As readers may know, I’ve been beating the drum for a while on the increasingly dangerous shortages that doctors are encountering in the availability of common, off-patent drugs used in hospital and clinical settings, including drugs that are important in chemotherapy, anesthesia, and infection control. Among the reasons for the shortages: the Food and Drug Administration has toughened its regulation of pharmaceutical makers in ways that lead to manufacturing line shutdowns and withdrawals from production.
John Goodman has a must-read blog post at Health Affairs Blog on the mounting crisis, amplified by a post by George Mason economist Alex Tabarrok at Marginal Revolution, getting into further specifics. In particular:
• 246 drugs are now considered to be in shortage, a record high, and the number has been rising for years. Rationing of scarce chemotherapy drugs is now making a difference in which patients have a chance at survival. In the absence of familiar compounds, doctors are falling back on inexact substitutes, sometimes more dangerous and less effective.
• After “tainted drugs” scares a few years ago, the FDA stepped up its Good Manufacturing Practice regulations, which control the production of pharmaceuticals. In particular, it now proclaims zero tolerance, barbed by tough fines, for many technical infractions whose actual impact on patient risk is at best doubtful, and it is unafraid of shutting down production lines again and again for retooling until its regulations are satisfied to the letter. It also changes its formulation and manufacturing requirements often, with scant forgiveness for makers who have trouble retooling to the new specifications quickly.
• Remarkably, the feds have inserted themselves into the role of central planners of drug output. Goodman:
For example, a drug manufacturer must get approval for how much of a drug it plans to produce, as well as the timeframe. If a shortage develops (because, say, the FDA shuts down a competitor’s plant), a drug manufacturer cannot increase its output of that drug without another round of approvals. Nor can it alter its timetable production (producing a shortage drug earlier than planned) without FDA approval.
That the results might include many unpleasant surprises will surprise only those unfamiliar with the record of a century of central planning failure.
• Pre-1938 drugs are suffering particular disruptions because of a separate FDA program, long demanded by consumer groups, to subject these “grandfathered” compounds to regulatory oversight just as tough as newer drugs. The dictates of the Drug Enforcement Administration also contribute to problems with some controlled substances.
• Several leading professional organizations, including the American Society of Anesthesiologists and the American Society of Clinical Oncology, collaborated on a meeting last November to raise the visibility of the issue and seek possible solutions. You can read its summary report here. Objectively, it’s a damning indictment, but be warned that — rather typically in a field where many key players live in fear of offending the FDA — the report refrains from outspoken criticism of the agency and in fact proposes widening the agency’s funding and powers.
Wouldn’t this make a good subject for hearings at the newly Waxman-liberated House Commerce Committee?