too involved and too 
influenced by big drug companies. So American consumers are now taking 
matters into their own hands. American consumers are importing 
prescription drugs today. We can help them do it safely or we can turn 
our backs and simply wish them well. This Senate, and the House, for 
too many years, along with this President, have turned our backs and 
wished them well.
  It is time for something different. Let's help our citizens import 
prescription drugs safely. Vote for Senator Dorgan's drug safety 
initiative and vote against Senator Cochran's poison pill.
  I yield the floor, and I suggest the absence of a quorum and ask 
unanimous consent that the time be charged equally to both sides.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The clerk will call the roll.
  The assistant legislative clerk proceeded to call the roll.
  Mr. GRASSLEY. Mr. President, I ask unanimous consent that the order 
for the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. GRASSLEY. We have 18 minutes remaining. I yield myself 9 minutes.
  The PRESIDING OFFICER. The Senator is recognized.

                          ____________________