What Can We Expect From FDA This Year Based What We Saw Last Year

Contrary to popular belief, most of what FDA does is not influenced much by political changes. The Agency has exhibited remarkable bipartisan support for most of its mandates, and exceptional resilience for almost all its activities. FDA review processes, compliance verification processes, most project management activities, safety monitoring activities, and most regulatory decisions affecting the general population have been built over decades of experience and seldom change significantly with political changes in the US government. Keeping that is mind, it is important for FDA-regulated industry to look at trends from the immediate past to guess what is coming down the pike. The top trends from last year show a multi-dimensional agenda from FDA. GMP compliance at international sites particularly in China and India will likely remain a concern. There have been improvements in compliance status internationally and this year we should expect similar higher FDA oversights and penalties at defaulters. Conflict of interest concerns with doctors writing prescription of drugs with better marketing remain. Most doctors have limited understanding of the FDA review and approval process, and many rely on marketing material and sales brochures for information on new drugs. FDA has raised concerns with companies using misleading advertisement in FDA’s opinion. New guidance documents are expected this year regarding FDA-acceptable use of off-label information in marketing which should radically change the long-held FDA policy in this regards. Drug price control is another area that received increased attention last year. FDA does not regulate price of drugs and has emphatically avoided being dragged into the politically controversial topic of price control. We should not see any changes in that regards. Documentation and transparency woes lead to several issues last year. The most common reason for delays in new drug approvals last year was GMP compliance issues, which mostly translate into unacceptable documentation. We should see similar enforcement of GMP laws by FDA this year as we saw last year.  Low patient recruitment in clinical trials has been an ongoing challenge for developing new treatments. The next two years we should major changes in patient involvement in regulatory decisions. Several elements of the 21^st Century Cures Act passed late last year require FDA to consider patient opinion in regulatory decisions, and allow companies to use evidence from real world patient experience for approval and post-marketing commitments. FDA is required to release guidance documents within 1 year and implement the law within 2-4 years. This should be an interesting year for advocates of patient involvement in regulatory decisions. This is no doubt an interesting political year; most of us cannot predict what the new administration will do. The industry hopes to see some critical pending issues resolved. But overall the key regulatory processes that affect the majority of FDA decisions will stay unchanged; and that’s a good thing.