President Obama is wielding a unilateral prerogative of his office – the executive order – to get something done about a worsening shortage of essential drugs.
It's a problem that earlier this month one administration official called "a dire public health situation." Many thousands of patients with cancer, life-threatening infections, cardiac disease, severe gastrointestinal disorders and many other conditions aren't able to get the drugs they need.
Every day, doctors, nurses and pharmacy managers scramble to find workarounds. Often, they say, patients aren't aware they're getting a substitute for the preferred, first-line drug that health providers would normally use.
With no immediate prospect of a congressional fix, the president is extending his recent penchant for executive orders to the drug shortage problem.
His order has three elements:
- The Food and Drug Administration will broaden its requirements and voluntary requests for drug manufacturers to report potential supply problems.
- The FDA will speed up reviews of manufacturers' applications to begin or alter production of a drug in potentially short supply.
- The FDA will tell the Justice Department about possible instances of collusion or price gouging among drug distributors taking advantage of shortages.
The White House says it's beefing up the FDA's staff to carry out the new mandates.
These are stopgaps. Obama also is expected to announce his support for pending legislation that would require drug manufacturers to notify the FDA six months in advance of a potential shortage. At the moment, companies are only required to notify the government is they're discontinuing production of drugs deemed medically necessary.
And expert observers say that legislation, if it passes, will only be a partial solution to a problem that's rooted in the gradual consolidation of drug production – especially the manufacture of injectable drugs used mainly in hospitals. Most of these are older, generic medicines with thin profit margins.
The Department of Health and Human Services has just put out a 20-page economic analysis of the problem.
Only seven companies make the vast majority of these drugs. So when a particular company has contamination on its production line, or can't get an essential ingredient from abroad, other manufacturers can't pick up the slack.
Meanwhile, the problem is getting steady worse. Last year the FDA reported 178 drug shortages, although some sources say the number was really 211. Earlier this month, the number for 2011 had already surpassed that.