BREAK IN TRANSCRIPT
Mr. HARKIN. Mr. President, as Senator Alexander has indicated, we have been working together for a long time to develop legislation that will ensure that patients have access to the compounded drug products they need and that they can have greater confidence that their compounded drugs are safe. We ultimately landed on a package that preserves current law for traditional compounders but creates a new option for entities that choose to operate outside the bounds of traditional pharmacy practice to allow them to serve as safe sources of the compounded drugs that providers and their patients need.
We have worked very hard to craft a proposal that preserves patient access to clinically necessary medications while helping to ensure that providers have access to safe sources of compounded drugs. As Senator Alexander noted, section 503A of the current Federal Food, Drug, and Cosmetic Act governs traditional compounding. This bill preserves current 503A but removes the unconstitutional advertising provisions so 503A is the uniform policy nationwide.
Similarly, we do not change current law regarding repackaging or biologics. The Senate bill established a new regulatory regime for repackaging and biologics, but ultimately, after our bipartisan, bicameral discussions, we made no changes to current law on those subjects nor do we change current law on the compounding of animal drugs. The existing restrictions on animal drug compounding have not been rigorously enforced. We will be asking GAO to take a closer look at the laws regulating animal compounding because we weren't able to address it in this package.
This bill also creates an entirely new source of quality compounded drugs. It permits entities that want to serve as outsourcers for entities that need large volumes of clinically necessary compounded drugs to provide those drugs, as long as they register with FDA and pay a registration fee, adhere to high quality standards, submit to FDA inspection, and tell the agency if adverse events occur.
I recognize that many patients need drugs that are not available from pharmaceutical manufacturers, and I have no interest in cutting off patients' access to those drugs. But I do want to ensure that when patients do need a compounded drug, it is safe. By ensuring that current law--FDCA section 503A--applies nationwide and creating a new safe source of outsourced drugs, this bill should enhance patients' ability to get the drugs they need without having to worry about their safety.
BREAK IN TRANSCRIPT
Mr. HARKIN. Mr. President, today, with final passage of the Drug Quality and Security Act, we have helped to ensure the safety of compounded drug products and secure the pharmaceutical supply chain. We have clarified the law governing traditional compounding and created a new source of high-quality compounded products for hospitals and other providers who need large volumes of compounded drugs. We have also set in motion a revolution in the distribution of pharmaceuticals--within a decade we will know exactly how our drug products travel through the often-complicated distribution system so that we can identify counterfeit and adulterated drugs before they get into American medicine cabinets.
By passing the Drug Quality and Security Act, we have taken an important step to improve American families' access to lifesaving drugs and medical devices.
The bipartisan process that produced this bill has been quite remarkable. I have worked closely with my colleagues on both sides of the aisle and both sides of the Capitol, as well as industry stakeholders, patient groups, and consumer groups, to solicit ideas and improvements on the critical provisions in this bill. We have a better product thanks to everyone's input.
I would like to extend a special thank you to my colleague, Ranking Member Alexander. I have been working with Senator Alexander on this since he became ranking member, and it has been a wonderful and cooperative partnership. I can honestly say that we would not have gotten this done without his excellent leadership and wise council. I thank the Senator.
I also thank all of the HELP Committee members, as well as members off the committee and their staff, who were thoroughly engaged with this process from the beginning as part of the bipartisan working groups. Each of you has contributed significantly to this legislation, and I am sincerely grateful for your contributions.
On that note, I specifically thank the staff of Ranking Member Alexander's office. I thank David Cleary, Mary-Sumpter Lapinski, and Grace Stuntz. I also thank Hannah Katch from Senator Franken's staff, Rohini Kosoglu from Senator Bennet's staff, Jennifer Boyer from Senator Roberts staff, and Anna Abram and Margaret Coulter from Senator Burr's staff. I know that they have developed close working relationships with my staff throughout this process, and I am sincerely grateful for your dedicated efforts.
I also thank my own staff on the HELP Committee, who have spent many a night and weekend with Senator Alexander's staff, other member offices, and our colleagues in the House working to come to consensus on the critical policy issues in this legislation. I thank Pam Smith, Jenelle Krishnamoorthy, Elizabeth Jungman, Nathan Brown, Emily Schlichting, Allison Preiss, Kate Frischmann, Abraham White, Jim Whitmire, Chung Shek, Frank Zhang and Evan Griffis.
We would be remiss if we did not also thank the Congressional Budget Office for their knowledgeable and capable team that dedicated many hours to estimating the budgetary effects of this legislation. Finally, we owe an enormous debt of gratitude to the staff members in the Legislative Counsel's Office--specifically Kim Tamber, Stacy Kern-Sheerer, and Bill Baird. They, too, worked long hours, nights, and weekends to assist my staff in drafting this legislation and working out technical issues.
This bill's final passage is a victory for the millions of Americans who need safe medicines--a victory that would not have been possible without the dedicated work of our Senate family. I thank you all for your extraordinary public service.
BREAK IN TRANSCRIPT