Joseph Pitts

Mr. PITTS

Mr. PITTS. Mr. Speaker, I yield back the balance of my time.

Mr. PITTS. Mr. Speaker, I yield 1 minute to the gentleman from California (Mr. McCarthy), the distinguished majority leader.

Mr. PITTS

Mr. PITTS. Mr. Speaker, I move to suspend the rules and pass the bill (H.R. 639) to amend the Controlled Substances Act with respect to drug scheduling recommendations by the Secretary of Health and Human Services, and with respect to registration of manufacturers and distributors seeking to conduct clinical testing, as amended.

Mr. PITTS. Mr. Speaker, I ask unanimous consent that all Members may have 5 legislative days in which to revise and extend their remarks and insert extraneous materials into the Record on the bill.

Mr. PITTS. Mr. Speaker, I yield myself such time as I may consume. I will include an exchange of letters between the Committee on Energy and Commerce and the Committee on the Judiciary. Mr. Speaker, H.R. 639 seeks to improve the transparency and consistency of the Drug Enforcement Administration's first scheduling of new FDA-approved drugs under the Controlled Substances Act, the CSA, and, secondly, its registration process for the manufacture of controlled substances for use in clinical trials. Ultimately, this will allow new and innovative treatments to get to patients who desperately need them. Due to the cost and uncertainty of the drug development process, there is broad agreement that a predictable timeline for approval decisions is a necessary component to successful drug development. Industry, the FDA, and Congress have taken steps to provide more transparency and consistency in the drug approval process through the negotiation and authorization of the Prescription Drug User Fee program and a commitment to review goals embedded in the PDUFA agreements. However, drugs that contain substances that have not been previously marketed in the U.S. and that have abuse potential must also be scheduled under the Controlled Substances Act, the CSA, by the DEA before they can reach patients. Under the CSA, there is no deadline for the DEA to make a scheduling decision, and the delays in DEA decisions have increased significantly. Between 1997 and 1999 and 2009 and 2013, the average time between FDA approval and DEA's final scheduling increased from an average of 49.3 days to an average of 237.6 days. Recently, a company had to wait over 13 months after FDA approval to receive a final scheduling recommendation from the DEA. The lack of predictability in the timing of DEA scheduling decisions leads to unnecessary uncertainty in the drug development process and needless delays in patient access to new therapies. Section 2 of H.R. 639, as amended by the full committee, would require DEA to issue an interim final rule, scheduling the new drug no later than 90 days after it is approved or when it receives the FDA's scheduling recommendation, whichever comes later. After receiving the FDA's recommendation, the DEA would continue to conduct its own analysis prior to scheduling the drug, but patients would now have peace of mind in knowing this will no longer be an open-ended process. Of note: since 1996, the DEA has not made any scheduling decision for a new drug that was contrary to the FDA recommendation. Further, section 3 of this bill would bring much-needed certainty to another open-ended DEA process. Manufacturers of controlled substances are required to be registered with the DEA. The requirement to register extends to manufacturers of controlled substances intended to be used in clinical trials for products not yet approved by the FDA. There is no timetable for the DEA to grant approval of registration applications, and there is not a process for the applicant to determine the reasons for delay in the application. The lack of transparency, predictability, and timeliness in the registration process leaves companies unable to properly plan clinical trial schedules for prospective new therapies. For registration applications related to schedule III, IV, and V drugs that will only be used in clinical trials, section 3, as amended by the full committee, would require the DEA to register the applicant or serve an order to show cause on why the applicant shall not be registered within 180 days of the filing of the application. For drugs in schedule I and II that will only be used in a clinical trial, the DEA would be required to issue a notice of application not later than 90 days after an application is accepted for filing. Ninety days after the end of the comment period, pursuant to the notice, the DEA would be required to register the applicant or serve an order to show cause on why the registrant should not be registered. 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 urge all Members to support this critical piece of legislation. I reserve the balance of my time. House of Representatives, Committee on the Judiciary, March 16, 2015. Hon. Fred Upton, Chairman, Committee on Energy and Commerce, Rayburn House Office Building, Washington, DC. Dear Chairman Upton: I am writing with respect to H.R. 639, the ``Improving Regulatory Transparency for New Medical Therapies Act.'' As a result of your having consulted with us on provisions in H.R. 639 that fall within the Rule X jurisdiction of the Committee on the Judiciary, I agree to discharge our Committee from further consideration of this bill so that it may proceed expeditiously to the House floor for consideration. The Judiciary Committee takes this action with our mutual understanding that by foregoing consideration of H.R. 639 at this time, we do not waive any jurisdiction over subject matter contained in this or similar legislation, and that our Committee will be appropriately consulted and involved as this bill or similar legislation moves forward so that we may address any remaining issues in our jurisdiction. Our Committee also reserves the right to seek appointment of an appropriate number of conferees to any House-Senate conference involving this or similar legislation, and asks that you support any such request. I would appreciate a response to this letter confirming this understanding with respect to H.R. 639, and would ask that a copy of our exchange of letters on this matter be included in the Congressional Record during Floor consideration of H.R. 639. Sincerely, Bob Goodlatte, Chairman.

Mr. PITTS. Mr. Speaker, I urge all Members to support this bipartisan legislation, and I yield back the balance of my time.

Mr. PITTS

Mr. PITTS. Mr. Speaker, last week, more than 80 million Americans lost personal information when health insurer Anthem was hacked. Almost immediately, Anthem customers started to receive suspicious email messages trying to con them. Anthem, Target, Home Depot, Sony--the list goes on and on of major hacks in the last year. In many of these cases, those who had their information stolen did not receive notice of the compromise promptly-- the best way for them to protect themselves. Because of ObamaCare, Federal and State governments now host a massive trove of private information. In hearing after hearing last year, we heard about the vulnerabilities of these systems. In order to protect consumers, the House passed my Health Exchange Security and Transparency Act, which would require the government to inform consumers of a breach within 2 days. This bill passed with an overwhelming veto-proof majority but went nowhere in Harry Reid's Senate. I have now reintroduced this bill, a commonsense measure to protect consumers if ObamaCare is the next major target for hackers. Maybe this year the Senate will act.

Mr. PITTS

Mr. PITTS. Mr. Speaker, with the rise of ISIS--or ISIL--in Syria and Iraq, we have seen the brutality of Islamic extremism to an extent previously unimaginable. In just the last week, ISIL beheaded two Japanese citizens and revealed that a Jordanian pilot had been burned alive in a cage. This is why it is more critical than ever that we support our moderate allies in the region and praise their efforts to protect religious minorities. In Egypt, President el-Sisi recently became the first modern leader in the country's history to visit a Coptic Christian church on Christmas Eve. The cathedral he visited had been attacked just 2 years earlier by Islamic extremists. By contrast, in regions controlled by ISIL, groups that have lived in the same community for more than 1,000 years have been killed or have fled for their lives. We must never forget that the mission of the extremists is not regional but global dominance, and it is aimed at all who refuse to submit to their harsh interpretation of their religion. We must stand together with leaders like the King of Jordan and the President of Egypt, who speak up and act to defeat Islamic extremism, and give them our strong support.

Mr. PITTS

Mr. PITTS. Mr. Speaker, a lot of those people are on Medicaid and can't even see a doctor. I am pleased to yield 2 minutes to an outstanding Member from Pennsylvania (Mr. Rothfus).

Mr. PITTS. Mr. Speaker, pursuant to House Resolution 70, I call up the bill (H.R. 596) to repeal the Patient Protection and Affordable Care Act and health care-related provisions in the Health Care and Education Reconciliation Act of 2010, and for other purposes, as amended, and ask for its immediate consideration in the House.

Mr. PITTS. Mr. Speaker, at this time, I am pleased to yield 2 minutes to the gentleman from Michigan (Mr. Moolenaar).

Mr. PITTS. Mr. Speaker, at this time, I am pleased to yield 2 minutes to the gentleman from Georgia (Mr. Jody B. Hice).

Mr. PITTS. Mr. Speaker, I continue to reserve the balance of my time.

Mr. PITTS. Mr. Speaker, I continue to reserve the balance of my time.

Mr. PITTS. Mr. Speaker, I continue to reserve the balance of my time.

Mr. PITTS. Mr. Speaker, might I inquire how many speakers the gentleman from New Jersey has remaining. We are prepared to close, Mr. Speaker, and I reserve the balance of my time.

Mr. PITTS. Mr. Speaker, at this time, I yield 2 minutes to the gentleman from Alabama (Mr. Palmer).

Mr. PITTS. Mr. Speaker, I ask unanimous consent that all Members may have 5 legislative days to revise and extend their remarks and to include extraneous material on H.R. 596.

Mr. PITTS. Mr. Speaker, I yield myself such time as I may consume. I rise today in support of H.R. 596, sponsored by Bradley Byrne of Alabama. Today, the House acts, once again, to repeal ObamaCare. Millions of Americans continue to feel the harmful effects of the President's health care law in almost every corner of their lives. Recently, I heard from a public schoolteacher who told me that many of our local schools are having trouble finding long-term substitutes for specialty classes such as art, music, and physical education. Under ObamaCare's new definition of full-time work, substitute teachers are strictly limited to 3\1/2\ days a week. Children are simply missing out on these important classes or are being pushed into packed, combined classes. Many of our local schools have already had to outsource cafeteria workers and other part-time positions. School districts are spending too much time worrying about Federal mandates rather than the best way to teach children. Republicans have no shortage of good ideas with which to replace the President's health care law. Last session, there were hundreds of bills introduced to reform health care with more affordable choices. We will hear many of these good ideas and other reasons for repeal today, and I look forward to hearing from my colleagues. The American people continue to oppose the President's health care law, and, today, House Republicans will stand with them again. I reserve the balance of my time.

Mr. PITTS. Mr. Speaker, I am pleased to yield 2 minutes to the gentlewoman from Tennessee (Mrs. Blackburn), the vice chair of the Energy and Commerce Committee.

Mr. PITTS. Mr. Speaker, I reserve the balance of my time.

Mr. PITTS. Mr. Speaker, I am pleased to yield 2 minutes to the gentlelady from North Carolina (Mrs. Ellmers), a member of the Subcommittee on Health.

Mr. PITTS. Mr. Speaker, may I inquire of the time remaining?

Mr. PITTS. Mr. Speaker, the number one health care concern of the American people is cost. The President promised American families that they would see a $2,500 reduction in premiums. President Obama was wrong. According to one study from the Manhattan Institute, American families are seeing premium increases on an average of 49 percent. At this time, I am pleased to yield 1 minute to the gentleman from Arkansas (Mr. Hill).

Mr. PITTS

Mr. PITTS. Mr. Speaker, I want to thank Speaker Boehner for appointing me to serve as the Republican cochair of the Tom Lantos Human Rights Commission. It is a great honor to serve as a voice defending the rights of people worldwide to live free of repression and violence. I have served as a member of the Commission since its establishment following the passing of our dear colleague Congressman Lantos. A Holocaust survivor, he understood what it was like to live under the thumb of a brutal and oppressive regime. While we vowed ``never again,'' today, hundreds of millions of people worldwide live under governments that restrict the rights of free speech and religious expression--regimes that persecute minorities, women, and children. We are blessed to live in a country where individual rights are protected and cherished. Despite our differences, Democrats and Republicans work hand in hand to protect these rights at home and expand them worldwide. I am particularly honored to share the leadership of the Commission with Congressman McGovern. We have worked together to promote human rights for many years now, and I think there is much we can accomplish together.