Mark Souder

Testimony before the U.S. House of Representatives

Opening Statement of Mark Souder Chairman, Subcommittee on Criminal Justice, Drug Policy, and Human Resources

Committee on House Government Reform Subcommittee on Criminal Justice, Drug Policy, and Human Resources

July 26, 2006

Good morning, and thank you for being here today. This hearing addresses a very important aspect of drug abuse in our country and one that I do not believe is getting enough attention: that is the non-medical use of prescription drugs as a form of drug abuse.

This somewhat quiet form of drug abuse today is so common, it is exceeded in prevalence only by marijuana use. Moreover, non- medical use of prescription drugs now supersedes marijuana as the pathway for initiates into the underworld of drug abuse. It is a problem facilitated by ease of access to the drugs, and a perception that prescription drugs are “safe,” because they are FDA approved.

Nonetheless, the statistics about prescription drug abuse are incredibly alarming:

– To start with, according to the most recent Household Survey, approximately six million people were current users of prescription drugs for non-medical purposes;

– Of the six million people abusing prescription drugs, most of them were abusing pain relievers such as OxyContin (4.4 million);

– The Drug Abuse Warning Network reported 495,000 emergency department visits in 2004 related to the non-medical use of prescription drugs;

– The most recent Monitoring the Future Survey – measuring drug use among our nation’s adolescents – found high rates of non- medical use of prescription pain relievers in each of the 8th, 10th, and 12th grade groups surveyed. The prevalence of OxyContin use, in particular, has increased 40% since 2002.

– The National Center on Addiction and Substance Abuse at Columbia University (CASA) found that between 1992 and 2003, the number of people abusing controlled prescription drugs increased 94 percent – twice the percentage increase of people abusing marijuana, five times the number of people abusing cocaine and 60 times the number of people abusing heroin;

– CASA also found that teens who abuse controlled prescription drugs are twice as likely to use alcohol, five times more likely to use marijuana, 12 times more likely to use heroin, 15 times more likely to use Ecstasy, and 21 times more likely to use cocaine than teens who do not abuse prescription drugs;

– The most recent Attitude Tracking Study by the Partnership for a Drug-Free America found that teen abuse of prescription drugs stems from the ease of availability, the lack of stigma associated with street drugs, and the false belief they are safe to use.

I don’t believe anyone can consider these very sobering statistics and survey results without concluding that the abuse of prescription drugs is a problem of epidemic proportions that demands focused attention and aggressive action by both the government and the private sectors.

One of the Congressional initiatives for addressing this problem targets the issue of obtaining controlled drugs over the internet without a prescription. H.R. 840, introduced by Chairman Davis and Ranking Member Waxman, amends the Food, Drug, and Cosmetic Act to establish disclosure standards for Internet pharmacies, prohibits Internet sites from selling or dispensing prescription drugs solely on the basis of an online questionnaire, and provides additional authority for states to take action against illegal Internet pharmacies.

I am interested in hearing from our Administration officials here today about the Administration’s work on the prescription drug abuse problem, and I’m interested in the concrete actions, NOT general statements about “working closely” with other agencies, “encouraging” solutions to the problem, or “developing action plans,” to address this issue. I am tired of empty rhetoric and long delays on important matters like this – and let me give you an example: As part of a hearing on November 18, 2004, I asked the DEA a number of questions regarding methamphetamine abuse; I just received responses to these questions last month, on June 27, 2006; it took DEA twenty months to respond. That is an unreasonable delay in providing crucial information to Congress about methamphetamine abuse.

Moreover, it took the Administration almost two years after releasing its Synthetic Drug Action Plan in October, 2004, to come up with what it calls a Synthetic Drug “Strategy,” despite repeated calls from Congress, and only after Congress had to pass a bill on the subject – the Combat Meth Act. Despite being twenty months in the making, this “strategy” is full of platitudes that don’t seem to be truly backed up with any assigned responsibility or interim goals prior to the end of this Administration.

I don’t want to hear platitudes today. And I hope the Administration witnesses are listening closely to me right now.

I want the ONDCP to tell us what it means in terms of concrete steps when it says in it is going to “call together representatives from the medical and pharmaceutical communities to discuss the problem and to encourage” them to educate patients. What does ONDCP mean in terms of concrete steps with its recommendation to “continue to support the efforts of firms that manufacture frequently diverted pharmaceutical products to reformulate their products so as to reduce diversion and abuse.”

I want to know if the FDA has responded to Congress’s year-old request for a report on how the agency might handle priority review of abuse-resistant formulations of prescription controlled drugs. This report was requested with FDA’s appropriations bill last year. Where is it? Why hasn’t FDA provided guidance on this important matter? I am asking FDA to provide this report to Congress, and to provide specific legislative recommendations for the reauthorization of the Prescription Drug User Fee Act that will provide incentives for developing, and allow for the accelerated approval of, abuse-resistant forms of highly-abused drugs. Since the Prescription Drug User Fee Act is important to the FDA’s bottom line, I’ll expect the FDA to provide this information promptly.

I want to know what the DEA really means when it says it is “working closely” with the FDA to urge the rapid reformulation of OxyContin. My staff has asked DEA officials about this on at least two occasions over the last twelve months, and DEA could not provide staff with anything concrete about its statement. I want to know what bar the DEA would set for categorizing a controlled drug reformulation as “abuse-resistant.”

I know that the National Institute on Drug Abuse has devoted significant resources to studying this problem; I want to know what the Institute’s research is showing about prescription drug abuse and treatment, and how we can apply this research to overcoming this tremendous problem.

Despite what has become standard practice around here, I challenge the Administration witnesses today to stay for the second panel and listen to the testimony that will be presented. The four Administration witnesses together requested that we reserve fifteen seats in this hearing room. These come at the expense of public attendance, so I hope that means you intend to stay for the entire hearing so you can hear the testimony of witnesses other than government officials. I think it will do some good for you to hear from people who have experienced the devastation of losing someone to prescription drug abuse, to hear from one of the companies actually working to develop abuse- resistant forms of pharmaceuticals, to hear from the organizations that are on the front lines working to educate doctors, parents and kids, or partnering with private industry, to reduce prescription drug abuse. The second panel gives a face to the problem and presents solutions.

Our first panel today consists of Dr. Bertha Madras, Deputy Director for Demand Reduction at the White House Office of National Drug Control Policy; Dr. Sandra Kweder, [KWEE-DER] Deputy Director in the Office of New Drugs, Center for Drug Evaluation and Review, at the Food and Drug Administration; Mr. Joe Rannazzisi, [REN-A-ZIZI] Deputy Assistant Administrator for the Office of Diversion Control in the Drug Enforcement Administration; and Dr. Nora D. Volkow, [VOL-KOV] Director of the National Institute on Drug Abuse.

Our second panel consists of Ms. Misty Fetko, a Registered nurse who lost her 18-year-old son Carl to Robitussin and Fentanyl abuse; Ms. Linda Surks, who lost her 19-year old son Jason to a prescription drug overdose related death; Ms. Barbara van Rooyan, [VAN ROYAN] who lost her 24-year old son Patrick to OxyContin use; Ms. Mathea Falco, President of Drug Strategies; Mr. Stephen Johnson, Executive Director of Commercial Planning with Pain Therapeutics Inc.;

Dr. Laxmaiah Manchikanti [LAX-MY-UH MAN-CHI-KONTY], Chief Executive Officer of the American Society of Interventional Pain Physicians; and Mr. Steve Pasierb, [PUH-SERB] President and CEO of the Partnership for a Drug-Free America.

Welcome to each of you and I look forward to your testimony.