U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb recently cited addressing the opioid crisis as his highest priority. As someone who has spent the bulk of my career focused on issues related to substance abuse, including more than 10 years with PhRMA and prior to that almost 8 years in the White House Drug Policy Office, I am heartened to see the FDA commit to helping solving this problem. The abuse of prescription opioids, counterfeit opioids and heroin has resulted in a deepening public health crisis. This has impacted individuals and their loved ones, our first responders who are on the front lines and communities across the country.
The challenge of prescription drug abuse and of treating addiction is multifaceted and requires a multi-pronged approach. America’s innovative biopharmaceutical companies share the FDA’s commitment to ensuring the appropriate treatment of acute and chronic pain, while simultaneously working to develop a wide range of new treatment options for pain. New medicines in development include abuse-deterrent formulations (ADFs) of opioid medications, non-opioid analgesic alternatives, and innovative medications to treat addiction and opioid overdose reversal agents.
The efforts being made in this important space aren’t insignificant. A recent review of the drug development pipeline identified 30 ADF versions of opioid products in development; 40 non-opioid analgesics in development for acute and chronic pain, many of these potential medicines offer novel mechanisms of action to target and treat pain; and nearly 40 medicines in development for the treatment of various forms of addiction and to prevent opioid overdose. This ongoing research offers significant promise in stemming the tide of addiction.
Our understanding of pain, addiction and treatment is evolving continually and being incorporated into new research and medical advances. It reinforces the need for ongoing prescriber training and mandatory education. Prescribers need up-to-date training and education on appropriate prescribing of controlled substances, potential signs of abuse and addiction, effective pain management, and the prescribing of opioids, non-opioid analgesics and other modalities of care. We support enhanced training that ensures prescribers to know how to identify patients at risk for prescription drug abuse, appropriate steps to take to refer them to needed treatment and available treatment options.
We applaud and fully support Commissioner Gottlieb’s focus on ensuring that prescribers have the right tools, including evidence-based clinical guidelines and ongoing education, to allow them to make more informed decisions for their patients. His extensive experience as a physician and breadth of health care knowledge will help ensure the FDA continues to play a vital role in protecting public health and working across the health care system to identify solutions.
We are committed to working with the administration’s newly established Opioid Policy Steering Committee and other stakeholders to find solutions to address this current public health crisis. This is an opportunity to collectively work together to support ongoing educational efforts so the public, patients, caregivers and others understand the dangers of prescription drug abuse and the role they can play in reducing the potential for abuse and misuse.
Anne McDonald Pritchett, PhD Anne McDonald Pritchett, Ph.D., is Senior Vice President, Policy and Research, at the Pharmaceutical Research and Manufacturers of America (PhRMA). Her primary focus is overseeing the development of legislative and policy analysis and research studies on a range of issues impacting innovative biopharmaceutical companies including intellectual property issues, FDA policy issues, and other issue areas impacting the environment for innovation. In addition to her public policy work, she and her team lead the development of a range of educational and other materials focused on explaining the R&D process, the value of innovation, and the role and contributions of the innovative biopharmaceutical industry.