Thank you, Chairman Pitts, for holding this hearing today.
Today's hearing focuses on three bills, all addressing important issues. Mr. Marino and Mrs. Blackburn's bill, H.R. 4069, makes changes to the Controlled Substances Act that will help drug distributors and others work with the Drug Enforcement Administration to keep controlled substance prescription drugs out of the hands of drug abusers. It also will help them avoid inappropriately limiting legitimate access to these same drugs by patients who need them. Achieving that balance is a difficult challenge. I will be interested to learn DEA's views on the bill.
Mr. Pitts and Mr. Pallone's bill, H.R. 4299, would speed up DEA decisions on scheduling of new FDA-approved drugs containing controlled substances, so that they could get to patients more quickly. It also would speed up the DEA registration process allowing the manufacture and distribution of controlled substances for use only in clinical trials. It is aiming to address a problem faced by those with epilepsy and other patients, the delay in getting new FDA approved controlled substance medications to patients in need. I think their bill could make a significant contribution to solving this problem, and I applaud them for releasing it.
DEA's mission and focus is combatting drug abuse. I applaud its work in that area. At the same time, we need to find a way for new FDA-approved controlled substance medicines to get to the patients who need them more quickly. I hope DEA shares that goal and will work with the Committee to achieve it.
Mr. Whitfield and Mr. Dingell's bill, H.R. 4250, aims to speed up FDA regulatory decisions on sunscreens that have been marketed in other countries for at least five years. Sunscreens are an important tool in lowering the risk of skin cancer. Skin cancer is the most common cancer in the United States, and its incidence continues to grow. Melanoma, the deadliest kind, kills over 9,000 Americans a year. One way to prevent skin cancer is to minimize exposure to UV rays.
I have had a long interest in this issue. I've been working with Chairman Upton to protect teenagers from the dangers of sunlamps.
Getting better sunscreens to market and increasing sunscreen use is another critical element in the fight against skin cancer.
We need a regulatory system that enables safe and effective sunscreens to make it to market in a reasonable amount of time. Under our current system, sunscreen applications have been languishing for five to ten years. I don't think anyone would call that a reasonable amount of time.
Mr. Whitfield and Mr. Dingell, working with the PASS Coalition, have made a good faith effort to come up with a bill that would help FDA reach decisions in a timely fashion on such sunscreen applications. I strongly support those efforts. However, I do have concerns with a number of elements of the bill. Most notably, the bill effectively cedes FDA's authority to an advisory committee. If the advisory committee recommends approval, the approval goes into effect unless FDA rejects it within 45 days. And even then, the burden is on FDA to justify its decision not to accept the recommendation. I think this would be a bad precedent.
I applaud the bill's sponsors and the PASS Coalition for working on this issue and developing a bill for us to consider. That alone is a step forward. I share the goal of having an FDA review process that enables safe and effective sunscreens to get to market in a timely manner. I recognize that the current system does not achieve that goal. I hope FDA will commit to work with the Committee and with the Coalition and other stakeholders to reach that goal.
I look forward to hearing from today's witnesses. Thank you.