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Prescription Drug User Fee Amendments of 2007

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Date:
Location: Washington, DC

PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007 -- (Senate - May 09, 2007)

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Mr. COBURN. Madam President, I appreciate the attention to drug safety on the part of Senators KENNEDY and ENZI. The drug safety problems our nation experienced surrounding Vioxx and the SSRIs demanded that we take a serious look at the FDA.

I appreciate the hundreds and hundreds of staff hours that have gone into working on this legislation both before and after the HELP Committee markup.

When the Health, Education, Labor, and Pensions Committee marked up this legislation, I strongly opposed it. I appreciate the willingness of Senators KENNEDY and ENZI to listen to my concerns and take action to address them. Many of the changes I requested are included in the final product that we vote on today.

This bill has come a very long ways since its consideration in the HELP Committee. Instead of requiring a risk evaluation and mitigation strategy, REMS, for every drug, a REMS may only be requested when there is a scientific reason for one. In giving new regulatory authority to the FDA, we must be extremely cautious that we do not hurt access to new and innovative prescription drugs.

I appreciate that the concept, introduced by Senators GREGG, BURR, and myself, to establish a surveillance system for adverse prescription drug events has been included in this legislation. This will now allow cooperation with academic institutions that have the expertise to evaluate the signals from that surveillance system and ensure that both patients and doctors have the information they need to make decisions about the risks and benefits of medical drugs.

As a practicing physician, I know that it is impossible to ever completely eliminate drug risks. The right approach is to provide accurate risk information and preserve the doctor-patient relationship. I appreciate the progress made in the bill towards this end.

I appreciate the willingness of Senators KENNEDY and ENZI to work with me on preserving the doctor-patient relationship. The FDA's job is to approve drugs as safe and effective--not to dictate which doctors can prescribe which drugs to which patients. Medicine is not just a science; it is also an art.

This legislation will ensure that patients have access to potentially lifesaving drugs that might not otherwise be approved because of known adverse events caused by the drug. This legislation establishes that the agency will not limit or restrict distribution or use unless a drug has been shown to actually cause an adverse event.

I also appreciate the efforts of my colleague Senator Roberts in preserving the right to commercial free speech, as intended by the Constitution, in direct-to-consumer, DTC, advertising. While I am not a big fan of DTC, I am a big fan of the Constitution. I am pleased that a compromise was reached to remove the ban on DTC from this bill and instead ensure that drug companies are held accountable if their advertisements are false or misleading.

I appreciate the willingness of Senators KENNEDY and ENZI to accept an amendment that will provide a date certain for a safety evaluation of the drug RU-486.

The two user fee agreements for prescription drugs and medical devices, PDUFA and MDUFMA, have been negotiated between industry representatives and the FDA. The industry indicates what it will pay for faster drug approvals and the FDA commits to achievable performance goals.

I appreciate the work of FDA Commissioner Dr. Andrew von Eschenbach in crafting fair and reasonable proposals for both prescription drug and medical device companies. It is critical that we focus on public health and safety, and also hold the FDA accountable for improved agency performance goals. Maintaining timely and efficient patient access to lifesaving and life-enhancing medical drugs and devices is a win for the industry, doctors, and patients. I look forward to seeing how the new performance goals in both the PDUFA and MDUFMA agreements will both help keep the pipeline of innovation moving forward and improve communication and understanding between agency staff and manufacturers.

I can vote in favor of this legislation today because of the enormous progress made. However, there are some workability issues with both the Best Pharmaceuticals for Children Act and the Pediatric Research Improvement Act. These issues need to be resolved so that the FDA has the authority to do its job quickly and effectively.

The Best Pharmaceuticals for Children Act, BPCA, has generated more clinical information for the pediatric population than any other legislative or regulatory effort to date. I am concerned about this reauthorization of the Best Pharmaceuticals for Children Act because chips away at incentives that have been getting real results for kids.

I am also concerned that part of the bill, pediatric medical devices, would authorize $30 million in demonstration grants for improving the availability of pediatric devices. While this has a worthy goal, more accountability is needed for this program to ensure that such grants are used for helping save the lives of children. Additionally, the bill's sponsors failed to do their homework in examining existing Federal programs. The fact is, the National Institutes of Health already has a program for this purpose. In order to preserve a heritage for our grandchildren, Congress needs to do the hard work of taking an inventory of existing programs before we authorize new ones.

Again, I appreciate the enormous amount of work that has gone into improving this legislation. It is critical that in addressing drug safety that we do not harm access to new and lifesaving medical technologies.

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Mr. COBURN. Madam President, as we debate the important issue of drug safety, I want to address the safety of one drug in particular: RU-486 or mifepristone. This drug was approved in 2000 under a special pathway, subpart H drug approval that is reserved for drugs that treat severe or life-threatening illnesses. Subpart H approvals generally require a special ``restricted distribution'' approval process. Unfortunately some drugs, RU-486 for example, approved under subpart H have caused serious adverse health events in women.

Every drug approved under Subpart H is listed on the Food and Drug Administration's Web site. The vast majority of drugs listed combat HIV or specific types of cancer. One governs the use of thalidomide in treating leprosy. These drugs are supposed to relate to the treatment of life-threatening illnesses.

One example of a subpart H approval makes a mockery of the regulatory process by an expedited approval of two extremely risky drugs for abortions. Pregnancy is not an illness and certainly not one that is life-threatening in the first 7 weeks, unless it is a tubal or ectopic pregnancy in which case RU-486 abortions are absolutely contraindicated.

RU-486 was inappropriately approved in 2000. RU-486 was approved using special ``subpart H'' regulations to address problems for ``certain new drug products that have been studied for their safety and effectiveness in treating serious or life-threatening illnesses . . .'' and under restricted distribution conditions due to serious hazards presented by the drug; for example, severe hemorrhage and ectopic pregnancies. This was an inappropriate approval of RU-486 as pregnancy is not normally a life-threatening condition. Today many health care providers do not follow the limited distribution requirements of RU-486's approval.

RU-486 has put women's lives at risk. To date there have been six North American deaths related to the use of the RU-486 abortion regimen: five Americans and one Canadian have died from septic shock stemming from infection by the anaerobic bacteria Clostridium sordellii. Five other international deaths have been related to RU-486.

RU-486 causes serious safety issues. More than 1,000 adverse event reports--232 hospitalizations, 116 blood transfusions, and 88 cases of infection--have been submitted regarding RU-486 and are significant because they confirm that large numbers of mifepristone patients require surgical intervention for infection, hemorrhage, complications from ectopic pregnancy, and incomplete abortions. While lives have been lost from the use of RU-486, not a single case has been documented where RU-486 has been used to save a woman's life.

RU-486 is not always effective and when it is not the consequences are dire. I recently learned of a woman who was given RU-486 after she had a seizure. Her physicians assumed that the seizure was life-threatening to the baby she was carrying and gave her RU-486 for a therapeutic abortion.

RU-486 was not effective in her case and the woman carried the baby to term. When the baby was born at a low birth weight, it also suffered from failure to thrive. That baby has had three subsequent brain surgeries due to hydrocephalus. The baby also suffers from idiopathic lymphocytocholitis--an inflammatory disease of the colon, which is extremely rare in children. It is clear that RU-486 not only is unsafe in women, but it is also not completely effective. And when it is not effective, the results are devastating.

I appreciate the desire to effect safer drugs through this bill. Senator Kennedy and Senator Enzi have done a great deal of work in designing the REMS scheme for certain drugs to ensure that they can be safely and effectively used.

Under the risk evaluation and mitigation system, REMS, provisions of this drug safety bill, a drug that has previously been approved under subpart H is deemed to have a REMS. Every REMS is subject to a periodic review. Therefore, RU-486 is deemed to have a REMS and is subject to periodic review.

I am pleased that the amendment offered by Senator DeMint was accepted by the full Senate. Senator DeMint's amendment sets a ``date certain'' REMS assessment for RU-486 to properly evaluate its drug safety risks in women. Women in this country deserve to know the safety risks associated with RU-486.


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