In recent years, FDA has made positive moves to foster innovation by streamling regulation. But the agency's recent proposal
to exempt manufacturing for phase 1 clinical trials from GMP requirements seems ill advised.
Evaluating the risks of this rule reminds me of a friend who built an addition to his house. He is very handy, so he considered
doing the framing himself. One day, however, the architect casually mentioned that lumber shrinks for a year or so after construction.
For the unsuspecting handyman, failing to account for the shrinkage could have resulted in poor construction. Realizing that
there was more to large-scale home-building than he could know from his small-scale projects, the homeowner hired a professional.
In manufacturing drugs, the stakes are obviously much higher. What if a small biotech, without any GMP experience, overestimates
its knowledge about avoiding contamination? The freedom from mandatory compliance might encourage small companies, who bear
heavy cost-containment and time pressures, to avoid investing in needed additional expertise. The results could be disastrous.
But could removing the GMP burden make drug development significantly cheaper and faster? In the Federal Register announcement,
FDA estimated that the rule would save manufacturers 24 to 40 hours and $1,440 per investigational new drug, by simplifying
methods validation and standard operating procedures. FDA also estimates that the new rule would exempt some 7,315 drugs from
GMP requirements, eliminating 50,493 hours of related paperwork from companies. That sounds like a lot, unless it means, as
it appears to, 6.9 hours per drug. Yes, these numbers are only estimates based on incomplete data. But they don't create a
In a worst-case scenario, the rule could even delay drug development. If the new rule resulted in the unthinkable—failure
to adequately protect trial participants from poorly manufactured drugs, drug development surely would slow down, as Congress,
the agency, and the public became even more risk averse than they are today.
Regulating drugs always requires balancing risk and benefit. In this case, the risks outweigh the rewards.