Drug Research and Review Issues on Radar at FDA

It will be a challenge for FDA to match or exceed its success this past year in approving record numbers of innovative and generic drugs. These achievements reflect the ability of biopharma companies to capitalize on important advances in science, as well as strong support from the regulators in clarifying requirements and R&D policies. While FDA’s Center for Drug Evaluation and Research (CDER) will strive to further enhance its

Jill Wechsler

operations, it also will support initiatives to ensure that all medicines are safe, effective, and of high quality.

Amidst these advances, CDER Director Janet Woodcock cites the importance of addressing the nation’s deadly opioid epidemic as FDA’s top priority for the coming year. The immediate need is to reduce the over 200 million outpatient prescriptions for these drugs each year. Recently enacted legislation instructs FDA to develop evidence-based prescribing guidelines and to explore how manufacturers can provide pain medicines in more secure packaging, Woodcock pointed out at the FDA/CMS Summit in December. At the same time, FDA will develop guidelines on developing non-opioid medicines for acute and chronic pain to improve treatment for patients. 

Ensuring quality

Woodcock also aims to advance the safety and quality of medicines. CDER has launched a two-year program to improve oversight of drug safety, featuring new methods to evaluate the more than two million adverse event reports received this year on marketed drugs. The agency is pressing drug companies to comply more fully with good manufacturing practices (GMPs) through more targeted inspections and recalls for those failing to meet standards. 

Drug compounding pharmacies and outsourcing facilities will remain in the spotlight, as FDA inspectors continue to find violations at these operations. A related initiative is to continue to implement requirements for tracking drugs through the supply chain to detect unauthorized medicines, an effort designed to have “a big impact on the gray market,” Woodcock commented. CDER’s Office of Pharmaceutical Quality (OPQ) will continue to seek more timely inspections of manufacturing facilities, a process that should be facilitated by a new inspection protocol for drugs, beginning with sterile drug manufacturing facilities. 

These efforts may be enhanced by visible progress in industry implementing advanced manufacturing systems. Woodcock noted at the Summit that five firms have filed applications with continuous manufacturing components, and that generic drugmakers are moving in this direction. Other federal agencies support such efforts as a way to enhance surge capacity when additional treatments are needed to manage infectious disease outbreaks or bioterrorism attacks. 

OPQ also aims to launch a structured approach to the manufacturing supplement review process to better manage product changes through the drug lifecycle. 

Accelerating approvals

An important goal for Woodcock is to complete the overhaul of the new drug review process to better manage CDER’s growing volume of applications. She recently named Peter Stein director of the Office of New Drugs (OND), and long-time CDER guru Bob Temple will become OND senior advisor, positioned to address the more controversial and difficult drug development and review issues. Woodcock hopes to finalize the OND reorganization by next summer, but it has been delayed by difficulties in gaining Congressional approval of a new user-fee program for improving the regulation of over-the-counter drugs. 

Modernizing the review process will involve implementing new automation tools for managing drug applications, study data, and review documents under a “multi-disciplinary, issue-based review document” system. CDER also will continue to carry out provisions of the 21st Century Cures Act and reauthorized user-fee programs to further advance patient-focused drug development, expanded use of real-world evidence, novel clinical trial design, and added authorities to hire more experts needed to carry out these multiple drug regulatory programs. 

Jill Wechsler is Pharmaceutical Executive’s Washington Correspondent. She can be reached at jillwechsler7@gmail.com