"This lack of predictability in the timing of DEA's scheduling decisions leads to unnecessary uncertainty in the drug development process."
"Today's legislative hearing focuses on three bills designed to improve the predictability and transparency in Drug Enforcement Administration (DEA) and Food and Drug Administration (FDA) regulation."
"H.R. 4069, the Ensuring Patient Access and Effective Drug Enforcement Act, introduced by Reps. Marino and Blackburn, will facilitate greater collaboration between industry stakeholders and regulators ..."
"H.R. 4299, the Improving Regulatory Transparency for New Medical Therapies Act, which Ranking Member Pallone and I introduced."
"It now takes, on average, well over a billion dollars and 14 years from the time a drug is discovered to the time of approval."
"This lack of predictability in the timing of DEA scheduling decisions leads to unnecessary uncertainty in the drug development process and needless delays in patients' access to new therapies."
"This provision will get products to the market faster because innovators will be able to get clinical trials underway in a timely and predictable way."
"Such a solution does not force the DEA to make a particular decision but will provide transparency to the process so companies can better plan when regulatory decisions will be made."
"I would like to thank all of our witnesses for being here today, and I look forward to having a constructive discussion on these legislative proposals."
"These bills touch on very important issues for this committee and they offer an excellent starting point for finding solutions."
"I yield back the balance of my time and, at this point, recognize the ranking member, Mr. Pallone, 5 minutes for an opening statement."
"I hope that we are going to have supportive testimony from Food and Drug and that the Food and Drug Administration will not let this kind of thing happen again."