Once considered a futuristic technology on the distant horizon, 3D printing of medical devices, medications and human tissue is quickly becoming a promising reality. Patients have already benefitted from 3D printed medical products through access to personalized devices and innovative drugs that have led to significant health improvements. But the FDA is now preparing for a significant wave of new technologies that are nearly certain to transform medical practice. We're working to provide a more comprehensive regulatory pathway that keeps pace with those advances, and helps facilitate efficient access to safe and effective innovations that are based on these technologies.

Mayo Clinic has launched a first-in-the-U.S. clinical test that will help patients who recently have been diagnosed with an inflammatory demyelinating disease (IDD) but may be unsure of the exact disorder. Neurologic-related diseases commonly affect the brain, optic nerves and the spinal cord, and this new test can distinguish other IDDs such as neuromyelitis optica, acute disseminated encephalomyelitis, optic neuritis, and transverse myelitis from multiple sclerosis (MS).

The U.S. Food and Drug Administration today approved Ogivri (trastuzumab-dkst) as a biosimilar to Herceptin (trastuzumab) for the treatment of patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors overexpress the HER2 gene (HER2+). Ogivri is the first biosimilar approved in the U.S. for the treatment of breast cancer or stomach cancer and the second biosimilar approved in the U.S. for the treatment of cancer.

With the approval today of a monthly formulation of the drug buprenorphine for the treatment of opioid use disorder, patients have access to a new and longer-acting option for the treatment of opioid addiction. Millions of Americans are suffering from addiction to opioid drugs, and millions more are worried that the overdose epidemic could claim the lives of a friend or loved one. We need immediate actions to help those suffering from an opioid use disorder transition to lives of sobriety.

Chairman Burgess, Ranking Member Greene, members of the subcommittee: Thank you for the opportunity to testify today on the anniversary of the 21st Century Cures Act, and to update you on FDA's progress in implementing the provisions of this landmark legislation.

On the eve of World AIDS Day 2017, the United States announced that the impact of President's Emergency Plan for AIDS Relief (PEPFAR) has reached historic highs through the program's rapid acceleration of HIV prevention and treatment efforts, driven by transparent, accountable, and cost-effective investments.