Conference Presentation, Fireside Chat, Interview
A Conversation with FDA Commissioner Scott Gottlieb
- The agency plans to leverage recently passed legislation to navigate a challenging environment with a steep learning curve, aiming to capitalize on new resources and authorities.
- FDA policy initiatives intend to reduce time and capital costs by streamlining review cycles, providing clearer guidance, and establishing benchmarks to de-risk development programs.
- Regulatory actions in Puerto Rico carry a risk of multiple product shortages if manufacturing facilities fail to restore electrical grid connectivity by the first quarter of 2018, though immediate logistical challenges regarding medical gases are resolved for the near term.
- Regarding opioids, where 90% of prescriptions are for immediate-release formulations, the agency intends to conduct risk-benefit assessments in illicit settings and recommend the withdrawal of specific drugs based on those risks.
- Generic alternatives to abuse deterrent formulations will be subject to specifications released soon, while testimony before Congress regarding medically assisted treatments and development incentives is expected immediately.
- Enforcement capacity has been tripled for inspectors in international mail facilities and quadrupled for package inspections, with cyber crime unit staff increased to address dark web activities in collaboration with Customs and Border Patrol and the USPS.
- A strategy to regulate nicotine content in combustible cigarettes aims to render them minimally non-addictive, a plan announced approximately two months ago using product standard authority.
- Application deadlines for non-combustible nicotine delivery, specifically e-cigarettes, are being extended to allow time for product innovation, alongside enforcement of existing regulations on minor access and labeling.
- Future implementation regulations will address specific e-cigarette features such as batteries and flavors, while a pathway for medicinal nicotine forms like patches and gums is anticipated to be detailed soon.
- Post-market information and practical setting evidence will be increasingly relied upon for effectiveness determinations as data collection vehicles improve, alongside continued vigorous enforcement against ineffective regenerative medicine products.
- The agency expects to develop regulatory frameworks for new technologies, potentially requiring legislative input for laboratory-developed tests, while piloting a "pre-cert" approach for low-risk digital health tools to permit post-market software updates without individual approval.
- Similar regulatory re-imagining is expected for cell-based regenerative medicine and new drug development, with further announcements planned for a National Press Club speech in approximately two weeks.