Medication shortages in the US appear to be a direct result of "over-aggressive and excessive regulatory action," say legislators, who accuse the Food and Drug Administration (FDA) of "failing to ensure the availability of quality products."
US patients and doctors currently face an unprecedented shortage of critical drugs, and this is leading to inferior treatment regimens, interruptions in care, higher health care costs and even premature death, say the members of the House Committee on Oversight and Government Reform, reporting the results of their ongoing examination into the problem.
The drugs in shortage are mostly generic injectable medications, and while the shortages have been attributed to myriad factors, the crisis was largely sparked by FDA action, says the panel.
The Committee says it has learned that FDA regulatory activity has effectively shut down 30% of the total manufacturing capacity at four of the largest US producers of generic injectable drugs - Bedford Laboratories, Hospira Pharmaceuticals, Sandoz Pharmaceuticals and Teva Pharmaceuticals.
"Of the 201 drugs listed on the American Society of Health System Pharmacists [ASHP] shortage list as of February 12, 2012, at least 128 - 58% of the drugs on the shortage list - were produced by at least one facility undergoing FDA remediation," says the report.
Since 2010, when the shortage crisis began, FDA Commissioner Margaret Hamburg and the agency have failed to ensure that ongoing enforcement is conducted in a manner that does not create unnecessary shortages or have unintended consequences, it adds.
"Among shuttered manufacturing lines that occurred over the two previous years, the Committee's review did not find any instances where the shutdown was associated with reports of drugs harming consumers," commented the Committee's chairman, Republican Darrell Issa.
"It is also important to note that the overall damage inflicted by the FDA's decisions to shutter manufacturing lines may extend well beyond the current drug shortage crisis - this shortage of injectable generic drugs is only the most visible result thus far of FDA enhanced enforcement action," he warned.
In its recommendations, the Committee report calls for "a commonsense approach" to regulation to be restored at the FDA, with agency protocols revised so that it is required to consider the implications of its actions on the nation's supply of critical drugs. Referring to the generic injectables in short supply, Rep Issa said: "there drugs can save lives and keep people who need them living healthy lives.”
The panel also notes that the drugs shortages have shed greater transparency on "the dysfunctional price system that governs generic injectable medications, and calls on Congress to reform the way Medicare pays for drugs, so that the programme's reimbursements better reflect actual supply and demand conditions in the market.
The legislators also consider that proposals made to them during their investigation, suggesting that drugmakers should be allowed to share information about each other's manufacturing capability and product availability, "may have merit," because of the extraordinary circumstances of the current shortage crisis.
However, they also warn that this type of information-sharing "potentially places consumers at risk as a result of collusion by the large manufacturers."
- On June 26, the Senate passed the final version of The Food and Drug Administration Safety and Innovation Act (S 3187), which contains a wide range of provisions including reauthorisation of the agency's user fee programmes. It would also establish an early notification system requiring drugmakers to notify the FDA of any production problems or if a product is to be discontinued.
The House of Representatives passed the bill the previous week, and President Barack Obama is now expected to sign it into law very shortly.